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

This study is currently recruiting participants.
Verified December 2013 by University of North Carolina, Chapel Hill
Sponsor:
Collaborators:
Kinshasa School of Public Health
Information provided by (Responsible Party):
Marcel Yotebieng, MD, Ohio State University
ClinicalTrials.gov Identifier:
NCT01838005
First received: March 22, 2013
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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),


Condition Intervention
HIV
Behavioral: Conditional cash transfer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Conditional Cash Transfers to Increase Uptake of and Retention of PMTCT Services

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 600
Study Start Date: April 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01838005

Contacts
Contact: Marcel Yotebieng, MD, PhD 614 688 2133 myotebieng@cph.osu.edu

Locations
Congo
Kinshasa School of Public Health Recruiting
Kinshasa, Congo
Contact: Jean Lambert Chalachala, MD       chalasjl@yahoo.fr   
Contact: Emile Okitolonda, MD, PhD       okitow@yahoo.fr   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Kinshasa School of Public Health
Investigators
Principal Investigator: Marcel Yotebieng, MD Ohio State University
Principal Investigator: Emile W Okitolonda, MD Kinshasa School of Public Health
  More Information

No publications provided

Responsible Party: Marcel Yotebieng, MD, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01838005     History of Changes
Other Study ID Numbers: 12-1676, 1R01HD075171-01
Study First Received: March 22, 2013
Last Updated: December 3, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board
Democratic Republic of Congo: Kinshasa School of Public Health

Keywords provided by University of North Carolina, Chapel Hill:
Contingency management
conditional cash transfer
PMTCT
Retention
HIV

ClinicalTrials.gov processed this record on April 17, 2014