Bringing South African Men Into HIV Counseling and Testing and Care

Not Applicable

Completed

• Conditions: Human Immunodeficiency Virus

• Registration Number: NCT03794245
• Lead Sponsor: University of California, Los Angeles

Brief Summary

This clinical trial seeks to determine if male-centered recruitment increases men's testing for HIV and whether or not individualized introduction to clinics increases male engagement in treatment for HIV. The study is being conducted in rural KwaZulu Natal.

Detailed Description

This study combines structural and individual level interventions for HIV and integrates the two to address the study's objective of identifying South African men in KwaZulu Natal with HIV and maintaining those diagnosed with HIV in care to the point of viral suppression.

The cluster-randomized design will randomize 8 communities to intervention or control to test the hypothesis whether male-centered mobilization and testing increases the population-level percentage of men who have been tested within the past 12 months by more than 10 absolute percentage points.

The individually randomized design will test whether individualized case management will effectively link HIV-positive men to treatment to the point of viral suppression.

The study will also examine the incremental cost-effectiveness of the interventions.

Study Timeline

• Study Start: 2015-07-07
• Study First Submitted: 2018-10-09
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-04
• Primary Completion: 2021-12-01
• Study Completion: 2022-04-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-06
• Last Update Posted: 2023-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1806

Inclusion Criteria

• Men residing in the target communities

Exclusion Criteria

• Men outside of the target communities
• Men who report being tested and HIV+

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of men tested for HIV	Tested within the past 12 months	Percentage of men in the community, selected through probability sampling, who report being tested for HIV

Trial Locations

Locations (1)

Human Sciences Research Council; 🇿🇦 Pietermaritzburg, KwaZulu-Natal, South Africa