Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring and Oral TRUVADA® Use in Pregnancy

Phase 3b, Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring and Oral TRUVADA® Use in Pregnancy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03965923

Enrollment

1104

Registered

2019-05-29

Start date

2020-01-09

Completion date

2024-05-13

Last updated

2025-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Brief summary

The purpose of this study is to evaluate the maternal and infant safety of the dapivirine (DPV) vaginal ring (VR) and daily oral Truvada in HIV-uninfected pregnant women and their infants.

Detailed description

The purpose of this study is to evaluate the maternal and infant safety of the dapivirine (DPV) vaginal ring (VR) and daily oral Truvada in HIV-uninfected pregnant women and their infants. Participants will be assigned to one of three cohorts based on gestational age: * Cohort 1: 36 0/7 weeks - 37 6/7 weeks * Cohort 2: 30 0/7 weeks - 35 6/7 weeks * Cohort 3: 12 0/7 weeks - 29 6/7 weeks Within each cohort, participants will be randomized to receive either DPV VR or oral Truvada. Participants randomized to the DPV VR will use the VR continuously for approximately one month, replacing the VR each month. Participants taking the Truvada tablet will take one tablet orally per day. Participants will use their assigned study product until their pregnancy outcome, but no later than 41 6/7 weeks of gestation. Participants will attend several study visits throughout the study and study staff will also contact participants by phone at different timepoints throughout the study. The total duration of study participation will vary depending on gestational age at time of enrollment and length of pregnancy prior to pregnancy outcome and will range from approximately 12 weeks or less for Cohort 1 to approximately 36 weeks or less for Cohort 3. Infants born to study participants will be followed for approximately 52 weeks.

Interventions

DRUGDapivirine (DPV) Vaginal Ring (VR)

Vaginal ring containing 25 mg of DPV

DRUGTruvada Tablet

Tablet taken orally

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Age 18 through 40 years (inclusive) at Enrollment, verified per site standard operating procedures (SOPs). * At Enrollment, evidence of a viable, intrauterine, singleton pregnancy with sonographic confirmation, including for gestational age assessment. * Note: If adequate (per judgment of Investigator of Record \[IoR\]/designee) sonographic results are not available from medical records at Screening, an ultrasound must be performed and results be available for review at Enrollment for all Cohorts. The ultrasound should be performed no later than the 36th week of gestation for Cohort 1 or the 28th week of gestation for Cohort 2. * At Enrollment, pregnancy within gestational age limits of the currently enrolling cohort (per the study protocol). * HIV-uninfected based on testing performed at Screening and Enrollment (per protocol algorithm in the study protocol). * At Screening and Enrollment, intending to continue her pregnancy until delivery. * At Screening and Enrollment, intending to deliver at a health center or hospital where adequate records may be obtained, as defined in site SOPs. * Note: Plans to deliver at a health center or hospital where adequate records may be obtained is inclusionary due to logistical challenges related to collection of vaginal rings (VRs), specimens and delivery outcome data outside of those settings. * At Screening and Enrollment, willing to be randomized at time of enrollment to either of the two study arms, and to continue study product use until delivery. * Able and willing to comply with all study requirements and complete all study procedures. * Able and willing to provide the following: * Informed consent for her and her infant to be screened for and to enroll in MTN-042, as defined in site SOPs. * Adequate locator information, as defined in site SOPs. * Adequate documentation of registration for antenatal care, as defined in site SOPs. * Permission to contact participant's antenatal and postpartum care provider(s) and to obtain copies of antenatal and postpartum care records. * At Screening and Enrollment, agrees not to participate in other research studies involving drugs, medical devices, vaginal products, or vaccines for the duration of study participation, unless approved by the Protocol Safety Review Team (PSRT).

Exclusion criteria

* Per participant report at Screening and/or Enrollment, intends to do any of the following during the study participation period: * Use oral pre-exposure prophylaxis (PrEP) outside the context of study participation. * Relocate away from the study site. * Travel away from the study site for a time period that would interfere with study participation. * At Screening or Enrollment, has a positive HIV test. * At Screening or Enrollment, diagnosed with urinary tract infection (UTI), cervicitis, sexually transmitted infection (STI) or reproductive tract infection (RTI) requiring treatment per World Health Organization (WHO) guidelines. * Note: Detection of bacterial vaginosis (BV) or candida in the absence of symptoms is not exclusionary. Otherwise eligible participants diagnosed during screening with a UTI, cervicitis, or STI/RTI requiring treatment per WHO guidelines are offered treatment consistent with WHO recommendations. If treatment is completed and symptoms have resolved within 35 days of obtaining informed consent for screening, the participant may be enrolled. * At Enrollment, has a clinically apparent Grade 2 or higher pelvic exam finding.\* * Note: Cervical friability bleeding associated with speculum insertion and/or specimen collection judged to be within the range of normal according to the clinical judgment of the Investigator of Record (IoR)/designee is considered expected bleeding and is not exclusionary. * Participant report, clinical evidence and/or antenatal/medical care record of any of the following: * Currently breastfeeding at Enrollment. * Known adverse reaction to any of the study products (ever). * Known adverse reaction to latex and polyurethane (ever). * Symptoms suggestive of acute HIV infection at Screening or Enrollment. * Non-therapeutic injection drug use in the 12 months prior to Enrollment. * Use of HIV post-exposure prophylaxis (PEP) and/or PrEP during the current pregnancy. * Participation in any other research study involving drugs, medical devices, vaginal products, or vaccines during the current pregnancy. * At Screening or Enrollment, known to have any of the following during the current pregnancy: * Multiple gestation * Placenta previa * Cervical cerclage * Abnormal fetal anatomy (in the opinion of the IoR or designee) * Intrauterine growth restriction * Pre-existing or gestational diabetes * Hypertensive disorder of pregnancy * Severe malaria * Treatment for preterm labor * Abnormal quantity of amniotic fluid (oligohydramnios or polyhydramnios) * At Screening, known to have had any of the following in a previous pregnancy: * Intrauterine growth restriction * Gestational diabetes * Hypertensive disorder of pregnancy * Intrauterine fetal demise (estimated gestational age greater than or equal to 20 weeks) * Delivery prior to 37 0/7 weeks * At Enrollment, as determined by the IoR/designee, has any significant obstetrical complication (e.g., premature rupture of membranes, any abnormal placentation) or uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease that would make study participation unsafe. * At Screening, has any of the following laboratory abnormalities: * Positive for hepatitis B surface antigen (HBsAg). * Aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than or equal to Grade 1.\*\* * Hemoglobin greater than or equal to Grade 2.\*\* * Platelet count greater than or equal to Grade 1.\*\* * Creatinine greater than or equal to Grade 1.\*\* * Estimated creatinine clearance greater than or equal to Grade 2 (Cockcroft Gault formula).\*\* * Glycosuria greater than or equal to Grade 2.\*\* * Proteinuria greater than or equal to Grade 2.\*\* * Note: Otherwise eligible participants with an exclusionary test (other than HBsAg) may be re-tested during the screening process; re-testing procedure details can be found in the MTN-042 Study Specific Procedures (SSP) Manual. If improvement to a non-exclusionary grade or resolution is documented within 35 days of providing informed consent for screening, the participant may be enrolled. * Has any condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives. * \*Female Genital Grading Table for Use in Microbicide Studies Addendum 1 (Dated November 2007) to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. * \*\*DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1, July 2017.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With a Composite Safety Endpoint Adverse Event (AE)	Measured through participant's last study visit. For mothers, this occurred at approximately Week 12 to 36, depending on participant's cohort, and for infants at approximately Week 52.	All AEs were reported as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Composite safety endpoint AEs were AEs that were either categorized as serious adverse events (SAEs) or were Grade 3 or higher. This measure is the number of participants with at least one composite AE.
Pregnancy Outcomes	Measured through participant's last study visit, at approximately Week 12 to 36, depending on participant's cohort	Frequency of different types of pregnancy outcomes among mothers.

Secondary

Measure	Time frame	Description
Infant Drug Levels: Number of Infants With Detectable Blood Emtricitabine Triphosphate (FTC-TP)	measured at the 2-week post pregnancy outcome (PPO) visit	Infant blood FTC-TP was measured at infants' PPO visit. The outcome is defined as having detectable drug level, with detectable drug levels defined as a FTC-TP concentration above the lower limit of quantification (LLOQ) for the assay.
Infant Drug Levels: Number of Infants With Detectable Plasma DPV	measured at the 2-week post pregnancy outcome (PPO) visit	Infant plasma DPV concentration was measured at infants' post pregnancy outcome (PPO) visit (up to 14 days after pregnancy outcome). The outcome is defined as having detectable drug level, with detectable drug levels defined as a DPV concentration above the lower limit of quantification (LLOQ) for the assay.
Adherence: Maternal Blood TFV-DP Concentrations	Measured through participant's 2-week PPO visit, at approximately Week 8-32, depending on participant's cohort	Maternal blood TFV-DP was collected at the 2-week, bi-weekly (starting at 4-weeks), and PPO visits for participants randomized to receive Truvada Tablet. In Cohort 1 this was done for a randomly selected subset of those participants. Participants are categorized as ever being exposed if they had at least one measure that was \>= 200 fmol/punch (if the sample was collected more than 6 weeks after randomization) or \>= 150 fmol/punch (if the sample was collected within 6 weeks of randomization). They are categorized as never being exposed if they had at least one analyzable sample and none met the criteria.
Adherence: Maternal Blood FTC-TP Concentrations	Measured through participant's 2-week PPO visit, at approximately Week 8-32, depending on participant's cohort	Maternal blood FTC-TP was collected at the 2-week, bi-weekly (starting at 4-weeks), and PPO visits for participants randomized to receive Truvada Tablet. In Cohort 1 this was done for a randomly selected subset of those participants.
Adherence: Maternal Plasma DPV Concentrations	Measured through participant's 2-week PPO visit, at approximately Week 8-32, depending on participant's cohort	Maternal plasma DPV was collected at the 2-week, bi-weekly (starting at 4-weeks), and PPO visits for a randomly selected subset of participants (approximately 50%) randomized to receive the VR. Participants are categorized as ever being exposed if they had at least one measure that was greater than the LLOQ (i.e., greater than or equal to 20 pg/mL). They are categorized as never being exposed if they had at least one analyzable sample and none met the criteria.
Pregnancy Complications: Frequency of Pregnancy Complications	Measured through participant's last study visit, at approximately Week 12 to 36, depending on participant's cohort	Frequency of different types of pregnancy complications among mothers. The categories of pregnancy complications were pre-defined on the case report form, and after the completion of Cohort 1 follow-up there were some changes made to the pregnancy complication categories. In Cohort 1 the category peripartum hemorrhage was collected, but in Cohort 2 and 3 this category was removed from the list of pre-defined complications. Two other categories, antepartum hemorrhage and intrapartum hemorrhage, were added to the list for Cohort 2 and Cohort 3. As a result, participants in Cohort 1 were not evaluated for antepartum or intrapartum hemorrhage, while participants in Cohorts 2 and 3 were not evaluated for peripartum hemorrhage. All other complications were collected for all three cohorts, and participants in all three cohorts were evaluated for each complication.
Adherence: Number of Participants With Product Exposure (Measured in Residual Drug Levels in Returned VRs)	Measured through participant's last study visit, at approximately Week 12 to 36, depending on participant's cohort	Residual drug levels were collected from returned VRs, which were expected to be returned at monthly visits throughout study follow-up. Drug release rate was calculated by subtracting the residual level from the amount of residual drug in the manufacturer lot, divided by the number of days the participant was expected to use that ring, times 28 days. For each individual ring, a ring was considered to show evidence of use if the residual drug level was greater than or equal to 0.9mg/28 days of use. Participants are categorized as either ever being exposed or never being exposed to product over the course of study follow-up. They are categorized as ever being exposed to product if they had at least one ring with evidence of use (i.e., greater than or equal to 0.9 mg/28 days of release). They are categorized as never being exposed if they had at least one analyzable returned ring and none of these rings had evidence of use.
Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	Measured at Week 4 and 6-Week PPO/SEV visits.	Based on participant report of whether they would be willing to use the study product they were randomized to receive when pregnant in the future. Only asked of participants in Cohorts 2 and 3.
Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	Measured at Week 4 visits.	Based on participant report of how much they liked or disliked the study product they were randomized to receive for HIV prevention, and of how much they liked or disliked male condoms for HIV prevention. Only asked of participants in Cohorts 2 and 3.
Adherence: Frequency of Ring Removal/Expulsion	Measured at Week 4 visit and Post-Pregnancy Outcome (PPO) (occurring within 2 weeks of pregnancy outcome) visit	Based on participant report, as defined by self-reported occurrences of the ring being out of the vagina for more than 12 hours, being out for any time. This was only reported by participants in Cohorts 2 and 3.
Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV	Measured at Week 4 visits.	Based on participant report of how satisfied they have been with the the study product they were randomized to receive for HIV prevention. Only asked of participants in Cohorts 2 and 3.
Adherence: Frequency of Missing Taking the Pills	Measured at Week 4 and PPO visits	Based on participant report, as defined by self-reported missed doses for oral Truvada. This was only reported by participants in Cohorts 2 and 3.
Infant Drug Levels: Number of Infants With Detectable Infant Blood Tenofovir Diphosphate (TFV-DP)	Measured at the 2-week post pregnancy outcome (PPO) visit	Infant blood TFV-DP was measured at infants' post pregnancy outcome (PPO) visit (up to 14 days after pregnancy outcome). The outcome is defined as having detectable drug level, with detectable drug levels defined as a TFV-DP concentration above the lower limit of quantification (LLOQ) for the assay.

