Activating Treatment as Prevention Through Community Mobilization in South Africa

NCT ID: NCT02197793

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2338 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2018-12-31

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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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)).

Group Type: EXPERIMENTAL

Community Mobilization Program

Intervention Type: BEHAVIORAL

Control Arm

The control arm does not receive the Community Mobilization Intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Community Mobilization Program

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Witwatersrand, South Africa

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Audrey Pettifor, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

MRC/Wits Rural Public Health and Heath Transitions Research Unit

Agincourt, Mpumalanga, South Africa

Countries

South Africa

References

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.

Reference Type: DERIVED

PMID: 36055294 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28095904 (View on PubMed)

Other Identifiers

14-13575

Identifier Type: -

Identifier Source: org_study_id