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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 : August 16, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
HIV Schooling Conditional Cash Transfers Unconditional Cash Transfers Behavioral: Zomba Cash Transfer Program

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3796 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Does Schooling Protect Young Women From HIV?
Study Start Date : September 2007
Primary Completion Date : September 2012
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Sexually Transmitted Infections [ Time Frame: 18 months ]
    HIV prevalence HSV-2 prevalence

  2. Schooling [ Time Frame: 12 months/24 months ]
    school enrollment


Secondary Outcome Measures :
  1. Sexually Transmitted Infections [ Time Frame: 18 months ]
    syphilis

  2. Marriage and fertility [ Time Frame: 12 months/24 months ]
    ever married currently pregnant

  3. sexual behavior [ Time Frame: 12 months/ 24 months ]
    new sexual debut unprotected sexual intercourse weekly sexual intercourse had a sexual partner 25 or older

  4. HIV Awareness [ Time Frame: 12 months/24 months ]
    ever tested for HIV received health training on HIV HIV knowledge


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female
  • 13-22 years old
  • never married
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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 ( Other Grant/Funding Number: World Bank )
First Posted: April 12, 2011    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017