Clinical trial NCT01838005: Conditional Cash Transfers to Increase Uptake of and Retention of PMTCT Services
Official title: Conditional Cash Transfers to Increase Uptake of and Retention of PMTCT Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Contingency management
conditional cash transfer
PMTCT
Retention
HIV
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Kinshasa School of Public Health
First posted: 2013-04-23
Enrollment: 433
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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),


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 6 weeks postpartum
Secondary outcomes:
measure: Mother to child transmission rate at six weeks and HIV-free survival.
timeFrame: 6 weeks post partum
measure: HIV-free survival at 18 month.
timeFrame: 18 months porstpartum
measure: Proportion of HIV-exposed infants who at their six week visit received extended Nevirapine (NVP) had a DNA PCR test
timeFrame: 6 weeks Postpartum
Other outcomes:
Locations:
city: Kinshasa
country: Congo
facility: Kinshasa School of Public Health
Study officials:
affiliation: Ohio State University
name: Marcel Yotebieng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kinshasa School of Public Health
name: Emile W Okitolonda, MD
role: PRINCIPAL_INVESTIGATOR
References:
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 Immune Defic Syndr. 2017 Feb 1;74(2):150-157. doi: 10.1097/QAI.0000000000001219.
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 randomised controlled trial. Lancet HIV. 2016 Feb;3(2):e85-93. doi: 10.1016/S2352-3018(15)00247-7.
citation: 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.
citation: Saleska JL, Turner AN, Gallo MF, Shoben A, Kawende B, Ravelomanana NLR, Thirumurthy H, Yotebieng M. Role of temporal discounting in a conditional cash transfer (CCT) intervention to improve engagement in the prevention of mother-to-child transmission (PMTCT) cascade. BMC Public Health. 2021 Mar 10;21(1):477. doi: 10.1186/s12889-021-10499-0.