NCT02447159

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
554

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 18, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

1.6 years

First QC Date

May 7, 2015

Last Update Submit

May 2, 2017

Conditions

Keywords

NigeriaDeveloping CountriesHospitals, Maternity/UtilizationHospitals/EconomicsHIV

Outcome Measures

Primary Outcomes (2)

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

    When the woman delivers her child

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

    6-8 weeks after the woman delivers her child

Secondary Outcomes (2)

  • 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

Study Arms (2)

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.

Behavioral: Conditional Cash Transfers

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.

Interventions

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

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Immanuel General Hospital

Eket, Akwa Ibom State, Nigeria

Location

General Hospital, Ikot Ekpene

Ikot Ekpene, Akwa Ibom State, Nigeria

Location

General Hospital, Iquita Oron

Oron, Akwa Ibom State, Nigeria

Location

Related Publications (7)

  • Sturt AS, Dokubo EK, Sint TT. Antiretroviral therapy (ART) for treating HIV infection in ART-eligible pregnant women. Cochrane Database Syst Rev. 2010 Mar 17;2010(3):CD008440. doi: 10.1002/14651858.CD008440.

    PMID: 20238370BACKGROUND
  • de Walque D, Dow WH, Nathan R, Abdul R, Abilahi F, Gong E, Isdahl Z, Jamison J, Jullu B, Krishnan S, Majura A, Miguel E, Moncada J, Mtenga S, Mwanyangala MA, Packel L, Schachter J, Shirima K, Medlin CA. Incentivising safe sex: a randomised trial of conditional cash transfers for HIV and sexually transmitted infection prevention in rural Tanzania. BMJ Open. 2012 Feb 8;2(1):e000747. doi: 10.1136/bmjopen-2011-000747. Print 2012.

    PMID: 22318666BACKGROUND
  • Pettifor A, MacPhail C, Nguyen N, Rosenberg M. Can money prevent the spread of HIV? A review of cash payments for HIV prevention. AIDS Behav. 2012 Oct;16(7):1729-38. doi: 10.1007/s10461-012-0240-z.

    PMID: 22760738BACKGROUND
  • Glassman A, Duran D, Fleisher L, Singer D, Sturke R, Angeles G, Charles J, Emrey B, Gleason J, Mwebsa W, Saldana K, Yarrow K, Koblinsky M. Impact of conditional cash transfers on maternal and newborn health. J Health Popul Nutr. 2013 Dec;31(4 Suppl 2):48-66.

    PMID: 24992803BACKGROUND
  • Baird SJ, Garfein RS, McIntosh CT, Ozler B. Effect of a cash transfer programme for schooling on prevalence of HIV and herpes simplex type 2 in Malawi: a cluster randomised trial. Lancet. 2012 Apr 7;379(9823):1320-9. doi: 10.1016/S0140-6736(11)61709-1. Epub 2012 Feb 15.

    PMID: 22341825BACKGROUND
  • Lim SS, Dandona L, Hoisington JA, James SL, Hogan MC, Gakidou E. India's Janani Suraksha Yojana, a conditional cash transfer programme to increase births in health facilities: an impact evaluation. Lancet. 2010 Jun 5;375(9730):2009-23. doi: 10.1016/S0140-6736(10)60744-1.

    PMID: 20569841BACKGROUND
  • Liu JX, Shen J, Wilson N, Janumpalli S, Stadler P, Padian N. Conditional cash transfers to prevent mother-to-child transmission in low facility-delivery settings: evidence from a randomised controlled trial in Nigeria. BMC Pregnancy Childbirth. 2019 Jan 16;19(1):32. doi: 10.1186/s12884-019-2172-3.

MeSH Terms

Conditions

HIV InfectionsInfant, Newborn, DiseasesPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Jenny Liu, PhD, MPP

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Economist

Study Record Dates

First Submitted

May 7, 2015

First Posted

May 18, 2015

Study Start

August 1, 2015

Primary Completion

March 1, 2017

Study Completion

April 1, 2017

Last Updated

May 3, 2017

Record last verified: 2017-05

Locations