Countries

Malawi, South Africa, Uganda, Zimbabwe

Participant flow

Participants by arm

Arm	Count
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR) Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation. Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV	101
Cohort 1 Mothers: Truvada Tablet Participants in Cohort 1 (36 0/7 weeks - 37 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation. Truvada Tablet: Tablet taken orally	49
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR) Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation. Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV	106
Cohort 2 Mothers: Truvada Tablet Participants in Cohort 2 (30 0/7 weeks - 35 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation. Truvada Tablet: Tablet taken orally	51
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR) Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will use one DPV VR continuously for approximately one month, replacing the DPV VR each month. Participants will use the DPV VR until their pregnancy outcome but no later than 41 6/7 weeks of gestation. Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV	202
Cohort 3 Mothers: Truvada Tablet Participants in Cohort 3 (12 0/7 weeks - 29 6/7 weeks) will take one Truvada oral tablet daily. Participants will take Truvada until their pregnancy outcome but no later than 41 6/7 weeks of gestation. Truvada Tablet: Tablet taken orally	49
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR) Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) DPV VR arm. Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV	99
Cohort 1 Infants: Truvada Tablet Infants born to maternal participants in the Cohort 1 (36 0/7 weeks - 37 6/7 weeks) Truvada oral tablet daily arm. Truvada Tablet: Tablet taken orally	48
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR) Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) DPV VR arm. Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV	103
Cohort 2 Infants: Truvada Tablet Infants born to maternal participants in the Cohort 2 (30 0/7 weeks - 35 6/7 weeks) Truvada oral tablet daily arm. Truvada Tablet: Tablet taken orally	51
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR) Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) DPV VR arm. Dapivirine (DPV) Vaginal Ring (VR): Vaginal ring containing 25 mg of DPV	197
Cohort 3 Infants: Truvada Tablet Infants born to maternal participants in the Cohort 3 (12 0/7 weeks - 29 6/7 weeks) Truvada oral tablet daily arm. Truvada Tablet: Tablet taken orally	48
Total	1,104

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007	FG008	FG009	FG010
Overall Study	Death	0	0	0	0	0	0	0	1	4	0	4
Overall Study	Lost to Follow-up	2	1	1	0	2	1	2	1	0	2	0
Overall Study	Other reason	0	0	0	1	0	0	0	0	0	0	2
Overall Study	Withdrawal by Subject	1	2	3	1	2	0	4	3	4	0	2

Baseline characteristics

Characteristic	Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Cohort 1 Mothers: Truvada Tablet	Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Cohort 2 Mothers: Truvada Tablet	Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Cohort 3 Mothers: Truvada Tablet	Total	Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)	Cohort 1 Infants: Truvada Tablet	Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)	Cohort 2 Infants: Truvada Tablet	Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)	Cohort 3 Infants: Truvada Tablet
Age, Continuous	25.4 years STANDARD_DEVIATION 5.4	25.1 years STANDARD_DEVIATION 5.4	26.2 years STANDARD_DEVIATION 5.5	26.7 years STANDARD_DEVIATION 6.2	25.7 years STANDARD_DEVIATION 5.4	24.0 years STANDARD_DEVIATION 5.1	39.7 weeks STANDARD_DEVIATION 1.7	40.1 weeks STANDARD_DEVIATION 1.6	39.6 weeks STANDARD_DEVIATION 1.6	39.6 weeks STANDARD_DEVIATION 1.8	39.4 weeks STANDARD_DEVIATION 1.7	39.8 weeks STANDARD_DEVIATION 1.6	39.4 weeks STANDARD_DEVIATION 1.5
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	101 Participants	49 Participants	106 Participants	51 Participants	202 Participants	49 Participants	1104 Participants	99 Participants	48 Participants	103 Participants	51 Participants	197 Participants	48 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Region of Enrollment Malawi	18 participants	9 participants	26 participants	14 participants	53 participants	13 participants	265 participants	18 participants	9 participants	26 participants	13 participants	53 participants	13 participants
Region of Enrollment South Africa	28 participants	14 participants	20 participants	8 participants	35 participants	9 participants	220 participants	26 participants	14 participants	18 participants	8 participants	32 participants	8 participants
Region of Enrollment Uganda	30 participants	14 participants	28 participants	14 participants	55 participants	13 participants	307 participants	30 participants	14 participants	27 participants	15 participants	54 participants	13 participants
Region of Enrollment Zimbabwe	25 participants	12 participants	32 participants	15 participants	59 participants	14 participants	312 participants	25 participants	11 participants	32 participants	15 participants	58 participants	14 participants
Sex: Female, Male Female	101 Participants	49 Participants	106 Participants	51 Participants	202 Participants	49 Participants	845 Participants	48 Participants	24 Participants	62 Participants	24 Participants	104 Participants	25 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	258 Participants	51 Participants	24 Participants	41 Participants	26 Participants	93 Participants	23 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk	EG010 affected / at risk	EG011 affected / at risk
deaths Total, all-cause mortality	0 / 101	0 / 49	0 / 106	0 / 51	0 / 202	0 / 49	0 / 99	1 / 48	4 / 103	0 / 51	4 / 197	0 / 48
other Total, other adverse events	43 / 101	29 / 49	73 / 106	39 / 51	169 / 202	37 / 49	91 / 99	39 / 48	92 / 103	44 / 51	176 / 197	43 / 48
serious Total, serious adverse events	1 / 101	3 / 49	8 / 106	2 / 51	11 / 202	2 / 49	14 / 99	7 / 48	22 / 103	5 / 51	30 / 197	3 / 48

Outcome results

Primary

Number of Participants With a Composite Safety Endpoint Adverse Event (AE)

All AEs were reported as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Composite safety endpoint AEs were AEs that were either categorized as serious adverse events (SAEs) or were Grade 3 or higher. This measure is the number of participants with at least one composite AE.

Time frame: Measured through participant's last study visit. For mothers, this occurred at approximately Week 12 to 36, depending on participant's cohort, and for infants at approximately Week 52.

Population: All mothers who were randomized and enrolled are included. All enrolled infants are included.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Number of Participants With a Composite Safety Endpoint Adverse Event (AE)	2 Participants
Cohort 1 Mothers: Truvada Tablet	Number of Participants With a Composite Safety Endpoint Adverse Event (AE)	6 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Number of Participants With a Composite Safety Endpoint Adverse Event (AE)	16 Participants
Cohort 2 Mothers: Truvada Tablet	Number of Participants With a Composite Safety Endpoint Adverse Event (AE)	5 Participants
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Number of Participants With a Composite Safety Endpoint Adverse Event (AE)	24 Participants
Cohort 3 Mothers: Truvada Tablet	Number of Participants With a Composite Safety Endpoint Adverse Event (AE)	4 Participants
Cohort 1 Infants: Dapivirine (DPV) Vaginal Ring (VR)	Number of Participants With a Composite Safety Endpoint Adverse Event (AE)	23 Participants
Cohort 1 Infants: Truvada Tablet	Number of Participants With a Composite Safety Endpoint Adverse Event (AE)	15 Participants
Cohort 2 Infants: Dapivirine (DPV) Vaginal Ring (VR)	Number of Participants With a Composite Safety Endpoint Adverse Event (AE)	30 Participants
Cohort 2 Infants: Truvada Tablet	Number of Participants With a Composite Safety Endpoint Adverse Event (AE)	10 Participants
Cohort 3 Infants: Dapivirine (DPV) Vaginal Ring (VR)	Number of Participants With a Composite Safety Endpoint Adverse Event (AE)	48 Participants
Cohort 3 Infants: Truvada Tablet	Number of Participants With a Composite Safety Endpoint Adverse Event (AE)	6 Participants

Primary

Pregnancy Outcomes

Frequency of different types of pregnancy outcomes among mothers.

Time frame: Measured through participant's last study visit, at approximately Week 12 to 36, depending on participant's cohort

Population: The analysis population is all randomized and enrolled participants with an obtainable pregnancy outcome. The number of units analyzed is the number of pregnancy outcomes, due to the potential for participants to have non-singleton pregnancies.

Arm	Measure	Category	Value (COUNT_OF_UNITS)
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Outcomes	Premature live birth (<37 0/7 weeks)	1 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Outcomes	Spontaneous abortion (<20 0/7 weeks)	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Outcomes	Full term live birth (>= 37 0/7 weeks)	98 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Outcomes	Stillbirth/intrauterine fetal demise (>= 20 0/7 weeks)	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Outcomes	Full term live birth (>= 37 0/7 weeks)	45 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Outcomes	Premature live birth (<37 0/7 weeks)	3 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Outcomes	Spontaneous abortion (<20 0/7 weeks)	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Outcomes	Stillbirth/intrauterine fetal demise (>= 20 0/7 weeks)	1 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Outcomes	Premature live birth (<37 0/7 weeks)	6 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Outcomes	Full term live birth (>= 37 0/7 weeks)	97 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Outcomes	Stillbirth/intrauterine fetal demise (>= 20 0/7 weeks)	1 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Outcomes	Spontaneous abortion (<20 0/7 weeks)	0 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Outcomes	Full term live birth (>= 37 0/7 weeks)	46 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Outcomes	Spontaneous abortion (<20 0/7 weeks)	0 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Outcomes	Stillbirth/intrauterine fetal demise (>= 20 0/7 weeks)	0 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Outcomes	Premature live birth (<37 0/7 weeks)	5 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Outcomes	Full term live birth (>= 37 0/7 weeks)	188 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Outcomes	Spontaneous abortion (<20 0/7 weeks)	1 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Outcomes	Stillbirth/intrauterine fetal demise (>= 20 0/7 weeks)	2 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Outcomes	Premature live birth (<37 0/7 weeks)	8 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Outcomes	Spontaneous abortion (<20 0/7 weeks)	0 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Outcomes	Stillbirth/intrauterine fetal demise (>= 20 0/7 weeks)	0 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Outcomes	Full term live birth (>= 37 0/7 weeks)	45 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Outcomes	Premature live birth (<37 0/7 weeks)	3 Obtainable pregnancy outcomes

Secondary

Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV

Based on participant report of how satisfied they have been with the the study product they were randomized to receive for HIV prevention. Only asked of participants in Cohorts 2 and 3.

Time frame: Measured at Week 4 visits.

Population: Participants enrolled and randomized.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV	Satisfied	34 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV	Very satisfied	68 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV	Very dissatisfied	0 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV	Dissatisfied	0 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV	Neutral	1 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV	Missing	1 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV	Satisfied	17 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV	Very dissatisfied	0 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV	Very satisfied	27 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV	Neutral	1 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV	Dissatisfied	0 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV	Missing	3 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV	Neutral	0 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV	Dissatisfied	0 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV	Satisfied	73 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV	Very satisfied	125 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV	Missing	1 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV	Very dissatisfied	0 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV	Satisfied	22 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV	Missing	0 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV	Neutral	1 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV	Dissatisfied	1 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV	Very dissatisfied	0 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV	Very satisfied	25 Participants

Secondary

Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods

Based on participant report of how much they liked or disliked the study product they were randomized to receive for HIV prevention, and of how much they liked or disliked male condoms for HIV prevention. Only asked of participants in Cohorts 2 and 3.

Time frame: Measured at Week 4 visits.

Population: Participants enrolled and randomized.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike the [pills/ring] for HIV prevention	Missing	3 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike male condoms for HIV prevention	Neither like nor dislike	10 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike the [pills/ring] for HIV prevention	Like very much	51 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike the [pills/ring] for HIV prevention	Dislike	2 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike the [pills/ring] for HIV prevention	Like	47 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike male condoms for HIV prevention	Like	28 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike male condoms for HIV prevention	Dislike	30 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike male condoms for HIV prevention	Dislike very much	23 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike male condoms for HIV prevention	Missing	3 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike male condoms for HIV prevention	Like very much	12 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike the [pills/ring] for HIV prevention	Dislike very much	2 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike the [pills/ring] for HIV prevention	Neither like nor dislike	1 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike male condoms for HIV prevention	Dislike very much	5 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike male condoms for HIV prevention	Missing	6 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike the [pills/ring] for HIV prevention	Dislike	0 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike the [pills/ring] for HIV prevention	Dislike very much	0 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike male condoms for HIV prevention	Dislike	19 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike the [pills/ring] for HIV prevention	Missing	6 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike the [pills/ring] for HIV prevention	Like	29 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike male condoms for HIV prevention	Neither like nor dislike	8 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike the [pills/ring] for HIV prevention	Like very much	12 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike male condoms for HIV prevention	Like	12 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike the [pills/ring] for HIV prevention	Neither like nor dislike	4 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike male condoms for HIV prevention	Like very much	1 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike the [pills/ring] for HIV prevention	Dislike	2 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike the [pills/ring] for HIV prevention	Missing	4 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike male condoms for HIV prevention	Dislike very much	25 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike male condoms for HIV prevention	Dislike	96 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike male condoms for HIV prevention	Neither like nor dislike	25 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike male condoms for HIV prevention	Like	45 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike male condoms for HIV prevention	Like very much	7 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike male condoms for HIV prevention	Missing	4 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike the [pills/ring] for HIV prevention	Dislike very much	3 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike the [pills/ring] for HIV prevention	Neither like nor dislike	1 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike the [pills/ring] for HIV prevention	Like	122 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike the [pills/ring] for HIV prevention	Like very much	70 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike the [pills/ring] for HIV prevention	Dislike	0 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike male condoms for HIV prevention	Like very much	2 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike male condoms for HIV prevention	Like	11 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike male condoms for HIV prevention	Neither like nor dislike	6 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike male condoms for HIV prevention	Dislike	23 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike the [pills/ring] for HIV prevention	Like very much	14 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike the [pills/ring] for HIV prevention	Like	32 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike male condoms for HIV prevention	Dislike very much	7 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike the [pills/ring] for HIV prevention	Neither like nor dislike	2 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike the [pills/ring] for HIV prevention	Dislike very much	1 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike male condoms for HIV prevention	Missing	0 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods	How much do you like or dislike the [pills/ring] for HIV prevention	Missing	0 Participants

Secondary

Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future

Based on participant report of whether they would be willing to use the study product they were randomized to receive when pregnant in the future. Only asked of participants in Cohorts 2 and 3.

