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

HIV Clinical Trial

Official title:

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

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
• 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

Related Conditions & MeSH terms

• HIV

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