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

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

Interventions

BEHAVIORAL

Provision of multiple self-tests

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

OTHER

Small monetary incentives

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

BEHAVIORAL

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

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.

Sponsors & Collaborators

• University of Pennsylvania

  collaborator OTHER

• Impact Research & Development Organization

  collaborator OTHER

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Duke University

  collaborator OTHER

• Kenya Medical Research Institute

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Carol S Camlin, MPH, PhD · University of California, San Francisco

• Harsha Thirumurthy, PhD · University of Pennsylvania

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-03-22

Primary Completion

2023-04-26

Completion

2023-04-26

Countries

• Kenya

Study Locations