Time frame: Measured at Week 4 and 6-Week PPO/SEV visits.

Population: Participants enrolled and randomized.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	Week 4 Visit	Not sure	3 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	6-Week PPO Visit/SEV	Yes	94 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	Week 4 Visit	Yes	98 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	6-Week PPO Visit/SEV	No	3 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	Week 4 Visit	N/A: doesn't plan to have future pregnancies	2 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	6-Week PPO Visit/SEV	Not sure	3 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	Week 4 Visit	No	0 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	6-Week PPO Visit/SEV	N/A: doesn't plan to have future pregnancies	1 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	Week 4 Visit	Missing	3 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	6-Week PPO Visit/SEV	Missing	5 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	Week 4 Visit	Missing	6 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	6-Week PPO Visit/SEV	Yes	46 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	6-Week PPO Visit/SEV	No	0 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	Week 4 Visit	No	2 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	Week 4 Visit	Yes	42 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	Week 4 Visit	Not sure	1 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	6-Week PPO Visit/SEV	N/A: doesn't plan to have future pregnancies	1 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	Week 4 Visit	N/A: doesn't plan to have future pregnancies	0 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	6-Week PPO Visit/SEV	Missing	3 Participants
Cohort 1 Mothers: Truvada Tablet	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	6-Week PPO Visit/SEV	Not sure	1 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	Week 4 Visit	Missing	1 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	6-Week PPO Visit/SEV	Not sure	1 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	Week 4 Visit	Yes	193 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	Week 4 Visit	No	3 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	Week 4 Visit	Not sure	2 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	Week 4 Visit	N/A: doesn't plan to have future pregnancies	0 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	6-Week PPO Visit/SEV	Yes	190 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	6-Week PPO Visit/SEV	No	2 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	6-Week PPO Visit/SEV	N/A: doesn't plan to have future pregnancies	0 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	6-Week PPO Visit/SEV	Missing	6 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	Week 4 Visit	Missing	0 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	6-Week PPO Visit/SEV	Not sure	0 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	Week 4 Visit	N/A: doesn't plan to have future pregnancies	0 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	Week 4 Visit	Not sure	0 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	6-Week PPO Visit/SEV	Missing	3 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	6-Week PPO Visit/SEV	N/A: doesn't plan to have future pregnancies	0 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	Week 4 Visit	No	0 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	6-Week PPO Visit/SEV	Yes	46 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	Week 4 Visit	Yes	49 Participants
Cohort 2 Mothers: Truvada Tablet	Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future	6-Week PPO Visit/SEV	No	0 Participants

Secondary

Adherence: Frequency of Missing Taking the Pills

Based on participant report, as defined by self-reported missed doses for oral Truvada. This was only reported by participants in Cohorts 2 and 3.

Time frame: Measured at Week 4 and PPO visits

Population: Participants enrolled and randomized to the Truvada Tablet arm.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Frequency of Missing Taking the Pills	PPO Visit	Never	39 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Frequency of Missing Taking the Pills	Week 4 Visit	Often	0 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Frequency of Missing Taking the Pills	Week 4 Visit	Never	36 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Frequency of Missing Taking the Pills	PPO Visit	Rarely	6 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Frequency of Missing Taking the Pills	PPO Visit	Often	2 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Frequency of Missing Taking the Pills	Week 4 Visit	Rarely	8 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Frequency of Missing Taking the Pills	PPO Visit	Missing	4 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Frequency of Missing Taking the Pills	Week 4 Visit	Missing	7 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Frequency of Missing Taking the Pills	PPO Visit	Missing	4 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Frequency of Missing Taking the Pills	Week 4 Visit	Missing	3 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Frequency of Missing Taking the Pills	PPO Visit	Rarely	10 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Frequency of Missing Taking the Pills	Week 4 Visit	Never	35 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Frequency of Missing Taking the Pills	Week 4 Visit	Rarely	11 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Frequency of Missing Taking the Pills	Week 4 Visit	Often	0 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Frequency of Missing Taking the Pills	PPO Visit	Never	35 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Frequency of Missing Taking the Pills	PPO Visit	Often	0 Participants

Secondary

Adherence: Frequency of Ring Removal/Expulsion

Based on participant report, as defined by self-reported occurrences of the ring being out of the vagina for more than 12 hours, being out for any time. This was only reported by participants in Cohorts 2 and 3.

Time frame: Measured at Week 4 visit and Post-Pregnancy Outcome (PPO) (occurring within 2 weeks of pregnancy outcome) visit

Population: Participants enrolled and randomized to the Truvada Tablet arm.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Frequency of Ring Removal/Expulsion	Ring out, even briefly, in past 4 weeks - Week 4 Visit	Missing	4 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Frequency of Ring Removal/Expulsion	Ring out for >12 hours in past 4 weeks - PPO Visit	Never	93 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Frequency of Ring Removal/Expulsion	Ring out for >12 hours in past 4 weeks - Week 4 Visit	Never	101 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Frequency of Ring Removal/Expulsion	Ring out for >12 hours in past 4 weeks - PPO Visit	Rarely	7 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Frequency of Ring Removal/Expulsion	Ring out, even briefly, in past 4 weeks - PPO Visit	Rarely	9 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Frequency of Ring Removal/Expulsion	Ring out for >12 hours in past 4 weeks - PPO Visit	Often	0 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Frequency of Ring Removal/Expulsion	Ring out for >12 hours in past 4 weeks - Week 4 Visit	Rarely	1 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Frequency of Ring Removal/Expulsion	Ring out for >12 hours in past 4 weeks - PPO Visit	Missing	6 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Frequency of Ring Removal/Expulsion	Ring out, even briefly, in past 4 weeks - PPO Visit	Never	91 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Frequency of Ring Removal/Expulsion	Ring out, even briefly, in past 4 weeks - Week 4 Visit	Never	101 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Frequency of Ring Removal/Expulsion	Ring out for >12 hours in past 4 weeks - Week 4 Visit	Often	0 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Frequency of Ring Removal/Expulsion	Ring out, even briefly, in past 4 weeks - Week 4 Visit	Rarely	1 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Frequency of Ring Removal/Expulsion	Ring out, even briefly, in past 4 weeks - PPO Visit	Often	0 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Frequency of Ring Removal/Expulsion	Ring out for >12 hours in past 4 weeks - Week 4 Visit	Missing	4 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Frequency of Ring Removal/Expulsion	Ring out, even briefly, in past 4 weeks - PPO Visit	Missing	6 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Frequency of Ring Removal/Expulsion	Ring out, even briefly, in past 4 weeks - Week 4 Visit	Often	0 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Frequency of Ring Removal/Expulsion	Ring out, even briefly, in past 4 weeks - PPO Visit	Missing	13 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Frequency of Ring Removal/Expulsion	Ring out, even briefly, in past 4 weeks - Week 4 Visit	Often	1 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Frequency of Ring Removal/Expulsion	Ring out, even briefly, in past 4 weeks - PPO Visit	Never	121 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Frequency of Ring Removal/Expulsion	Ring out, even briefly, in past 4 weeks - PPO Visit	Rarely	66 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Frequency of Ring Removal/Expulsion	Ring out, even briefly, in past 4 weeks - PPO Visit	Often	2 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Frequency of Ring Removal/Expulsion	Ring out for >12 hours in past 4 weeks - Week 4 Visit	Never	190 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Frequency of Ring Removal/Expulsion	Ring out for >12 hours in past 4 weeks - Week 4 Visit	Rarely	4 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Frequency of Ring Removal/Expulsion	Ring out for >12 hours in past 4 weeks - Week 4 Visit	Often	2 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Frequency of Ring Removal/Expulsion	Ring out for >12 hours in past 4 weeks - Week 4 Visit	Missing	6 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Frequency of Ring Removal/Expulsion	Ring out for >12 hours in past 4 weeks - PPO Visit	Never	145 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Frequency of Ring Removal/Expulsion	Ring out for >12 hours in past 4 weeks - PPO Visit	Rarely	42 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Frequency of Ring Removal/Expulsion	Ring out for >12 hours in past 4 weeks - PPO Visit	Often	2 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Frequency of Ring Removal/Expulsion	Ring out for >12 hours in past 4 weeks - PPO Visit	Missing	13 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Frequency of Ring Removal/Expulsion	Ring out, even briefly, in past 4 weeks - Week 4 Visit	Never	184 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Frequency of Ring Removal/Expulsion	Ring out, even briefly, in past 4 weeks - Week 4 Visit	Rarely	11 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Frequency of Ring Removal/Expulsion	Ring out, even briefly, in past 4 weeks - Week 4 Visit	Missing	6 Participants

Secondary

Adherence: Maternal Blood FTC-TP Concentrations

Maternal blood FTC-TP was collected at the 2-week, bi-weekly (starting at 4-weeks), and PPO visits for participants randomized to receive Truvada Tablet. In Cohort 1 this was done for a randomly selected subset of those participants.

Time frame: Measured through participant's 2-week PPO visit, at approximately Week 8-32, depending on participant's cohort

Population: Participants enrolled and randomized to the Truvada Tablet arm who had an analyzable blood FTC-TP sample collected during at their PPO visit.

Arm	Measure	Value (MEAN)	Dispersion
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Maternal Blood FTC-TP Concentrations	0.1 pmol	Standard Deviation 0.2
Cohort 1 Mothers: Truvada Tablet	Adherence: Maternal Blood FTC-TP Concentrations	0 pmol	Standard Deviation 0
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Maternal Blood FTC-TP Concentrations	0 pmol	Standard Deviation 0

Secondary

Adherence: Maternal Blood TFV-DP Concentrations

Maternal blood TFV-DP was collected at the 2-week, bi-weekly (starting at 4-weeks), and PPO visits for participants randomized to receive Truvada Tablet. In Cohort 1 this was done for a randomly selected subset of those participants. Participants are categorized as ever being exposed if they had at least one measure that was \>= 200 fmol/punch (if the sample was collected more than 6 weeks after randomization) or \>= 150 fmol/punch (if the sample was collected within 6 weeks of randomization). They are categorized as never being exposed if they had at least one analyzable sample and none met the criteria.

Time frame: Measured through participant's 2-week PPO visit, at approximately Week 8-32, depending on participant's cohort

Population: Participants enrolled and randomized to the Truvada Tablet arm who had at least one analyzable blood TFV-DP sample collected during study follow-up.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Maternal Blood TFV-DP Concentrations	Ever exposed	8 Participants
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Maternal Blood TFV-DP Concentrations	Never exposed	7 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Maternal Blood TFV-DP Concentrations	Ever exposed	37 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Maternal Blood TFV-DP Concentrations	Never exposed	14 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Maternal Blood TFV-DP Concentrations	Ever exposed	41 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Maternal Blood TFV-DP Concentrations	Never exposed	8 Participants

Secondary

Adherence: Maternal Plasma DPV Concentrations

Maternal plasma DPV was collected at the 2-week, bi-weekly (starting at 4-weeks), and PPO visits for a randomly selected subset of participants (approximately 50%) randomized to receive the VR. Participants are categorized as ever being exposed if they had at least one measure that was greater than the LLOQ (i.e., greater than or equal to 20 pg/mL). They are categorized as never being exposed if they had at least one analyzable sample and none met the criteria.

Time frame: Measured through participant's 2-week PPO visit, at approximately Week 8-32, depending on participant's cohort

Population: Participants enrolled and randomized to the VR arm who had at least one analyzable plasma DPV sample collected during study follow-up.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Maternal Plasma DPV Concentrations	43 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Maternal Plasma DPV Concentrations	51 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Maternal Plasma DPV Concentrations	98 Participants

Secondary

Adherence: Number of Participants With Product Exposure (Measured in Residual Drug Levels in Returned VRs)

Residual drug levels were collected from returned VRs, which were expected to be returned at monthly visits throughout study follow-up. Drug release rate was calculated by subtracting the residual level from the amount of residual drug in the manufacturer lot, divided by the number of days the participant was expected to use that ring, times 28 days. For each individual ring, a ring was considered to show evidence of use if the residual drug level was greater than or equal to 0.9mg/28 days of use. Participants are categorized as either ever being exposed or never being exposed to product over the course of study follow-up. They are categorized as ever being exposed to product if they had at least one ring with evidence of use (i.e., greater than or equal to 0.9 mg/28 days of release). They are categorized as never being exposed if they had at least one analyzable returned ring and none of these rings had evidence of use.

Time frame: Measured through participant's last study visit, at approximately Week 12 to 36, depending on participant's cohort

Population: Participants enrolled and randomized to the VR arm who had at least one analyzable residual drug level collected during study follow-up.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Number of Participants With Product Exposure (Measured in Residual Drug Levels in Returned VRs)	95 Participants
Cohort 1 Mothers: Truvada Tablet	Adherence: Number of Participants With Product Exposure (Measured in Residual Drug Levels in Returned VRs)	93 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Adherence: Number of Participants With Product Exposure (Measured in Residual Drug Levels in Returned VRs)	193 Participants

Secondary

Infant Drug Levels: Number of Infants With Detectable Blood Emtricitabine Triphosphate (FTC-TP)

Infant blood FTC-TP was measured at infants' PPO visit. The outcome is defined as having detectable drug level, with detectable drug levels defined as a FTC-TP concentration above the lower limit of quantification (LLOQ) for the assay.

