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

April 21, 2017 updated by: University of North Carolina, Chapel Hill

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

433

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Congo
      • Kinshasa, Congo
        • Kinshasa School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Contingency management

What is the study measuring?

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
Time Frame: 6 weeks postpartum

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
6 weeks postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks post partum
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
18 months porstpartum
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
6 weeks Postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

March 22, 2013

First Submitted That Met QC Criteria

April 22, 2013

First Posted (Estimate)

April 23, 2013

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 21, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 12-1676
  • 1R01HD075171-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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