HIVSIHRNCT01333826
Schooling, Income, and HIV Risk in Malawi
A study testing Zomba Cash Transfer Program in people with HIV and Schooling, run by George Washington University at 1 site in Malawi.
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… Read more about this study
- Who is it for?
- Ages 13 to 22 years, women only
- Conditions the study is for
- HIV, Schooling, Conditional Cash Transfers
- What is being tested?
- Zomba Cash Transfer Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,796 participants
- Where
- 1 siteMalawi
- Study dates
- Sep 2007to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 22 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- female
- 13-22 years old
- never married
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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?
- Being tested
- Zomba Cash Transfer Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zomba Cash Transfer ProgramBehavioural
Cash transfers were provided monthly to a randomly selected sample of school aged girls. Amounts were also varied in both treatment arms.
| Study group | Role | What they receive |
|---|---|---|
| Unconditional cash transfers | Experimental | Monthly cash transfers given to households with school aged girls with no strings attached. Transfer amounts randomized within this arm. Receives: Behavioral: Zomba Cash Transfer Program |
| Conditional Cash Transfer | Experimental | Monthly cash transfers given to households with school aged girls conditional on regular school attendance (80%). Transfer amounts randomized within this arm. Receives: Behavioral: Zomba Cash Transfer Program |
| Control Group | No intervention | No cash transfer program implemented in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexually Transmitted Infections
HIV prevalence HSV-2 prevalence
Measured: 18 months
Schooling
school enrollment
Measured: 12 months/24 months
Secondary outcomes (4)
Sexually Transmitted Infections
syphilis
Measured: 18 months
Marriage and fertility
ever married currently pregnant
Measured: 12 months/24 months
sexual behavior
new sexual debut unprotected sexual intercourse weekly sexual intercourse had a sexual partner 25 or older
Measured: 12 months/ 24 months
HIV Awareness
ever tested for HIV received health training on HIV HIV knowledge
Measured: 12 months/24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startSep 2007
- Primary completionSep 2012
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,796 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- World Bank, University of California, San Diego, University of Malawi
- Responsible party
- Principal investigator, Sarah Baird, George Washington University
- Investigators
- Berk Ozler, PhD, Principal investigator, World BankCraig T McIntosh, PhD, Principal investigator, University of California, San DiegoSarah J Baird, PhD, Principal investigator, George Washington UniversityEphraim Chirwa, PhD, Principal investigator, University of MalawiRichard S Garfein, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333826
- Sponsor's protocol ID
- KCP: RF-P109215-RESE-TF090932
- Other IDs
- RSB: RF-P109215-RESE-BBRSB
- Acronym
- SIHR
- Status last verified
- Aug 2025
- First submitted
- 11 Apr 2011
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19946887Baird 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.
PubMed 22341825
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Schooling Protect Young Women From HIV?
- ClinicalTrials.gov ID
- NCT01333826
- Acronym / sponsor ID
- SIHR / KCP: RF-P109215-RESE-TF090932
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,796 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- World Bank, University of California, San Diego, University of Malawi
- Study start
- Sep 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 12 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unconditional cash transfers | Experimental | Behavioral: Zomba Cash Transfer ProgramMonthly cash transfers given to households with school aged girls with no strings attached. Transfer amounts randomized within this arm. |
| Conditional Cash Transfer | Experimental | Behavioral: Zomba Cash Transfer ProgramMonthly cash transfers given to households with school aged girls conditional on regular school attendance (80%). Transfer amounts randomized within this arm. |
| Control Group | No intervention | –No cash transfer program implemented in this group. |
Who may qualify
- Ages
- 13 to 22 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- female
- 13-22 years old
- never married
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zomba Cash Transfer ProgramCash transfers were provided monthly to a randomly selected sample of school aged girls. Amounts were also varied in both treatment arms. | Behavioural | Conditional Cash Transfer, Unconditional cash transfers |
Primary outcome
Sexually Transmitted Infections
Time frame: 18 months
HIV prevalence HSV-2 prevalence
Schooling
Time frame: 12 months/24 months
school enrollment
4 secondary outcomes
Sexually Transmitted Infections
Time frame: 18 months
Marriage and fertility
Time frame: 12 months/24 months
sexual behavior
Time frame: 12 months/ 24 months
HIV Awareness
Time frame: 12 months/24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Results publication: PubMed 19946887Baird 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.
- Derived from this study: PubMed 22341825Baird 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berk Ozler, PhD principal investigator
World Bank
Craig T McIntosh, PhD principal investigator
University of California, San Diego
Sarah J Baird, PhD principal investigator
George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zomba Cash Transfer Program in people with HIV and Schooling, run by George Washington University at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexually Transmitted Infections (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01333826, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.