Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men

NCT04772469 | Completed Results DMC

• 2 other identifiers: 19-282051R01MH120176
• Study Type: interventional
• Target: 934
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Human Immunodeficiency Virus; Acquired Immunodeficiency Syndrome; HIV Infections; Sexually Transmitted Diseases, Viral; Retroviridae Infections; Virus Diseases; Virus-HIV; RNA Virus Infections

Keywords

HIV/AIDS; Social Networks; Behavioral Economics; Incentives; PrEP; HIV Self-Testing; Fishermen; Sub Saharan Africa; Men; HIV Prevention

Outcome Measures

Primary Outcomes (2)

• Self-reported HIV Testing

  Percentage of participants who self-report HIV testing (yes/no) within the past 3 months, measured at 3-month follow-up.

  Up to 3 months

• Percentage of Participants Who Linked to a Study-affiliated Clinic Within 3 Months

  The percentage of participants who attended a study-affiliated clinic for HIV treatment or care within 3 months of the intervention baseline

  Up to 3 months

Secondary Outcomes (3)

• Linkage to PrEP

  Up to 3 months

• Adherence to PrEP (% With Detectable Tenofovir in the Urine)

  Up to 6 months

• Adherence to ART

  Up to 6 months

Study Arms (2)

Promoter training, multiple self-test kits, and incentives

EXPERIMENTAL

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.

Behavioral: Provision of multiple self-tests; Other: Small monetary incentives; Behavioral: Use of SMS/text reminders to motivate adherence to ART or PrEP

Short training and referral for testing

NO INTERVENTION

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.

Interventions

Provision of multiple self-tests BEHAVIORAL

Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for men in their social networks.

Promoter training, multiple self-test kits, and incentives

Small monetary incentives OTHER

Use of small incentive voucher (\~$5) to encourage linkage to confirmatory testing.

Promoter training, multiple self-test kits, and incentives

Use of SMS/text reminders to motivate adherence to ART or PrEP BEHAVIORAL

Messages will be motivational, will not include any identifying information and will include generic texts such as "maintain your good health", to cater for status-neutral language that can work for both HIV positive individuals taking ARVs, as well as HIV-negative individuals on PrEP who may need adherence support.

Promoter training, multiple self-test kits, and incentives

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of Pennsylvania: collaborator
• Impact Research & Development Organization: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Duke University: collaborator
• Kenya Medical Research Institute: collaborator

Study Sites (1)

Impact Research Development Organization

Siaya, Kenya

Location

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• Camlin 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.

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• Sheira 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.

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MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections; Sexually Transmitted Diseases, Viral; Retroviridae Infections; Virus Diseases; RNA Virus Infections; Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases; Lentivirus Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Carol Camlin
• Organization: University of California San Francisco

Carol.Camlin@ucsf.edu

5109679558

Study Officials

• Carol S Camlin, MPH, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Harsha Thirumurthy, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study design is a cluster randomized controlled trial where the unit of randomization will be a clusters of men's close social network in study communities.

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 26, 2021
• Study Start: March 22, 2021
• Primary Completion: April 26, 2023
• Study Completion: April 26, 2023
• Last Updated: April 29, 2025
• Results First Posted: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)