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OpenTrials
Completed

NCT Number: NCT01838005

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

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),

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Key information

Conditions

HIV

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kinshasa School of Public Health

Kinshasa, Republic of the Congo

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conditional cash transfer

Behavioral

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.

Other names: Contingency management

Primary outcomes

  1. 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

    Time frame: 6 weeks postpartum

    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

Secondary outcomes

  1. Mother to child transmission rate at six weeks and HIV-free survival.

    Time frame: 6 weeks post partum

    Proportion of HIV-exposed infant who tested positive at 6 week postpartum

  2. HIV-free survival at 18 month.

    Time frame: 18 months porstpartum

    Proportion of children born to HIV+ enrolled mothers who are alive and non infected with HIV

  3. Proportion of HIV-exposed infants who at their six week visit received extended Nevirapine (NVP) had a DNA PCR test

    Time frame: 6 weeks Postpartum

    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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Kinshasa School of Public Health

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 23, 2013
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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