HIV/AIDS Clinical Trial
Official title:
Adaptation and Evaluation of the PMTCT Community Score Card Approach in Dedza and Ntcheu Districts, Malawi
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 |
Verified date | April 2020 |
Source | Elizabeth Glaser Pediatric AIDS Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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: - |
Country | Name | City | State |
---|---|---|---|
Malawi | Elizabeth Glaser Pediatric AIDS Foundation | Lilongwe |
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 |
Malawi,
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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