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Bringing South African Men Into HIV Counseling and Testing and Care

Primary Purpose

Human Immunodeficiency Virus

Status

Completed

Phase

Not Applicable

Locations

South Africa

Study Type

Interventional

Intervention

Men-Centered HIV Testing

Linkage to Care for HIV+ Men

Clinic-based HIV Testing

Clinic Referral for HIV+ Men

About this trial

This is an interventional prevention trial for Human Immunodeficiency Virus focused on measuring Prevention, Testing and Diagnosis, Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts 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+

Sites / Locations

Human Sciences Research Council

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Men-Centered HIV Testing

Clinic-based HIV Testing

Linkage to Care for HIV+ Men

Clinic Referral for HIV+ Men

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Percentage of men tested for HIV

Percentage of men in the community, selected through probability sampling, who report being tested for HIV

Secondary Outcome Measures

Full Information

NCT ID

NCT03794245

First Posted

October 9, 2018

Last Updated

July 6, 2023

Sponsor

University of California, Los Angeles

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03794245

Brief Title

Bringing South African Men Into HIV Counseling and Testing and Care

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

July 7, 2015 (Actual)

Primary Completion Date

December 1, 2021 (Actual)

Study Completion Date

April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Human Immunodeficiency Virus

Keywords

Prevention, Testing and Diagnosis, Treatment

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Care ProviderOutcomes Assessor

Masking Description

The Care Provider and Outcomes Assessors do not know the arms to which an individual has been assigned

Allocation

Randomized

Enrollment

1806 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Men-Centered HIV Testing

Arm Type

Experimental

Arm Description

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

Arm Title

Clinic-based HIV Testing

Arm Type

Active Comparator

Arm Description

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

Arm Title

Linkage to Care for HIV+ Men

Arm Type

Experimental

Arm Description

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

Arm Title

Clinic Referral for HIV+ Men

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Men-Centered HIV Testing

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Linkage to Care for HIV+ Men

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Clinic-based HIV Testing

Intervention Description

Individuals present to a clinic and request HIV counseling and testing

Intervention Type

Behavioral

Intervention Name(s)

Clinic Referral for HIV+ Men

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of men tested for HIV

Description

Percentage of men in the community, selected through probability sampling, who report being tested for HIV

Time Frame

Tested within the past 12 months

Other Pre-specified Outcome Measures:

Title

Percentage of HIV+ men initiating treatment for HIV

Description

Percentage of men HIV+ enrolling in treatment centers and starting treatment for HIV

Time Frame

Within 6 months of receiving HIV diagnosis

Title

Percentage of men with suppressed viral load

Description

Percentage of men with HIV viral load <50 copies/ml

Time Frame

12 months after initiating treatment

10. Eligibility

Sex

Male

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

THOMAS J COATES, PhD

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Heidi Van Rooyen, PhD

Organizational Affiliation

Human Sciences Research Council

Official's Role

Principal Investigator

Facility Information:

Facility Name

Human Sciences Research Council

City

Pietermaritzburg

State/Province

KwaZulu-Natal

Country

South Africa

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31888701

Citation

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.

Results Reference

derived

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Bringing South African Men Into HIV Counseling and Testing and Care

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