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Clinical Trials/NCT02447159
NCT02447159CompletedNot Applicable

Evaluation of Conditional Cash Transfers to Increase Retention in PMTCT Services in Akwa Ibom State, Nigeria

University of California, San Francisco3 sites in 1 country554 target enrollmentStarted: August 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
554
Locations
3
Primary Endpoint
Number and percentage of mothers who obtain early infant diagnosis testing 6-8 weeks after giving birth to their child

Study Overview

Brief Summary

A randomized controlled trial will be conducted to assess the effectiveness of conditional cash transfers (CCTs) at increasing retention in prevention of mother-to-child transmission (PMTCT) services specifically, in relation to pickup of ARV drugs for infected mothers, delivery in the hospital setting, and receipt of drugs for exposed infants. Administrative data will be extracted from the All Babies are Equal program and hospital records. At 8-10 weeks after delivery, an endline survey will also be conducted with each participant to provide a deeper understanding of the impact of the CCTs and to assess the reasons for retention in PMTCT services.

Detailed Description

Background:

Nigeria, home to only 2% of the world's population, accounts for 30% of the world's mother-to-child transmissions of HIV. Over the past three years, and in collaboration with bilateral aid agencies, the Nigerian government has strengthened hundreds of free rural clinics, trained thousands of birth attendants, and begun free distribution of antiretroviral (ARV) drugs. Despite this, only 1.8% of low-income women deliver a baby with a skilled birth attendant, only 16% of HIV-positive pregnant women receive ARVs to prevent mother-to-child transmission (PMTCT) of HIV, and only 2.3% of infants born to HIV-infected women received ARV prophylaxis to reduce the risk of virus transmission. Pregnant women are lost at each step along the PMTCT cascade, from attending a prenatal visit to giving life-saving antiretroviral therapy to their newborns.

Operated by New Incentives, a non-profit organization focused on maternal and child health, the All Babies are Equal (ABAE) program was established in June 2014 in Akwa Ibom to improve utilization of health services for PMTCT. The ABAE program provides conditional cash transfers (CCTs) to pregnant, HIV-positive women conditional on obtaining specific ante-, peri-, and postnatal services at public facilities to prevent mother-to-child transmission of HIV. The CCT is primarily a demand-side intervention that aims to reduce the barriers that women may face when seeking care, as well as encourage uptake of and retention in PMTCT services.

Preliminary studies:

A large body of evidence indicates that providing ARV drugs to HIV-positive pregnant women during pregnancy and at the time of birth to both mother and baby can drastically reduce the transmission of the virus to the newborn. However, in Nigeria, even though drugs for PMTCT are free and available, many women do not use them. Additionally, knowledge of mother-to-child transmission of HIV and PMTCT is high among the investigators' target population. Recent research shows that 91% of women of reproductive age have high awareness of PMTCT in southern Nigeria, yet 71% have poor attitudes towards PMTCT treatment and services, resulting in low uptake of services.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
15 Years to 45 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • HIV positive
  • Attended an antenatal care visit at one of three participating clinics.

Exclusion Criteria

  • Not HIV positive
  • Not pregnant
  • Not registered for antenatal care at a participating clinic.

Arms & Interventions

Intervention

Experimental

Each participant in the intervention arm will receive conditional cash transfers when she: (1) registers pregnancy, (2)picks up her medication in the first two months after her first visit, (3) delivers at the health clinic, and (4) receives early infant diagnosis test for newborn. Eight to ten weeks after delivery, the participant will also be asked to participate in an endline survey and will be compensated for her time.

Intervention: Conditional Cash Transfers (Behavioral)

Control

No Intervention

Antenatal care utilization data will be extracted from the administrative records. Eight to ten weeks after delivery, the participant will also be asked to participate in an endline survey and will be compensated for her time.

Outcomes

Primary Outcomes

Number and percentage of mothers who obtain early infant diagnosis testing 6-8 weeks after giving birth to their child

Time Frame: 6-8 weeks after the woman delivers her child

Number and percentage of pregnant women who deliver their baby at the facility in which they were first enrolled for antenatal care

Time Frame: When the woman delivers her child

Secondary Outcomes

  • Number and percentage of pregnant women who pick up their antiretroviral treatment drugs at least once between enrolling in antenatal care and giving birth to their baby at the facility where they first enrolled in antenatal care(Between enrollment into antenatal care until the woman delivers her child)
  • Number and percentage of mothers who pick up Nevirapine for their newborn infant at the facility where they first enrolled in antenatal care after giving birth(48 hours after the woman delivers her child)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor
Principal Investigator

Jenny Liu, PhD, MPP

Economist

University of California, San Francisco

Study Sites (3)

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