Safer Conception for Women - Understanding Use of Periconception PrEP

October 19, 2023 updated by: Lynn T Matthews, Massachusetts General Hospital

Safer Conception for Women: PrEP Uptake/Adherence to Reduce Periconception HIV Risk for South African Women

Women who choose to conceive with an infected or unknown serostatus partner in HIV-endemic settings need prevention strategies to reduce periconception HIV acquisition risk. Women at high risk for acquiring HIV during pregnancy need risk reduction strategies to protect themselves and their babies. Evaluating uptake of and adherence to antiretrovirals as pre-exposure prophylaxis in this population is crucial to understanding whether and how this novel prevention strategy should be incorporated into HIV-risk reduction packages for at- risk women planning or with pregnancy.

Study Overview

Status

Completed

Detailed Description

In HIV-endemic settings, many HIV-uninfected women choose to conceive with an HIV-infected or unknown-serostatus partner. For a woman who cannot depend on a partner to test, initiate and adhere to ART, sex without condoms puts her at high risk of acquiring HIV and increases the risk of perinatal transmission to her child. Daily, oral TDF/FTC PrEP dramatically reduces a woman's risk of HIV-acquisition and is the only female-controlled option for reducing the risk of periconception HIV-acquisition. Understanding whether daily, oral PrEP is feasible for uninfected women seeking pregnancy is critical to reducing HIV incidence among women and their children.

Placebo-controlled trials identified adherence as a major challenge to long-term PrEP use. However, women are eager for prevention strategies that allow for conception, and we hypothesize that adherence to a proven prevention strategy, for a limited time with the motivation to have a healthy child, will confer drug levels required to prevent HIV transmission. This project will inform whether daily, oral PrEP is a feasible HIV-prevention strategy for South African women who intend to conceive with risky partners. Given the repercussions of acquiring HIV during conception and pregnancy, this is an important step towards providing a key prevention strategy to women and their children.

Study Type

Interventional

Enrollment (Actual)

330

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4001
        • Maternal, Adolescent, and Child Health Research Unit (MRU)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female, Aged 18-35 years
  • Not pregnant, HIV-uninfected
  • Likely to be fertile based on responses to reproductive history assessment
  • Not on a long-acting family planning method
  • Likely to have a child in the next year, either by response to modified CDC Pregnancy Risk Assessment [2-5]), or meeting the other inclusion criteria.
  • With a stable (>= 6 months) partner she reports as HIV-infected or HIV-serostatus unknown, (if >1 desired pregnancy partner, we will ask her to identify the most likely pregnancy partner- based on her own assessment of sexual frequency, fertility, etc.)
  • Able to participate in the informed consent process
  • Fluent in English or isiZulu

Exclusion Criteria:

  • Living at or planning to relocate to a location incompatible with study participation in the next year
  • Active drug or alcohol use that, in the opinion of the research study team, would interfere with adherence to study requirements
  • Active illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry that in the opinion of the research study team, might otherwise interfere with adherence to study requirements
  • Inability to adhere to the study schedule and/or study procedures
  • Enrolment in studies which may conflict with their participation in this proposed study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: HIV-uninfected women
A sample of 350 HIV-uninfected women who are not currently pregnant, in a stable relationship (≥6 months) with a self-reported infected or unknown serostatus partner and personal or partner plans for pregnancy in the next 12 months. Women will be offered safer conception counseling based on South African guidelines plus daily, oral tenofovir/emtricitabine (TDF/FTC) as pre-exposure prophylaxis (PrEP) during periconception and pregnancy.
Evaluation of uptake of and adherence to PrEP and safer conception strategies including: CHCT, ART for the infected partner, and uptake of contraception for those who decide not to conceive by enrolled women, during periconception and pregnancy follow up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of uptake of and adherence to PrEP
Time Frame: minimum of 12 months through pregnancy outcome (maximum 21 months)
The primary objective will be the evaluation of uptake of (collection of one month's supply) and adherence to PrEP (measured by quarterly plasma tenofovir levels) by women, during periconception and pregnancy follow up.
minimum of 12 months through pregnancy outcome (maximum 21 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safer Conception Strategies
Time Frame: minimum of 12 months through pregnancy outcome (maximum 21 months)
Secondary outcomes include uptake of safer conception strategies including CHCT, ART for the infected partner, uptake of contraception for those who decide not to conceive; HIV transmission events, infant outcomes, and findings from qualitative interviews to further inform the conceptual framework for periconception PrEP uptake and adherence.
minimum of 12 months through pregnancy outcome (maximum 21 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lynn T Matthews, MD, MPH, Mass General Hosptial

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2017

Primary Completion (Actual)

July 21, 2021

Study Completion (Actual)

July 21, 2021

Study Registration Dates

First Submitted

June 19, 2017

First Submitted That Met QC Criteria

June 19, 2017

First Posted (Actual)

June 21, 2017

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2016P001535
  • 1R01MH108412 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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