NCT02197793

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,338

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

4.1 years

First QC Date

July 21, 2014

Last Update Submit

September 3, 2020

Conditions

HIV

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Median CD4 of people initiating ART

    3 years follow-up

  • Re-engagement in care

    3 years follow-up

  • Testing Yield

    3 years follow-up

  • First Time Testers

    3 years follow-up

Study Arms (2)

Community Mobilization Program

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

The control arm does not receive the Community Mobilization Intervention.

Interventions

Community Mobilization ProgramBEHAVIORAL
Community Mobilization Program

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MRC/Wits Rural Public Health and Heath Transitions Research Unit

Agincourt, Mpumalanga, South Africa

Location

Related Publications (2)

  • 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.

    PMID: 36055294DERIVED

  • 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.

    PMID: 28095904DERIVED

Study Officials

  • Audrey Pettifor, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2014

First Posted

July 23, 2014

Study Start

July 1, 2014

Primary Completion

August 1, 2018

Study Completion

December 1, 2018

Last Updated

September 9, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)