Conditional Cash Transfers to Increase Uptake of and Retention of PMTCT Services
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| ClinicalTrials.gov Identifier: NCT01838005 |
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Recruitment Status
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Completed
First Posted
: April 23, 2013
Last Update Posted
: April 25, 2017
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV | Behavioral: Conditional cash transfer | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 433 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Care Provider) |
| Primary Purpose: | Health Services Research |
| Official Title: | Conditional Cash Transfers to Increase Uptake of and Retention of PMTCT Services |
| Study Start Date : | April 2013 |
| Actual Primary Completion Date : | April 2015 |
| Actual Study Completion Date : | April 2015 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Standard of Care
Routine implementation of the national PMTCT guidelines which are an adaptation of the WHO's "Option A"
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Experimental: Conditional Cash Transfer
Financial incentive to attend regular clinic visits and receive PMTCT care
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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
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- 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:
- 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
- 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
- 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
- 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
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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838005
| Congo | |
| Kinshasa School of Public Health | |
| Kinshasa, Congo | |
| Principal Investigator: | Marcel Yotebieng, MD | Ohio State University | |
| Principal Investigator: | Emile W Okitolonda, MD | Kinshasa School of Public Health |
Publications of Results:
| Responsible Party: | University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01838005 History of Changes |
| Other Study ID Numbers: |
12-1676 1R01HD075171-01 ( U.S. NIH Grant/Contract ) |
| First Posted: | April 23, 2013 Key Record Dates |
| Last Update Posted: | April 25, 2017 |
| Last Verified: | January 2017 |
Keywords provided by University of North Carolina, Chapel Hill:
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Contingency management conditional cash transfer PMTCT Retention HIV |