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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- HIV CDC Category A1
- 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 group | Role | What they receive |
|---|---|---|
| Community 1 | Other | Receives Mzake ndi Mzake T1 immediately after baseline Receives: Behavioral: Mzake ndi Mzake T1 |
| Community 2 | Other | Receives Mzake ndi Mzake T2 immediately after Post-T1 evaluation Receives: Behavioral: Mzake ndi Mzake T2 |
| Community 3 | Other | Receives 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.
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)
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
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
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
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.
- First posted6 May 2016 (estimated)
- Study startJun 2016
- Primary completion30 Apr 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV CDC Category A1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malawi, National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Kathy Norr, University of Illinois at Chicago
- Investigators
- Kathleen F. Norr, PhD, Principal investigator, University of Illinois at Chicago
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 30071866Norr 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 38831266Norr 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 37461672Kumbani 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-based Implementation Model for HIV Prevention and Testing in Malawi
- ClinicalTrials.gov ID
- NCT02765659
- Acronym / sponsor ID
- 2015-0691
- Conditions
- HIV CDC Category A1
- Keywords
- HIV, Prevention, Implementation, Community based participatory research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,353 participants (actual)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Collaborators
- University of Malawi, National Institute of Nursing Research (NINR)
- Study start
- Jun 2016 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 6 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Community 1 | Other | Behavioral: Mzake ndi Mzake T1Receives Mzake ndi Mzake T1 immediately after baseline |
| Community 2 | Other | Behavioral: Mzake ndi Mzake T2Receives Mzake ndi Mzake T2 immediately after Post-T1 evaluation |
| Community 3 | Other | Behavioral: Mzake ndi Mzake T3Receives Mzake ndi Mzake T3 immediately after Post-T2 Evaluation |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- reside in specified community,
- parental permission if under age 18
Key exclusion criteria (1 listed)
- not in designated community
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mzake ndi Mzake T1a 6-session peer group intervention focusing on primary HIV prevention and early testing and entry to treatment for secondary prevention - offered immediately after baseline | Behavioural | Community 1 |
| Mzake ndi Mzake T2a 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 | Behavioural | Community 2 |
| Mzake ndi Mzake T3a 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 | Behavioural | Community 3 |
Primary outcome
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
4 secondary outcomes
HIV test in last 12 months
Time frame: Change from baseline up to 33 months
Reported sexually transmitted infection (STI) symptoms
Time frame: 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
condom used at last intercourse
Time frame: Change from baseline up to 33 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Background: PubMed 30071866Jere 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.
- Derived from this study: PubMed 38831266Norr 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.
- Derived from this study: PubMed 37461672Norr 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.
- Derived from this study: PubMed 36765344Kumbani 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.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen F. Norr, PhD principal investigator
University of Illinois at Chicago
1 site in 1 country: see every site and its status.
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.