Bringing South African Men Into HIV Counseling and Testing and Care

NCT03794245 | Completed DMC

• 1 other identifier: R01MH105534
• Study Type: interventional
• Target: 1,806
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus

Keywords

Prevention; Testing and Diagnosis; Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of HIV+ men initiating treatment for HIV

  Within 6 months of receiving HIV diagnosis

• Percentage of men with suppressed viral load

  12 months after initiating treatment

Study Arms (4)

Men-Centered HIV Testing

EXPERIMENTAL

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

Behavioral: Men-Centered HIV Testing

Clinic-based HIV Testing

ACTIVE COMPARATOR

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

Behavioral: Clinic-based HIV Testing

Linkage to Care for HIV+ Men

EXPERIMENTAL

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

Clinic Referral for HIV+ Men

ACTIVE COMPARATOR

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

Behavioral: Clinic Referral for HIV+ Men

Interventions

Men-Centered HIV Testing BEHAVIORAL

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.

Men-Centered HIV Testing

Linkage to Care for HIV+ Men BEHAVIORAL

Men diagnosed with HIV are accompanied to the clinic and registered there with the help of a community health worker.

Linkage to Care for HIV+ Men

Clinic-based HIV Testing BEHAVIORAL

Individuals present to a clinic and request HIV counseling and testing

Clinic-based HIV Testing

Clinic Referral for HIV+ Men BEHAVIORAL

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

Clinic Referral for HIV+ Men

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men residing in the target communities

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Human Sciences Research Council: collaborator
• Medical University of South Carolina: collaborator
• Charles University, Czech Republic: collaborator

Study Sites (1)

Human Sciences Research Council

Pietermaritzburg, KwaZulu-Natal, South Africa

Location

Related Publications (1)

• 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.

  PMID: 31888701 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Disease

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• THOMAS J COATES, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Heidi Van Rooyen, PhD

  Human Sciences Research Council

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The Care Provider and Outcomes Assessors do not know the arms to which an individual has been assigned
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Men-Centered HIV Testing vs. Clinic-Based HIV Testing; Personalized Linkage to Care for HIV+ Men vs. Clinic Referral for HIV+ Men.

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: January 4, 2019
• Study Start: July 7, 2015
• Primary Completion: December 1, 2021
• Study Completion: April 30, 2022
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)