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

August 13, 2023 updated by: Sarah Baird, George Washington University

Does Schooling Protect Young Women From HIV?

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.

Study Overview

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

Enrollment (Actual)

3796

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zomba, Malawi
        • Zomba District, Malawi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 22 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • female
  • 13-22 years old
  • never married

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
ever tested for HIV received health training on HIV HIV knowledge
12 months/24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

September 1, 2012

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

April 11, 2011

First Submitted That Met QC Criteria

April 11, 2011

First Posted (Estimated)

April 12, 2011

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 13, 2023

Last Verified

August 1, 2023

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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