Time frame: measured at the 2-week post pregnancy outcome (PPO) visit

Population: Enrolled infants with an analyzable sample collected at the PPO visit.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Infant Drug Levels: Number of Infants With Detectable Blood Emtricitabine Triphosphate (FTC-TP)	7 Participants
Cohort 1 Mothers: Truvada Tablet	Infant Drug Levels: Number of Infants With Detectable Blood Emtricitabine Triphosphate (FTC-TP)	6 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Infant Drug Levels: Number of Infants With Detectable Blood Emtricitabine Triphosphate (FTC-TP)	1 Participants

Secondary

Infant Drug Levels: Number of Infants With Detectable Infant Blood Tenofovir Diphosphate (TFV-DP)

Infant blood TFV-DP was measured at infants' post pregnancy outcome (PPO) visit (up to 14 days after pregnancy outcome). The outcome is defined as having detectable drug level, with detectable drug levels defined as a TFV-DP concentration above the lower limit of quantification (LLOQ) for the assay.

Time frame: Measured at the 2-week post pregnancy outcome (PPO) visit

Population: Enrolled infants with an analyzable sample collected at the PPO visit.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Infant Drug Levels: Number of Infants With Detectable Infant Blood Tenofovir Diphosphate (TFV-DP)	30 Participants
Cohort 1 Mothers: Truvada Tablet	Infant Drug Levels: Number of Infants With Detectable Infant Blood Tenofovir Diphosphate (TFV-DP)	35 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Infant Drug Levels: Number of Infants With Detectable Infant Blood Tenofovir Diphosphate (TFV-DP)	30 Participants

Secondary

Infant Drug Levels: Number of Infants With Detectable Plasma DPV

Infant plasma DPV concentration was measured at infants' post pregnancy outcome (PPO) visit (up to 14 days after pregnancy outcome). The outcome is defined as having detectable drug level, with detectable drug levels defined as a DPV concentration above the lower limit of quantification (LLOQ) for the assay.

Time frame: measured at the 2-week post pregnancy outcome (PPO) visit

Population: Enrolled infants with an analyzable sample collected at the PPO visit.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Infant Drug Levels: Number of Infants With Detectable Plasma DPV	22 Participants
Cohort 1 Mothers: Truvada Tablet	Infant Drug Levels: Number of Infants With Detectable Plasma DPV	31 Participants
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Infant Drug Levels: Number of Infants With Detectable Plasma DPV	30 Participants

Secondary

Pregnancy Complications: Frequency of Pregnancy Complications

Frequency of different types of pregnancy complications among mothers. The categories of pregnancy complications were pre-defined on the case report form, and after the completion of Cohort 1 follow-up there were some changes made to the pregnancy complication categories. In Cohort 1 the category peripartum hemorrhage was collected, but in Cohort 2 and 3 this category was removed from the list of pre-defined complications. Two other categories, antepartum hemorrhage and intrapartum hemorrhage, were added to the list for Cohort 2 and Cohort 3. As a result, participants in Cohort 1 were not evaluated for antepartum or intrapartum hemorrhage, while participants in Cohorts 2 and 3 were not evaluated for peripartum hemorrhage. All other complications were collected for all three cohorts, and participants in all three cohorts were evaluated for each complication.

Time frame: Measured through participant's last study visit, at approximately Week 12 to 36, depending on participant's cohort

