Activating Treatment as Prevention Through Community Mobilization in South Africa

HIV Clinical Trial

Official title:

Activating Treatment as Prevention Through Community Mobilization in South Africa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02197793
• Other study ID #: 14-13575
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: December 2018

Study information

• Verified date: September 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2338
• Est. completion date: December 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• lived in the study area for 12 months

• age 18-49 years

• able to provide informed consent.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Community Mobilization Program

Locations

Country	Name	City	State
South Africa	MRC/Wits Rural Public Health and Heath Transitions Research Unit	Agincourt	Mpumalanga

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	University of North Carolina, Chapel Hill, University of Witwatersrand, South Africa

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of HIV Testing	Tested /Untested past 12 mos, among HIV-negative or unknown status residents	3 years follow-up
Primary	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
Primary	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	Median CD4 of people initiating ART	Median CD4 at entry into care	3 years follow-up
Secondary	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
Secondary	Testing Yield	Number of new diagnoses	3 years follow-up
Secondary	First Time Testers	Number of first time testers (in particular the number of HIV infected undiagnosed)	3 years follow-up