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Clinical Trials/NCT02197793
NCT02197793
Completed
Not Applicable

Activating Treatment as Prevention Through Community Mobilization in South Africa

University of California, San Francisco1 site in 1 country2,338 target enrollmentJuly 2014
ConditionsHIV

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
University of California, San Francisco
Enrollment
2338
Locations
1
Primary Endpoint
Rates of retention in care
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
December 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • lived in the study area for 12 months
  • age 18-49 years
  • able to provide informed consent.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Rates of retention in care

Time Frame: 3 years follow-up

No treatment default (no more than a 90-day gap in medication or visit schedule)

Rates of HIV Testing

Time Frame: 3 years follow-up

Tested /Untested past 12 mos, among HIV-negative or unknown status residents

Rates of linkage to care CD4 within 3 months

Time Frame: 3 years follow-up

Received CD4 results or had clinical visit within 3 mos of testing HIV positive among recent positives

Secondary Outcomes

  • Median CD4 of people initiating ART(3 years follow-up)
  • Re-engagement in care(3 years follow-up)
  • Testing Yield(3 years follow-up)
  • First Time Testers(3 years follow-up)

Study Sites (1)

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