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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD090987-01 | U.S. NIH Grant/Contract | View source | |
| Z 31606 | Other Identifier | IGHID |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal Progesterone | Active Comparator | Daily self-administered vaginal progesterone |
|
| Placebo | Placebo Comparator | Daily self-administered indistinguishable placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal Progesterone | Drug | 200 mg micronized vaginal progesterone suppository |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Enrollment through 36th gestational week, an overall total of up to 17 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At enrollment (20-24 weeks gestation), at 28 weeks gestation, and at 36 weeks gestation |
| Reported Barriers and Facilitators to Adherence to Study Product, Returning Used Applicators, and Retention in the Study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Stringer, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kamwala District Health Centre | Lusaka | Zambia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28729911 | Derived | Price JT, Mollan KR, Fuseini NM, Freeman BL, Mulenga HB, Corbett AH, Vwalika B, Stringer JSA. Vaginal progesterone to reduce preterm birth among HIV-infected pregnant women in Zambia: a feasibility study protocol. Pilot Feasibility Stud. 2017 Jul 18;4:21. doi: 10.1186/s40814-017-0170-7. eCollection 2018. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vaginal Progesterone | Daily self-administered vaginal progesterone Vaginal Progesterone: 200 mg micronized vaginal progesterone suppository |
| FG001 | Placebo | Daily self-administered indistinguishable placebo Placebo: Indistinguishable placebo vaginal suppository |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vaginal Progesterone | Daily self-administered vaginal progesterone Vaginal Progesterone: 200 mg micronized vaginal progesterone suppository |
| BG001 | Placebo | Daily self-administered indistinguishable placebo Placebo: Indistinguishable placebo vaginal suppository |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Participants who returned for at least one follow-up study visit following enrollment | Posted | Count of Participants | Participants | Enrollment through 36th gestational week, an overall total of up to 17 weeks |
|
From the time of enrollment through delivery, a total of approximately 16-20 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vaginal Progesterone | Daily self-administered vaginal progesterone Vaginal Progesterone: 200 mg micronized vaginal progesterone suppository |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stillbirth | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joan Price, MD, MPH | University of North Carolina at Chapel Hill | 919-962-4717 | joni@email.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 10, 2017 | Nov 6, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Placebo |
| Drug |
Indistinguishable placebo vaginal suppository |
|
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. |
| Late in pregnancy or postpartum |
| 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. | Late in pregnancy or postpartum |
| 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. | Visit 9.0 (36 weeks of gestation) |
| 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. | Visit 9.0 (36 weeks of gestation) |
| 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) | Enrollment through 36th gestational week, an overall total of up to 17 weeks |
| Enrollment of Eligible Participants | Number of eligible participants who enrolled in the study | Screening through Enrollment |
| 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 | Visit 10.0 (Delivery) |
| 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 | Visit 10.0 (Delivery) |
| Birth Weight | Number of participants with neonates weighing less than 2500 grams at birth | Visit 10.0 (Delivery) |
| Stillbirth | Number of participants who experienced a stillbirth | Visit 10.0 (Delivery) |
| Adverse Events | Number of women experiencing a serious adverse event or event that resulted in study product discontinuation | Enrollment through Visit 10.0 (Delivery) |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
Daily self-administered indistinguishable placebo
Placebo: Indistinguishable placebo vaginal suppository
|
|
| 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. | 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 | Posted | At enrollment (20-24 weeks gestation), at 28 weeks gestation, and at 36 weeks gestation |
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Late in pregnancy or postpartum |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Late in pregnancy or postpartum |
|
|
|
| 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. | 131 randomized participants who completed an exit satisfaction survey | Posted | Count of Participants | Participants | Visit 9.0 (36 weeks of gestation) |
|
|
|
| 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. | 131 randomized participants who completed an exit satisfaction survey | Posted | Count of Participants | Participants | Visit 9.0 (36 weeks of gestation) |
|
|
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| 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) | 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. | Posted | Number | 95% Confidence Interval | Proportion of ppts correctly identified | Enrollment through 36th gestational week, an overall total of up to 17 weeks | Daily dose diaries | Daily dose diaries |
|
|
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| Secondary | Enrollment of Eligible Participants | Number of eligible participants who enrolled in the study | Women with a completed ultrasound who were eligible for study screening procedures | Posted | Count of Participants | Participants | Screening through Enrollment |
|
|
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| 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 | All enrolled participants | Posted | Count of Participants | Participants | Visit 10.0 (Delivery) |
|
|
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| 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 | Posted | Count of Participants | Participants | Visit 10.0 (Delivery) |
|
|
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| Secondary | Birth Weight | Number of participants with neonates weighing less than 2500 grams at birth | Randomized participants with birth weight data ascertained | Posted | Count of Participants | Participants | Visit 10.0 (Delivery) |
|
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| Secondary | Stillbirth | Number of participants who experienced a stillbirth | Posted | Count of Participants | Participants | Visit 10.0 (Delivery) |
|
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| Secondary | Adverse Events | Number of women experiencing a serious adverse event or event that resulted in study product discontinuation | Posted | Count of Participants | Participants | Enrollment through Visit 10.0 (Delivery) |
|
|
|
| 0 |
| 70 |
| 3 |
| 70 |
| 34 |
| 70 |
| EG001 | Placebo | Daily self-administered indistinguishable placebo Placebo: Indistinguishable placebo vaginal suppository | 0 | 70 | 2 | 70 | 29 | 70 |
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Lower Abdominal Pain | General disorders | Systematic Assessment |
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| Vaginal Itching/Burning | Reproductive system and breast disorders | Systematic Assessment |
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| D000091642 | Urogenital Diseases |
| Reported any facilitators to medication use |
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| Reported barrier to returning used applicators |
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| Reported barriers to returning for study visits |
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| Reported positive experience with study clinic |
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| Disclosed study participation to others |
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| Neutral |
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| Agree |
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| Strongly agree |
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| Did not mind taking daily vaginal medication |
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| Would choose daily vag med over wkly injection |
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| Other women would like to take med to stop PTB |
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| Obtaining refills at clinic |
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| Disclosing participation to partner or family |
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| Inserting the medication |
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| Nothing was hard about taking the medication |
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| Negative Predictive Value Pr(DSA-/DD-) |
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| Preterm birth <34 weeks |
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| Spontaneous preterm birth <34 weeks |
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