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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: Community Mobilization Program

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.

• Study Type: Interventional
• Enrollment (Actual): 2338
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Mpumalanga
    • Agincourt, Mpumalanga, South Africa
      • MRC/Wits Rural Public Health and Heath Transitions Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Community Mobilization Program; 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
No Intervention: Control Arm; The control arm does not receive the Community Mobilization Intervention.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: University of North Carolina, Chapel Hill; University of Witwatersrand, South Africa
• Investigators: Principal Investigator: Audrey Pettifor, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• Lippman SA, Pettifor A, Dufour MK, Kabudula CW, Twine R, Peacock D, Mathebula R, Julien A, West R, Neilands TB, Wagner R, Gottert A, Gómez-Olivé FX, Rebombo D, Haberland N, Pulerwitz J, Majuba LP, Tollman S, Kahn K. A community mobilisation intervention to improve engagement in HIV testing, linkage to care, and retention in care in South Africa: a cluster-randomised controlled trial. Lancet HIV. 2022 Sep;9(9):e617-e626. doi: 10.1016/S2352-3018(22)00192-8.
• Lippman SA, Pettifor A, Rebombo D, Julien A, Wagner RG, Kang Dufour MS, Kabudula CW, Neilands TB, Twine R, Gottert A, Gomez-Olive FX, Tollman SM, Sanne I, Peacock D, Kahn K. Evaluation of the Tsima community mobilization intervention to improve engagement in HIV testing and care in South Africa: study protocol for a cluster randomized trial. Implement Sci. 2017 Jan 17;12(1):9. doi: 10.1186/s13012-016-0541-0.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: July 21, 2014
• First Submitted That Met QC Criteria: July 22, 2014
• First Posted (Estimate): July 23, 2014

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 14-13575

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No