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A Community-based Implementation Model for HIV Prevention and Testing in Malawi

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ClinicalTrials.gov Identifier: NCT02765659
Recruitment Status : Active, not recruiting
First Posted : May 6, 2016
Last Update Posted : July 16, 2019
Sponsor:
Collaborator:
Kamuzu College of Nursing, University of Malawi
Information provided by (Responsible Party):
Kathy Norr, University of Illinois at Chicago

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV CDC Category A1 Behavioral: Mzake ndi Mzake T1 Behavioral: Mzake ndi Mzake T2 Behavioral: Mzake ndi Mzake T3 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1353 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Community-based Implementation Model for HIV Prevention and Testing in Malawi
Study Start Date : June 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Community 1
Receives Mzake ndi Mzake T1 immediately after baseline
Behavioral: Mzake ndi Mzake T1
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

Community 2
Receives Mzake ndi Mzake T2 immediately after Post-T1 evaluation
Behavioral: Mzake ndi Mzake T2
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

Community 3
Receives Mzake ndi Mzake T3 immediately after Post-T2 Evaluation
Behavioral: Mzake ndi Mzake T3
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • reside in specified community,
  • parental permission if under age 18

Exclusion Criteria:

  • not in designated community

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02765659


Locations
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Malawi
Phalombe district communitie
Phalombe, Malawi
Sponsors and Collaborators
University of Illinois at Chicago
Kamuzu College of Nursing, University of Malawi
Investigators
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Principal Investigator: Kathleen F. Norr, PhD University of Illinois at Chicago

Publications:
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Responsible Party: Kathy Norr, Professor Emerita, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02765659     History of Changes
Other Study ID Numbers: 2015-0691
R01NR015409 ( U.S. NIH Grant/Contract )
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.
Keywords provided by Kathy Norr, University of Illinois at Chicago:
HIV
Prevention
Implementation
Community based participatory research