Advancing Community Level Action for Improving MCH/PMTCT

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: Community leader engagement; Behavioral: Community days; Behavioral: Community Peer Groups

• Registration Number: NCT01971710
• Lead Sponsor: Elizabeth Glaser Pediatric AIDS Foundation

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.

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 Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-08-13
• Study First Submitted QC: 2013-10-24
• Study First Posted: 2013-10-29
• Primary Completion: 2015-12
• Study Completion: 2016-04
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187335

Inclusion Criteria

• Must be a member of the community surveyed

Exclusion Criteria

• Under 18 years of age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Community Peer Groups	Community leader engagement	Pregnant women attend 4 weekly peer-led classes in community peer groups. Men attending 4 peer-led education sessions in community peer groups
Community Days	Community days	Community gatherings involving participatory dialogue, guided discussion, and the provision of education and selected health services.
Community Peer Groups	Community days	Pregnant women attend 4 weekly peer-led classes in community peer groups. Men attending 4 peer-led education sessions in community peer groups
Community Leader Engagement	Community leader engagement	Trained formal and informal community leaders conducting community dialogues and advocacy, and developing community action plans
Community Days	Community leader engagement	Community gatherings involving participatory dialogue, guided discussion, and the provision of education and selected health services.
Community Peer Groups	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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Elizabeth Glaser Pediatric AIDS Foundation; 🇿🇼 Harare, Zimbabwe