Clinical trial NCT03794245: 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
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: Prevention
Testing and Diagnosis
Treatment
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Human Sciences Research Council
name: Medical University of South Carolina
name: Charles University, Czech Republic
First posted: 2019-01-04
Enrollment: 1806
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Men-Centered HIV Testing vs. Clinic-Based HIV Testing; Personalized Linkage to Care for HIV+ Men vs. Clinic Referral for HIV+ Men.
Primary purpose: PREVENTION

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.

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+

Primary outcomes:
measure: Percentage of men tested for HIV
timeFrame: Tested within the past 12 months
Secondary outcomes:
Other outcomes:
measure: Percentage of HIV+ men initiating treatment for HIV
timeFrame: Within 6 months of receiving HIV diagnosis
measure: Percentage of men with suppressed viral load
timeFrame: 12 months after initiating treatment
Locations:
city: Pietermaritzburg
country: South Africa
facility: Human Sciences Research Council
state: KwaZulu-Natal
Study officials:
affiliation: University of California, Los Angeles
name: THOMAS J COATES, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Human Sciences Research Council
name: Heidi Van Rooyen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.