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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01333826
Other study ID # KCP: RF-P109215-RESE-TF090932
Secondary ID RSB: RF-P109215-
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 2007
Est. completion date May 2025

Study information

Verified date August 2023
Source George Washington University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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?


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 3796
Est. completion date May 2025
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Female
Age group 13 Years to 22 Years
Eligibility Inclusion Criteria: - female - 13-22 years old - never married

Study Design


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.

Locations

Country Name City State
Malawi Zomba District, Malawi Zomba

Sponsors (4)

Lead Sponsor Collaborator
George Washington University University of California, San Diego, University of Malawi, World Bank

Country where clinical trial is conducted

Malawi, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Sexually Transmitted Infections HIV prevalence HSV-2 prevalence 18 months
Primary Schooling school enrollment 12 months/24 months
Secondary Sexually Transmitted Infections syphilis 18 months
Secondary Marriage and fertility ever married currently pregnant 12 months/24 months
Secondary sexual behavior new sexual debut unprotected sexual intercourse weekly sexual intercourse had a sexual partner 25 or older 12 months/ 24 months
Secondary HIV Awareness ever tested for HIV received health training on HIV HIV knowledge 12 months/24 months
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