Conditional Cash Transfers to Increase Uptake of and Retention of PMTCT Services

Study Overview
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Brief Summary
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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),

Official Title
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Conditional Cash Transfers to Increase Uptake of and Retention of PMTCT Services

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Conditional cash transfer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed as HIV-positive Pregnant between 28 and 32 weeks of gestation (>27 and <32 completed weeks of pregnancy) Intend to stay in Kinshasa through delivery and six weeks postpartum Able and willing to participate (provide informed consent) Exclusion Criteria: Women will be excluded from the study if they are severely ill and require extended hospitalization or need to be cared for at a referral hospital out of the PMTCT network
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Routine implementation of the national PMTCT guidelines which are an adaptation of the WHO's Option A | |
| Experimental: Conditional Cash Transfer<br>Financial incentive to attend regular clinic visits and receive PMTCT care | Behavioral: Conditional cash transfer<br>* 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.<br>* Other names: Contingency management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: attended the scheduled visit on time (+/- 5 days) accept HIV status and services proposed to them 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 | 6 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mother to child transmission rate at six weeks and HIV-free survival. | Proportion of HIV-exposed infant who tested positive at 6 week postpartum | 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 | 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 | 6 weeks Postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contingency management, conditional cash transfer, PMTCT, Retention, HIV