HIV Infections
Conditions
Brief summary
The purpose of this study is to evaluate the safety and pharmacokinetics of rectal administration of a tenofovir alafenamide (TAF)/elvitegravir (EVG) insert at two dose levels in HIV-uninfected individuals.
Detailed description
This study will evaluate the safety and pharmacokinetics of rectal administration of a tenofovir alafenamide (TAF)/elvitegravir (EVG) insert at two dose levels in HIV-uninfected individuals. All participants will receive a single TAF/EVG Insert at Study Visit 3. After a washout period of at least 7 days, participants will receive two TAF/EVG Inserts at Study Visit 7. The inserts will be administered rectally by study staff. After each dosing visit, samples will be collected over a 3-day period. Participants will attend 10 study visits and will be followed for approximately 6 to 13 weeks. Study visits may include physical and rectal examinations; collection of blood, urine, rectal and vaginal fluid; and interviews. The total duration of the study will be approximately 11 months.
Interventions
DRUGTAF/EVG Insert
TAF/EVG Insert (20/16 mg) administered rectally by study staff
Sponsors
CONRAD
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Individuals who are 18 years of age or older at Screening, verified per site standard operating procedure (SOP) * Able and willing to provide written informed consent to be screened for and enrolled in MTN-039 * HIV-1/2 uninfected at Screening and Enrollment, per applicable algorithm in the study protocol and willing to receive HIV test results * Able and willing to provide adequate locator information, as defined in site SOP * Able to communicate in spoken and written English * Available for all visits and able and willing to comply with all study procedural requirements * In general good health at Screening and Enrollment, as determined by the site Investigator of Record (IoR) or designee * At Screening, history of consensual receptive anal intercourse (RAI) at least once in lifetime per participant report * Willing not to take part in other research studies involving drugs, medical devices, genital or rectal products, or vaccines for the duration of study participation (including the time between Screening and Enrollment) * Willing to comply with abstinence and other protocol requirements as outlined in the study protocol * For participants of childbearing potential: a negative pregnancy test at Screening and Enrollment * For participants of childbearing potential: Per participant report at Enrollment, using an effective method of contraception for at least 30 days (inclusive) prior to Enrollment and intending to use an effective method for the duration of study participation. Effective methods include: * Hormonal methods * Intrauterine device (IUD) inserted at least 30 days prior to Enrollment (but not past the maximum length of recommended usage according to package instructions) * Sterilization (of participant or partner, as defined in site SOPs) * Sexually abstinent as defined by abstaining from penile-vaginal intercourse for 90 days prior to Enrollment and intending to remain abstinent for the duration of study participation; this includes having sex exclusively with individuals assigned female sex at birth
Exclusion criteria
* At Screening: * Hemoglobin Grade 1 or higher\* * Platelet count Grade 1 or higher\* * Aspartate aminotransferase (AST) or alanine transaminase (ALT) Grade 1 or higher\* * Serum creatinine greater than 1.3 times the site laboratory upper limit of normal (ULN) * International normalized ratio (INR) greater than 1.5 times the site laboratory ULN * History of inflammatory bowel disease by participant report * Positive hepatitis B surface antigen (HBsAg) test result * \*As per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1, July 2017. * Note: Otherwise eligible participants with an exclusionary test result (other than HIV) can be re-tested during the screening process. If a participant is re-tested and a non-exclusionary result is documented within 45 days of providing informed consent for screening, the participant may be enrolled. * Anticipated use of and/or unwillingness to abstain from the following medications during study participation: * Anticoagulant medications * Non-study rectally-administered medications and any products containing nonoxynol-9 (N-9) * Known adverse reaction to any of the components of the study product * Use of approved or other investigational pre-exposure prophylaxis (PrEP) for HIV prevention within 3 months prior to Enrollment, and/or anticipated use and/or unwillingness to abstain from PrEP during trial participation * Use of post-exposure prophylaxis (PEP) for potential HIV exposure within 6 months prior to Enrollment * Condomless RAI and/or penile-vaginal intercourse with a partner who is known to be HIV-positive or whose status is unknown in the 6 months prior to Enrollment * History of transactional sex in the 12 months prior to Enrollment * Non-therapeutic injection drug use or use of non-therapeutic, non-injection stimulant drugs in the 12 months prior to Enrollment * Participation in research studies involving drugs, medical devices, genital or rectal products, or vaccines