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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

Tracking Information
First Submitted Date  ICMJE April 23, 2016
First Posted Date  ICMJE May 6, 2016
Last Update Posted Date July 16, 2019
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02765659 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2017)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2016)
  • 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
  • Positive sexually transmitted infection (STI) test [ Time Frame: Change from baseline up to 33 months ]
    Positive rapid test result for 1 or more STI
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Community-based Implementation Model for HIV Prevention and Testing in Malawi
Official Title  ICMJE A Community-based Implementation Model for HIV Prevention and Testing in Malawi
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HIV CDC Category A1
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Community 1
    Receives Mzake ndi Mzake T1 immediately after baseline
    Intervention: Behavioral: Mzake ndi Mzake T1
  • Community 2
    Receives Mzake ndi Mzake T2 immediately after Post-T1 evaluation
    Intervention: Behavioral: Mzake ndi Mzake T2
  • Community 3
    Receives Mzake ndi Mzake T3 immediately after Post-T2 Evaluation
    Intervention: Behavioral: Mzake ndi Mzake T3
Publications * Jere DLN, Banda CK, Kumbani LC, Liu L, McCreary LL, Park CG, Patil CL, Norr KF. A hybrid design testing a 3-step implementation model for community scale-up of an HIV prevention intervention in rural Malawi: study protocol. BMC Public Health. 2018 Aug 2;18(1):950. doi: 10.1186/s12889-018-5800-3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 3, 2019)
1353
Original Estimated Enrollment  ICMJE
 (submitted: May 5, 2016)
864
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • not in designated community
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malawi
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02765659
Other Study ID Numbers  ICMJE 2015-0691
R01NR015409 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party Kathy Norr, University of Illinois at Chicago
Study Sponsor  ICMJE University of Illinois at Chicago
Collaborators  ICMJE Kamuzu College of Nursing, University of Malawi
Investigators  ICMJE
Principal Investigator: Kathleen F. Norr, PhD University of Illinois at Chicago
PRS Account University of Illinois at Chicago
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP