HIV/AIDSNCT04372667
Adaptation and Evaluation of the PMTCT CSC in Dedza and Ntcheu Districts, Malawi
A study testing Community score card approach in people with HIV/AIDS and Infant Morbidity, run by Elizabeth Glaser Pediatric AIDS Foundation at 1 site in Malawi.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- HIV/AIDS, Infant Morbidity
- What is being tested?
- Community score card approach
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,233 participants
- Where
- 1 siteMalawi
- Study dates
- 7 Jun 2017to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation and Evaluation of the PMTCT Community Score Card Approach in Dedza and Ntcheu Districts, Malawi
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.
Read the 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.
- Conditions
- HIV/AIDS, Infant Morbidity
- Being tested
- Community score card approach
- Keywords
- PMTCT, HIV, Quality improvement, Social accountability, Patient centered, Retention in care, Early infant diagnosis of HIV
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community score card approachBehavioural
Also called social accountability, user involvement, patient engagement
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
| Study group | Role | What they receive |
|---|---|---|
| Post intervention | Experimental | Community score card approach Receives: Behavioral: Community score card approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early diagnosis of HIV exposed infants (HEI)
Proportion of HEI receiving a DNA PCR test
Measured: 6 - 8 weeks after birth
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
Measured: 1 to 6 months
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
Measured: 1 to 6 months
Implementation cost of CSC
Estimate the total cost of implementing of the CSC intervention at community and facility levels.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start7 Jun 2017
- Primary completion1 Nov 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Community score card approach
- Masking
- None (open label)
- Enrolment
- 1,233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Cooperative for Assistance and Relief Everywhere, Inc. (CARE), Centers for Disease Control and Prevention, Ministry of Health, Malawi
- Responsible party
- Sponsor
- Investigators
- Godfrey Woelk, PhD, Principal investigator, E. Glaser Pediatric AIDS Found
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372667
- Sponsor's protocol ID
- EG0163
- Status last verified
- Apr 2020
- First submitted
- 29 Apr 2020
- Last updated
- 4 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32698814
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Evaluation of the PMTCT Community Score Card Approach in Dedza and Ntcheu Districts, Malawi
- ClinicalTrials.gov ID
- NCT04372667
- Acronym / sponsor ID
- EG0163
- Conditions
- HIV/AIDS, Infant Morbidity
- Keywords
- PMTCT, HIV, Quality improvement, Social accountability, Patient centered, Retention in care, Early infant diagnosis of HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,233 participants (actual)
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS FoundationUniversity, hospital or other
- Collaborators
- Cooperative for Assistance and Relief Everywhere, Inc. (CARE), Centers for Disease Control and Prevention, Ministry of Health, Malawi
- Study start
- 7 Jun 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Community score card approach
| Arm | Type | Receives |
|---|---|---|
| Post intervention | Experimental | Behavioral: Community score card approachCommunity score card approach |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community score card approachAlso: social accountability, user involvement, patient engagementThe 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 | Behavioural | Post intervention |
Primary outcome
Early diagnosis of HIV exposed infants (HEI)
Time frame: 6 - 8 weeks after birth
Proportion of HEI receiving a DNA PCR test
Early retention of pregnant and breastfeeding HIV positive women in PMTCT
Time frame: 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
Early retention of newly diagnosed HIV-positive women in HIV care
Time frame: 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
Implementation cost of CSC
Time frame: 12 months
Estimate the total cost of implementing of the CSC intervention at community and facility levels.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
- Derived from this study: PubMed 32698814Laterra 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Godfrey Woelk, PhD principal investigator
E. Glaser Pediatric AIDS Found
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community score card approach in people with HIV/AIDS and Infant Morbidity, run by Elizabeth Glaser Pediatric AIDS Foundation at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early diagnosis of HIV exposed infants (HEI) (time frame: 6 - 8 weeks after birth). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04372667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2020.