within 30 days of the Enrollment Visit * Per participant report, medical records, clinical diagnosis and/or diagnostic testing at either Screening or Enrollment: * Diagnosis or treatment of an anogenital sexually transmitted infection (STI) in the 3 months prior to enrollment (including window between Screening and Enrollment). * Symptoms, clinical or laboratory diagnosis of active pharyngeal, anorectal, or reproductive tract infection (RTI) requiring treatment per current Centers for Disease Control and Prevention (CDC) guidelines (http://www.cdc.gov/std/treatment). * Current symptomatic urinary tract infection (UTI). * Infections requiring treatment include Neisseria gonorrhea (GC), Chlamydia trachomatis (CT) infection, syphilis, active herpes simplex virus (HSV) lesions, or symptomatic genital warts, chancroid, pelvic inflammatory disease (PID), bacterial vaginosis (BV), symptomatic vaginal candidiasis, and trichomoniasis. * Note: Otherwise eligible participants with an exclusionary UTI, BV and/or candida finding may be re-tested during the screening process. * For participants of childbearing potential: Pregnant or breastfeeding at either Screening or Enrollment or planning to become pregnant during study participation * Note: A documented negative pregnancy test performed by study staff is required for inclusion; however, a self-reported pregnancy is adequate for exclusion from screening/enrollment into the study. * For participants of childbearing potential: Last pregnancy outcome 90 days or less prior to Screening * Has any other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate the interpretation of study outcome data, or otherwise interfere with achieving the study objectives including any significant uncontrolled active or chronic medical condition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tenofovir Diphosphate (TFV-DP) Concentration in Rectal Mucosal Tissue Cell Isolates | Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose) | Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose |
| Tenofovir (TFV) Concentration in Blood | Samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose) | Based on laboratory evaluations on samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours post dose |
| Tenofovir (TFV) Concentration in Rectal Fluid | Samples collected at 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose) | Based on laboratory evaluations on samples collected at 2, 4, 6, 24, 48, and 72 hours post dose |
| Tenofovir (TFV) Concentration in Rectal Mucosal Tissue Homogenates | Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose) | Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose |
| Number of Participants With Grade 2 and Higher Adverse Events (AEs) | Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days. | Graded per the Division of AIDS (DAIDS) Table for Grading Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 and/or Addenda 1, 2 and 3 (Female Genital \[Dated November 2007\], Male Genital \[Dated November 2007\] and Rectal \[Clarification Dated May 2012\] Grading Tables for Use in Microbicide Studies). |
| Elvitegravir (EVG) Concentration in Blood | Samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose) | Based on laboratory evaluations on samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours post dose |
| Elvitegravir (EVG) Concentration in Rectal Fluid | Samples collected at 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose) | Based on laboratory evaluations on samples collected at 2, 4, 6, 24, 48, and 72 hours post dose |
| Elvitegravir (EVG) Concentration in Rectal Mucosal Tissue Homogenates | Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose) | Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose |
| Tenofovir Alafenamide (TAF) Concentration in Blood | Samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose) | Based on laboratory evaluations on samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours post dose |
| Tenofovir Alafenamide (TAF) Concentration in Rectal Fluid | Samples collected at 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose) | Based on laboratory evaluations on samples collected at 2, 4, 6, 24, 48, and 72 hours post dose |
| Tenofovir Alafenamide (TAF) Concentration in Rectal Mucosal Tissue Homogenates | Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose) | Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Self-report Rectal Insert Acceptability - Feeling When Inserted | 24 hours after each dose (Visits 4 and 8) (up to 9 weeks after first dose) | Response for How did it feel to have the insert inside you? |
| Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | 24 hours after each dose (Visits 4 and 8) (up to 9 weeks after first dose) | Responses for questions related to problems with Rectal Insert |
| Participant Self-report Rectal Insert Acceptability - Ease of Use | 24 hours after each dose (Visits 4 and 8) (up to 9 weeks after first dose) | Response for Overall, how easy or difficult was it to use the study product when inserted by clinic staff? |
Countries
United States
Participant flow
Pre-assignment details
