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

This study has been completed.
Sponsor:
Collaborator:
Canadian International Development Agency
Information provided by (Responsible Party):
Elizabeth Glaser Pediatric AIDS Foundation
ClinicalTrials.gov Identifier:
NCT01971710
First received: August 13, 2013
Last updated: January 13, 2017
Last verified: January 2017

August 13, 2013
January 13, 2017
April 2013
December 2015   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01971710 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
HIV
  • 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.
  • Community Leader Engagement
    Trained formal and informal community leaders conducting community dialogues and advocacy, and developing community action plans
    Intervention: Behavioral: Community leader engagement
  • Community Days
    Community gatherings involving participatory dialogue, guided discussion, and the provision of education and selected health services.
    Interventions:
    • Behavioral: Community leader engagement
    • Behavioral: Community days
  • 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
    Interventions:
    • Behavioral: Community leader engagement
    • Behavioral: Community days
    • Behavioral: Community Peer Groups
Woelk GB, Kieffer MP, Walker D, Mpofu D, Machekano R; Project ACCLAIM Study Group.. Evaluating the effectiveness of selected community-level interventions on key maternal, child health, and prevention of mother-to-child transmission of HIV outcomes in three countries (the ACCLAIM Project): a study protocol for a randomized controlled trial. Trials. 2016 Feb 16;17:88. doi: 10.1186/s13063-016-1202-y.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
187335
April 2016
December 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must be a member of the community surveyed

Exclusion Criteria:

  • Under 18 years of age
Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Swaziland,   Uganda,   Zimbabwe
 
 
NCT01971710
EGPAF-003
No
Not Provided
No
The dataset may be available in 2018. Enquiries may be made with the organization.
Elizabeth Glaser Pediatric AIDS Foundation
Elizabeth Glaser Pediatric AIDS Foundation
Canadian International Development Agency
Principal Investigator: Godfrey Woelk, PhD Elizabeth Glaser Pediatric AIDS Foundation
Elizabeth Glaser Pediatric AIDS Foundation
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP