# PrEP Uptake/Adherence to Reduce Periconception HIV Risk for South African Women

> **NIH NIH R01** · UNIVERSITY OF ALABAMA AT BIRMINGHAM · 2020 · $288,561

## Abstract

PROJECT SUMMARY / ABSTRACT
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 perinatal transmission risks. Daily, oral
TDF/FTC PrEP dramatically reduces a woman’s risk of HIV-acquisition and is the only female-controlled option
for reducing her 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.
We are conducting a single-arm study to offer daily, oral PrEP for periconception use to 330 HIV-uninfected
women in KwaZulu-Natal, South Africa who report personal or partner plans for pregnancy with an infected or
unknown serostatus partner (R01MH108412). Women who become pregnant on PrEP have the option to
continue PrEP during pregnancy. PrEP is offered as part of a safer conception package inclusive of couples-
based HIV counseling and testing. In Aim 1, we evaluate the proportion of women initiating PrEP and
determine factors associated with uptake. In Aim 2, we evaluate objectively-measured PrEP adherence during
periconception and pregnancy follow-up. Level, patterns, and correlates of adherence are evaluated using
plasma drug concentrations and electronic pill caps. From formative studies in South Africa, we hypothesize
that adherence to a proven intervention (TDF/FTC PrEP) for a defined risk period (periconception, pregnancy)
with a clear end point (live birth) will be high (protective tenofovir concentrations at 80% of visits, adherence to
>80% of prescribed pills). In Aim 3, longitudinal quantitative data and in-depth interviews will inform our
conceptual framework for periconception PrEP uptake and adherence.
To date, we enrolled 330 women and 64% initiated PrEP. During the first 3 months, mean weekly adherence
was 71% (95% CI: 66-77%). This project will determine whether oral PrEP is a feasible HIV-prevention
strategy for HIV-exposed women who conceive. 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.
We now propose to supplement this proposal by adding STI testing and treatment in order to further minimize
HIV acquisition risks for this HIV-exposed population, describe curable STI prevalence and incidence among
women planning for or with pregnancy to inform STI and PrEP policy, explore how STI diagnosis influences
HIV risk perceptions, PrEP uptake, and adherence. The supplemental aims align with the Parent Study Aims
and address OAR priorities to reduce HIV incidence.

## Key facts

- **NIH application ID:** 10136184
- **Project number:** 3R01MH108412-05S1
- **Recipient organization:** UNIVERSITY OF ALABAMA AT BIRMINGHAM
- **Principal Investigator:** Lynn T Matthews
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $288,561
- **Award type:** 3
- **Project period:** 2016-08-25 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10136184

## Citation

> US National Institutes of Health, RePORTER application 10136184, PrEP Uptake/Adherence to Reduce Periconception HIV Risk for South African Women (3R01MH108412-05S1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10136184. Licensed CC0.

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