HIVNCT02197793
Activating Treatment as Prevention Through Community Mobilization in South Africa
A study testing Community Mobilization Program in people with HIV, run by University of California, San Francisco at 1 site in South Africa.
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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Community Mobilization Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,338 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jul 2014to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- lived in the study area for 12 months
- age 18-49 years
- able to provide informed consent.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
South Africa1 site
MRC/Wits Rural Public Health and Heath Transitions Research Unit
Agincourt, Mpumalanga
About this study
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.
Read the 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
- Being tested
- Community Mobilization Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Mobilization ProgramBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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)). Receives: Behavioral: Community Mobilization Program |
| Control Arm | No intervention | The control arm does not receive the Community Mobilization Intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of HIV Testing
Tested /Untested past 12 mos, among HIV-negative or unknown status residents
Measured: 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
Measured: 3 years follow-up
Rates of retention in care
No treatment default (no more than a 90-day gap in medication or visit schedule)
Measured: 3 years follow-up
Secondary outcomes (4)
Median CD4 of people initiating ART
Median CD4 at entry into care
Measured: 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
Measured: 3 years follow-up
Testing Yield
Number of new diagnoses
Measured: 3 years follow-up
First Time Testers
Number of first time testers (in particular the number of HIV infected undiagnosed)
Measured: 3 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionAug 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,338 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of Witwatersrand, South Africa, University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Audrey Pettifor, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197793
- Sponsor's protocol ID
- 14-13575
- Status last verified
- Sep 2020
- First submitted
- 21 Jul 2014
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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, 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.
PubMed 36055294Lippman 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.
PubMed 28095904
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activating Treatment as Prevention Through Community Mobilization in South Africa
- ClinicalTrials.gov ID
- NCT02197793
- Acronym / sponsor ID
- 14-13575
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,338 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of Witwatersrand, South Africa, University of North Carolina, Chapel Hill
- Study start
- Jul 2014 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 23 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Mobilization Program | Experimental | Behavioral: Community Mobilization ProgramIntervention 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)). |
| Control Arm | No intervention | –The control arm does not receive the Community Mobilization Intervention. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- lived in the study area for 12 months
- age 18-49 years
- able to provide informed consent.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Mobilization Program | Behavioural | Community Mobilization Program |
Primary outcome
Rates of HIV Testing
Time frame: 3 years follow-up
Tested /Untested past 12 mos, among HIV-negative or unknown status residents
Rates of linkage to care CD4 within 3 months
Time frame: 3 years follow-up
Received CD4 results or had clinical visit within 3 mos of testing HIV positive among recent positives
Rates of retention in care
Time frame: 3 years follow-up
No treatment default (no more than a 90-day gap in medication or visit schedule)
4 secondary outcomes
Median CD4 of people initiating ART
Time frame: 3 years follow-up
Re-engagement in care
Time frame: 3 years follow-up
Testing Yield
Time frame: 3 years follow-up
First Time Testers
Time frame: 3 years follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Derived from this study: PubMed 36055294Lippman 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.
- Derived from this study: PubMed 28095904Lippman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audrey Pettifor, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Mobilization Program in people with HIV, run by University of California, San Francisco at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of HIV Testing (time frame: 3 years follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02197793, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.