MedDataX Logo

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

NCT ID: NCT02765659

Last Updated: 2021-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1353 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV CDC Category A1

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

HIV Prevention Implementation Community based participatory research

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Community 1

Receives Mzake ndi Mzake T1 immediately after baseline

Group Type OTHER

Mzake ndi Mzake T1

Intervention Type BEHAVIORAL

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

Group Type OTHER

Mzake ndi Mzake T2

Intervention Type BEHAVIORAL

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

Group Type OTHER

Mzake ndi Mzake T3

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* not in designated community
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kamuzu College of Nursing, University of Malawi

UNKNOWN

Sponsor Role collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kathy Norr

Professor Emerita

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kathleen F. Norr, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Phalombe district communitie

Phalombe, , Malawi

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Malawi

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 30071866 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38831266 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37461672 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36765344 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01NR015409

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2015-0691

Identifier Type: -

Identifier Source: org_study_id