NCT02765659

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,353

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
26 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

4.9 years

First QC Date

April 23, 2016

Last Update Submit

November 11, 2021

Conditions

HIV CDC Category A1

Keywords

HIVPreventionImplementationCommunity based participatory research

Outcome Measures

Primary Outcomes (1)

  • Reported condom use in the last 2 months

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

    Change from baseline up to 33 months to 33 months

Secondary Outcomes (4)

  • HIV test in last 12 months

    Change from baseline up to 33 months

  • Reported sexually transmitted infection (STI) symptoms

    Change from baseline up to 33 months

  • Reported high-risk behaviors in the last 2 months

    Change from baseline up to 33 months

  • condom used at last intercourse

    Change from baseline up to 33 months

Study Arms (3)

Community 1

OTHER

Receives Mzake ndi Mzake T1 immediately after baseline

Behavioral: Mzake ndi Mzake T1

Community 2

OTHER

Receives Mzake ndi Mzake T2 immediately after Post-T1 evaluation

Behavioral: Mzake ndi Mzake T2

Community 3

OTHER

Receives Mzake ndi Mzake T3 immediately after Post-T2 Evaluation

Behavioral: Mzake ndi Mzake T3

Interventions

Mzake ndi Mzake T1BEHAVIORAL

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 1
Mzake ndi Mzake T2BEHAVIORAL

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 2
Mzake ndi Mzake T3BEHAVIORAL

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

Community 3

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • not in designated community

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phalombe district communitie

Phalombe, Malawi

Location

Related Publications (4)

  • 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.

    PMID: 30071866BACKGROUND

  • 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.

    PMID: 38831266DERIVED

  • 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.

    PMID: 37461672DERIVED

  • 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.

    PMID: 36765344DERIVED

Study Officials

  • Kathleen F. Norr, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Emerita

Study Record Dates

First Submitted

April 23, 2016

First Posted

May 6, 2016

Study Start

June 1, 2016

Primary Completion

April 30, 2021

Study Completion

June 30, 2021

Last Updated

November 15, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

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.

Locations

MA(1)