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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04372667
Other study ID # EG0163
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 7, 2017
Est. completion date March 31, 2019

Study information

Verified date April 2020
Source Elizabeth Glaser Pediatric AIDS Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1233
Est. completion date March 31, 2019
Est. primary completion date November 1, 2018
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Malawi Elizabeth Glaser Pediatric AIDS Foundation Lilongwe

Sponsors (4)

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

Country where clinical trial is conducted

Malawi, 

Outcome

Type Measure Description Time frame Safety issue
Primary Early diagnosis of HIV exposed infants (HEI) Proportion of HEI receiving a DNA PCR test 6 - 8 weeks after birth
Primary 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
Primary 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
Primary Implementation cost of CSC Estimate the total cost of implementing of the CSC intervention at community and facility levels. 12 months
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