A total of 23 participants were eligible and enrolled. Two participants terminated early due to Refused participation, so 21 participants received the one insert dose. After the one insert dose, two additional participants terminated early due to Refused participation, so 19 participants received the two insert dose.
Participants by arm
| Arm | Count |
|---|---|
| Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Insert On the first dosing visit (Visit 3), participants will receive a single TAF/EVG Insert for rectal administration. On the second dosing visit (Visit 7), after a washout period of at least 7 days, participants will receive two TAF/EVG Inserts for rectal administration. Each participant will be on study for approximately 6-13 weeks.
TAF/EVG Insert: TAF/EVG Insert (20/16 mg) administered rectally by study staff | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Enrollment (Pre-dose) Period | Refused Participation | 2 |
| Washout Period | Refused Participation | 2 |
Baseline characteristics
| Characteristic | Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Insert |
|---|---|
| Age, Continuous | 34.0 years |
| Age, Customized 24 years or Under | 6 Participants |
| Age, Customized 25-29 years | 2 Participants |
| Age, Customized 30-34 years | 4 Participants |
| Age, Customized 35-39 years | 3 Participants |
| Age, Customized 40-44 years | 4 Participants |
| Age, Customized 45-49 years | 1 Participants |
| Age, Customized 50+ years | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Participant BMI (kg/m^2) | 30.8 kg/m^2 |
| Participant Height (cm) | 175.0 cm |
| Participant Weight (kg) | 93.0 kg |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants |
| Race/Ethnicity, Customized Race Black or African American | 8 Participants |
| Race/Ethnicity, Customized Race Mixed | 1 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants |
| Race/Ethnicity, Customized Race White | 13 Participants |
| Region of Enrollment United States Birmingham | 12 Participants |
| Region of Enrollment United States Pittsburgh | 11 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 6 Participants |
| Sex/Gender, Customized Gender Female | 6 Participants |
| Sex/Gender, Customized Gender Gender Nonconforming/Gender Variant | 0 Participants |
| Sex/Gender, Customized Gender Male | 15 Participants |
| Sex/Gender, Customized Gender Multiple Genders | 1 Participants |
| Sex/Gender, Customized Gender Prefer Not to Answer | 0 Participants |
| Sex/Gender, Customized Gender Self-identify | 0 Participants |
| Sex/Gender, Customized Gender Transgender Female | 1 Participants |
| Sex/Gender, Customized Gender Transgender Male | 0 Participants |
| Sexual Orientation Additional Category | 1 Participants |
| Sexual Orientation Bisexual | 6 Participants |
| Sexual Orientation Gay/Lesbian/Homosexual | 11 Participants |
| Sexual Orientation Not sure | 0 Participants |
| Sexual Orientation Prefer not to Answer | 0 Participants |
| Sexual Orientation Queer | 0 Participants |
| Sexual Orientation Straight/Heterosexual | 5 Participants |
| Sexual Orientation Two Spirit | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 21 | 0 / 19 |
| other Total, other adverse events | 3 / 23 | 4 / 21 | 4 / 19 |
| serious Total, serious adverse events | 0 / 23 | 0 / 21 | 0 / 19 |
Outcome results
Primary
Elvitegravir (EVG) Concentration in Blood
Based on laboratory evaluations on samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours post dose
Time frame: Samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Population: Baseline data were collected once at the enrollment visit prior to receiving both one insert and two inserts.~Participants had post dose blood samples collected at 1, 2, 4, 6, 24, 48, and 72 hours (One insert (n=21); Two inserts (n=19))).~Missed sample collection (One insert (24-hour missed (n=1)); Two inserts (48-hour missed (n=1) and 72-hour missed (n=1))).~Unable to draw sample (One insert (72-hours (n=1))).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| One Insert | Elvitegravir (EVG) Concentration in Blood | 6 hours postdosing | 713.0 pg/mL |
| One Insert | Elvitegravir (EVG) Concentration in Blood | 24 hours postdosing | 39.0 pg/mL |
| One Insert | Elvitegravir (EVG) Concentration in Blood | 2 hours postdosing | 1230 pg/mL |
| One Insert | Elvitegravir (EVG) Concentration in Blood | 48 hours postdosing | NA pg/mL |
| One Insert | Elvitegravir (EVG) Concentration in Blood | 1 hour postdosing | 1010.0 pg/mL |
| One Insert | Elvitegravir (EVG) Concentration in Blood | 72 hours postdosing | NA pg/mL |
| One Insert | Elvitegravir (EVG) Concentration in Blood | 4 hours postdosing | 1080.0 pg/mL |
| One Insert | Elvitegravir (EVG) Concentration in Blood | Baseline (Enrollment Visit) | NA pg/mL |
| Two Inserts | Elvitegravir (EVG) Concentration in Blood | 72 hours postdosing | NA pg/mL |
| Two Inserts | Elvitegravir (EVG) Concentration in Blood | 1 hour postdosing | 1510.0 pg/mL |
| Two Inserts | Elvitegravir (EVG) Concentration in Blood | 2 hours postdosing | 2140.0 pg/mL |
| Two Inserts | Elvitegravir (EVG) Concentration in Blood | 4 hours postdosing | 1740.0 pg/mL |
| Two Inserts | Elvitegravir (EVG) Concentration in Blood | 24 hours postdosing | 76.0 pg/mL |
| Two Inserts | Elvitegravir (EVG) Concentration in Blood | 48 hours postdosing | NA pg/mL |
