Bringing South African Men Into HIV Counseling and Testing and Care

Not Applicable

Completed

• Conditions: Human Immunodeficiency Virus
• Interventions: Behavioral: Clinic Referral for HIV+ Men; Behavioral: Clinic-based HIV Testing; Behavioral: Linkage to Care for HIV+ Men; Behavioral: Men-Centered HIV Testing

• 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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clinic Referral for HIV+ Men	Clinic Referral for HIV+ Men	Men diagnosed with HIV are referred to the nearest clinic for treatment of HIV
Clinic-based HIV Testing	Clinic-based HIV Testing	Men are referred to the nearest clinic for HIV counseling and testing
Linkage to Care for HIV+ Men	Linkage to Care for HIV+ Men	The patient coordinator arranges an appointment time at the clinic and accompanies the patient to the initial visit
Men-Centered HIV Testing	Men-Centered HIV Testing	Mobile HIV testing is conducted at sites in the community where men gather.

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