NCT04372667

Brief Summary

This CDC-funded study sought to evaluate the effect of an adapted Community Score Card Approach on maternal retention in ART, maternal retention across the PMTCT service cascade, and the uptake of early infant diagnosis services in Malawi. The study also estimated the cost of the implementation of the Community Score Card Approach.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,233

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

June 7, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2020

Completed
Last Updated

May 4, 2020

Status Verified

April 1, 2020

Enrollment Period

1.4 years

First QC Date

April 29, 2020

Last Update Submit

April 30, 2020

Conditions

HIV/AIDSInfant Morbidity

Keywords

PMTCTHIVQuality improvementSocial accountabilityPatient centeredRetention in careEarly infant diagnosis of HIV

Outcome Measures

Primary Outcomes (4)

  • Early diagnosis of HIV exposed infants (HEI)

    Proportion of HEI receiving a DNA PCR test

    6 - 8 weeks after birth

  • Early retention of pregnant and breastfeeding HIV positive women in PMTCT

    Proportions of HIV-positive pregnant and breastfeeding women (including women newly-identified and already-known to be HIV positive) retained in PMTCT services

    1 to 6 months

  • Early retention of newly diagnosed HIV-positive women in HIV care

    Proportions of HIV-positive women (pregnant and breastfeeding women as well as non-pregnant women) newly initiating ART services retained in HIV care

    1 to 6 months

  • Implementation cost of CSC

    Estimate the total cost of implementing of the CSC intervention at community and facility levels.

    12 months

Study Arms (1)

Post intervention

EXPERIMENTAL

Community score card approach

Behavioral: Community score card approach

Interventions

Community score card approachBEHAVIORAL

The CSC intervention is a participatory community approach. Health care workers (HCWs), PMTCT clients identified the issues that most impacted PMTCT service quality and uptake, and came together to implement actions for improvement. The core implementation strategy is using dialogue in a participatory forum that engages both service users and service providers. The CSC consists of five core phases, repeated on a regular basis (called "rounds"), for the life of the project. The five core phases include: 1. Phase I: Planning and preparation 2. Phase II: Conducting the Score Card with the community 3. Phase III: Conducting the Score Card with service providers 4. Phase IV: Interface meeting and action planning 5. Phase V: Action plan implementation and follow-up

Also known as: social accountability, user involvement, patient engagement
Post intervention

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • New born infants of HIV-positive women
  • Women 18 years and over newly initiating antiretroviral therapy (ART) at ART clinic
  • HIV-positive pregnant women \>15 years of age newly receiving care at first ANC (ANC1)
  • Women who are HIV-positive at ANC1 (known positive, already on treatment)
  • Women who are newly identified HIV-positive and initiated on treatment at ANC (newly identified at ANC or labor and delivery)
  • Women known HIV-positive but not yet on treatment prior to enrollment at ANC and initiated on treatment at ANC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elizabeth Glaser Pediatric AIDS Foundation

Lilongwe, Malawi

Location

Related Publications (1)

  • Laterra A, Callahan T, Msiska T, Woelk G, Chowdhary P, Gullo S, Mwale PM, Modi S, Chauwa F, Kayira D, Kalua T, Wako E. Bringing women's voices to PMTCT CARE: adapting CARE's Community Score Card(c) to engage women living with HIV to build quality health systems in Malawi. BMC Health Serv Res. 2020 Jul 22;20(1):679. doi: 10.1186/s12913-020-05538-2.

    PMID: 32698814DERIVED

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

    E. Glaser Pediatric AIDS Found

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Community score card approach
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 4, 2020

Study Start

June 7, 2017

Primary Completion

November 1, 2018

Study Completion

March 31, 2019

Last Updated

May 4, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

MA(1)