Owete study design
“Fishermen are hard to deal with and the people coming to meet them need to have a good rapport with them before giving out the test kits.”
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 support to connect men in their close social networks to HIV prevention and treatment services.
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.
Study population
At least 650 and up to 1,800 men aged ≥18 years who are primarily working in the fishing industry or related activities, who reside in beach communities in Siaya. The study population will consist of up to 140 clusters of men with close social network ties with a variable number of men in each cluster.
Study sites
The study sites include 10 Lake Victoria beach communities and associated health clinics, within one or more sub-counties: Rarieda, Bondo and Alego Usonga, in Siaya County in western Kenya.
Study aims and intervention
Aim 1
Self-reported HIV testing uptake within 3 months
Aim 2
Linkage to ART or to PrEP within 3 months after self-reported HIV testing. Initiation of ART or PrEP (among those eligible), within 3 months of confirmatory testing (linkage)
Aim 3
Viral suppression (HIV RNA <400 c/mL) and adherence at 6 & 12 months. Adherence to PrEP (TFV levels of >=1500 ng/mL in urine = adequate adherence28) at 6 months
Study intervention 
The intervention strategy is to recruit and train highly socially-connected men to distribute HIVST and provide linkage support to HIV services (encouragement, along with small financial incentives to offset transport costs) to other men in their close social networks.
Study status
The Owete Study is underway at three beaches, Wichlum, Honge, and Uhanya. Social network surveys with fishermen were completed in February 2022. The social networking surveys resulted in identifying 994 socially connected men who were randomized to intervention and control arms at each beach. We completed study enrolment in June 2022 with 733 men enrolled. The intervention and control activities kicked off after the enrolment concluded at each beach. We are currently monitoring HIV self-test kit use and linkage to local health facilities for HIV prevention or treatment services, carrying out 3- and 6-month follow-up activities, and conducting qualitative interviews and focus group discussions.
Publications
Testing a social network approach to promote HIV self-testing and linkage to care among fishermen at Lake Victoria: study protocol for the Owete cluster randomized controlled trial
Lila A. Sheira, Zachary A. Kwena, Edwin D. Charlebois, Kawango Agot, Benard Ayieko, Monica Gandhi, Elizabeth A. Bukusi, Harsha Thirumurthy & Carol S. Camlin. Trials June 2022.
