An interventional study of Conditional cash transfer in HIV, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in Congo. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-25.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Health services research
The goals of the proposed study are to: 1) test whether small, increasing cash payments to HIV-infected pregnant women, on the condition that they attend scheduled clinic visits and receive proposed services, will increase the proportion of women who receive the most effective antiretroviral regimen they are eligible for by the time of delivery, and 2) elucidate factors that facilitate or inhibit the uptake and adherence to the PMTCT cascade, and to what extent the conditional cash payment program addresses these factors.
This intervention will be implemented and evaluated within our well-established PMTCT program in Kinshasa, Democratic Republic of Congo (DRC),
University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Routine implementation of the national PMTCT guidelines which are an adaptation of the WHO's "Option A"
Financial incentive to attend regular clinic visits and receive PMTCT care
Behavioral: Conditional cash transfer
Eligible women randomized to the intervention group will receive the standard of care plus small and increasing cash payments, on the condition that they attend scheduled clinic visits on time (+/-5days), accept HIV services, deliver in a health facility, and at six weeks postpartum adhere to prescribed infant prophylactic drugs (cotrimoxazole, extended NVP) and provide blood sample for DNA PCR infant early HIV diagnosis.
Also known as: Contingency management
proportion of women who were adherent to all conditionalities and received the most effective ARV intervention they were eligible to receive and delivered at an affiliated maternity
At each monthly visit starting at randomization (28 weeks), participants will be evaluated for the following conditionalities: 1. attended the scheduled visit on time (+/- 5 days) 2. accept HIV status and services proposed to them 3. return to deliver in the clinic At the end of the follow-up (6 weeks post-partum)the proportion of participants who adhered to all these conditions will be calculated for each study group
Time frame: 6 weeks postpartum
Mother to child transmission rate at six weeks and HIV-free survival.
Proportion of HIV-exposed infant who tested positive at 6 week postpartum
Time frame: 6 weeks post partum
HIV-free survival at 18 month.
Proportion of children born to HIV+ enrolled mothers who are alive and non infected with HIV
Time frame: 18 months porstpartum
Proportion of HIV-exposed infants who at their six week visit received extended Nevirapine (NVP) had a DNA PCR test
Proportion of infants born to HIV-infected participants who at 6 weeks postpartum are receiving the extended nevirapine prophylaxis and have been tested for HIV
Time frame: 6 weeks Postpartum
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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