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

Primary Purpose

HIV/AIDS, Infant Morbidity

Status
Completed
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
Community score card approach
Sponsored by
Elizabeth Glaser Pediatric AIDS Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV/AIDS focused on measuring PMTCT, HIV, Quality improvement, Social accountability, Patient centered, Retention in care, Early infant diagnosis of HIV

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Elizabeth Glaser Pediatric AIDS Foundation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Post intervention

Arm Description

Community score card approach

Outcomes

Primary Outcome Measures

Early diagnosis of HIV exposed infants (HEI)
Proportion of HEI receiving a DNA PCR test
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
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
Implementation cost of CSC
Estimate the total cost of implementing of the CSC intervention at community and facility levels.

Secondary Outcome Measures

Full Information

First Posted
April 29, 2020
Last Updated
April 30, 2020
Sponsor
Elizabeth Glaser Pediatric AIDS Foundation
Collaborators
Cooperative for Assistance and Relief Everywhere, Inc. (CARE), Centers for Disease Control and Prevention, Ministry of Health, Malawi
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1. Study Identification

Unique Protocol Identification Number
NCT04372667
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 7, 2017 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elizabeth Glaser Pediatric AIDS Foundation
Collaborators
Cooperative for Assistance and Relief Everywhere, Inc. (CARE), Centers for Disease Control and Prevention, Ministry of Health, Malawi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Infant Morbidity
Keywords
PMTCT, HIV, Quality improvement, Social accountability, Patient centered, Retention in care, Early infant diagnosis of HIV

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Community score card approach
Masking
None (Open Label)
Allocation
N/A
Enrollment
1233 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post intervention
Arm Type
Experimental
Arm Description
Community score card approach
Intervention Type
Behavioral
Intervention Name(s)
Community score card approach
Other Intervention Name(s)
social accountability, user involvement, patient engagement
Intervention Description
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
Primary Outcome Measure Information:
Title
Early diagnosis of HIV exposed infants (HEI)
Description
Proportion of HEI receiving a DNA PCR test
Time Frame
6 - 8 weeks after birth
Title
Early retention of pregnant and breastfeeding HIV positive women in PMTCT
Description
Proportions of HIV-positive pregnant and breastfeeding women (including women newly-identified and already-known to be HIV positive) retained in PMTCT services
Time Frame
1 to 6 months
Title
Early retention of newly diagnosed HIV-positive women in HIV care
Description
Proportions of HIV-positive women (pregnant and breastfeeding women as well as non-pregnant women) newly initiating ART services retained in HIV care
Time Frame
1 to 6 months
Title
Implementation cost of CSC
Description
Estimate the total cost of implementing of the CSC intervention at community and facility levels.
Time Frame
12 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Godfrey Woelk, PhD
Organizational Affiliation
E. Glaser Pediatric AIDS Found
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elizabeth Glaser Pediatric AIDS Foundation
City
Lilongwe
Country
Malawi

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32698814
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.
Results Reference
derived

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

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