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NCT Number: NCT03794245

Bringing South African Men Into HIV Counseling and Testing 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Human Sciences Research Council

Pietermaritzburg, KwaZulu-Natal, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men residing in the target communities

Exclusion criteria

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

Treatment and study plan

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.

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.

Clinic-based HIV Testing

Behavioral

Individuals present to a clinic and request HIV counseling and testing

Clinic Referral for HIV+ Men

Behavioral

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

Primary outcomes

  1. 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

Other outcomes

  1. 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

  2. Percentage of men with suppressed viral load

    Time frame: 12 months after initiating treatment

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

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2021
Study completion
2022
First posted
Jan 4, 2019
Registry last updated
Jul 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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