ACCLAIM: Advancing Community Level Action for Improving MCH/PMTCT

Sponsor

Elizabeth Glaser Pediatric AIDS Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT01971710

Collaborator

Canadian International Development Agency (Other)

187,335

Enrollment

Locations

Arms

Duration (Months)

62445

Patients Per Site

1734.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
HIV	Behavioral: Community leader engagement Behavioral: Community days Behavioral: Community Peer Groups	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

187335 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Proportion of HIV-exposed infants returning to health facility HIV testing [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Must be a member of the community surveyed

Exclusion Criteria:

Under 18 years of age

Contacts and Locations

Locations

	Site	City	Country
1	Elizabeth Glaser Pediatric AIDS Foundation	Mbabane	Swaziland
2	Elizabeth Glaser Pediatric AIDS Foundation	Kampala	Uganda
3	Elizabeth Glaser Pediatric AIDS Foundation	Harare	Zimbabwe

Sponsors and Collaborators

Elizabeth Glaser Pediatric AIDS Foundation
Canadian International Development Agency

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elizabeth Glaser Pediatric AIDS Foundation

ClinicalTrials.gov Identifier:

NCT01971710

Other Study ID Numbers:

EG112/113/115

First Posted:

Oct 29, 2013

Last Update Posted:

Feb 8, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Elizabeth Glaser Pediatric AIDS Foundation

HIV

AIDS

PMTCT

Study Results

No Results Posted as of Feb 8, 2021