| Two Inserts | Elvitegravir (EVG) Concentration in Blood | 6 hours postdosing | 1290.0 pg/mL |
Primary
Elvitegravir (EVG) Concentration in Rectal Fluid
Based on laboratory evaluations on samples collected at 2, 4, 6, 24, 48, and 72 hours post dose
Time frame: Samples collected at 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Population: Participants are randomly assigned 1:1 to post dose rectal fluid sampling at either 2, 6, and 48 hours (One insert (n=10); Two inserts (n=9)) or 4, 24, and 72 hours (One insert (n=11); Two inserts (n=10)).~Missed sample collection (One insert (24-hour missed (n=1) but replaced by 48-hour sample); Two inserts (48-hour missed (n=1))).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| One Insert | Elvitegravir (EVG) Concentration in Rectal Fluid | 2 hours postdosing | 67542.0 ng/mL |
| One Insert | Elvitegravir (EVG) Concentration in Rectal Fluid | 4 hours postdosing | 125676.0 ng/mL |
| One Insert | Elvitegravir (EVG) Concentration in Rectal Fluid | 6 hours postdosing | 4095.5 ng/mL |
| One Insert | Elvitegravir (EVG) Concentration in Rectal Fluid | 24 hours postdosing | 2233.5 ng/mL |
| One Insert | Elvitegravir (EVG) Concentration in Rectal Fluid | 48 hours postdosing | 16.9 ng/mL |
| One Insert | Elvitegravir (EVG) Concentration in Rectal Fluid | 72 hours postdosing | 5.9 ng/mL |
| Two Inserts | Elvitegravir (EVG) Concentration in Rectal Fluid | 48 hours postdosing | 36.4 ng/mL |
| Two Inserts | Elvitegravir (EVG) Concentration in Rectal Fluid | 2 hours postdosing | 176672.0 ng/mL |
| Two Inserts | Elvitegravir (EVG) Concentration in Rectal Fluid | 24 hours postdosing | 2596.5 ng/mL |
| Two Inserts | Elvitegravir (EVG) Concentration in Rectal Fluid | 4 hours postdosing | 93888.5 ng/mL |
| Two Inserts | Elvitegravir (EVG) Concentration in Rectal Fluid | 72 hours postdosing | 29.1 ng/mL |
| Two Inserts | Elvitegravir (EVG) Concentration in Rectal Fluid | 6 hours postdosing | 7791.0 ng/mL |
Primary
Elvitegravir (EVG) Concentration in Rectal Mucosal Tissue Homogenates
Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose
Time frame: Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Population: Participants are randomly assigned 1:1 to post dose rectal tissue sampling at either 2 and 48 hours (One insert (n=10)); Two inserts (n=9)) or 24 and 72 hours (One insert (n=11); Two inserts (n=10)).~Missed sample collection (One insert (24-hour missed (n=1)); Two inserts (48-hour missed (n=1) and 72-hour missed (n=1))).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| One Insert | Elvitegravir (EVG) Concentration in Rectal Mucosal Tissue Homogenates | 2 hours postdosing | 5.4 ng/mg |
| One Insert | Elvitegravir (EVG) Concentration in Rectal Mucosal Tissue Homogenates | 24 hours postdosing | NA ng/mg |
| One Insert | Elvitegravir (EVG) Concentration in Rectal Mucosal Tissue Homogenates | 48 hours postdosing | NA ng/mg |
| One Insert | Elvitegravir (EVG) Concentration in Rectal Mucosal Tissue Homogenates | 72 hours postdosing | NA ng/mg |
| Two Inserts | Elvitegravir (EVG) Concentration in Rectal Mucosal Tissue Homogenates | 72 hours postdosing | NA ng/mg |
| Two Inserts | Elvitegravir (EVG) Concentration in Rectal Mucosal Tissue Homogenates | 2 hours postdosing | 9.0 ng/mg |
| Two Inserts | Elvitegravir (EVG) Concentration in Rectal Mucosal Tissue Homogenates | 48 hours postdosing | NA ng/mg |
| Two Inserts | Elvitegravir (EVG) Concentration in Rectal Mucosal Tissue Homogenates | 24 hours postdosing | 0.1 ng/mg |
Primary
Number of Participants With Grade 2 and Higher Adverse Events (AEs)
Graded per the Division of AIDS (DAIDS) Table for Grading Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 and/or Addenda 1, 2 and 3 (Female Genital \[Dated November 2007\], Male Genital \[Dated November 2007\] and Rectal \[Clarification Dated May 2012\] Grading Tables for Use in Microbicide Studies).
Time frame: Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days.
Population: All participants with dosing of one insert or two inserts.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| One Insert | Number of Participants With Grade 2 and Higher Adverse Events (AEs) | Participants experiencing grade 2+ AE | Yes | 1 Participants |
| One Insert | Number of Participants With Grade 2 and Higher Adverse Events (AEs) | Participants experiencing grade 2+ AE | No | 20 Participants |
| One Insert | Number of Participants With Grade 2 and Higher Adverse Events (AEs) | Gastritis | Yes | 0 Participants |
| One Insert | Number of Participants With Grade 2 and Higher Adverse Events (AEs) | Gastritis | No | 21 Participants |
| One Insert | Number of Participants With Grade 2 and Higher Adverse Events (AEs) | Reactogenicity event | Yes | 1 Participants |
| One Insert | Number of Participants With Grade 2 and Higher Adverse Events (AEs) | Reactogenicity event | No | 20 Participants |
| Two Inserts | Number of Participants With Grade 2 and Higher Adverse Events (AEs) | Reactogenicity event | Yes | 0 Participants |
| Two Inserts | Number of Participants With Grade 2 and Higher Adverse Events (AEs) | Participants experiencing grade 2+ AE | Yes | 1 Participants |
