PreTerm Birth
Conditions
Keywords
PreTerm Birth, HIV, Vaginal Progesterone, ART, Adherence, Feasibility
Brief summary
More than 1.5 million HIV-infected women become pregnant each year. Approximately half have access to antiretroviral therapy (ART), but all are at increased risk of preterm birth (PTB). Vaginal progesterone (VP) is a promising and cost-effective intervention to prevent PTB that should be studied in this high-risk population. This pilot study will provide critical insight into the feasibility of a phase III trial by determining whether women are willing to participate, to adhere to study drug, and to complete follow-up.
Detailed description
This will be a mixed method study to evaluate the feasibility and acceptability of a trial of VP to prevent PTB among HIV-infected Zambian women. To assess the feasibility of a full-scale clinical trial, the investigators will implement a pilot two-arm, double-masked, placebo-controlled trial of VP among HIV-infected women in antenatal care in Lusaka, Zambia. Participants will be randomly assigned to either daily self-administered VP or indistinguishable placebo prior to 24 weeks gestational age. In this pilot study, the investigators will be able to estimate study uptake, adherence to study product and protocol, and study retention. To assess the acceptability of a trial to test VP among HIV-infected women in Zambia, the investigators will employ a qualitative approach of longitudinal semi-structured interviews among women agreeing to trial participation and one-time semi-structured interviews (SSIs) among those who decline to participate.
Interventions
DRUGVaginal Progesterone
200 mg micronized vaginal progesterone suppository
DRUGPlacebo
Indistinguishable placebo vaginal suppository
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older 2. viable intrauterine pregnancy confirmed by ultrasound 3. presentation to antenatal care prior to 24 weeks gestation 4. antibody-confirmed HIV-1 infection 5. initiating or continuing ART treatment in pregnancy 6. ability and willingness to provide written informed consent 7. willing to adhere to study visit schedule
Exclusion criteria
1. multiple gestation 2. non-research indication for antenatal progesterone (i.e. prior spontaneous PTB and/or cervical length \<20mm on screening ultrasound) 3. planned or in situ cervical cerclage 4. evidence of threatened abortion, preterm labor, or ruptured membranes 5. major fetal anomaly detected on screening ultrasound 6. known uterine anomaly 7. known or suspected allergy or contraindication to VP or placebo components
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adequate Adherence to Study Product | Enrollment through 36th gestational week, an overall total of up to 17 weeks | Number of participants who achieved adequate adherence to study product, defined as proper self-administration of at least 80% of prescribed study product doses, as measured by a dye stain assay of returned applicators |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reported Barriers and Facilitators to Adherence to Study Product, Returning Used Applicators, and Retention in the Study | Late in pregnancy or postpartum | Number of participants reporting barriers and facilitators to study product adherence, returning used applicators, and retention in the study during a semi-structured interview. Participants were selected for an interview based on their overall adherence rates, including those with excellent adherence throughout the study and those with lower adherence rates early or late in their participation. A trained female staff member conducted each 30-minute interview using an interview guide. Interviews were audiotaped, transcribed, and translated into English as necessary. |
| Summary of Reported Knowledge, Attitudes, and Practices Related to HIV, Antiretroviral Therapy (ART), Risk of Preterm Birth, and Participation in Placebo Controlled Randomized Clinical Trials (RCTs) | Late in pregnancy or postpartum | Number of participants reporting attitudes and practices related to participation in placebo controlled RCTs during a semi-structured interview. Participants were selected for an interview based on their overall adherence rates, including those with excellent adherence throughout the study and those with lower adherence rates early or late in their participation. A trained female staff member conducted each 30-minute interview using an interview guide. Participants were asked about their attitudes toward participation in the study and research in general as HIV-infected women taking ART and at risk of preterm birth, but they were not specifically asked about their underlying knowledge of these conditions. Interviews were audio-taped, transcribed, and translated into English as necessary. |
