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

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ClinicalTrials.gov Identifier: NCT01971710
Recruitment Status : Completed
First Posted : October 29, 2013
Last Update Posted : January 16, 2017
Sponsor:
Collaborator:
Canadian International Development Agency
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
HIV Behavioral: Community leader engagement Behavioral: Community days Behavioral: Community Peer Groups Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : April 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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

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

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.




Primary Outcome Measures :
  1. Proportion of HIV-exposed infants returning to health facility HIV testing [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be a member of the community surveyed

Exclusion Criteria:

  • Under 18 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01971710


Locations
Swaziland
Elizabeth Glaser Pediatric AIDS Foundation
Mbabane, Swaziland
Uganda
Elizabeth Glaser Pediatric AIDS Foundation
Kampala, Uganda
Zimbabwe
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elizabeth Glaser Pediatric AIDS Foundation
ClinicalTrials.gov Identifier: NCT01971710     History of Changes
Other Study ID Numbers: EGPAF-003
First Posted: October 29, 2013    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The dataset may be available in 2018. Enquiries may be made with the organization.

Keywords provided by Elizabeth Glaser Pediatric AIDS Foundation:
HIV
AIDS
PMTCT