Bringing South African Men Into HIV Counseling and Testing and Care

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

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

4

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	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	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	Percentage of men with HIV viral load <50 copies/ml	12 months after initiating treatment

Collaborators and Investigators

• 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

General Publications

• van Rooyen H, Makusha T, Joseph P, Ngubane T, Kulich M, Sweat M, Coates T. Zwakala Ndoda: a cluster and individually randomized trial aimed at improving testing, linkage, and adherence to treatment for hard-to reach men in KwaZulu-Natal, South Africa. Trials. 2019 Dec 30;20(1):798. doi: 10.1186/s13063-019-3908-0.

Study record dates

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: Treatment; Prevention; Testing and Diagnosis
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• 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