| Acceptability of a Vaginal Medication to Prevent Preterm Birth | Visit 9.0 (36 weeks of gestation) | Number of participants reporting specific attitudes about medications for the prevention of preterm birth (PTB), including acceptability of daily vaginal administration as measured on the Exit Satisfaction Survey using a Likert scale of five possible options ranging from strongly agree to strongly disagree. The form included a range of facial illustrations to facilitate comprehension of the answer choices, particularly for illiterate participants. |
| Reported Barriers to Adherence to Study Product | Visit 9.0 (36 weeks of gestation) | Number of participants reporting challenges with taking the study medication as measured on the Exit Satisfaction Survey. The survey was administered by a study nurse who asked each participant what was the hardest part about taking the medication and presented all possible answer choices. Participant were asked to select only one answer. |
| Sensitivity, Specificity, and Predictive Value of Dose Diaries | Enrollment through 36th gestational week, an overall total of up to 17 weeks | Comparison of self-reported adherence rates (Dose Diary/DD) and use of returned applicators measured by dye stain assay (DSA) |
| Acceptability of Use of Vaginal Progesterone (VP) | At enrollment (20-24 weeks gestation), at 28 weeks gestation, and at 36 weeks gestation | Semi-structured interviews will be held with a random sample of participants who enroll and those who decline enrollment. |
| Ascertainment of Date of Delivery and Infant Vital Status | Visit 10.0 (Delivery) | Number of women for whom date of delivery and infant vital status at birth was ascertained |
| Preliminary Efficacy | Visit 10.0 (Delivery) | Number of participants delivering before 34 and 37 completed weeks of gestation, grouped based on whether the participant went into labor spontaneously or was induced by a provider |
| Birth Weight | Visit 10.0 (Delivery) | Number of participants with neonates weighing less than 2500 grams at birth |
| Stillbirth | Visit 10.0 (Delivery) | Number of participants who experienced a stillbirth |
| Adverse Events | Enrollment through Visit 10.0 (Delivery) | Number of women experiencing a serious adverse event or event that resulted in study product discontinuation |
| Enrollment of Eligible Participants | Screening through Enrollment | Number of eligible participants who enrolled in the study |
Countries
Zambia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vaginal Progesterone Daily self-administered vaginal progesterone
Vaginal Progesterone: 200 mg micronized vaginal progesterone suppository | 70 |
| Placebo Daily self-administered indistinguishable placebo
Placebo: Indistinguishable placebo vaginal suppository | 70 |
| Total | 140 |
Baseline characteristics
| Characteristic | Vaginal Progesterone | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants | 70 Participants | 140 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 70 Participants | 70 Participants | 140 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Zambia | 70 Participants | 70 Participants | 140 Participants |
| Sex: Female, Male Female | 70 Participants | 70 Participants | 140 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 70 |
| other Total, other adverse events | 34 / 70 | 29 / 70 |
| serious Total, serious adverse events | 3 / 70 | 2 / 70 |
Outcome results
Primary
Adequate Adherence to Study Product
Number of participants who achieved adequate adherence to study product, defined as proper self-administration of at least 80% of prescribed study product doses, as measured by a dye stain assay of returned applicators
Time frame: Enrollment through 36th gestational week, an overall total of up to 17 weeks
Population: Participants who returned for at least one follow-up study visit following enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vaginal Progesterone | Adequate Adherence to Study Product | 62 Participants |
| Placebo | Adequate Adherence to Study Product | 63 Participants |
Secondary
Acceptability of a Vaginal Medication to Prevent Preterm Birth
Number of participants reporting specific attitudes about medications for the prevention of preterm birth (PTB), including acceptability of daily vaginal administration as measured on the Exit Satisfaction Survey using a Likert scale of five possible options ranging from strongly agree to strongly disagree. The form included a range of facial illustrations to facilitate comprehension of the answer choices, particularly for illiterate participants.
