HIV Infections Clinical Trial
Official title:
Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men
Verified date | August 2023 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1509 |
Est. completion date | April 26, 2023 |
Est. primary completion date | April 26, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Kenya | Impact Research Development Organization | Siaya |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Duke University, Impact Research & Development Organization, Kenya Medical Research Institute, National Institute of Mental Health (NIMH), University of Pennsylvania |
Kenya,
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* Note: There are 125 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-reported HIV testing | Proportion of participants who self-report HIV testing (yes/no) within the past 3 months, measured at 3-month follow-up. | Up to 3 months | |
Primary | Linkage to care or prevention | For HIV-positive participants (care): the proportion of participants who obtained confirmatory HIV testing (yes/no), 3-months following self-reported HIV testing AND the proportion of participants who had an HIV clinic visit (yes/no), 3-months following confirmatory HIV testing.
For HIV-negative participants (prevention): the proportion of participants who obtained confirmatory HIV testing (yes/no) 3-months following self-reported testing AND the proportion of participants who were evaluated for PrEP (yes/no), 3-months following confirmatory HIV testing. |
Up to 3 months | |
Secondary | Linkage to ART or to PrEP | ART: Proportion of HIV-positive participants who initiate ART prescription (yes/no), 3-months following confirmatory testing and eligibility screening.
PrEP: Proportion of PrEP-eligible HIV-negative participants who initiate PrEP prescription (yes/no), 3-months following confirmatory testing and eligibility screening. |
Up to 3 months | |
Secondary | Adherence to ART or PrEP | ART: Proportion of HIV-positive participants who attain viral suppression (HIV RNA <400 c/mL), 6 months following ART initiation.
PrEP: proportion of PrEP-taking HIV-negative participants who are adherent to PrEP (TFV levels of >= 1500 ng/mL) at 6 months following PrEP initiation. |
Up to 6 months | |
Secondary | HIV testing after 3 months | Confirmatory HIV testing uptake 3 to 6 months after intervention start | 3 to 6 months |
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