| Two Inserts | Number of Participants With Grade 2 and Higher Adverse Events (AEs) | Gastritis | No | 18 Participants |
| Two Inserts | Number of Participants With Grade 2 and Higher Adverse Events (AEs) | Participants experiencing grade 2+ AE | No | 18 Participants |
| Two Inserts | Number of Participants With Grade 2 and Higher Adverse Events (AEs) | Reactogenicity event | No | 19 Participants |
| Two Inserts | Number of Participants With Grade 2 and Higher Adverse Events (AEs) | Gastritis | Yes | 1 Participants |
Primary
Tenofovir Alafenamide (TAF) Concentration in Blood
Based on laboratory evaluations on samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours post dose
Time frame: Samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Population: Baseline data were collected once at the enrollment visit prior to receiving both one insert and two inserts.~Participants had post dose blood samples collected at 1, 2, 4, 6, 24, 48, and 72 hours (One insert (n=21); Two inserts (n=19))).~Missed sample collection (One insert (24-hour missed (n=1)); Two inserts (48-hour missed (n=1) and 72-hour missed (n=1))).~Unable to draw sample (One insert (72-hours (n=1))).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| One Insert | Tenofovir Alafenamide (TAF) Concentration in Blood | Baseline (Enrollment visit) | NA pg/mL |
| One Insert | Tenofovir Alafenamide (TAF) Concentration in Blood | 1 hour postdosing | 29500.0 pg/mL |
| One Insert | Tenofovir Alafenamide (TAF) Concentration in Blood | 2 hours postdosing | 14000.0 pg/mL |
| One Insert | Tenofovir Alafenamide (TAF) Concentration in Blood | 4 hours postdosing | 747.0 pg/mL |
| One Insert | Tenofovir Alafenamide (TAF) Concentration in Blood | 6 hours postdosing | 56.0 pg/mL |
| One Insert | Tenofovir Alafenamide (TAF) Concentration in Blood | 24 hours postdosing | NA pg/mL |
| One Insert | Tenofovir Alafenamide (TAF) Concentration in Blood | 48 hours postdosing | NA pg/mL |
| One Insert | Tenofovir Alafenamide (TAF) Concentration in Blood | 72 hours postdosing | NA pg/mL |
| Two Inserts | Tenofovir Alafenamide (TAF) Concentration in Blood | 6 hours postdosing | 95.0 pg/mL |
| Two Inserts | Tenofovir Alafenamide (TAF) Concentration in Blood | 1 hour postdosing | 40400.0 pg/mL |
| Two Inserts | Tenofovir Alafenamide (TAF) Concentration in Blood | 48 hours postdosing | NA pg/mL |
| Two Inserts | Tenofovir Alafenamide (TAF) Concentration in Blood | 2 hours postdosing | 26200.0 pg/mL |
| Two Inserts | Tenofovir Alafenamide (TAF) Concentration in Blood | 24 hours postdosing | NA pg/mL |
| Two Inserts | Tenofovir Alafenamide (TAF) Concentration in Blood | 4 hours postdosing | 1350.0 pg/mL |
| Two Inserts | Tenofovir Alafenamide (TAF) Concentration in Blood | 72 hours postdosing | NA pg/mL |
Primary
Tenofovir Alafenamide (TAF) Concentration in Rectal Fluid
Based on laboratory evaluations on samples collected at 2, 4, 6, 24, 48, and 72 hours post dose
Time frame: Samples collected at 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Population: Participants are randomly assigned 1:1 to post dose rectal fluid sampling at either 2, 6, and 48 hours (One insert (n=10); Two inserts (n=9)) or 4, 24, and 72 hours (One insert (n=11); Two inserts (n=10)).~Missed sample collection (One insert (24-hour missed (n=1) but replaced by 48-hour sample); Two inserts (48-hour missed (n=1))).~Rejected samples, no results (One insert (2-hours (n=1), 4-hours (n=2), and 6-hours (n=2)); Two inserts (6-hours (n=1) and 48-hours (n=1))).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| One Insert | Tenofovir Alafenamide (TAF) Concentration in Rectal Fluid | 2 hours postdosing | 1394.0 ng/mL |
| One Insert | Tenofovir Alafenamide (TAF) Concentration in Rectal Fluid | 4 hours postdosing | 1279.0 ng/mL |
| One Insert | Tenofovir Alafenamide (TAF) Concentration in Rectal Fluid | 6 hours postdosing | 10.8 ng/mL |
| One Insert | Tenofovir Alafenamide (TAF) Concentration in Rectal Fluid | 24 hours postdosing | NA ng/mL |
| One Insert | Tenofovir Alafenamide (TAF) Concentration in Rectal Fluid | 48 hours postdosing | NA ng/mL |
| One Insert | Tenofovir Alafenamide (TAF) Concentration in Rectal Fluid | 72 hours postdosing | NA ng/mL |
| Two Inserts | Tenofovir Alafenamide (TAF) Concentration in Rectal Fluid | 48 hours postdosing | NA ng/mL |
| Two Inserts | Tenofovir Alafenamide (TAF) Concentration in Rectal Fluid | 2 hours postdosing | 531.0 ng/mL |
| Two Inserts | Tenofovir Alafenamide (TAF) Concentration in Rectal Fluid | 24 hours postdosing | 0.6 ng/mL |
| Two Inserts | Tenofovir Alafenamide (TAF) Concentration in Rectal Fluid | 4 hours postdosing | 954.0 ng/mL |
| Two Inserts | Tenofovir Alafenamide (TAF) Concentration in Rectal Fluid | 72 hours postdosing | NA ng/mL |
| Two Inserts | Tenofovir Alafenamide (TAF) Concentration in Rectal Fluid | 6 hours postdosing | 12.4 ng/mL |
Primary
Tenofovir Alafenamide (TAF) Concentration in Rectal Mucosal Tissue Homogenates
Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose
