Clinical trial NCT04372667: Adaptation and Evaluation of the PMTCT CSC in Dedza and Ntcheu Districts, Malawi
Official title: Adaptation and Evaluation of the PMTCT Community Score Card Approach in Dedza and Ntcheu Districts, Malawi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Infant Morbidity
Keywords: PMTCT
HIV
Quality improvement
Social accountability
Patient centered
Retention in care
Early infant diagnosis of HIV
Lead sponsor: Elizabeth Glaser Pediatric AIDS Foundation
Sponsor class: OTHER
Collaborators: name: Cooperative for Assistance and Relief Everywhere, Inc. (CARE)
name: Centers for Disease Control and Prevention
name: Ministry of Health, Malawi
First posted: 2020-05-04
Enrollment: 1233
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Community score card approach
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Early diagnosis of HIV exposed infants (HEI)
timeFrame: 6 - 8 weeks after birth
measure: Early retention of pregnant and breastfeeding HIV positive women in PMTCT
timeFrame: 1 to 6 months
measure: Early retention of newly diagnosed HIV-positive women in HIV care
timeFrame: 1 to 6 months
measure: Implementation cost of CSC
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Elizabeth Glaser Pediatric AIDS Foundation
Study officials:
affiliation: E. Glaser Pediatric AIDS Found
name: Godfrey Woelk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.