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

• ClinicalTrials.gov Identifier: NCT01333826
• Recruitment Status: Active, not recruiting
• First Posted: April 12, 2011
• Last Update Posted: July 29, 2021
• Sponsor: George Washington University
• 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: April 11, 2011
• First Posted Date: April 12, 2011
• Last Update Posted Date: July 29, 2021
• Study Start Date: September 2007
• Actual Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Schooling, Income, and HIV Risk in Malawi
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• HIV
• Schooling
• Conditional Cash Transfers
• Unconditional Cash Transfers

Intervention

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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 11, 2011): 3796
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: May 2022
• Actual Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Malawi

Administrative Information

• NCT Number: NCT01333826
• Other Study ID Numbers: 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: George Washington University

Collaborators

• 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

• PRS Account: George Washington University
• Verification Date: July 2021