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
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Tracking Information | ||||||||||||||||
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First Submitted Date ICMJE | April 11, 2011 | |||||||||||||||
First Posted Date ICMJE | April 12, 2011 | |||||||||||||||
Last Update Posted Date | August 16, 2017 | |||||||||||||||
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 |
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Original Primary Outcome Measures ICMJE | Same as current | |||||||||||||||
Change History | Complete list of historical versions of study NCT01333826 on ClinicalTrials.gov Archive Site | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||||||||||||||
Current Other Outcome Measures ICMJE | Not Provided | |||||||||||||||
Original Other Outcome Measures ICMJE | 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:
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Study Type ICMJE | Interventional | |||||||||||||||
Study Phase | Not Applicable | |||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE |
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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. |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||||||||
Recruitment Status ICMJE | Active, not recruiting | |||||||||||||||
Actual Enrollment ICMJE |
3796 | |||||||||||||||
Original Actual Enrollment ICMJE | Same as current | |||||||||||||||
Estimated Study Completion Date | May 2019 | |||||||||||||||
Actual Primary Completion Date | September 2012 (Final data collection date for primary outcome measure) | |||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
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Sex/Gender |
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Ages | 13 Years to 22 Years (Child, Adult) | |||||||||||||||
Accepts Healthy Volunteers | 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 ) |
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Has Data Monitoring Committee | No | |||||||||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||||||||
IPD Sharing Statement | Not Provided | |||||||||||||||
Responsible Party | Sarah Baird, George Washington University | |||||||||||||||
Study Sponsor ICMJE | George Washington University | |||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | George Washington University | |||||||||||||||
Verification Date | August 2017 | |||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |