Activating Treatment as Prevention Through Community Mobilization in South Africa

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the impact of a community mobilization intervention on the uptake of HIV testing, linkage to and retention in HIV care using a community, cluster randomized trial.

Detailed Description
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Eight of 16 intervention naïve communities in the Agincourt HDSS will be randomized to receive the CM intervention to activate TasP based on the investigators CM conceptual framework. The 16 villages will be randomized based on the restricted randomization approach, a stratification method to ensure overall balance between intervention and control communities. Intervention activities will map onto the investigators six mobilization domains identified in the investigators preliminary work as key components for communities to mobilize for change around HIV prevention. These activities will support communities to: 1) identify a shared concern around testing, linkage and retention in care; 2) enable communities to develop critical consciousness around TasP; 3) facilitate identification and development of structures and networks to disseminate information and activities around TasP; 4) identify and engage community leadership around TasP; 5) take collection action to support TasP; and 6) build community cohesion to address the HIV epidemic and support access to care. The investigators will evaluate the impact of the intervention using a linked data set including electronic clinic records and the HDSS census data, which will allow us to determine whether people in the intervention communities test at higher proportions than those in control communities, whether individuals who test positive in the intervention communities are more likely to receive CD4 testing and initiate treatment within 3 months than the control communities, and whether those who are eligible and not eligible for treatment are retained in care. The investigators will implement a representative cross-sectional survey in all 16 villages prior to and following the intervention in order to examine changes in CM domains across villages and the mechanisms through which the intervention affects HIV testing, linkage and retention. In addition, intervention progress and dosage will be carefully monitored through a tracking system to document all workshops and activities that are carried out in each village.

Official Title
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Activating Treatment as Prevention Through Community Mobilization in South Africa

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Community Mobilization Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: lived in the study area for 12 months age 18-49 years able to provide informed consent. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Community Mobilization Program<br>Intervention activities will map onto six mobilization domains identified as key components for communities to mobilize for change around testing, linkage and retention in care (Treatment as Prevention (TasP)). | Behavioral: Community Mobilization Program<br> <br> |
| No Intervention: Control Arm<br>The control arm does not receive the Community Mobilization Intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of HIV Testing | Tested /Untested past 12 mos, among HIV-negative or unknown status residents | 3 years follow-up | 
| Rates of linkage to care CD4 within 3 months | Received CD4 results or had clinical visit within 3 mos of testing HIV positive among recent positives | 3 years follow-up | 
| Rates of retention in care | No treatment default (no more than a 90-day gap in medication or visit schedule) | 3 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median CD4 of people initiating ART | Median CD4 at entry into care | 3 years follow-up | 
| Re-engagement in care | Patients out of care for ≥ 12 months who are re-engaged in care, as evidenced by a clinical visit or CD4 test | 3 years follow-up | 
| Testing Yield | Number of new diagnoses | 3 years follow-up | 
| First Time Testers | Number of first time testers (in particular the number of HIV infected undiagnosed) | 3 years follow-up |