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

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ClinicalTrials.gov Identifier: NCT01333826
Recruitment Status : Active, not recruiting
First Posted : April 12, 2011
Last Update Posted : July 29, 2021
Sponsor:
Collaborators:
World Bank
University of California, San Diego
University of Malawi
Information provided by (Responsible Party):
Sarah Baird, George Washington University

Tracking Information
First Submitted Date  ICMJE April 11, 2011
First Posted Date  ICMJE April 12, 2011
Last Update Posted Date July 29, 2021
Study Start Date  ICMJE September 2007
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2011)
  • Sexually Transmitted Infections [ Time Frame: 18 months ]
    HIV prevalence HSV-2 prevalence
  • Schooling [ Time Frame: 12 months/24 months ]
    school enrollment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2011)
  • Sexually Transmitted Infections [ Time Frame: 18 months ]
    syphilis
  • Marriage and fertility [ Time Frame: 12 months/24 months ]
    ever married currently pregnant
  • sexual behavior [ Time Frame: 12 months/ 24 months ]
    new sexual debut unprotected sexual intercourse weekly sexual intercourse had a sexual partner 25 or older
  • HIV Awareness [ Time Frame: 12 months/24 months ]
    ever tested for HIV received health training on HIV HIV knowledge
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Schooling, Income, and HIV Risk in Malawi
Official Title  ICMJE Does Schooling Protect Young Women From HIV?
Brief Summary 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.
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?
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • HIV
  • Schooling
  • Conditional Cash Transfers
  • Unconditional Cash Transfers
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Unconditional cash transfers
    Monthly cash transfers given to households with school aged girls with no strings attached. Transfer amounts randomized within this arm.
    Intervention: Behavioral: Zomba Cash Transfer Program
  • 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.
    Intervention: Behavioral: Zomba Cash Transfer Program
  • No Intervention: Control Group
    No cash transfer program implemented in this group.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 11, 2011)
3796
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • female
  • 13-22 years old
  • never married
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 13 Years to 22 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malawi
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01333826
Other Study ID Numbers  ICMJE KCP: RF-P109215-RESE-TF090932
RSB: RF-P109215-RESE-BBRSB ( Other Grant/Funding Number: World Bank )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sarah Baird, George Washington University
Study Sponsor  ICMJE George Washington University
Collaborators  ICMJE
  • World Bank
  • University of California, San Diego
  • University of Malawi
Investigators  ICMJE
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
PRS Account George Washington University
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP