# Co-benefits of co-delivery of long-acting antiretrovirals and contraceptives

> **NIH NIH R01** · UNIVERSITY OF WASHINGTON · 2022 · $693,687

## Abstract

PROJECT SUMMARY
 The first complete long-acting (LA) formulation of an antiretroviral therapy (ART), injectable cabotegravir
and rilpivirine, is at the cusp of clinical approval—this is a potential game-changing development in the HIV
treatment field. LA ART regimens increase options for patients and providers to improve patient adherence and
persistence to treatment. Several subpopulations, including adolescent girls and young women (AGYW, ages
15-24), lag behind the 3rd 90-90-90 UNAIDS goal of viral suppression, including in Kenya. AGYW living with HIV
(AGYWLHIV) face unique challenges in persistence to ART, and LA ART options have the potential to help
overcome some of these challenges through greater confidentiality and reduced stigma compared to oral ART.
 Another major threat to AGYW’s health is unintended pregnancies, and AGYWLHIV also face unique
challenges in uptake and continuation rates of LA contraceptives. More recently, the use of LA contraceptives,
which include injectable and implantable methods, has gained marked momentum in Kenya, where many HIV
treatment programs have integrated contraceptive provision into routine HIV care including for AGWY.
Furthermore, AGYWLHIV are highly interested in co-delivery of ART and contraceptives. However, co-delivery
also raises potential issues, both pharmacological and behavioral, that require further investigation.
 We propose foundational pharmacokinetic (PK) and qualitative studies leading up to a hybrid type I
effectiveness-implementation trial randomizing individual AGYWLHIV to receive LA injectable
cabotegravir/rilpivirine vs. standard of care in Kenya. Our central premise is that use of LA ART will foster long-
term thinking for health, including for pregnancy prevention, and that leveraging existing LA contraceptive
delivery platform will make LA ART highly feasible. Aim 1a will determine if combined injectable
cabotegravir/rilpivirine use has any bidirectional drug-drug interactions with injectable or implantable
contraceptives. Method: Parallel group PK evaluation with repeat plasma sampling among cabotegravir/rilpivirine
users initiating injectable or implantable contraceptives vs. those not using any hormonal contraceptives (total 5
groups, n=21 per group). Aim 1b will qualitatively explore points of convergence and divergence, preferences
and values, and health systems readiness around wider-scale co-delivery of LA ART/contraceptives. Method:
20-40 serial, semi-structured, in-depth interviews with AGYW from above sentinel cohort, and 2-4 focus group
discussions with providers, policymakers, and stakeholders. Aim 2 will evaluate the impact of co-delivery of LA
ART and contraceptives among AGYWLHIV via a hybrid trial on: (a) effectiveness outcomes of HIV treatment
(viral suppression [primary outcome] and adherence/persistence) and contraception (uptake and continuation
rates), and (b) implementation outcomes of acceptability, feasibility, and fidelity. Method: Open label, clinic-
pro...

## Key facts

- **NIH application ID:** 10393063
- **Project number:** 5R01AI155052-02
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** Rena Chiman Patel
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $693,687
- **Award type:** 5
- **Project period:** 2021-04-14 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10393063

## Citation

> US National Institutes of Health, RePORTER application 10393063, Co-benefits of co-delivery of long-acting antiretrovirals and contraceptives (5R01AI155052-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10393063. Licensed CC0.

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