Time frame: Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Population: Participants are randomly assigned 1:1 to post dose rectal tissue sampling at either 2 and 48 hours (One insert (n=10)); Two inserts (n=9)) or 24 and 72 hours (One insert (n=11); Two inserts (n=10)).~Missed sample collection (One insert (24-hour missed (n=1)); Two inserts (48-hour missed (n=1) and 72-hour missed (n=1))).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| One Insert | Tenofovir Alafenamide (TAF) Concentration in Rectal Mucosal Tissue Homogenates | 2 hours postdosing | NA ng/mg |
| One Insert | Tenofovir Alafenamide (TAF) Concentration in Rectal Mucosal Tissue Homogenates | 24 hours postdosing | NA ng/mg |
| One Insert | Tenofovir Alafenamide (TAF) Concentration in Rectal Mucosal Tissue Homogenates | 48 hours postdosing | NA ng/mg |
| One Insert | Tenofovir Alafenamide (TAF) Concentration in Rectal Mucosal Tissue Homogenates | 72 hours postdosing | NA ng/mg |
| Two Inserts | Tenofovir Alafenamide (TAF) Concentration in Rectal Mucosal Tissue Homogenates | 72 hours postdosing | NA ng/mg |
| Two Inserts | Tenofovir Alafenamide (TAF) Concentration in Rectal Mucosal Tissue Homogenates | 2 hours postdosing | NA ng/mg |
| Two Inserts | Tenofovir Alafenamide (TAF) Concentration in Rectal Mucosal Tissue Homogenates | 48 hours postdosing | NA ng/mg |
| Two Inserts | Tenofovir Alafenamide (TAF) Concentration in Rectal Mucosal Tissue Homogenates | 24 hours postdosing | NA ng/mg |
Primary
Tenofovir Diphosphate (TFV-DP) Concentration in Rectal Mucosal Tissue Cell Isolates
Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose
Time frame: Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Population: Participants are randomly assigned 1:1 to post dose rectal tissue sampling at either 2 and 48 hours (One insert (n=10)); Two inserts (n=9)) or 24 and 72 hours (One insert (n=11); Two inserts (n=10)).~Missed sample collection (One insert (24-hour missed (n=1)); Two inserts (48-hour missed (n=1) and 72-hour missed (n=1))).~Rejected samples, no results (One insert (2-hours (n=2) and 48-hours (n=2)); Two inserts (48-hours (n=1) and 72-hours (n=1))).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| One Insert | Tenofovir Diphosphate (TFV-DP) Concentration in Rectal Mucosal Tissue Cell Isolates | 2 hours postdosing | 8219.0 fmol/10^6 Cells |
| One Insert | Tenofovir Diphosphate (TFV-DP) Concentration in Rectal Mucosal Tissue Cell Isolates | 24 hours postdosing | 2315.5 fmol/10^6 Cells |
| One Insert | Tenofovir Diphosphate (TFV-DP) Concentration in Rectal Mucosal Tissue Cell Isolates | 48 hours postdosing | 2459.0 fmol/10^6 Cells |
| One Insert | Tenofovir Diphosphate (TFV-DP) Concentration in Rectal Mucosal Tissue Cell Isolates | 72 hours postdosing | 149.0 fmol/10^6 Cells |
| Two Inserts | Tenofovir Diphosphate (TFV-DP) Concentration in Rectal Mucosal Tissue Cell Isolates | 72 hours postdosing | 2022.0 fmol/10^6 Cells |
| Two Inserts | Tenofovir Diphosphate (TFV-DP) Concentration in Rectal Mucosal Tissue Cell Isolates | 2 hours postdosing | 6230.0 fmol/10^6 Cells |
| Two Inserts | Tenofovir Diphosphate (TFV-DP) Concentration in Rectal Mucosal Tissue Cell Isolates | 48 hours postdosing | 2822.0 fmol/10^6 Cells |
| Two Inserts | Tenofovir Diphosphate (TFV-DP) Concentration in Rectal Mucosal Tissue Cell Isolates | 24 hours postdosing | 6727.0 fmol/10^6 Cells |
Primary
Tenofovir (TFV) Concentration in Blood
Based on laboratory evaluations on samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours post dose
Time frame: Samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Population: Baseline data were collected once at the enrollment visit prior to receiving both one insert and two inserts.~Participants had post dose blood samples collected at 1, 2, 4, 6, 24, 48, and 72 hours (One insert (n=21); Two inserts (n=19))).~Missed sample collection (One insert (24-hour missed (n=1)); Two inserts (48-hour missed (n=1) and 72-hour missed (n=1))).~Unable to draw sample (One insert (72-hours (n=1))).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| One Insert | Tenofovir (TFV) Concentration in Blood | Baseline (Enrollment visit) | NA pg/mL |
| One Insert | Tenofovir (TFV) Concentration in Blood | 1 hour postdosing | 1290.0 pg/mL |
| One Insert | Tenofovir (TFV) Concentration in Blood | 2 hours postdosing | 2080.0 pg/mL |
| One Insert | Tenofovir (TFV) Concentration in Blood | 4 hours postdosing | 2380.0 pg/mL |
| One Insert | Tenofovir (TFV) Concentration in Blood | 6 hours postdosing | 1780.0 pg/mL |
| One Insert | Tenofovir (TFV) Concentration in Blood | 24 hours postdosing | 1105.0 pg/mL |
| One Insert | Tenofovir (TFV) Concentration in Blood | 48 hours postdosing | 570.0 pg/mL |
| One Insert | Tenofovir (TFV) Concentration in Blood | 72 hours postdosing | 340.5 pg/mL |
| Two Inserts | Tenofovir (TFV) Concentration in Blood | 6 hours postdosing | 3420.0 pg/mL |
| Two Inserts | Tenofovir (TFV) Concentration in Blood | 1 hour postdosing | 2140.0 pg/mL |
| Two Inserts | Tenofovir (TFV) Concentration in Blood | 48 hours postdosing | 1085.0 pg/mL |
| Two Inserts | Tenofovir (TFV) Concentration in Blood | 2 hours postdosing | 3700.0 pg/mL |
| Two Inserts | Tenofovir (TFV) Concentration in Blood | 24 hours postdosing | 1910.0 pg/mL |
| Two Inserts | Tenofovir (TFV) Concentration in Blood | 4 hours postdosing | 4080.0 pg/mL |
| Two Inserts | Tenofovir (TFV) Concentration in Blood | 72 hours postdosing | 687.0 pg/mL |
Primary
