Bringing South African Men Into HIV Counseling and Testing and Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bringing South African Men Into HIV Counseling (HCT) and Care

Conditions
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Human Immunodeficiency Virus

Intervention / Treatment
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* Behavioral: Men-Centered HIV Testing
* Behavioral: Linkage to Care for HIV+ Men
* Behavioral: Clinic-based HIV Testing
* Behavioral: Clinic Referral for HIV+ Men


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men residing in the target communities Exclusion Criteria: Men outside of the target communities Men who report being tested and HIV+

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Men-Centered HIV Testing vs. Clinic-Based HIV Testing; Personalized Linkage to Care for HIV+ Men vs. Clinic Referral for HIV+ Men.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Men-Centered HIV Testing<br>Mobile HIV testing is conducted at sites in the community where men gather. | Behavioral: Men-Centered HIV Testing<br>* The intervention involves bringing mobile HIV testing to venues where men congregate, talking to them as a group about HIV testing, and then providing testing at that venue.<br>|
| Active Comparator: Clinic-based HIV Testing<br>Men are referred to the nearest clinic for HIV counseling and testing | Behavioral: Clinic-based HIV Testing<br>* Individuals present to a clinic and request HIV counseling and testing<br>|
| Experimental: Linkage to Care for HIV+ Men<br>The patient coordinator arranges an appointment time at the clinic and accompanies the patient to the initial visit | Behavioral: Linkage to Care for HIV+ Men<br>* Men diagnosed with HIV are accompanied to the clinic and registered there with the help of a community health worker.<br>|
| Active Comparator: Clinic Referral for HIV+ Men<br>Men diagnosed with HIV are referred to the nearest clinic for treatment of HIV | Behavioral: Clinic Referral for HIV+ Men<br>* Individuals diagnosed with HIV are referred to the nearest clinic for treatment of HIV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of men tested for HIV | Percentage of men in the community, selected through probability sampling, who report being tested for HIV | Tested within the past 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Testing and Diagnosis, Treatment