# Combining PrEP with contraception: a pilot test of an intervention to increase adherence to PrEP in adolescent girls and young women in Zimbabwe

> **NIH NIH R34** · POPULATION COUNCIL · 2020 · $325,011

## Abstract

HIV is the leading cause of death in adolescent girls and young women (AGYW) aged 15-24 years. Despite advances in
HIV treatment and prevention, AGYW remain at high risk, particularly in sub-Saharan Africa. Oral pre-exposure
prophylaxis (PrEP) is highly effective and has the potential to make a dramatic impact on the HIV epidemic. Yet to date,
most trials of PrEP in women have been unable to demonstrate efficacy, largely due to poor adherence among AGYW.
Emerging evidence indicates that women may be more likely to use an HIV prevention method that also prevents
pregnancy. We will test an intervention consisting of a single oral capsule providing both PrEP and contraception – a
contraceptive multipurpose prevention technology (cMPT) – as a strategy for increasing PrEP adherence compared to oral
PrEP alone. We will enroll AGYW who already use a COCs in Harare, Zimbabwe, where AGYW continue to be at high
risk of HIV, more than half of contracepting women use COCs, and less than 1% of 15-35-year-old women are using
PrEP. The cMPT intervention will contain two marketed products: Truvada® [emtricitabine and tenofovir disoproxil
fumarate (TDF)] and a combined oral contraceptive (COC) [levonorgestrel (LNG)/ethinyl estradiol (EE)]. This research
will implemented through a collaboration between the Population Council, which has global expertise in clinical trial,
implementation science, feasibility studies and evaluation around female-initiated HIV prevention methods, and the
University of Zimbabwe College of Health Sciences (UZCHS), which has a long history of conducting HIV clinical
studies and prevention research. In Aim 1, we will conduct qualitative formative research to explore the acceptability of
combining Truvada with a COC to increase PrEP adherence through focus group discussions with AGYW and in-depth
interviews (IDIs) with healthcare providers. In Aim 2, we will incorporate formative research findings into the
development and pre-testing of 1) cMPT packaging and client information materials; 2) adherence and acceptability
questionnaires; and 3) a provider training manual. In Aim 3, we will compare the acceptability, preference, and adherence
of the cMPT intervention versus standard of care (2 separate pills: Truvada® and COC). In a 6-month randomized,
crossover study, 30 AGYW (16-24 years old) in Harare, Zimbabwe will be assigned in random order to the sequence of
the 2 regimens: the cMPT intervention or standard of care (2 separate pills). Each regimen will be used for 3 28-day
menstrual cycles (approximately 3 months per regimen). At the end of 6 months, women will be asked to state their
preference for the cMPT intervention or the 2 separate pills. We will assess and compare acceptability and adherence (via
dried blood spots) of the 2 regimens, and socioecological factors (e.g., individual-, partner-, family-, clinic-level)
associated with adherence and acceptability. We will explore facilitators and barriers to use through IDIs with 5 AGYW...

## Key facts

- **NIH application ID:** 10018645
- **Project number:** 5R34MH119982-02
- **Recipient organization:** POPULATION COUNCIL
- **Principal Investigator:** BARBARA A FRIEDLAND
- **Activity code:** R34 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $325,011
- **Award type:** 5
- **Project period:** 2019-09-16 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10018645

## Citation

> US National Institutes of Health, RePORTER application 10018645, Combining PrEP with contraception: a pilot test of an intervention to increase adherence to PrEP in adolescent girls and young women in Zimbabwe (5R34MH119982-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10018645. Licensed CC0.

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