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.
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
|
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.
|
Community leaders conducting advocacy, community dialogue and community action plans on PMTCT/MCH
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
|
Community leaders conducting advocacy, community dialogue and community action plans on PMTCT/MCH
The provision of facilitated dialogues, advocacy and education, and selected health services, to a community on a specific day
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.
Collaborators
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.
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
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.