Time frame: Visit 9.0 (36 weeks of gestation)
Population: 131 randomized participants who completed an exit satisfaction survey
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Vaginal Progesterone | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Happy that I took part in the study | Strongly disagree | 0 Participants |
| Vaginal Progesterone | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Happy that I took part in the study | Disagree | 0 Participants |
| Vaginal Progesterone | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Happy that I took part in the study | Neutral | 0 Participants |
| Vaginal Progesterone | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Happy that I took part in the study | Agree | 1 Participants |
| Vaginal Progesterone | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Happy that I took part in the study | Strongly agree | 66 Participants |
| Vaginal Progesterone | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Did not mind taking daily vaginal medication | Strongly disagree | 0 Participants |
| Vaginal Progesterone | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Did not mind taking daily vaginal medication | Disagree | 0 Participants |
| Vaginal Progesterone | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Did not mind taking daily vaginal medication | Neutral | 0 Participants |
| Vaginal Progesterone | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Did not mind taking daily vaginal medication | Agree | 9 Participants |
| Vaginal Progesterone | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Did not mind taking daily vaginal medication | Strongly agree | 58 Participants |
| Vaginal Progesterone | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Would choose daily vag med over wkly injection | Strongly disagree | 13 Participants |
| Vaginal Progesterone | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Would choose daily vag med over wkly injection | Disagree | 3 Participants |
| Vaginal Progesterone | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Would choose daily vag med over wkly injection | Neutral | 1 Participants |
| Vaginal Progesterone | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Would choose daily vag med over wkly injection | Agree | 7 Participants |
| Vaginal Progesterone | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Would choose daily vag med over wkly injection | Strongly agree | 43 Participants |
| Vaginal Progesterone | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Other women would like to take med to stop PTB | Strongly disagree | 1 Participants |
| Vaginal Progesterone | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Other women would like to take med to stop PTB | Disagree | 1 Participants |
| Vaginal Progesterone | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Other women would like to take med to stop PTB | Neutral | 9 Participants |
| Vaginal Progesterone | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Other women would like to take med to stop PTB | Agree | 16 Participants |
| Vaginal Progesterone | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Other women would like to take med to stop PTB | Strongly agree | 40 Participants |
| Placebo | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Other women would like to take med to stop PTB | Neutral | 3 Participants |
| Placebo | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Happy that I took part in the study | Strongly disagree | 0 Participants |
| Placebo | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Would choose daily vag med over wkly injection | Strongly disagree | 15 Participants |
| Placebo | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Happy that I took part in the study | Disagree | 0 Participants |
| Placebo | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Other women would like to take med to stop PTB | Strongly disagree | 0 Participants |
| Placebo | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Happy that I took part in the study | Neutral | 1 Participants |
| Placebo | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Would choose daily vag med over wkly injection | Disagree | 0 Participants |
| Placebo | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Happy that I took part in the study | Agree | 3 Participants |
| Placebo | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Other women would like to take med to stop PTB | Strongly agree | 44 Participants |
| Placebo | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Happy that I took part in the study | Strongly agree | 60 Participants |
| Placebo | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Would choose daily vag med over wkly injection | Neutral | 2 Participants |
| Placebo | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Did not mind taking daily vaginal medication | Strongly disagree | 0 Participants |
| Placebo | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Other women would like to take med to stop PTB | Disagree | 2 Participants |
| Placebo | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Did not mind taking daily vaginal medication | Disagree | 0 Participants |
| Placebo | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Would choose daily vag med over wkly injection | Agree | 5 Participants |
| Placebo | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Did not mind taking daily vaginal medication | Neutral | 1 Participants |
| Placebo | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Other women would like to take med to stop PTB | Agree | 15 Participants |
| Placebo | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Did not mind taking daily vaginal medication | Agree | 3 Participants |
| Placebo | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Would choose daily vag med over wkly injection | Strongly agree | 42 Participants |
| Placebo | Acceptability of a Vaginal Medication to Prevent Preterm Birth | Did not mind taking daily vaginal medication | Strongly agree | 60 Participants |
Secondary
Acceptability of Use of Vaginal Progesterone (VP)
Semi-structured interviews will be held with a random sample of participants who enroll and those who decline enrollment.
