Adaptation and Evaluation of the PMTCT CSC in Dedza and Ntcheu Districts, Malawi (NCT04372667) | Clinical Trial Compass
CompletedNot Applicable
Adaptation and Evaluation of the PMTCT CSC in Dedza and Ntcheu Districts, Malawi
Malawi1,233 participantsStarted 2017-06-07
Plain-language 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.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Early diagnosis of HIV exposed infants (HEI)
Timeframe: 6 - 8 weeks after birth
2
Early retention of pregnant and breastfeeding HIV positive women in PMTCT
Timeframe: 1 to 6 months
3
Early retention of newly diagnosed HIV-positive women in HIV care