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Completed

NCT Number: NCT01971710

Advancing Community Level Action for Improving MCH/PMTCT

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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elizabeth Glaser Pediatric AIDS Foundation, Mbabane, Eswatini

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be a member of the community surveyed

Exclusion criteria

  • Under 18 years of age

Treatment and study plan

Community leader engagement

Behavioral

Community leaders conducting advocacy, community dialogue and community action plans on PMTCT/MCH

Community days

Behavioral

The provision of facilitated dialogues, advocacy and education, and selected health services, to a community on a specific day

Community Peer Groups

Behavioral

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Other

Collaborators

  • Canadian International Development Agency

Registry information

Official study 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

Acronym: ACCLAIM

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Oct 29, 2013
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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