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Completed

NCT Number: NCT02970552

Feasibility of Vaginal Progesterone to Reduce HIV-Associated Preterm Birth

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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Kamwala District Health Centre

Lusaka, Zambia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older
  • viable intrauterine pregnancy confirmed by ultrasound
  • presentation to antenatal care prior to 24 weeks gestation
  • antibody-confirmed HIV-1 infection
  • initiating or continuing ART treatment in pregnancy
  • ability and willingness to provide written informed consent
  • willing to adhere to study visit schedule

Exclusion criteria

  • multiple gestation
  • non-research indication for antenatal progesterone (i.e. prior spontaneous PTB and/or cervical length <20mm on screening ultrasound)
  • planned or in situ cervical cerclage
  • evidence of threatened abortion, preterm labor, or ruptured membranes
  • major fetal anomaly detected on screening ultrasound
  • known uterine anomaly
  • known or suspected allergy or contraindication to VP or placebo components

Treatment and study plan

vaginal progesterone

Drug

200 mg micronized vaginal progesterone suppository

Placebo

Drug

Indistinguishable placebo vaginal suppository

Primary outcomes

  1. Adequate Adherence to Study Product

    Time frame: 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 outcomes

  1. Acceptability of Use of Vaginal Progesterone (VP)

    Time frame: 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.

  2. Reported Barriers and Facilitators to Adherence to Study Product, Returning Used Applicators, and Retention in the Study

    Time frame: 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.

  3. 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)

    Time frame: 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.

  4. Acceptability of a Vaginal Medication to Prevent Preterm Birth

    Time frame: 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.

  5. Reported Barriers to Adherence to Study Product

    Time frame: 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.

  6. Sensitivity, Specificity, and Predictive Value of Dose Diaries

    Time frame: 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)

  7. Enrollment of Eligible Participants

    Time frame: Screening through Enrollment

    Number of eligible participants who enrolled in the study

  8. Ascertainment of Date of Delivery and Infant Vital Status

    Time frame: Visit 10.0 (Delivery)

    Number of women for whom date of delivery and infant vital status at birth was ascertained

  9. Preliminary Efficacy

    Time frame: 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

  10. Birth Weight

    Time frame: Visit 10.0 (Delivery)

    Number of participants with neonates weighing less than 2500 grams at birth

  11. Stillbirth

    Time frame: Visit 10.0 (Delivery)

    Number of participants who experienced a stillbirth

  12. Adverse Events

    Time frame: Enrollment through Visit 10.0 (Delivery)

    Number of women experiencing a serious adverse event or event that resulted in study product discontinuation

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

A Pilot Study of Vaginal Progesterone to Reduce Preterm Birth Among Women Receiving Antiretroviral Therapy in Pregnancy

Acronym: VP

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 22, 2016
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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