Feasibility of Vaginal Progesterone to Reduce HIV-Associated Preterm Birth

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-11-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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PreTerm Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Vaginal Progesterone

Daily self-administered vaginal progesterone

Group Type ACTIVE_COMPARATOR

Vaginal Progesterone

Intervention Type DRUG

200 mg micronized vaginal progesterone suppository

Placebo

Daily self-administered indistinguishable placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Indistinguishable placebo vaginal suppository

Interventions

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Vaginal Progesterone

200 mg micronized vaginal progesterone suppository

Intervention Type DRUG

Placebo

Indistinguishable placebo vaginal suppository

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No