Conditional Cash Transfers to Increase Uptake of and Retention of PMTCT Services
This study is ongoing, but not recruiting participants.
Sponsor:
University of North Carolina, Chapel Hill
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: February 5, 2015
Last verified: February 2015
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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:
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:
- 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 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 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | June 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
|
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01838005
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
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: | February 5, 2015 |
| 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 February 27, 2015