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

Elizabeth Glaser Pediatric AIDS Foundation

Status: Completed

Conditions: HIV

Treatments: Behavioral: Community leader engagement; Behavioral: Community days; Behavioral: Community Peer Groups

Study type: Interventional

Funder types: Other

Identifiers

NCT01971710

EG112/113/115

Details and patient eligibility

About

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.

Full 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.

Enrollment: 187,335 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Must be a member of the community surveyed

Exclusion criteria

• Under 18 years of age

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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187,335 participants in 3 patient groups

Community Leader Engagement

Other group

Description:

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

Treatment:

Behavioral: Community leader engagement

Community Days

Other group

Description:

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

Treatment:

Behavioral: Community days

Behavioral: Community leader engagement

Community Peer Groups

Other group

Description:

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

Treatment:

Behavioral: Community Peer Groups

Behavioral: Community days

Behavioral: Community leader engagement