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Completed

NCT Number: NCT02197793

Activating Treatment as Prevention Through Community Mobilization in South Africa

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.

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Key information

Conditions

HIV

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MRC/Wits Rural Public Health and Heath Transitions Research Unit

Agincourt, Mpumalanga, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Community Mobilization Program

Behavioral

Primary outcomes

  1. Rates of HIV Testing

    Time frame: 3 years follow-up

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

  2. 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

  3. 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)

Secondary outcomes

  1. Median CD4 of people initiating ART

    Time frame: 3 years follow-up

    Median CD4 at entry into care

  2. Re-engagement in care

    Time frame: 3 years follow-up

    Patients out of care for ≥ 12 months who are re-engaged in care, as evidenced by a clinical visit or CD4 test

  3. Testing Yield

    Time frame: 3 years follow-up

    Number of new diagnoses

  4. First Time Testers

    Time frame: 3 years follow-up

    Number of first time testers (in particular the number of HIV infected undiagnosed)

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • University of North Carolina, Chapel Hill
  • University of Witwatersrand, South Africa

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jul 23, 2014
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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