Clinical trial NCT02197793: Activating Treatment as Prevention Through Community Mobilization in South Africa
Official title: Activating Treatment as Prevention Through Community Mobilization in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Witwatersrand, South Africa
name: University of North Carolina, Chapel Hill
First posted: 2014-07-23
Enrollment: 2338
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Rates of HIV Testing
timeFrame: 3 years follow-up
measure: Rates of linkage to care CD4 within 3 months
timeFrame: 3 years follow-up
measure: Rates of retention in care
timeFrame: 3 years follow-up
Secondary outcomes:
measure: Median CD4 of people initiating ART
timeFrame: 3 years follow-up
measure: Re-engagement in care
timeFrame: 3 years follow-up
measure: Testing Yield
timeFrame: 3 years follow-up
measure: First Time Testers
timeFrame: 3 years follow-up
Other outcomes:
Locations:
city: Agincourt
country: South Africa
facility: MRC/Wits Rural Public Health and Heath Transitions Research Unit
state: Mpumalanga
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Audrey Pettifor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lippman SA, Pettifor A, Dufour MK, Kabudula CW, Twine R, Peacock D, Mathebula R, Julien A, West R, Neilands TB, Wagner R, Gottert A, Gomez-Olive 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.
citation: 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.