Bringing South African Men Into HIV Counseling and Testing and Care

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Human Immunodeficiency Virus

Treatments: Behavioral: Linkage to Care for HIV+ Men; Behavioral: Men-Centered HIV Testing; Behavioral: Clinic Referral for HIV+ Men; Behavioral: Clinic-based HIV Testing

Study type: Interventional

Funder types: Other

Identifiers

NCT03794245

R01MH105534

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,806 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men residing in the target communities

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,806 participants in 4 patient groups

Men-Centered HIV Testing

Experimental group

Description:

Mobile HIV testing is conducted at sites in the community where men gather.

Treatment:

Behavioral: Men-Centered HIV Testing

Clinic-based HIV Testing

Active Comparator group

Description:

Men are referred to the nearest clinic for HIV counseling and testing

Treatment:

Behavioral: Clinic-based HIV Testing

Linkage to Care for HIV+ Men

Experimental group

Description:

The patient coordinator arranges an appointment time at the clinic and accompanies the patient to the initial visit

Treatment:

Behavioral: Linkage to Care for HIV+ Men

Clinic Referral for HIV+ Men

Active Comparator group

Description:

Men diagnosed with HIV are referred to the nearest clinic for treatment of HIV

Treatment:

Behavioral: Clinic Referral for HIV+ Men