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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Condition (as posted)
Mapped entity
Match
Confidence
Acquired Immunodeficiency Syndrome
—
UNRESOLVED
—
HIV Infections
—
UNRESOLVED
—
Human Immunodeficiency Virus
—
UNRESOLVED
—
Retroviridae Infections
—
UNRESOLVED
—
RNA Virus Infections
—
UNRESOLVED
—
Sexually Transmitted Diseases, Viral
—
UNRESOLVED
—
Virus Diseases
—
UNRESOLVED
—
Virus-HIV
—
UNRESOLVED
—
Interventions
Interventions (3)
Intervention
Type
Mapped drug
Match
Provision of multiple self-tests
Behavioral
—
UNRESOLVED
Small monetary incentives
Other
—
UNRESOLVED
Use of SMS/text reminders to motivate adherence to ART or PrEP
Behavioral
—
UNRESOLVED
Design
Arms and outcomes
Arms (2)
type
EXPERIMENTAL
label
Promoter training, multiple self-test kits, and incentives
description
Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration (transport voucher) for themselves and to distribute to men in their networks.
interventionNames
Behavioral: Provision of multiple self-tests
Other: Small monetary incentives
Behavioral: Use of SMS/text reminders to motivate adherence to ART or PrEP
type
NO_INTERVENTION
label
Short training and referral for testing
description
Promoters in the control group will a short training on the basics of HIV prevention and treatment and will be encouraged to refer men in their networks for standard of care testing at the local health facilities- this may include HIV testing with a counselor or HIV self-test from the local health clinic, depending on what is available.
Primary outcomes (2)
Eligibility
Eligibility (as posted)
Sex
Male
Minimum age
18 Years
Show eligibility criteria text
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
References
Publications (130)
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measure
Self-reported HIV Testing
timeFrame
Up to 3 months
description
Percentage of participants who self-report HIV testing (yes/no) within the past 3 months, measured at 3-month follow-up.
measure
Percentage of Participants Who Linked to a Study-affiliated Clinic Within 3 Months
timeFrame
Up to 3 months
description
The percentage of participants who attended a study-affiliated clinic for HIV treatment or care within 3 months of the intervention baseline
Secondary outcomes (3)
measure
Linkage to PrEP
timeFrame
Up to 3 months
description
Percentage of PrEP-eligible HIV-negative participants who initiate PrEP prescription (yes/no), 3-months following confirmatory testing and eligibility screening (combined)
measure
Adherence to PrEP (% With Detectable Tenofovir in the Urine)
timeFrame
Up to 6 months
description
PrEP: Percentage of PrEP-taking HIV-negative participants who are adherent to PrEP (TFV levels of \>= 1500 ng/mL) at 6 months following PrEP initiation.
measure
Adherence to ART
timeFrame
Up to 6 months
description
ART: Percentage of HIV-positive participants who attain viral suppression (HIV RNA \<400 c/mL), 6 months following ART initiation.
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DERIVEDAyieko BO, Charlebois ED, Sheira LA, Gutin SA, Olugo P, Lewis-Kulzer J, Kwena ZA, Thirumurthy H, Agot K, Camlin CS. Systematic dissemination of study findings from local to national stakeholders: a case of a social network-based study on HIV self-testing and linkage among fishermen in Kenya. SAHARA J. 2026 Dec;23(1):2705180. doi: 10.1080/17290376.2026.2705180. Epub 2026 Jul 29. PMID 42527878
DERIVEDSheira LA, Ayieko B, Gutin SA, Kwena ZA, Charlebois ED, Agot K, Moody J, Olugo P, Adede D, Lewis-Kulzer J, Gandhi M, Thirumurthy H, Bukusi EA, Camlin CS. Gaps in Effective HIV Pre-exposure Prophylaxis Screening and Uptake Among Fishermen in Kenya. AIDS Behav. 2026 Apr;30(4):1211-1220. doi: 10.1007/s10461-025-04950-1. Epub 2025 Nov 18. PMID 41251869
DERIVEDCamlin CS, Sheira LA, Kwena ZA, Charlebois ED, Agot K, Moody J, Ayieko B, Gutin SA, Ochung A, Olugo P, Lewis-Kulzer J, Nishimura H, Gandhi M, Bukusi EA, Thirumurthy H. The effect of a social network-based intervention to promote HIV testing and linkage to HIV services among fishermen in Kenya: a cluster-randomised trial. Lancet Glob Health. 2025 Apr;13(4):e669-e678. doi: 10.1016/S2214-109X(24)00539-4. PMID 40155104
DERIVEDLewis-Kulzer J, Olugo P, Gutin SA, Kwena ZA, Nishimura H, Thorp M, Agot K, Ayieko B, Bukusi EA, Oluoch L, Angawa D, Thirumurthy H, Camlin CS. "There is no need to leave the beach to test": a qualitative study of HIV self-testing knowledge and acceptability of HIV self-test kit distribution among social networks of fishermen in Western Kenya. BMC Public Health. 2025 Mar 14;25(1):1005. doi: 10.1186/s12889-025-22136-1. PMID 40087617
DERIVEDSheira LA, Kwena ZA, Charlebois ED, Agot K, Ayieko B, Gandhi M, Bukusi EA, Thirumurthy H, Camlin CS. 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. Trials. 2022 Jun 6;23(1):463. doi: 10.1186/s13063-022-06409-3. PMID 35668499