- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01333826
Schooling, Income, and HIV Risk in Malawi (SIHR)
Does Schooling Protect Young Women From HIV?
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Zomba, Malawi
- Zomba District, Malawi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- female
- 13-22 years old
- never married
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sexually Transmitted Infections
Time Frame: 18 months
|
HIV prevalence HSV-2 prevalence
|
18 months
|
Schooling
Time Frame: 12 months/24 months
|
school enrollment
|
12 months/24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sexually Transmitted Infections
Time Frame: 18 months
|
syphilis
|
18 months
|
Marriage and fertility
Time Frame: 12 months/24 months
|
ever married currently pregnant
|
12 months/24 months
|
sexual behavior
Time Frame: 12 months/ 24 months
|
new sexual debut unprotected sexual intercourse weekly sexual intercourse had a sexual partner 25 or older
|
12 months/ 24 months
|
HIV Awareness
Time Frame: 12 months/24 months
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ever tested for HIV received health training on HIV HIV knowledge
|
12 months/24 months
|
Collaborators and Investigators
Sponsor
Investigators
- 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
- Principal Investigator: Berk Ozler, PhD, World Bank
Publications and helpful links
General 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KCP: RF-P109215-RESE-TF090932
- RSB: RF-P109215-RESE-BBRSB (Other Grant/Funding Number: World Bank)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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