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

Tracking Information
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; (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	Complete list of historical versions of study NCT01333826 on ClinicalTrials.gov Archive Site
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 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: Are the observed effects of a CCT associated with the transfer or the conditionality imposed on the recipient?; Do the outcomes of interest improve with increased benefit levels set by the program?; 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	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	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 *	Baird S, Chirwa E, McIntosh C, Ozler B. The short-term impacts of a schooling conditional cash transfer program on the sexual behavior of young women. Health Econ. 2010 Sep;19 Suppl:55-68. doi: 10.1002/hec.1569.; 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.
* 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	May 2019
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	Sexes Eligible for Study: Female
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 )
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	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	August 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP