The ACCLAIM Project

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Elizabeth Glaser Pediatric AIDS Foundation
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: August 5, 2014
Last verified: August 2014
  Purpose

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 Intervention
HIV
Behavioral: Community leader engagement
Behavioral: Community days
Behavioral: Community Peer Groups

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Advancing Community Level Action for Improving MCH/PMTCT

Resource links provided by NLM:


Further study details as provided by Elizabeth Glaser Pediatric AIDS Foundation:

Primary Outcome Measures:
  • Proportion of HIV-exposed infants returning to health facility HIV testing [ Time Frame: 6-8 weeks after birth ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 187335
Study Start Date: April 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Leaders
Formal and informal community leaders
Behavioral: Community leader engagement
Community Members
Community members recruited from general community gatherings
Behavioral: Community leader engagement Behavioral: Community days
Peer Groups
MCH classes and men's groups
Behavioral: Community leader engagement Behavioral: Community days Behavioral: Community Peer Groups

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be a member of the community surveyed

Exclusion Criteria:

  • Under 18 years of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01971710

Contacts
Contact: Godfrey Woelk, PhD gwoelk@pedaids.org
Contact: Suzanne May, MPH smay@pedaids.org

Locations
Swaziland
Elizabeth Glaser Pediatric AIDS Foundation Recruiting
Mbabane, Swaziland
Principal Investigator: Mohammed A Mahdi, MD         
Uganda
Elizabeth Glaser Pediatric AIDS Foundation Recruiting
Kampala, Uganda
Principal Investigator: Edward Bitarakwate, MD         
Zimbabwe
Elizabeth Glaser Pediatric AIDS Foundation Recruiting
Harare, Zimbabwe
Principal Investigator: Batsirai M Chikwinya         
Sponsors and Collaborators
Elizabeth Glaser Pediatric AIDS Foundation
Canadian International Development Agency
Investigators
Principal Investigator: Godfrey Woelk, PhD Elizabeth Glaser Pediatric AIDS Foundation
  More Information

No publications provided

Responsible Party: Elizabeth Glaser Pediatric AIDS Foundation
ClinicalTrials.gov Identifier: NCT01971710     History of Changes
Other Study ID Numbers: EGPAF-003
Study First Received: August 13, 2013
Last Updated: August 5, 2014
Health Authority: Zimbabwe: Medical Research Council
Uganda: National Council for Science and Technology
Swaziland: Scientific and Ethics Commitee - Ministry of Health

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

ClinicalTrials.gov processed this record on August 28, 2014