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

Award Number: R34MH119982
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Combining PrEP with contraception: a pilot test of an intervention to increase adherence to PrEP in adolescent girls and young women in Zimbabwe - 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 combined oral contraceptives (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 – a dual prevention pill (DPP) – will contain two marketed products: Truvada® [emtricitabine and tenofovir disoproxil fumarate (TDF)] and a 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 Clinical Trials Research Centre (UZ-CTRC), 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) DPP 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 DPP 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 DPP 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 DPP 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 who complete the study and all AGYW who withdraw early. Acquiring confirmation now on the preference for a DPP from actual use with currently approved products will accelerate the availability of such a product in the marketplace. Given supportive findings in this project, we will outline a process for regulatory approval of the more cost-effective co- formulated pill.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	THE POPULATION COUNCIL, INC.	1 DAG HAMMARSKJOLD PLZ	NEW YORK	NY	10017	NEW YORK	USA	Mental Health Research Grants	000	3	9/16/2024	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $119,473 )
2023	2023	POPULATION COUNCIL, INC., THE	1 DAG HAMMARSKJOLD PLZ FL 3	NEW YORK	NY	10017	NEW YORK	USA	Mental Health Research Grants	000	3	5/9/2023	SUPPLEMENT FOR EXPANSION	$119,473
2023	2021	POPULATION COUNCIL, INC., THE	1 DAG HAMMARSKJOLD PLZ FL 3	NEW YORK	NY	10017	NEW YORK	USA	Mental Health Research Grants	001	3	7/21/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $119,473

Issue Date FY: 2021 ( Subtotal = $174,024 )
2021	2021	POPULATION COUNCIL, INC., THE	1 DAG HAMMARSKJOLD PLZ FL 3	NEW YORK	NY	10017	NEW YORK	USA	Mental Health Research Grants	002	3	8/13/2021	NON-COMPETING CONTINUATION	$174,024
2021	2020	POPULATION COUNCIL, INC., THE	1 DAG HAMMARSKJOLD PLZ FL 3	NEW YORK	NY	10017	NEW YORK	USA	Mental Health Research Grants	000	2	12/21/2020	NON-COMPETING CONTINUATION	$0
2021	2020	POPULATION COUNCIL, INC., THE	1 DAG HAMMARSKJOLD PLZ FL 3	NEW YORK	NY	10017	NEW YORK	USA	Mental Health Research Grants	001	2	7/30/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $174,024

Issue Date FY: 2020 ( Subtotal = $325,011 )
2020	2020	POPULATION COUNCIL, INC., THE	1 DAG HAMMARSKJOLD PLZ FL 3	NEW YORK	NY	10017	NEW YORK	USA	Mental Health Research Grants	001	2	7/27/2020	NON-COMPETING CONTINUATION	$325,011
2020	2019	POPULATION COUNCIL, INC., THE	1 DAG HAMMARSKJOLD PLZ FL 3	NEW YORK	NY	10017	NEW YORK	USA	Mental Health Research Grants	000	1	11/5/2019	NEW	$0
														Subtotal = $325,011

Issue Date FY: 2019 ( Subtotal = $281,239 )
2019	2019	POPULATION COUNCIL, INC., THE	1 DAG HAMMARSKJOLD PLZ FL 3	NEW YORK	NY	10017	NEW YORK	USA	Mental Health Research Grants	000	1	9/14/2019	NEW	$281,239
														Subtotal = $281,239

Grand Total All Awards = $899,747

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

Award Number: R34MH119982

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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