Arm	Measure	Group	Category	Value (COUNT_OF_UNITS)
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Fever of unclear etiology	No	99 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Chorioamnionitis	Yes	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Pre-eclampsia with severe features	No	99 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Unspecified hypertensive disorder	No	99 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Unspecified hypertensive disorder	Yes	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Eclampsia	Yes	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Eclampsia	No	99 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Preterm premature rupture of membranes (PPROM)	No	99 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Preterm premature rupture of membranes (PPROM)	Yes	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Fever of unclear etiology	Yes	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Hypertensive disorders of pregnancy	Yes	3 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Postpartum hemorrhage	No	97 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Other complication	No	98 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Postpartum hemorrhage	Yes	2 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Hypertensive disorders of pregnancy	No	96 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Peripartum hemorrhage	Yes	2 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Intrapartum hemorrhage	No	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Chronic hypertensive disorder	Yes	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Antepartum hemorrhage	No	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Intrapartum hemorrhage	Yes	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Chronic hypertensive disorder	No	99 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Antepartum hemorrhage	Yes	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Peripartum hemorrhage	No	97 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Gestational hypertensive disorder	Yes	3 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Other complication	Yes	1 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Endometritis	No	99 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Gestational hypertensive disorder	No	96 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Endometritis	Yes	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Pre-eclampsia without severe features	Yes	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Puerperal sepsis	No	99 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Puerperal sepsis	Yes	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Pre-eclampsia without severe features	No	99 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Chorioamnionitis	No	99 Obtainable pregnancy outcomes
Cohort 1 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Pre-eclampsia with severe features	Yes	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Hypertensive disorders of pregnancy	Yes	4 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Preterm premature rupture of membranes (PPROM)	Yes	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Chorioamnionitis	Yes	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Antepartum hemorrhage	No	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Unspecified hypertensive disorder	No	49 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Antepartum hemorrhage	Yes	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Puerperal sepsis	No	49 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Unspecified hypertensive disorder	Yes	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Chronic hypertensive disorder	No	49 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Other complication	Yes	1 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Eclampsia	Yes	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Pre-eclampsia with severe features	No	48 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Eclampsia	No	49 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Pre-eclampsia without severe features	No	48 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Peripartum hemorrhage	No	48 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Fever of unclear etiology	No	49 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Other complication	No	48 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Pre-eclampsia without severe features	Yes	1 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Postpartum hemorrhage	No	48 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Fever of unclear etiology	Yes	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Gestational hypertensive disorder	Yes	2 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Preterm premature rupture of membranes (PPROM)	No	49 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Peripartum hemorrhage	Yes	1 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Postpartum hemorrhage	Yes	1 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Endometritis	No	49 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Intrapartum hemorrhage	No	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Puerperal sepsis	Yes	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Hypertensive disorders of pregnancy	No	45 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Chorioamnionitis	No	49 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Gestational hypertensive disorder	No	47 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Intrapartum hemorrhage	Yes	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Pre-eclampsia with severe features	Yes	1 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Chronic hypertensive disorder	Yes	0 Obtainable pregnancy outcomes
Cohort 1 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Endometritis	Yes	0 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Chorioamnionitis	Yes	1 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Pre-eclampsia with severe features	No	102 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Preterm premature rupture of membranes (PPROM)	Yes	1 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Other complication	No	100 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Hypertensive disorders of pregnancy	Yes	9 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Hypertensive disorders of pregnancy	No	95 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Chronic hypertensive disorder	Yes	0 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Chronic hypertensive disorder	No	104 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Gestational hypertensive disorder	Yes	5 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Gestational hypertensive disorder	No	99 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Pre-eclampsia without severe features	Yes	1 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Pre-eclampsia without severe features	No	103 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Pre-eclampsia with severe features	Yes	2 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Eclampsia	Yes	0 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Eclampsia	No	104 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Unspecified hypertensive disorder	Yes	1 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Unspecified hypertensive disorder	No	103 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Chorioamnionitis	No	103 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Puerperal sepsis	Yes	0 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Puerperal sepsis	No	104 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Endometritis	Yes	0 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Endometritis	No	104 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Peripartum hemorrhage	Yes	0 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Peripartum hemorrhage	No	0 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Antepartum hemorrhage	Yes	2 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Antepartum hemorrhage	No	102 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Intrapartum hemorrhage	Yes	0 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Intrapartum hemorrhage	No	104 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Postpartum hemorrhage	Yes	2 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Postpartum hemorrhage	No	102 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Preterm premature rupture of membranes (PPROM)	No	103 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Fever of unclear etiology	Yes	0 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Fever of unclear etiology	No	104 Obtainable pregnancy outcomes
Cohort 2 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Other complication	Yes	4 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Fever of unclear etiology	No	51 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Peripartum hemorrhage	Yes	0 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Chorioamnionitis	Yes	0 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Other complication	Yes	0 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Hypertensive disorders of pregnancy	Yes	7 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Intrapartum hemorrhage	No	50 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Puerperal sepsis	Yes	2 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Peripartum hemorrhage	No	0 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Pre-eclampsia without severe features	No	51 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Intrapartum hemorrhage	Yes	1 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Chronic hypertensive disorder	No	51 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Chronic hypertensive disorder	Yes	0 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Antepartum hemorrhage	No	50 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Antepartum hemorrhage	Yes	1 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Unspecified hypertensive disorder	Yes	0 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Pre-eclampsia without severe features	Yes	0 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Eclampsia	No	51 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Eclampsia	Yes	0 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Puerperal sepsis	No	49 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Fever of unclear etiology	Yes	0 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Preterm premature rupture of membranes (PPROM)	No	51 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Chorioamnionitis	No	51 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Gestational hypertensive disorder	No	44 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Preterm premature rupture of membranes (PPROM)	Yes	0 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Endometritis	Yes	1 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Unspecified hypertensive disorder	No	51 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Postpartum hemorrhage	No	51 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Hypertensive disorders of pregnancy	No	44 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Pre-eclampsia with severe features	No	51 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Other complication	No	51 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Endometritis	No	50 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Pre-eclampsia with severe features	Yes	0 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Postpartum hemorrhage	Yes	0 Obtainable pregnancy outcomes
Cohort 2 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Gestational hypertensive disorder	Yes	7 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Chronic hypertensive disorder	No	198 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Chorioamnionitis	Yes	0 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Pre-eclampsia without severe features	No	196 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Pre-eclampsia without severe features	Yes	3 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Fever of unclear etiology	Yes	0 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Puerperal sepsis	Yes	0 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Puerperal sepsis	No	199 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Gestational hypertensive disorder	No	183 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Endometritis	Yes	0 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Gestational hypertensive disorder	Yes	16 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Endometritis	No	199 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Peripartum hemorrhage	Yes	0 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Fever of unclear etiology	No	199 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Peripartum hemorrhage	No	0 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Antepartum hemorrhage	Yes	2 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Chronic hypertensive disorder	Yes	1 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Intrapartum hemorrhage	Yes	3 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Antepartum hemorrhage	No	197 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Hypertensive disorders of pregnancy	No	179 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Other complication	No	197 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Intrapartum hemorrhage	No	196 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Hypertensive disorders of pregnancy	Yes	20 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Postpartum hemorrhage	No	195 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Other complication	Yes	2 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Preterm premature rupture of membranes (PPROM)	Yes	3 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Chorioamnionitis	No	199 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Eclampsia	Yes	0 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Preterm premature rupture of membranes (PPROM)	No	196 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Eclampsia	No	199 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Pre-eclampsia with severe features	No	198 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Postpartum hemorrhage	Yes	4 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Unspecified hypertensive disorder	Yes	0 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Unspecified hypertensive disorder	No	199 Obtainable pregnancy outcomes
Cohort 3 Mothers: Dapivirine (DPV) Vaginal Ring (VR)	Pregnancy Complications: Frequency of Pregnancy Complications	Pre-eclampsia with severe features	Yes	1 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Postpartum hemorrhage	Yes	0 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Gestational hypertensive disorder	Yes	6 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Other complication	No	47 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Other complication	Yes	1 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Endometritis	Yes	0 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Chorioamnionitis	No	48 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Chorioamnionitis	Yes	0 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Intrapartum hemorrhage	Yes	0 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Puerperal sepsis	Yes	0 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Preterm premature rupture of membranes (PPROM)	Yes	0 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Preterm premature rupture of membranes (PPROM)	No	48 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Postpartum hemorrhage	No	48 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Unspecified hypertensive disorder	No	48 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Puerperal sepsis	No	48 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Eclampsia	Yes	0 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Antepartum hemorrhage	Yes	0 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Pre-eclampsia without severe features	Yes	0 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Fever of unclear etiology	Yes	0 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Fever of unclear etiology	No	48 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Antepartum hemorrhage	No	48 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Chronic hypertensive disorder	Yes	0 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Hypertensive disorders of pregnancy	No	41 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Pre-eclampsia with severe features	Yes	1 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Peripartum hemorrhage	No	0 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Gestational hypertensive disorder	No	42 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Hypertensive disorders of pregnancy	Yes	7 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Unspecified hypertensive disorder	Yes	0 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Pre-eclampsia without severe features	No	48 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Eclampsia	No	48 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Intrapartum hemorrhage	No	48 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Pre-eclampsia with severe features	No	47 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Chronic hypertensive disorder	No	48 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Peripartum hemorrhage	Yes	0 Obtainable pregnancy outcomes
Cohort 3 Mothers: Truvada Tablet	Pregnancy Complications: Frequency of Pregnancy Complications	Endometritis	No	48 Obtainable pregnancy outcomes

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring and Oral TRUVADA® Use in Pregnancy

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Number of Participants With a Composite Safety Endpoint Adverse Event (AE)

Pregnancy Outcomes

Acceptability: Participants Who Are Satisfied With the Study Products for Preventing HIV

Acceptability: Participants Who Find the Study Products to be at Least as Acceptable as Other HIV Prevention Methods

Acceptability: Participant Willingness to Use Study Products During Pregnancy in the Future

Adherence: Frequency of Missing Taking the Pills

Adherence: Frequency of Ring Removal/Expulsion

Adherence: Maternal Blood FTC-TP Concentrations

Adherence: Maternal Blood TFV-DP Concentrations

Adherence: Maternal Plasma DPV Concentrations

Adherence: Number of Participants With Product Exposure (Measured in Residual Drug Levels in Returned VRs)

Infant Drug Levels: Number of Infants With Detectable Blood Emtricitabine Triphosphate (FTC-TP)

Infant Drug Levels: Number of Infants With Detectable Infant Blood Tenofovir Diphosphate (TFV-DP)

Infant Drug Levels: Number of Infants With Detectable Plasma DPV

Pregnancy Complications: Frequency of Pregnancy Complications