Bringing South African Men Into HIV Counseling and Testing and Care

Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03794245
• Other study ID #: R01MH105534
• Status: Completed
• Phase: N/A
• Start date: July 7, 2015
• Est. completion date: April 30, 2022

Study information

• Verified date: July 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1806
• Est. completion date: April 30, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men residing in the target communities

Exclusion Criteria:

• Men outside of the target communities

• Men who report being tested and HIV+

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Intervention

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.
• 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.
• Clinic-based HIV Testing
Individuals present to a clinic and request HIV counseling and testing
• Clinic Referral for HIV+ Men
Individuals diagnosed with HIV are referred to the nearest clinic for treatment of HIV

Locations

Country	Name	City	State
South Africa	Human Sciences Research Council	Pietermaritzburg	KwaZulu-Natal

Sponsors (4)

Lead Sponsor	Collaborator
University of California, Los Angeles	Charles University, Czech Republic, Human Sciences Research Council, Medical University of South Carolina

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Percentage of men with suppressed viral load	Percentage of men with HIV viral load <50 copies/ml	12 months after initiating treatment
Primary	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