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Schooling, Income, and HIV Risk in Malawi (SIHR)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
World Bank
University of California, San Diego
University of Malawi
Information provided by (Responsible Party):
Sarah Baird, George Washington University
ClinicalTrials.gov Identifier:
NCT01333826
First received: April 11, 2011
Last updated: February 7, 2013
Last verified: February 2013
History of Changes
  Purpose

This study is designed to evaluate a two-year randomized intervention in Malawi that provides cash transfers to current schoolgirls (and young women who have recently dropped out of school) to stay in (and return to) school in order to understand the possible effects of such programs on the sexual behavior of the beneficiaries and their subsequent HIV risk.


Condition Intervention
HIV
Schooling
Conditional Cash Transfers
Unconditional Cash Transfers
 Behavioral: Zomba Cash Transfer Program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Does Schooling Protect Young Women From HIV?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by George Washington University:

Primary Outcome Measures:
  • Sexually Transmitted Infections [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    HIV prevalence HSV-2 prevalence

  • Schooling [ Time Frame: 12 months/24 months ] [ Designated as safety issue: No ]
    school enrollment


Secondary Outcome Measures:
  • Sexually Transmitted Infections [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    syphilis

  • Marriage and fertility [ Time Frame: 12 months/24 months ] [ Designated as safety issue: No ]
    ever married currently pregnant

  • sexual behavior [ Time Frame: 12 months/ 24 months ] [ Designated as safety issue: No ]
    new sexual debut unprotected sexual intercourse weekly sexual intercourse had a sexual partner 25 or older

  • HIV Awareness [ Time Frame: 12 months/24 months ] [ Designated as safety issue: No ]
    ever tested for HIV received health training on HIV HIV knowledge


Enrollment: 3796
Study Start Date: September 2007
Estimated Study Completion Date: May 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Unconditional cash transfers
Monthly cash transfers given to households with school aged girls with no strings attached. Transfer amounts randomized within this arm.
 Behavioral: Zomba Cash Transfer Program
Cash transfers were provided monthly to a randomly selected sample of school aged girls. Amounts were also varied in both treatment arms.
Experimental: Conditional Cash Transfer
Monthly cash transfers given to households with school aged girls conditional on regular school attendance (80%). Transfer amounts randomized within this arm.
 Behavioral: Zomba Cash Transfer Program
Cash transfers were provided monthly to a randomly selected sample of school aged girls. Amounts were also varied in both treatment arms.
No Intervention: Control Group
No cash transfer program implemented in this group.

Detailed Description:

Motivation:

Education has been suggested as a "social vaccine" to prevent the spread of HIV (Jukes, Simmons, and Bundy, 2008), but almost all of the evidence we have on the link between school attendance (or attainment) and the risk of HIV infection comes from cross-sectional studies. Furthermore, the role of income (especially that of women's poverty) has been hypothesized as a significant factor in the spread of HIV in SSA, but again there is no credible evidence showing a causal link between income and HIV risk. A randomized intervention, such as the one proposed here, that provides randomly varied amounts of cash transfers to young individuals and their guardians is the perfect setting to examine the possible existence of such causal relationships.

Objectives:

The objective of the proposed study here is to provide credible evidence on issues about which we still know very little. Specifically, the main questions the study will try to answer are the following:

  1. Are the observed effects of a CCT associated with the transfer or the conditionality imposed on the recipient?
  2. Do the outcomes of interest improve with increased benefit levels set by the program?
  3. Do CCT programs for schooling have any positive health impacts, including prevention of STIs such as HIV/AIDS among young people?
  Eligibility

Ages Eligible for Study:   13 Years to 22 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female
  • 13-22 years old
  • never married
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333826

Locations
Malawi
Zomba District, Malawi
Zomba, Malawi
Sponsors and Collaborators
George Washington University
World Bank
University of California, San Diego
University of Malawi
Investigators
Principal Investigator: Berk Ozler, PhD World Bank
Principal Investigator: Craig T McIntosh, PhD University of California, San Diego
Principal Investigator: Sarah J Baird, PhD George Washington University
Principal Investigator: Ephraim Chirwa, PhD University of Malawi
Principal Investigator: Richard S Garfein, PhD University of California, San Diego
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sarah Baird, Assistant Professor, George Washington University
ClinicalTrials.gov Identifier: NCT01333826     History of Changes
Other Study ID Numbers: KCP: RF-P109215-RESE-TF090932, RSB: RF-P109215-RESE-BBRSB
Study First Received: April 11, 2011
Last Updated: February 7, 2013
Health Authority: United States: Institutional Review Board
Malawi: National Health Sciences Research Committee

ClinicalTrials.gov processed this record on March 03, 2013