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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01838005
Other study ID # 12-1676
Secondary ID 1R01HD075171-01
Status Completed
Phase N/A
First received March 22, 2013
Last updated April 21, 2017
Start date April 2013
Est. completion date April 2015

Study information

Verified date January 2017
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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),


Recruitment information / eligibility

Status Completed
Enrollment 433
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Congo Kinshasa School of Public Health Kinshasa

Sponsors (3)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Kinshasa School of Public Health

Country where clinical trial is conducted

Congo, 

References & Publications (3)

Yotebieng KA, Fokong K, Yotebieng M. Depression, retention in care, and uptake of PMTCT service in Kinshasa, the Democratic Republic of Congo: a prospective cohort. AIDS Care. 2017 Mar;29(3):285-289. doi: 10.1080/09540121.2016.1255708. Epub 2016 Nov 6. — View Citation

Yotebieng M, Moracco KE, Thirumurthy H, Edmonds A, Tabala M, Kawende B, Wenzi LK, Okitolonda EW, Behets F. Conditional Cash Transfers Improve Retention in PMTCT Services by Mitigating the Negative Effect of Not Having Money to Come to the Clinic. J Acquir — View Citation

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 r — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
6 weeks postpartum
Secondary Mother to child transmission rate at six weeks and HIV-free survival. Proportion of HIV-exposed infant who tested positive at 6 week postpartum 6 weeks post partum
Secondary HIV-free survival at 18 month. Proportion of children born to HIV+ enrolled mothers who are alive and non infected with HIV 18 months porstpartum
Secondary Proportion of HIV-exposed infants who at their six week visit received extended Nevirapine (NVP) had a DNA PCR test 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
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