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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

World Bank

University of California, San Diego

University of Malawi

Information provided by (Responsible Party):

Sarah Baird, George Washington University

ClinicalTrials.gov Identifier:

NCT01333826

First received: April 11, 2011

Last updated: August 9, 2016

Last verified: August 2016

History of Changes

Purpose

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	Intervention
HIV Schooling Conditional Cash Transfers Unconditional Cash Transfers	Behavioral: Zomba Cash Transfer Program


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Does Schooling Protect Young Women From HIV?

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by George Washington University:

Primary Outcome Measures:

Sexually Transmitted Infections [ Time Frame: 18 months ] [ Designated as safety issue: No ]
HIV prevalence HSV-2 prevalence
Schooling [ Time Frame: 12 months/24 months ] [ Designated as safety issue: No ]
school enrollment

Secondary Outcome Measures:

Sexually Transmitted Infections [ Time Frame: 18 months ] [ Designated as safety issue: No ]
syphilis
Marriage and fertility [ Time Frame: 12 months/24 months ] [ Designated as safety issue: No ]
ever married currently pregnant
sexual behavior [ Time Frame: 12 months/ 24 months ] [ Designated as safety issue: No ]
new sexual debut unprotected sexual intercourse weekly sexual intercourse had a sexual partner 25 or older
HIV Awareness [ Time Frame: 12 months/24 months ] [ Designated as safety issue: No ]
ever tested for HIV received health training on HIV HIV knowledge


Enrollment:	3796
Study Start Date:	September 2007
Estimated Study Completion Date:	May 2019
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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?

Eligibility


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

Criteria

Inclusion Criteria:

female
13-22 years old
never married

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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
Study First Received:	April 11, 2011
Last Updated:	August 9, 2016
Health Authority:	United States: Institutional Review Board Malawi: National Health Sciences Research Committee

ClinicalTrials.gov processed this record on September 29, 2016

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