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HIV CDC Category A1NCT02765659

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

A study testing Mzake ndi Mzake T1, Mzake ndi Mzake T2 and Mzake ndi Mzake T3 in people with HIV CDC Category A1, run by University of Illinois at Chicago at 1 site in Malawi.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 years and olderHealthy volunteers can take part
Conditions the study is for
HIV CDC Category A1
What is being tested?
Mzake ndi Mzake T1, Mzake ndi Mzake T2 and Mzake ndi Mzake T3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,353 participants
Where
1 siteMalawi
Study dates
Jun 2016to 30 Jun 2021
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 13 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • not in designated community

Trial locations and contacts

1 site in 1 country.

Malawi1 site
  • Phalombe district communitie

    Phalombe

Other trials in Malawi

About this study

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.

Read the 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.

Being tested
Mzake ndi Mzake T1, Mzake ndi Mzake T2, Mzake ndi Mzake T3
Keywords
HIV, Prevention, Implementation, Community based participatory research

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mzake ndi Mzake T1Behavioural

    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

  • Mzake ndi Mzake T2Behavioural

    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

  • Mzake ndi Mzake T3Behavioural

    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 groups in NCT02765659
Study groupRoleWhat they receive
Community 1OtherReceives Mzake ndi Mzake T1 immediately after baseline
Receives: Behavioral: Mzake ndi Mzake T1
Community 2OtherReceives Mzake ndi Mzake T2 immediately after Post-T1 evaluation
Receives: Behavioral: Mzake ndi Mzake T2
Community 3OtherReceives Mzake ndi Mzake T3 immediately after Post-T2 Evaluation
Receives: Behavioral: Mzake ndi Mzake T3

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reported condom use in the last 2 months

    If used condoms (always, sometimes, never) in last 2 months with all sexual partners

    Measured: Change from baseline up to 33 months to 33 months

Secondary outcomes (4)
  1. HIV test in last 12 months

    up to 33 months If reports having an HIV test in the last 12 months

    Measured: Change from baseline up to 33 months

  2. Reported sexually transmitted infection (STI) symptoms

    STI symptoms reported during the last week in an interview with a nurse

    Measured: Change from baseline up to 33 months

  3. Reported high-risk behaviors in the last 2 months

    Number of risky behaviors: unprotected sex, sex for money, sex while drinking, multiple partners, STI symptoms or positive test

    Measured: Change from baseline up to 33 months

  4. condom used at last intercourse

    if reported using a condom the last time had sexual intercourse

    Measured: Change from baseline up to 33 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2016 (estimated)
  2. Study startJun 2016
  3. Primary completion30 Apr 2021
  4. Study completion30 Jun 2021

Resources

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
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,353 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02765659
Sponsor's protocol ID
2015-0691
Other IDs
R01NR015409
Status last verified
Nov 2021
First submitted
23 Apr 2016
Last updated
15 Nov 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: 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.

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.

    PubMed 30071866
  • Norr KF, Banda CK, Chang C, Krishna S, Kumbani LC, Liu L, McCreary LL, Patil CL. Condom use increased after a peer group intervention implemented by community volunteers in Malawi. BMC Public Health. 2024 Jun 3;24(1):1483. doi: 10.1186/s12889-024-18991-z.

    PubMed 38831266
  • Norr KF, Banda CK, Chang C, Krishna S, Kumbani LC, Liu L, McCreary LL, Patil CL. Condom use increased after a peer group intervention implemented by community volunteers in Malawi. Res Sq [Preprint]. 2023 Jul 4:rs.3.rs-3120974. doi: 10.21203/rs.3.rs-3120974/v1.

    PubMed 37461672
  • Kumbani LC, Jere DL, Banda CK, Chang C, Liu L, McCreary LL, Patil CL, Norr KF. A peer group intervention implemented by community volunteers increased HIV prevention knowledge. BMC Public Health. 2023 Feb 10;23(1):301. doi: 10.1186/s12889-022-14715-3.

    PubMed 36765344

Questions about this trial

What is this clinical trial studying?

A study testing Mzake ndi Mzake T1, Mzake ndi Mzake T2 and Mzake ndi Mzake T3 in people with HIV CDC Category A1, run by University of Illinois at Chicago at 1 site in Malawi.

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 2 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 15 Nov 2021. 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 Malawi. 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?

Reported condom use in the last 2 months (time frame: Change from baseline up to 33 months to 33 months). 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 NCT02765659, which also lists 4 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 15 Nov 2021; AzTrials last refreshed its copy on 28 Oct 2026.

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