Advancing Community Level Action for Improving MCH/PMTCT

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Community leader engagement
* Behavioral: Community days
* Behavioral: Community Peer Groups


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be a member of the community surveyed Exclusion Criteria: Under 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Community Leader Engagement<br>Trained formal and informal community leaders conducting community dialogues and advocacy, and developing community action plans | Behavioral: Community leader engagement<br>* Community leaders conducting advocacy, community dialogue and community action plans on PMTCT/MCH<br>|
| Other: Community Days<br>Community gatherings involving participatory dialogue, guided discussion, and the provision of education and selected health services. | Behavioral: Community leader engagement<br>* Community leaders conducting advocacy, community dialogue and community action plans on PMTCT/MCH<br>Behavioral: Community days<br>* The provision of facilitated dialogues, advocacy and education, and selected health services, to a community on a specific day<br>|
| Other: Community Peer Groups<br>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<br>* Community leaders conducting advocacy, community dialogue and community action plans on PMTCT/MCH<br>Behavioral: Community days<br>* The provision of facilitated dialogues, advocacy and education, and selected health services, to a community on a specific day<br>Behavioral: Community Peer Groups<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of HIV-exposed infants returning to health facility HIV testing | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, AIDS, PMTCT