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Activating Treatment as Prevention Through Community Mobilization in South Africa

Activating Treatment as Prevention Through Community Mobilization in South Africa

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02197793
Enrollment
2338
Registered
2014-07-23
Start date
2014-07-31
Completion date
2018-12-31
Last updated
2020-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

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.

Interventions

BEHAVIORALCommunity Mobilization Program

Sponsors

University of Witwatersrand, South Africa
CollaboratorOTHER
University of North Carolina, Chapel Hill
CollaboratorOTHER
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Rates of HIV Testing3 years follow-upTested /Untested past 12 mos, among HIV-negative or unknown status residents
Rates of linkage to care CD4 within 3 months3 years follow-upReceived CD4 results or had clinical visit within 3 mos of testing HIV positive among recent positives
Rates of retention in care3 years follow-upNo treatment default (no more than a 90-day gap in medication or visit schedule)

Secondary

MeasureTime frameDescription
Median CD4 of people initiating ART3 years follow-upMedian CD4 at entry into care
First Time Testers3 years follow-upNumber of first time testers (in particular the number of HIV infected undiagnosed)
Re-engagement in care3 years follow-upPatients out of care for ≥ 12 months who are re-engaged in care, as evidenced by a clinical visit or CD4 test
Testing Yield3 years follow-upNumber of new diagnoses

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026