NCT01971710

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187,335

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable hiv

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 29, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

2.7 years

First QC Date

August 13, 2013

Last Update Submit

February 3, 2021

Conditions

HIV

Keywords

HIVAIDSPMTCT

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Community Leader Engagement

OTHER

Trained formal and informal community leaders conducting community dialogues and advocacy, and developing community action plans

Behavioral: Community leader engagement

Community Days

OTHER

Community gatherings involving participatory dialogue, guided discussion, and the provision of education and selected health services.

Behavioral: Community leader engagementBehavioral: Community days

Community Peer Groups

OTHER

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 engagementBehavioral: Community daysBehavioral: Community Peer Groups

Interventions

Community leader engagementBEHAVIORAL

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

Community DaysCommunity Leader EngagementCommunity Peer Groups
Community daysBEHAVIORAL

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

Community DaysCommunity Peer Groups
Community Peer GroupsBEHAVIORAL

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 Peer Groups

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be a member of the community surveyed

You may not qualify if:

  • Under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Elizabeth Glaser Pediatric AIDS Foundation

Mbabane, Eswatini

Location

Elizabeth Glaser Pediatric AIDS Foundation

Kampala, Uganda

Location

Elizabeth Glaser Pediatric AIDS Foundation

Harare, Zimbabwe

Location

Related Publications (1)

  • 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.

    PMID: 26883307DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Godfrey Woelk, PhD

    Elizabeth Glaser Pediatric AIDS Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2013

First Posted

October 29, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2015

Study Completion

April 1, 2016

Last Updated

February 8, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

The dataset may be available in 2018. Enquiries may be made with the organization.

Locations

ES(1)UG(1)ZI(1)