Time frame: At enrollment (20-24 weeks gestation), at 28 weeks gestation, and at 36 weeks gestation
Population: Activation was delayed by 6 months because of a protracted regulatory process. Resulting low resources limited investigators' ability to conduct interviews at all specified times or with decliners. Investigators did conduct a single interview with a sample of participants late in pregnancy or postpartum; these data are captured in outcomes #3 and 4
Secondary
Adverse Events
Number of women experiencing a serious adverse event or event that resulted in study product discontinuation
Time frame: Enrollment through Visit 10.0 (Delivery)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaginal Progesterone | Adverse Events | Pre-eclampsia | 1 Participants |
| Vaginal Progesterone | Adverse Events | Stillbirth | 2 Participants |
| Placebo | Adverse Events | Pre-eclampsia | 0 Participants |
| Placebo | Adverse Events | Stillbirth | 2 Participants |
Secondary
Ascertainment of Date of Delivery and Infant Vital Status
Number of women for whom date of delivery and infant vital status at birth was ascertained
Time frame: Visit 10.0 (Delivery)
Population: All enrolled participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vaginal Progesterone | Ascertainment of Date of Delivery and Infant Vital Status | 67 Participants |
| Placebo | Ascertainment of Date of Delivery and Infant Vital Status | 67 Participants |
Secondary
Birth Weight
Number of participants with neonates weighing less than 2500 grams at birth
Time frame: Visit 10.0 (Delivery)
Population: Randomized participants with birth weight data ascertained
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vaginal Progesterone | Birth Weight | 9 Participants |
| Placebo | Birth Weight | 12 Participants |
Secondary
Enrollment of Eligible Participants
Number of eligible participants who enrolled in the study
Time frame: Screening through Enrollment
Population: Women with a completed ultrasound who were eligible for study screening procedures
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaginal Progesterone | Enrollment of Eligible Participants | Randomized | 140 Participants |
| Vaginal Progesterone | Enrollment of Eligible Participants | Successfully Screened | 154 Participants |
Secondary
Preliminary Efficacy
Number of participants delivering before 34 and 37 completed weeks of gestation, grouped based on whether the participant went into labor spontaneously or was induced by a provider
Time frame: Visit 10.0 (Delivery)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaginal Progesterone | Preliminary Efficacy | Preterm birth <37 weeks | 9 Participants |
| Vaginal Progesterone | Preliminary Efficacy | Spontaneous preterm birth <37 weeks | 8 Participants |
| Vaginal Progesterone | Preliminary Efficacy | Preterm birth <34 weeks | 5 Participants |
| Vaginal Progesterone | Preliminary Efficacy | Spontaneous preterm birth <34 weeks | 4 Participants |
| Placebo | Preliminary Efficacy | Spontaneous preterm birth <34 weeks | 6 Participants |
| Placebo | Preliminary Efficacy | Preterm birth <37 weeks | 10 Participants |
| Placebo | Preliminary Efficacy | Preterm birth <34 weeks | 6 Participants |
| Placebo | Preliminary Efficacy | Spontaneous preterm birth <37 weeks | 10 Participants |
Secondary
Reported Barriers and Facilitators to Adherence to Study Product, Returning Used Applicators, and Retention in the Study
Number of participants reporting barriers and facilitators to study product adherence, returning used applicators, and retention in the study during a semi-structured interview. Participants were selected for an interview based on their overall adherence rates, including those with excellent adherence throughout the study and those with lower adherence rates early or late in their participation. A trained female staff member conducted each 30-minute interview using an interview guide. Interviews were audiotaped, transcribed, and translated into English as necessary.