Tenofovir (TFV) Concentration in Rectal Fluid
Based on laboratory evaluations on samples collected at 2, 4, 6, 24, 48, and 72 hours post dose
Time frame: Samples collected at 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Population: Participants are randomly assigned 1:1 to post dose rectal fluid sampling at either 2, 6, and 48 hours (One insert (n=10); Two inserts (n=9)) or 4, 24, and 72 hours (One insert (n=11); Two inserts (n=10)).~Missed sample collection (One insert (24-hour missed (n=1) but replaced by 48-hour sample); Two inserts (48-hour missed (n=1))).~Rejected samples, no results (One insert (2-hours (n=1), 4-hours (n=2), and 6-hours (n=2)); Two inserts (6-hours (n=1) and 48-hours (n=1))).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| One Insert | Tenofovir (TFV) Concentration in Rectal Fluid | 2 hours postdosing | 18086.0 ng/mL |
| One Insert | Tenofovir (TFV) Concentration in Rectal Fluid | 4 hours post dosing | 85434.0 ng/mL |
| One Insert | Tenofovir (TFV) Concentration in Rectal Fluid | 6 hours postdosing | 9794.0 ng/mL |
| One Insert | Tenofovir (TFV) Concentration in Rectal Fluid | 24 hours postdosing | 2909.0 ng/mL |
| One Insert | Tenofovir (TFV) Concentration in Rectal Fluid | 48 hours postdosing | 924.0 ng/mL |
| One Insert | Tenofovir (TFV) Concentration in Rectal Fluid | 72 hours postdosing | 380.0 ng/mL |
| Two Inserts | Tenofovir (TFV) Concentration in Rectal Fluid | 48 hours postdosing | 1057.0 ng/mL |
| Two Inserts | Tenofovir (TFV) Concentration in Rectal Fluid | 2 hours postdosing | 43188.0 ng/mL |
| Two Inserts | Tenofovir (TFV) Concentration in Rectal Fluid | 24 hours postdosing | 8276.5 ng/mL |
| Two Inserts | Tenofovir (TFV) Concentration in Rectal Fluid | 4 hours post dosing | 100834.5 ng/mL |
| Two Inserts | Tenofovir (TFV) Concentration in Rectal Fluid | 72 hours postdosing | 545.5 ng/mL |
| Two Inserts | Tenofovir (TFV) Concentration in Rectal Fluid | 6 hours postdosing | 10214.5 ng/mL |
Primary
Tenofovir (TFV) Concentration in Rectal Mucosal Tissue Homogenates
Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose
Time frame: Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Population: Participants are randomly assigned 1:1 to post dose rectal tissue sampling at either 2 and 48 hours (One insert (n=10)); Two inserts (n=9)) or 24 and 72 hours (One insert (n=11); Two inserts (n=10)).~Missed sample collection (One insert (24-hour missed (n=1)); Two inserts (48-hour missed (n=1) and 72-hour missed (n=1))).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| One Insert | Tenofovir (TFV) Concentration in Rectal Mucosal Tissue Homogenates | 2 hours postdosing | 15.4 ng/mg |
| One Insert | Tenofovir (TFV) Concentration in Rectal Mucosal Tissue Homogenates | 24 hours postdosing | 1.5 ng/mg |
| One Insert | Tenofovir (TFV) Concentration in Rectal Mucosal Tissue Homogenates | 48 hours postdosing | 2.3 ng/mg |
| One Insert | Tenofovir (TFV) Concentration in Rectal Mucosal Tissue Homogenates | 72 hours postdosing | NA ng/mg |
| Two Inserts | Tenofovir (TFV) Concentration in Rectal Mucosal Tissue Homogenates | 72 hours postdosing | 1.0 ng/mg |
| Two Inserts | Tenofovir (TFV) Concentration in Rectal Mucosal Tissue Homogenates | 2 hours postdosing | 28.4 ng/mg |
| Two Inserts | Tenofovir (TFV) Concentration in Rectal Mucosal Tissue Homogenates | 48 hours postdosing | 3.3 ng/mg |
| Two Inserts | Tenofovir (TFV) Concentration in Rectal Mucosal Tissue Homogenates | 24 hours postdosing | 10.2 ng/mg |
Secondary
Participant Self-report Rectal Insert Acceptability - Ease of Use
Response for Overall, how easy or difficult was it to use the study product when inserted by clinic staff?
Time frame: 24 hours after each dose (Visits 4 and 8) (up to 9 weeks after first dose)
Population: All participants who completed the follow-up computer-administered self-interview (CASI) questionnaire at 24 hours post-dosing.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| One Insert | Participant Self-report Rectal Insert Acceptability - Ease of Use | Difficult | 0 Participants |
| One Insert | Participant Self-report Rectal Insert Acceptability - Ease of Use | Very easy | 14 Participants |
| One Insert | Participant Self-report Rectal Insert Acceptability - Ease of Use | Easy | 7 Participants |
| One Insert | Participant Self-report Rectal Insert Acceptability - Ease of Use | Decline to answer | 0 Participants |
| One Insert | Participant Self-report Rectal Insert Acceptability - Ease of Use | Very difficult | 0 Participants |
| Two Inserts | Participant Self-report Rectal Insert Acceptability - Ease of Use | Decline to answer | 0 Participants |
| Two Inserts | Participant Self-report Rectal Insert Acceptability - Ease of Use | Very difficult | 0 Participants |
| Two Inserts | Participant Self-report Rectal Insert Acceptability - Ease of Use | Difficult | 0 Participants |
| Two Inserts | Participant Self-report Rectal Insert Acceptability - Ease of Use | Easy | 8 Participants |
| Two Inserts | Participant Self-report Rectal Insert Acceptability - Ease of Use | Very easy | 11 Participants |
Secondary
Participant Self-report Rectal Insert Acceptability - Feeling When Inserted
Response for How did it feel to have the insert inside you?
