Advancing Community Level Action for Improving MCH/PMTCT

NCT ID: NCT01971710

Last Updated: 2021-02-08

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

187335 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-04-30

Brief Summary

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The goal of the ACCLAIM (Advancing Community-Level Action for Improving MCH/PMTCT) project is to increase community demand for, uptake of, and retention in Maternal and Child Health (MCH) and/Prevention of Mother-to-child transmission of HIV (PMTCT) services to improve country progress toward elimination of pediatric HIV/AIDS.

Detailed Description

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This study will undertake a three-arm randomized trial in Swaziland, Uganda and Zimbabwe. Districts/regions (n=9) with 45 PMTCT-implementing health facilities and their catchment areas (populations 7300-27500), will be randomly allocated to three intervention arms: 1) community leader engagement, 2) community leader engagement with community days, or 3) community leader engagement with community days and male and female community peer groups. The primary study outcome is HIV exposed infants (HEI) returning to the health facility within two months for early infant diagnosis (EID) of HIV. Secondary study outcomes include: gestational age of women attending for first antenatal care, male partners tested for HIV, and HEI receiving nevirapine prophylaxis at birth. Changes in community knowledge, attitudes, practices and beliefs on MCH/PMTCT will be assessed through household surveys.

Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Community Leader Engagement

Trained formal and informal community leaders conducting community dialogues and advocacy, and developing community action plans

Group Type OTHER

Community leader engagement

Intervention Type BEHAVIORAL

Community leaders conducting advocacy, community dialogue and community action plans on PMTCT/MCH

Community Days

Community gatherings involving participatory dialogue, guided discussion, and the provision of education and selected health services.

Group Type OTHER

Community leader engagement

Intervention Type BEHAVIORAL

Community leaders conducting advocacy, community dialogue and community action plans on PMTCT/MCH

Community days

Intervention Type BEHAVIORAL

The provision of facilitated dialogues, advocacy and education, and selected health services, to a community on a specific day

Community Peer Groups

Pregnant women attend 4 weekly peer-led classes in community peer groups. Men attending 4 peer-led education sessions in community peer groups

Group Type OTHER

Community leader engagement

Intervention Type BEHAVIORAL

Community leaders conducting advocacy, community dialogue and community action plans on PMTCT/MCH

Community days

Intervention Type BEHAVIORAL

The provision of facilitated dialogues, advocacy and education, and selected health services, to a community on a specific day

Community Peer Groups

Intervention Type BEHAVIORAL

Pregnant women in community peer groups receiving information and education on PMTCT/MCH through 4 weekly peer-led classes . Men in community peer groups receiving information and education on their role in supporting women and families through 4 peer-led education sessions.

Interventions

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Community leader engagement

Community leaders conducting advocacy, community dialogue and community action plans on PMTCT/MCH

Intervention Type BEHAVIORAL

Community days

The provision of facilitated dialogues, advocacy and education, and selected health services, to a community on a specific day

Intervention Type BEHAVIORAL

Community Peer Groups

Pregnant women in community peer groups receiving information and education on PMTCT/MCH through 4 weekly peer-led classes . Men in community peer groups receiving information and education on their role in supporting women and families through 4 peer-led education sessions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Must be a member of the community surveyed

Exclusion Criteria

* Under 18 years of age
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian International Development Agency

OTHER_GOV

Sponsor Role collaborator

Elizabeth Glaser Pediatric AIDS Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Godfrey Woelk, PhD

Role: PRINCIPAL_INVESTIGATOR

Elizabeth Glaser Pediatric AIDS Foundation

Locations

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Elizabeth Glaser Pediatric AIDS Foundation

Mbabane, , Eswatini

Site Status

Elizabeth Glaser Pediatric AIDS Foundation

Kampala, , Uganda

Site Status

Elizabeth Glaser Pediatric AIDS Foundation

Harare, , Zimbabwe

Site Status

Countries

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Eswatini Uganda Zimbabwe

References

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Woelk GB, Kieffer MP, Walker D, Mpofu D, Machekano R; Project ACCLAIM Study Group. Evaluating the effectiveness of selected community-level interventions on key maternal, child health, and prevention of mother-to-child transmission of HIV outcomes in three countries (the ACCLAIM Project): a study protocol for a randomized controlled trial. Trials. 2016 Feb 16;17:88. doi: 10.1186/s13063-016-1202-y.

Reference Type DERIVED
PMID: 26883307 (View on PubMed)

Other Identifiers

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EG112/113/115

Identifier Type: -

Identifier Source: org_study_id

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