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Advancing Community Level Action for Improving MCH/PMTCT

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01971710
Acronym
ACCLAIM
Enrollment
187335
Registered
2013-10-29
Start date
2013-04-30
Completion date
2016-04-30
Last updated
2021-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

HIV, AIDS, PMTCT

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.

Interventions

BEHAVIORALCommunity leader engagement

Community leaders conducting advocacy, community dialogue and community action plans on PMTCT/MCH

BEHAVIORALCommunity days

The provision of facilitated dialogues, advocacy and education, and selected health services, to a community on a specific day

BEHAVIORALCommunity 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.

Sponsors

Canadian International Development Agency
CollaboratorOTHER_GOV
Elizabeth Glaser Pediatric AIDS Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* Must be a member of the community surveyed

Exclusion criteria

* Under 18 years of age

Design outcomes

Primary

MeasureTime frameDescription
Proportion of HIV-exposed infants returning to health facility HIV testing6-8 weeks after birthThe 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.

Countries

Eswatini, Uganda, Zimbabwe

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026