Time frame: 24 hours after each dose (Visits 4 and 8) (up to 9 weeks after first dose)
Population: All participants who completed the follow-up computer-administered self-interview (CASI) questionnaire at 24 hours post-dosing.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| One Insert | Participant Self-report Rectal Insert Acceptability - Feeling When Inserted | Comfortable | 10 Participants |
| One Insert | Participant Self-report Rectal Insert Acceptability - Feeling When Inserted | Very uncomfortable | 0 Participants |
| One Insert | Participant Self-report Rectal Insert Acceptability - Feeling When Inserted | Uncomfortable | 2 Participants |
| One Insert | Participant Self-report Rectal Insert Acceptability - Feeling When Inserted | Decline to answer | 1 Participants |
| One Insert | Participant Self-report Rectal Insert Acceptability - Feeling When Inserted | Very comfortable | 8 Participants |
| Two Inserts | Participant Self-report Rectal Insert Acceptability - Feeling When Inserted | Decline to answer | 0 Participants |
| Two Inserts | Participant Self-report Rectal Insert Acceptability - Feeling When Inserted | Very comfortable | 8 Participants |
| Two Inserts | Participant Self-report Rectal Insert Acceptability - Feeling When Inserted | Comfortable | 10 Participants |
| Two Inserts | Participant Self-report Rectal Insert Acceptability - Feeling When Inserted | Uncomfortable | 1 Participants |
| Two Inserts | Participant Self-report Rectal Insert Acceptability - Feeling When Inserted | Very uncomfortable | 0 Participants |
Secondary
Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert
Responses for questions related to problems with Rectal Insert
Time frame: 24 hours after each dose (Visits 4 and 8) (up to 9 weeks after first dose)
Population: All participants who completed the follow-up computer-administered self-interview (CASI) questionnaire at 24 hours post-dosing.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| One Insert | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Since your last study visit, have you experienced any diarrhea? | Yes | 1 Participants |
| One Insert | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Did you have any problems using the study insert after it was inserted? | No | 20 Participants |
| One Insert | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Did you have any problems using the study insert after it was inserted? | Yes | 1 Participants |
| One Insert | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Did you have any problems using the study insert after it was inserted? | Decline to answer | 0 Participants |
| One Insert | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Did you experience any leakage after you used the insert? | No | 20 Participants |
| One Insert | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Did you experience any leakage after you used the insert? | Yes | 1 Participants |
| One Insert | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Did you experience any leakage after you used the insert? | Decline to answer | 0 Participants |
| One Insert | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Since your last study visit, have you experienced any soiling of your underwear or linens? | No | 20 Participants |
| One Insert | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Since your last study visit, have you experienced any soiling of your underwear or linens? | Yes | 1 Participants |
| One Insert | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Since your last study visit, have you experienced any soiling of your underwear or linens? | Decline to answer | 0 Participants |
| One Insert | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Since your last study visit, have you experienced any diarrhea? | No | 20 Participants |
| One Insert | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Since your last study visit, have you experienced any diarrhea? | Decline to answer | 0 Participants |
| One Insert | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Since your last visit, have you experienced any other stomach or abdominal problems? | No | 12 Participants |
| One Insert | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Since your last visit, have you experienced any other stomach or abdominal problems? | Yes | 9 Participants |
| One Insert | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Since your last visit, have you experienced any other stomach or abdominal problems? | Decline to answer | 0 Participants |
| Two Inserts | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Since your last study visit, have you experienced any diarrhea? | Decline to answer | 0 Participants |
| Two Inserts | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Since your last study visit, have you experienced any soiling of your underwear or linens? | Yes | 1 Participants |
| Two Inserts | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Did you have any problems using the study insert after it was inserted? | No | 19 Participants |
| Two Inserts | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Since your last visit, have you experienced any other stomach or abdominal problems? | Yes | 10 Participants |
| Two Inserts | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Did you have any problems using the study insert after it was inserted? | Yes | 0 Participants |
| Two Inserts | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Since your last study visit, have you experienced any soiling of your underwear or linens? | Decline to answer | 0 Participants |
| Two Inserts | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Did you have any problems using the study insert after it was inserted? | Decline to answer | 0 Participants |
| Two Inserts | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Since your last visit, have you experienced any other stomach or abdominal problems? | No | 9 Participants |
| Two Inserts | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Did you experience any leakage after you used the insert? | No | 18 Participants |
| Two Inserts | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Since your last study visit, have you experienced any diarrhea? | No | 18 Participants |
| Two Inserts | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Did you experience any leakage after you used the insert? | Yes | 1 Participants |
| Two Inserts | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Since your last study visit, have you experienced any diarrhea? | Yes | 1 Participants |
| Two Inserts | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Did you experience any leakage after you used the insert? | Decline to answer | 0 Participants |
| Two Inserts | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Since your last visit, have you experienced any other stomach or abdominal problems? | Decline to answer | 0 Participants |
| Two Inserts | Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert | Since your last study visit, have you experienced any soiling of your underwear or linens? | No | 18 Participants |