Adaptation and Evaluation of the PMTCT CSC in Dedza and Ntcheu Districts, Malawi

Adaptation and Evaluation of the PMTCT Community Score Card Approach in Dedza and Ntcheu Districts, Malawi

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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS; Infant Morbidity
• Intervention / Treatment: Behavioral: Community score card approach

Detailed Description

Prevention of Mother to Child HIV Transmission (PMTCT) services aim to identify HIV-infected pregnant and breastfeeding mothers and initiate them on antiretroviral treatment (ART) for improving the health of the mother as well as reducing HIV transmission to their infants. In 2011, Malawi was the first country to adopt lifelong ART for HIV- pregnant and breastfeeding women, known as 'Option B+'. Despite leading the way on operationalization of this approach, Malawi has faced challenges retaining HIV-infected pregnant and breastfeeding women on lifelong ART as well as with improving uptake of early infant HIV testing for HIV-exposed infants. Innovative approaches are needed which engage health service users (i.e. patients) as part of quality improvement solutions within clinical settings to improve retention throughout the PMTCT cascade and ultimately improve PMTCT outcomes for mothers and infants.

One approach to broadly engage health service users in quality improvement activities is the Community Score Card (CSC). The CSC engages both service providers and users within a clinical setting in dialogues to identify solutions to the perceived barriers with health service delivery and utilization.

CARE developed the CSC intervention in Malawi in 2002 as part of a project aimed at developing innovative and sustainable models to improve general maternal and child health services. The main goal of the CSC intervention is to positively influence the quality, efficiency, and accountability with which health services are provided at different levels. The original CSC consists of five core phases, repeated on a regular basis (called "rounds"), for the life of the project.

This project adapted the CSC to the PMTCT setting across 11 sites in two priority PEPFAR scale-up districts in Malawi. The adaptation of the CSC was evaluated through a pre-post design to measure change in maternal retention on ART, change in maternal retention across the PMTCT service cascade, and uptake of Early Infant Diagnosis (EID) services following CSC implementation. Additionally, the project estimated the cost of the adapted CSC implementation.

• Study Type: Interventional
• Enrollment (Actual): 1233
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malawi
  • Lilongwe, Malawi
    • Elizabeth Glaser Pediatric AIDS Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Post intervention; Community score card approach

Behavioral: Community score card approach; 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: Phase I: Planning and preparation; Phase II: Conducting the Score Card with the community; Phase III: Conducting the Score Card with service providers; Phase IV: Interface meeting and action planning; Phase V: Action plan implementation and follow-up; Other Names: social accountability; user involvement; patient engagement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Elizabeth Glaser Pediatric AIDS Foundation
• Collaborators: Centers for Disease Control and Prevention; Ministry of Health, Malawi; Cooperative for Assistance and Relief Everywhere, Inc. (CARE)
• Investigators: Principal Investigator: Godfrey Woelk, PhD, E. Glaser Pediatric AIDS Found

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2017
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (Actual): May 4, 2020

Study Record Updates

• Last Update Posted (Actual): May 4, 2020
• Last Update Submitted That Met QC Criteria: April 30, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: HIV; Quality improvement; Retention in care; PMTCT; Patient centered; Social accountability; Early infant diagnosis of HIV
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: EG0163

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No