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

Not Applicable

Completed

• Conditions: HIV/AIDS; Infant Morbidity
• Interventions: Behavioral: Community score card approach

• Registration Number: NCT04372667
• Lead Sponsor: Elizabeth Glaser Pediatric AIDS Foundation

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.

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 Timeline

• Study Start: 2017-06-07
• Primary Completion: 2018-11-01
• Study Completion: 2019-03-31
• Status Verified: 2020-04
• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-04-30
• Last Update Submitted: 2020-04-30
• Study First Posted: 2020-05-04
• Last Update Posted: 2020-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1233

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Post intervention	Community score card approach	Community score card approach

Primary Outcome Measures

Name	Time	Method
Early retention of newly diagnosed HIV-positive women in HIV care	1 to 6 months	Proportions of HIV-positive women (pregnant and breastfeeding women as well as non-pregnant women) newly initiating ART services retained in HIV care
Early diagnosis of HIV exposed infants (HEI)	6 - 8 weeks after birth	Proportion of HEI receiving a DNA PCR test
Early retention of pregnant and breastfeeding HIV positive women in PMTCT	1 to 6 months	Proportions of HIV-positive pregnant and breastfeeding women (including women newly-identified and already-known to be HIV positive) retained in PMTCT services
Implementation cost of CSC	12 months	Estimate the total cost of implementing of the CSC intervention at community and facility levels.

Trial Locations

Locations (1)

Elizabeth Glaser Pediatric AIDS Foundation; 🇲🇼 Lilongwe, Malawi