Feasibility of Vaginal Progesterone to Reduce HIV-Associated Preterm Birth (VP)

University of North Carolina (UNC)

Status and phase: Completed; Phase 4

Conditions: PreTerm Birth

Treatments: Drug: Placebo; Drug: Vaginal Progesterone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02970552

16-2174

1R21HD090987-01 (U.S. NIH Grant/Contract)

Z 31606 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups, including a placebo group

Vaginal Progesterone

Active Comparator group

Description:

Daily self-administered vaginal progesterone

Treatment:

Drug: Vaginal Progesterone

Placebo

Placebo Comparator group

Description:

Daily self-administered indistinguishable placebo

Treatment:

Drug: Placebo