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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04372667
Enrollment
1233
Registered
2020-05-04
Start date
2017-06-07
Completion date
2019-03-31
Last updated
2020-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS, Infant Morbidity

Keywords

PMTCT, HIV, Quality improvement, Social accountability, Patient centered, Retention in care, Early infant diagnosis of HIV

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.

Interventions

BEHAVIORALCommunity 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: 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

Sponsors

Cooperative for Assistance and Relief Everywhere, Inc. (CARE)
CollaboratorUNKNOWN
Centers for Disease Control and Prevention
CollaboratorFED
Ministry of Health, Malawi
CollaboratorOTHER_GOV
Elizabeth Glaser Pediatric AIDS Foundation
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Community score card approach

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Early diagnosis of HIV exposed infants (HEI)6 - 8 weeks after birthProportion of HEI receiving a DNA PCR test
Early retention of pregnant and breastfeeding HIV positive women in PMTCT1 to 6 monthsProportions of HIV-positive pregnant and breastfeeding women (including women newly-identified and already-known to be HIV positive) retained in PMTCT services
Early retention of newly diagnosed HIV-positive women in HIV care1 to 6 monthsProportions of HIV-positive women (pregnant and breastfeeding women as well as non-pregnant women) newly initiating ART services retained in HIV care
Implementation cost of CSC12 monthsEstimate the total cost of implementing of the CSC intervention at community and facility levels.

Countries

Malawi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026