Advancing Community Level Action for Improving MCH/PMTCT (ACCLAIM)

February 3, 2021 updated by: Elizabeth Glaser Pediatric AIDS Foundation

Advancing Community Level Action for Improving MCH/PMTCT (ACCLAIM): A Multi-Country Randomized Trial to Evaluate the Effectiveness of Selected Community-Level Interventions on Key MCH/PMTCT Outcomes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

187335

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Swaziland
      • Mbabane, Swaziland
        • Elizabeth Glaser Pediatric AIDS Foundation
  • Uganda
      • Kampala, Uganda
        • Elizabeth Glaser Pediatric AIDS Foundation
  • Zimbabwe
      • Harare, Zimbabwe
        • Elizabeth Glaser Pediatric AIDS Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be a member of the community surveyed

Exclusion Criteria:

  • Under 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Community Leader Engagement
Trained formal and informal community leaders conducting community dialogues and advocacy, and developing community action plans
Behavioral: Community leader engagement
Community leaders conducting advocacy, community dialogue and community action plans on PMTCT/MCH
Other: Community Days
Community gatherings involving participatory dialogue, guided discussion, and the provision of education and selected health services.
Behavioral: Community leader engagement
Community leaders conducting advocacy, community dialogue and community action plans on PMTCT/MCH
Behavioral: Community days
The provision of facilitated dialogues, advocacy and education, and selected health services, to a community on a specific day
Other: 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
Behavioral: Community leader engagement
Community leaders conducting advocacy, community dialogue and community action plans on PMTCT/MCH
Behavioral: Community days
The provision of facilitated dialogues, advocacy and education, and selected health services, to a community on a specific day
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of HIV-exposed infants returning to health facility HIV testing
Time Frame: 6-8 weeks after birth
The general objective for the study is to assess the efficacy of the three study arm activities on the uptake of, and retention of HIV positive pregnant/postpartum women in MCH/PMTCT services as measured by the proportion of infants returning to the health facility at 6-8 weeks of age for the early infant diagnosis (EID) of HIV.
6-8 weeks after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Collaborators

Canadian International Development Agency

Investigators

  • Principal Investigator: Godfrey Woelk, PhD, Elizabeth Glaser Pediatric AIDS Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

August 13, 2013

First Submitted That Met QC Criteria

October 24, 2013

First Posted (Estimate)

October 29, 2013

Study Record Updates

Last Update Posted (Actual)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EG112/113/115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The dataset may be available in 2018. Enquiries may be made with the organization.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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