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| Name | Class |
|---|---|
| Human Sciences Research Council | OTHER_GOV |
| Medical University of South Carolina | OTHER |
| Charles University, Czech Republic | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Men-Centered HIV Testing | Experimental | Mobile HIV testing is conducted at sites in the community where men gather. |
|
| Clinic-based HIV Testing | Active Comparator | Men are referred to the nearest clinic for HIV counseling and testing |
|
| Linkage to Care for HIV+ Men | Experimental | The patient coordinator arranges an appointment time at the clinic and accompanies the patient to the initial visit |
|
| Clinic Referral for HIV+ Men | Active Comparator | Men diagnosed with HIV are referred to the nearest clinic for treatment of HIV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Percentage of men with suppressed viral load |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| THOMAS J COATES, PhD | University of California, Los Angeles | Principal Investigator |
| Heidi Van Rooyen, PhD | Human Sciences Research Council | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Sciences Research Council | Pietermaritzburg | KwaZulu-Natal | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31888701 | Derived | 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. |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D004194 | Disease |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Men-Centered HIV Testing vs. Clinic-Based HIV Testing; Personalized Linkage to Care for HIV+ Men vs. Clinic Referral for HIV+ Men.
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The Care Provider and Outcomes Assessors do not know the arms to which an individual has been assigned
| 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 |
|
Percentage of men with HIV viral load <50 copies/ml
| 12 months after initiating treatment |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |