A Multilevel Intervention to Reduce PrEP Stigma and Increase Effective PrEP Use Among Adolescent Girls and Young Women in Kenya

Project Summary/Abstract
The goal of this small R01 application is to develop and pilot test a multilevel, community-based
intervention to reduce pre-exposure prophylaxis (PrEP) stigma and increase PrEP uptake and
continuation among adolescent girls and young women (AGYW) in western Kenya. AGYW ages
15–24 represent 10% of the population but account for more than 25% of new HIV infections in
East and Southern Africa. Despite the effectiveness of daily oral PrEP in reducing HIV
acquisition, uptake, adherence, and continuation remain low in this region. In our formative
work, AGYW reported significant stigma around PrEP use from friends, male partners, and the
broader community (i.e., “key influencers”), which was associated with 30–50% lower PrEP
adherence. To address this challenge, we propose to develop an intervention to reduce PrEP
stigma among key influencers and mitigate the impact of stigma among AGYW (Aim 1) using
education, skills-building, empathy-building, and psychosocial support strategies at the
community, interpersonal, and individual levels. Guided by the Six Essential Actions for Quality
Intervention Development framework, our formative research, and established best practices for
stigma reduction, we will conduct participatory co-design workshops with 30 AGYW and
stakeholders to identify change mechanisms and effective delivery platforms to target the
drivers of PrEP stigma. We will draft an intervention manual and training materials and pre-test
them with approximately 12 AGYW, 56 key influencers, and 8 intervention providers. We will
then assess the feasibility, acceptability, and preliminary evidence of intervention effectiveness
through a pilot cluster-randomized controlled trial (cRCT) in four communities (Aim 2). We will
enroll 20 AGYW ages 15–24 from each community (n=80 total) with follow-up at intervention
midpoint (3 months) and endpoint (6 months), supplemented by pre-post-intervention surveys
with 80 key influencers and post-intervention qualitative data from 16 AGYW, 12 key influencers,
and all intervention providers. Primary outcomes are intervention feasibility; acceptability to
AGYW, key influencers, and providers; and PrEP stigma scores among AGYW. Secondary
outcomes include stigma among key influencers and PrEP uptake, PrEP continuation
(measured with a urine tenofovir biomarker), and depression and anxiety symptoms among
AGYW. The proposed study builds directly on our formative research establishing the high
prevalence of PrEP stigma and its association with low PrEP adherence. If successful, it will
provide robust data to support a fully powered cRCT to evaluate the intervention’s effectiveness
on PrEP stigma, PrEP uptake and continuation, and biomarkers of PrEP adherence.

Grant Number: 1R01TW013189-01
NIH Institute/Center: NIH
Principal Investigator: Mark Ayallo