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

University of North Carolina, Chapel Hill433 enrolled

Overview

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),

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

433

Conditions

HIV

Interventions

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.

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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