Advancing Community Level Action for Improving MCH/PMTCT

HIV Clinical Trial

— ACCLAIM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01971710
• Other study ID #: EG112/113/115
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: April 2016

Study information

• Verified date: February 2021
• Source: Elizabeth Glaser Pediatric AIDS Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187335
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Must be a member of the community surveyed

Exclusion Criteria:

• Under 18 years of age

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Community leader engagement
Community leaders conducting advocacy, community dialogue and community action plans on PMTCT/MCH
• 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 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.

Locations

Country	Name	City	State
Swaziland	Elizabeth Glaser Pediatric AIDS Foundation	Mbabane
Uganda	Elizabeth Glaser Pediatric AIDS Foundation	Kampala
Zimbabwe	Elizabeth Glaser Pediatric AIDS Foundation	Harare

Sponsors (2)

Lead Sponsor	Collaborator
Elizabeth Glaser Pediatric AIDS Foundation	Canadian International Development Agency

Countries where clinical trial is conducted

Swaziland,  Uganda,  Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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