Time frame: Late in pregnancy or postpartum
Population: A sample of enrolled participants selected to participate in a semi-structured interview. Investigators included 30 trial participants based on expectations regarding saturation of qualitative themes.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaginal Progesterone | Reported Barriers and Facilitators to Adherence to Study Product, Returning Used Applicators, and Retention in the Study | Discontinued med due to challenges or discomfort | 0 Participants |
| Vaginal Progesterone | Reported Barriers and Facilitators to Adherence to Study Product, Returning Used Applicators, and Retention in the Study | Reported barrier to returning used applicators | 0 Participants |
| Vaginal Progesterone | Reported Barriers and Facilitators to Adherence to Study Product, Returning Used Applicators, and Retention in the Study | Reported any barriers to medication use | 7 Participants |
| Vaginal Progesterone | Reported Barriers and Facilitators to Adherence to Study Product, Returning Used Applicators, and Retention in the Study | Reported barriers to returning for study visits | 2 Participants |
| Vaginal Progesterone | Reported Barriers and Facilitators to Adherence to Study Product, Returning Used Applicators, and Retention in the Study | Reported positive experience with study clinic | 19 Participants |
| Vaginal Progesterone | Reported Barriers and Facilitators to Adherence to Study Product, Returning Used Applicators, and Retention in the Study | Reported any facilitators to medication use | 19 Participants |
| Placebo | Reported Barriers and Facilitators to Adherence to Study Product, Returning Used Applicators, and Retention in the Study | Reported positive experience with study clinic | 11 Participants |
| Placebo | Reported Barriers and Facilitators to Adherence to Study Product, Returning Used Applicators, and Retention in the Study | Reported any barriers to medication use | 1 Participants |
| Placebo | Reported Barriers and Facilitators to Adherence to Study Product, Returning Used Applicators, and Retention in the Study | Discontinued med due to challenges or discomfort | 0 Participants |
| Placebo | Reported Barriers and Facilitators to Adherence to Study Product, Returning Used Applicators, and Retention in the Study | Reported any facilitators to medication use | 11 Participants |
| Placebo | Reported Barriers and Facilitators to Adherence to Study Product, Returning Used Applicators, and Retention in the Study | Reported barrier to returning used applicators | 0 Participants |
| Placebo | Reported Barriers and Facilitators to Adherence to Study Product, Returning Used Applicators, and Retention in the Study | Reported barriers to returning for study visits | 0 Participants |
Secondary
Reported Barriers to Adherence to Study Product
Number of participants reporting challenges with taking the study medication as measured on the Exit Satisfaction Survey. The survey was administered by a study nurse who asked each participant what was the hardest part about taking the medication and presented all possible answer choices. Participant were asked to select only one answer.
Time frame: Visit 9.0 (36 weeks of gestation)
Population: 131 randomized participants who completed an exit satisfaction survey
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaginal Progesterone | Reported Barriers to Adherence to Study Product | Remembering to take it | 0 Participants |
| Vaginal Progesterone | Reported Barriers to Adherence to Study Product | Didn't like using the product | 0 Participants |
| Vaginal Progesterone | Reported Barriers to Adherence to Study Product | Obtaining refills at clinic | 0 Participants |
| Vaginal Progesterone | Reported Barriers to Adherence to Study Product | Disclosing participation to partner or family | 0 Participants |
| Vaginal Progesterone | Reported Barriers to Adherence to Study Product | Inserting the medication | 1 Participants |
| Vaginal Progesterone | Reported Barriers to Adherence to Study Product | Nothing was hard about taking the medication | 66 Participants |
| Placebo | Reported Barriers to Adherence to Study Product | Inserting the medication | 0 Participants |
| Placebo | Reported Barriers to Adherence to Study Product | Remembering to take it | 2 Participants |
| Placebo | Reported Barriers to Adherence to Study Product | Disclosing participation to partner or family | 0 Participants |
| Placebo | Reported Barriers to Adherence to Study Product | Didn't like using the product | 0 Participants |
| Placebo | Reported Barriers to Adherence to Study Product | Nothing was hard about taking the medication | 62 Participants |
