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

This study has been completed.

Sponsor:

Collaborators:

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

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: February 10, 2016

Last verified: February 2016

History of Changes

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: Single Blind (Caregiver) Primary Purpose: Health Services Research
Official Title:	Conditional Cash Transfers to Increase Uptake of and Retention of PMTCT Services

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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


Enrollment:	433
Study Start Date:	April 2013
Study Completion Date:	April 2015
Primary Completion Date:	April 2015 (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

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


Ages Eligible for Study:	Child, Adult, Senior
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


Congo
Kinshasa School of Public Health
Kinshasa, Congo

Sponsors and Collaborators

University of North Carolina, Chapel Hill

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Yotebieng M, Thirumurthy H, Moracco KE, Kawende B, Chalachala JL, Wenzi LK, Ravelomanana NL, Edmonds A, Thompson D, Okitolonda EW, Behets F. Conditional cash transfers and uptake of and retention in prevention of mother-to-child HIV transmission care: a randomised controlled trial. Lancet HIV. 2016 Feb;3(2):e85-93. doi: 10.1016/S2352-3018(15)00247-7.


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:	February 10, 2016
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 September 29, 2016

To Top