- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02765659
A Community-based Implementation Model for HIV Prevention and Testing in Malawi
November 11, 2021 updated by: Kathy Norr, University of Illinois at Chicago
This implementation study is testing whether community members can use a 3-step model (prepare, roll-out and sustain) to implement an efficacious peer group HIV prevention intervention with fidelity and effectiveness in a single district in Southern Malawi.
A collaborative partnership including university researchers and district government, health system and traditional leaders will support community volunteers in implementation.
Both the implementation process and the effectiveness of the intervention when implemented by communities will be evaluated.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In response to the National Institutes of Health's call for empirically-supported models to implement research-tested health behavior change interventions, the investigators are testing a 3-step (prepare, roll-out, and sustain) Community Implementation Model (Model) in low-resource African communities.
The Model is adapted from a theory-based model that was effective in implementing a hospital-based intervention in South Africa.
Its participatory approach, clear steps, observable benchmarks and multimedia Toolkit will facilitate community ownership and build capacity to use the Model with fidelity.
The investigators test whether community members can use the Model to effectively implement a peer group HIV prevention intervention called Mzake ndi Mzake (Friend to Friend) with fidelity and effectiveness.
Developed and tested among several populations in Malawi (R01-NR08058), This intervention was efficacious in rural, central Malawi.
Intervention communities had significantly better outcomes, including higher condom use and HIV testing for both adults and adolescents, than control communities.
The investigators evaluate the Model's implementation success in Phalombe District, in southern Malawi, where the HIV prevalence of 14.5% is twice that of other regions.
Our implementation partnership builds on the strengths and contributions of four sectors.
Traditional community leaders mobilize their communities' assets, including volunteers to implement the peer group intervention.
The District health system has formal authority in health organizations, contributes health knowledge, and provides local District health data.
The District political administration supports this effort by negotiating donated space for an HIV/AIDS Resource Centre and by pledging funds to sustain and expand implementation of the intervention if communities demonstrate that they can use the Model.
Researchers from both US and Malawi universities contribute the Model and the Mzake ndi Mzake peer group intervention, provide supportive technical assistance for program implementation and conduct evaluations.
Specific aims and their evaluation are: Aim 1) Prepare and support 3 communities in using the Model to implement Mzake, evaluated with community self-rated benchmarks.
Aim 2) Identify implementation patterns across sites and over time, evaluated using mixed-methods to integrate benchmarks with observations, focus groups, and interview.
Aim 3) Assess communities' effectiveness in using the Model to implement Mzake, evaluated with a stepped wedge design (N = 864).
Analysis uses multi-level hierarchical models to detect improvements over time in HIV-related behavioral outcomes and a symptoms interview with a nurse for sexually transmitted infections (STIs) in participants who have received the intervention compared to the delayed-intervention control group.
(Our original plan to use rapid STI tests appropriate for community use had to be modified because of new data indicating unacceptable reliability and withdrawal of one test from the market).
Aim 4) Evaluate whether the Model is feasible, acceptable, effective and sustainable when used by communities to implement Mzake, examined by integrating data from Aims 1-3.
If successful, this study will advance implementation science by providing a replicable evidence-based model for implementation of HIV prevention interventions and other health interventions by low-resource communities.
Study Type
Interventional
Enrollment (Actual)
1353
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Phalombe, Malawi
- Phalombe district communitie
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- reside in specified community,
- parental permission if under age 18
Exclusion Criteria:
- not in designated community
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Community 1
Receives Mzake ndi Mzake T1 immediately after baseline
|
a 6-session peer group intervention focusing on primary HIV prevention and early testing and entry to treatment for secondary prevention - offered immediately after baseline
|
Other: Community 2
Receives Mzake ndi Mzake T2 immediately after Post-T1 evaluation
|
a 6-session peer group intervention focusing on primary HIV prevention and early testing and entry to treatment for secondary prevention - offered immediately after post-T2 evaluation
|
Other: Community 3
Receives Mzake ndi Mzake T3 immediately after Post-T2 Evaluation
|
a 6-session peer group intervention focusing on primary HIV prevention and early testing and entry to treatment for secondary prevention - offered immediately after post-T3 evaluation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reported condom use in the last 2 months
Time Frame: Change from baseline up to 33 months to 33 months
|
If used condoms (always, sometimes, never) in last 2 months with all sexual partners
|
Change from baseline up to 33 months to 33 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV test in last 12 months
Time Frame: Change from baseline up to 33 months
|
up to 33 months If reports having an HIV test in the last 12 months
|
Change from baseline up to 33 months
|
Reported sexually transmitted infection (STI) symptoms
Time Frame: Change from baseline up to 33 months
|
STI symptoms reported during the last week in an interview with a nurse
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Change from baseline up to 33 months
|
Reported high-risk behaviors in the last 2 months
Time Frame: Change from baseline up to 33 months
|
Number of risky behaviors: unprotected sex, sex for money, sex while drinking, multiple partners, STI symptoms or positive test
|
Change from baseline up to 33 months
|
condom used at last intercourse
Time Frame: Change from baseline up to 33 months
|
if reported using a condom the last time had sexual intercourse
|
Change from baseline up to 33 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kathleen F. Norr, PhD, University of Illinois at Chicago
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2016
Primary Completion (Actual)
April 30, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
April 23, 2016
First Submitted That Met QC Criteria
May 5, 2016
First Posted (Estimate)
May 6, 2016
Study Record Updates
Last Update Posted (Actual)
November 15, 2021
Last Update Submitted That Met QC Criteria
November 11, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2015-0691
- R01NR015409 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
De-identified data will be made available to other researchers for secondary analyses after the primary outcome publications have been accepted for publication, approximately 3 years after the grant ends.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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