Bringing South African Men Into HIV Counseling and Testing and Care

July 6, 2023 updated by: Thomas J. Coates, University of California, Los Angeles

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1806

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • KwaZulu-Natal
      • Pietermaritzburg, KwaZulu-Natal, South Africa
        • Human Sciences Research Council

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Men residing in the target communities

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Men-Centered HIV Testing
Mobile HIV testing is conducted at sites in the community where men gather.
Behavioral: Men-Centered HIV Testing
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.
Active Comparator: Clinic-based HIV Testing
Men are referred to the nearest clinic for HIV counseling and testing
Behavioral: Clinic-based HIV Testing
Individuals present to a clinic and request HIV counseling and testing
Experimental: Linkage to Care for HIV+ Men
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
Men diagnosed with HIV are accompanied to the clinic and registered there with the help of a community health worker.
Active Comparator: Clinic Referral for HIV+ Men
Men diagnosed with HIV are referred to the nearest clinic for treatment of HIV
Behavioral: Clinic Referral for HIV+ Men
Individuals diagnosed with HIV are referred to the nearest clinic for treatment of HIV

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of HIV+ men initiating treatment for HIV
Time Frame: Within 6 months of receiving HIV diagnosis
Percentage of men HIV+ enrolling in treatment centers and starting treatment for HIV
Within 6 months of receiving HIV diagnosis
Percentage of men with suppressed viral load
Time Frame: 12 months after initiating treatment
Percentage of men with HIV viral load <50 copies/ml
12 months after initiating treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

Medical University of South Carolina
Charles University, Czech Republic
Human Sciences Research Council

Investigators

  • Principal Investigator: THOMAS J COATES, PhD, University of California, Los Angeles
  • Principal Investigator: Heidi Van Rooyen, PhD, Human Sciences Research Council

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2015

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

October 9, 2018

First Submitted That Met QC Criteria

January 3, 2019

First Posted (Actual)

January 4, 2019

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

July 6, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH105534 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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