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R01MH127955

Project Grant

Overview

Grant Description
Reaching the Last 20%: A Targeted HIV Self-Test Secondary Distribution Intervention to Engage High-Risk Men in Kenya - Project Summary

Limited use of HIV services by those at highest risk is one of the primary reasons for continued HIV transmission in sub-Saharan Africa. Identifying and engaging these individuals—particularly the 20% of people living with HIV who are unaware of their status—is a major challenge that is not being met by existing service delivery approaches.

Men who purchase sex (MPS) are of particularly high priority because they are twice as likely to be HIV-infected as other men and are inherently challenging to identify and reach with HIV services. The proposed project will take place in the region of Kenya with the highest HIV prevalence and seeks to promote engagement in HIV testing, prevention, and care by MPS.

Preliminary data demonstrate that "secondary distribution" of HIV self-tests by women who sell sex (WSS) to their sexual partners is acceptable, feasible, and safe and leads to high male partner testing. However, the use of post-self-test services has seldom been promoted or measured in a secondary distribution model. Our interdisciplinary and experienced team of investigators will address this key gap.

Led by an early stage investigator, this project will use a pair-matched cluster-randomized trial design to test an innovative, well-targeted HIV self-test secondary distribution intervention to promote uptake of HIV services by MPS. Clusters served by Ministry of Health-supported HIV clinics will be randomized to receive the secondary distribution intervention or standard of care.

In intervention clusters, we will recruit WSS from key population clinics and transactional sex "hot spots." WSS will be provided with oral fluid-based HIV self-tests and encouraged to distribute them to their male transactional sex partners. Self-test kits will include salient information for men on clinic location and hours within their cluster, and pilot-tested messaging on the importance of early ART initiation, and the availability and benefits of PrEP.

In Aim 1, we will evaluate programmatic data from HIV clinics in study clusters to objectively determine the intervention's impact on uptake of confirmatory testing, ART initiation, and PrEP initiation by men.

In Aim 2, we will conduct a process evaluation to characterize factors influencing intervention effectiveness. We will assess secondary distribution patterns and characterize the MPS population receiving self-tests through quantitative program data and a follow-up questionnaire among enrolled WSS. We will use qualitative data obtained through in-depth interviews with MPS to explore pathways and contextual factors influencing whether they accessed post-test services.

In Aim 3, we will compute the incremental cost-effectiveness of our intervention to inform decisions about broader implementation.

This project has the potential to break new ground on ways to engage high-risk and hard-to-reach populations in HIV services. If effective, our approach could be readily adapted to other settings and help advance global goals for HIV elimination.
Funding Goals
NOT APPLICABLE
Place of Performance
Durham, North Carolina 277132852 United States
Geographic Scope
Single Zip Code
Analysis Notes
Amendment Since initial award the total obligations have increased 352% from $668,916 to $3,021,186.
Research Triangle Institute was awarded HIV Self-Test Secondary Distribution Intervention High-Risk Men in Kenya Project Grant R01MH127955 worth $3,021,186 from the National Institute of Mental Health in June 2022 with work to be completed primarily in Durham North Carolina United States. The grant has a duration of 4 years 10 months and was awarded through assistance program 93.242 Mental Health Research Grants. The Project Grant was awarded through grant opportunity Engaging Men in HIV Testing, Prevention, and Care (R01 Clinical Trial Optional).

Status
(Ongoing)

Last Modified 7/6/26

Period of Performance
6/6/22
Start Date
4/30/27
End Date
83.0% Complete

Funding Split
$3.0M
Federal Obligation
$0.0
Non-Federal Obligation
$3.0M
Total Obligated
100.0% Federal Funding
0.0% Non-Federal Funding

Activity Timeline

Interactive chart of timeline of amendments to R01MH127955

Subgrant Awards

Disclosed subgrants for R01MH127955

Transaction History

Modifications to R01MH127955

Additional Detail

Award ID FAIN
R01MH127955
SAI Number
R01MH127955-3634553209
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Nonprofit With 501(c)(3) IRS Status (Other Than An Institution Of Higher Education)
Awarding Office
75N700 NIH National Institute of Mental Health
Funding Office
75N700 NIH National Institute of Mental Health
Awardee UEI
JJHCMK4NT5N3
Awardee CAGE
3A730
Performance District
NC-09
Senators
Thom Tillis
Ted Budd

Budget Funding

Federal Account Budget Subfunction Object Class Total Percentage
National Institute of Mental Health, National Institutes of Health, Health and Human Services (075-0892) Health research and training Grants, subsidies, and contributions (41.0) $1,297,809 100%
Modified: 7/6/26