# Integrated PrEP and ART delivered in Ugandan public health clinics to improve HIV and ART outcomes for HIV serodiscordant couples

> **NIH NIH R01** · UNIVERSITY OF WASHINGTON · 2020 · $577,467

## Abstract

ABSTRACT
There has been great progress in the past 30 years towards controlling the HIV epidemic and the 
tools to end AIDS are now available. One of the most profound tools is antiretrovirals used as HIV 
treatment (ART) by HIV-positive individuals and pre-exposure prophylaxis (PrEP) by HIV-negative 
individuals. Each have tremendous benefits for HIV prevention proven in controlled research 
environments. For HIV serodiscordant couples, stable couples where one is HIV-positive and one is 
HIV-negative, these two interventions can be delivered in an integrated fashion where PrEP use is 
encouraged until the point when the HIV-positive partner has sustained use of ART and is no longer 
infectious.  This strategy nearly eliminated HIV transmission within
>1000 couples in our recent demonstration project but it is not clear that this intervention would 
be delivered as effectively in a public health setting by staff without in depth prescribing 
experience. Preliminary data from this study also suggest an effect of the integrated PrEP and ART 
strategy on ART initiation with rates close to 90% within 12 months of a recommendation to start 
and ART adherence with >90% of HIV-positive partners being virally suppressed within 6 months. 
These rates far exceed those seen in Ugandan public health clinics. A true effect of PrEP use on 
ART initiation and adherence, through modeled behavior or other mechanisms, would be a compelling 
argument to drive forward PrEP as part of Ugandan HIV prevention policy and facilitate more people 
to initiate and adhere to ART.
Through close collaboration with the Ugandan Ministry of Health, we propose to implement scalable 
delivery of integrated PrEP and ART for HIV serodiscordant couples in public health clinics in 
Kampala, Uganda. Intervention delivery will be launched in a staggered fashion among clinics 
through a stepped wedge cluster randomized trial providing a rigorous research opportunity to 
measure the effect of the intervention on PrEP and ART initiation and adherence. To measure these 
outcomes using clinic records and biomarkers, we will enroll a cohort of 1248 HIV serodiscordant 
couples. Additionally, we will collect qualitative and quantitative data to determine if 
PrEP-taking is a modeled behavior that facilitates ART use and characterize the way that PrEP and 
ART use interact within couples and estimate the programmatic costs of the integrated PrEP and ART 
strategy. Results from this study will provide compelling data to inform widespread delivery of 
integrated PrEP and ART for HIV serodiscordant couples as a component of Ugandan national HIV 
prevention policy. The proposed project will launch sustainable delivery of PrEP in Uganda through 
public health clinics and it has the potential to demonstrate a scalable and cost-effective 
approach for providing powerful HIV prevention tools to HIV serodiscordant couples.

## Key facts

- **NIH application ID:** 9989155
- **Project number:** 5R01MH110296-04
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** Renee A. Heffron
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $577,467
- **Award type:** 5
- **Project period:** 2017-08-23 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9989155

## Citation

> US National Institutes of Health, RePORTER application 9989155, Integrated PrEP and ART delivered in Ugandan public health clinics to improve HIV and ART outcomes for HIV serodiscordant couples (5R01MH110296-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9989155. Licensed CC0.

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