Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Kinshasa School of Public Health
Information provided by (Responsible Party):
Marcel Yotebieng, MD, Ohio State University Identifier:
First received: March 22, 2013
Last updated: February 5, 2015
Last verified: February 2015

March 22, 2013
February 5, 2015
April 2013
June 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]

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
Same as current
Complete list of historical versions of study NCT01838005 on Archive Site
  • Mother to child transmission rate at six weeks and HIV-free survival. [ Time Frame: 6 weeks post partum ] [ Designated as safety issue: No ]
    Proportion of HIV-exposed infant who tested positive at 6 week postpartum
  • HIV-free survival at 18 month. [ Time Frame: 18 months porstpartum ] [ Designated as safety issue: No ]
    Proportion of children born to HIV+ enrolled mothers who are alive and non infected with HIV
  • 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 ] [ Designated as safety issue: No ]
    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
Same as current
Not Provided
Not Provided
Conditional Cash Transfers to Increase Uptake of and Retention of PMTCT Services
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),

Not Provided
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Health Services Research
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.
Other Name: Contingency management
  • No Intervention: Standard of Care
    Routine implementation of the national PMTCT guidelines which are an adaptation of the WHO's "Option A"
  • Experimental: Conditional Cash Transfer
    Financial incentive to attend regular clinic visits and receive PMTCT care
    Intervention: Behavioral: Conditional cash transfer
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
October 2015
June 2015   (final data collection date for primary outcome measure)

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
Not Provided
Contact information is only displayed when the study is recruiting subjects
12-1676, 1R01HD075171-01
Marcel Yotebieng, MD, Ohio State University
University of North Carolina, Chapel Hill
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Kinshasa School of Public Health
Principal Investigator: Marcel Yotebieng, MD Ohio State University
Principal Investigator: Emile W Okitolonda, MD Kinshasa School of Public Health
University of North Carolina, Chapel Hill
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP