Human Immunodeficiency Virus
Conditions
Keywords
Prevention, Testing and Diagnosis, Treatment
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.
Interventions
BEHAVIORALClinic Referral for HIV+ Men
Individuals diagnosed with HIV are referred to the nearest clinic for treatment of HIV
BEHAVIORALMen-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.
BEHAVIORALLinkage 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.
BEHAVIORALClinic-based HIV Testing
Individuals present to a clinic and request HIV counseling and testing
Sponsors
Human Sciences Research Council
Medical University of South Carolina
Charles University, Czech Republic
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
The Care Provider and Outcomes Assessors do not know the arms to which an individual has been assigned
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Men residing in the target communities
Exclusion criteria
* Men outside of the target communities * Men who report being tested and HIV+
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of men tested for HIV | Tested within the past 12 months | Percentage of men in the community, selected through probability sampling, who report being tested for HIV |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of HIV+ men initiating treatment for HIV | Within 6 months of receiving HIV diagnosis | Percentage of men HIV+ enrolling in treatment centers and starting treatment for HIV |
| Percentage of men with suppressed viral load | 12 months after initiating treatment | Percentage of men with HIV viral load \<50 copies/ml |
Countries
South Africa
Outcome results
None listed