N/A
Completed N=934
Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men
Human Immunodeficiency Virus Infection · Acquired Immunodeficiency Syndrome · HIV · Sexually Transmitted Diseases, Viral
Source: ClinicalTrials.gov NCT04772469 ↗
Enrolled (actual)
934
Serious AEs
1.9%
Results posted
Apr 2025
Primary outcomePrimary: Self-reported HIV Testing — 65.6; 31.3 percentage of participants
Summary
This is a randomized controlled trial to test a combination behavioral and biomedical interventions to improve the HIV prevention and care cascades in a population of mobile men in a high priority setting (fishermen in Kenya). The intervention strategy is to recruit and train highly socially-connected men to distribute HIV self-tests and provide linkage support to men in their close social networks. The study will determine whether this social network-based approach along with small financial incentives in the form of transport vouchers can increase men's self-testing, linkage to and uptake of ART and PrEP after self-testing, virologic suppression at 6 months (for those initiating ART) and PrEP adherence (for those initiating PrEP) at 6 months. The study includes a longitudinal qualitative and mixed methods (quantitative and qualitative assessments) to identify the pathways of intervention action, and understand how the social network-based approach with support for linkage affects testing and ART and PrEP uptake and retention in men.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-reported HIV Testing |
65.6; 31.3 | — |
| PRIMARY Percentage of Participants Who Linked to a Study-affiliated Clinic Within 3 Months |
67.3; 15.6 | — |
| SECONDARY Linkage to PrEP |
19.7; 19.6 | — |
| SECONDARY Adherence to PrEP (% With Detectable Tenofovir in the Urine) |
18.7; 8.3 | — |
| SECONDARY Adherence to ART |
35.7; 40.2 | — |
Eligibility Criteria
Inclusion Criteria
- Adult (18 years or older)
- Male
- Working as a fisherman or fishing-related occupation
- Willing and able to provide informed consent for participation
- Not participating in another research study related to HIV testing, treatment and/or prevention
Exclusion Criteria
- Younger than 18 years of age
- Female
- Included in another intervention study on HIV/AIDS
- Inadequate cognitive and/or hearing capacity to complete planned study procedures, at the discretion of the study team
Data sourced from ClinicalTrials.gov (NCT04772469). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.