| Placebo | Reported Barriers to Adherence to Study Product | Obtaining refills at clinic | 0 Participants |
Secondary
Sensitivity, Specificity, and Predictive Value of Dose Diaries
Comparison of self-reported adherence rates (Dose Diary/DD) and use of returned applicators measured by dye stain assay (DSA)
Time frame: Enrollment through 36th gestational week, an overall total of up to 17 weeks
Population: Dose diaries completed by randomized participants returned at each follow-up visit, reported among participants who returned for at least 1 visit. Outcome assessed the reliability of dose diaries against DSA gold standard regardless of study arm to measure feasibility for future use. Estimates are presented in aggregate per original analysis plan.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaginal Progesterone | Sensitivity, Specificity, and Predictive Value of Dose Diaries | Sensitivity Pr(DD+/DSA+) | 0.999 Proportion of ppts correctly identified |
| Vaginal Progesterone | Sensitivity, Specificity, and Predictive Value of Dose Diaries | Specificity Pr(DD-/DSA-) | 0.571 Proportion of ppts correctly identified |
| Vaginal Progesterone | Sensitivity, Specificity, and Predictive Value of Dose Diaries | Positive Predictive Value Pr(DSA+/DD+) | 0.985 Proportion of ppts correctly identified |
| Vaginal Progesterone | Sensitivity, Specificity, and Predictive Value of Dose Diaries | Negative Predictive Value Pr(DSA-/DD-) | 0.975 Proportion of ppts correctly identified |
Secondary
Stillbirth
Number of participants who experienced a stillbirth
Time frame: Visit 10.0 (Delivery)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vaginal Progesterone | Stillbirth | 2 Participants |
| Placebo | Stillbirth | 2 Participants |
Secondary
Summary of Reported Knowledge, Attitudes, and Practices Related to HIV, Antiretroviral Therapy (ART), Risk of Preterm Birth, and Participation in Placebo Controlled Randomized Clinical Trials (RCTs)
Number of participants reporting attitudes and practices related to participation in placebo controlled RCTs during a semi-structured interview. Participants were selected for an interview based on their overall adherence rates, including those with excellent adherence throughout the study and those with lower adherence rates early or late in their participation. A trained female staff member conducted each 30-minute interview using an interview guide. Participants were asked about their attitudes toward participation in the study and research in general as HIV-infected women taking ART and at risk of preterm birth, but they were not specifically asked about their underlying knowledge of these conditions. Interviews were audio-taped, transcribed, and translated into English as necessary.
Time frame: Late in pregnancy or postpartum
Population: A sample of enrolled participants selected to participate in a semi-structured interview. Investigators included 30 trial participants based on expectations regarding saturation of qualitative themes.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaginal Progesterone | Summary of Reported Knowledge, Attitudes, and Practices Related to HIV, Antiretroviral Therapy (ART), Risk of Preterm Birth, and Participation in Placebo Controlled Randomized Clinical Trials (RCTs) | Belief that being in the study prevented PTB | 15 Participants |
| Vaginal Progesterone | Summary of Reported Knowledge, Attitudes, and Practices Related to HIV, Antiretroviral Therapy (ART), Risk of Preterm Birth, and Participation in Placebo Controlled Randomized Clinical Trials (RCTs) | Belief that women might refuse a placebo RCT | 9 Participants |
| Vaginal Progesterone | Summary of Reported Knowledge, Attitudes, and Practices Related to HIV, Antiretroviral Therapy (ART), Risk of Preterm Birth, and Participation in Placebo Controlled Randomized Clinical Trials (RCTs) | Disclosed study participation to others | 19 Participants |
| Placebo | Summary of Reported Knowledge, Attitudes, and Practices Related to HIV, Antiretroviral Therapy (ART), Risk of Preterm Birth, and Participation in Placebo Controlled Randomized Clinical Trials (RCTs) | Belief that being in the study prevented PTB | 6 Participants |
| Placebo | Summary of Reported Knowledge, Attitudes, and Practices Related to HIV, Antiretroviral Therapy (ART), Risk of Preterm Birth, and Participation in Placebo Controlled Randomized Clinical Trials (RCTs) | Belief that women might refuse a placebo RCT | 3 Participants |
| Placebo | Summary of Reported Knowledge, Attitudes, and Practices Related to HIV, Antiretroviral Therapy (ART), Risk of Preterm Birth, and Participation in Placebo Controlled Randomized Clinical Trials (RCTs) | Disclosed study participation to others | 10 Participants |