Human Immunodeficiency VirusNCT05385484
A Savings Intervention to Reduce Men's Engagement in HIV Risk Behaviors
A study testing Receives mobile banking account with incentives to save and Basic Health and financial education in people with Human Immunodeficiency Virus and STI, run by University of Pennsylvania at 1 site in Kenya.
Trial summary
This randomized control trial will test an economic intervention to reduce Kenyan men's engagement in behaviors that increase the risk of HIV/STIs. Participants randomized to the intervention group will be able to open accounts with a partner bank and will be incentivized to save with lottery-based rewards. Read more about this study
- Who is it for?
- Ages 18 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus, STI, Alcohol Consumption
- What is being tested?
- Receives mobile banking account with incentives to save and Basic Health and financial education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteKenya
- Study dates
- 18 Jul 2022to Mar 2027
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Age 18-39 years
- Resides in study community and plans to remain for the next 2 years
- Used alcohol or other substances in the past month
- Engagement in any transactional sex (defined as payment of money, goods, or services in exchange for sex) in the past 3 months
- Has a steady income source that typically results in earnings every week
Show all 10Show fewer
- Owns mobile phone
- Already has or is willing to open an account with partner banking institution
- Has national identification card (required for opening bank account)
- Has Kenya Revenue Authority personal identification number or is willing to create one (required for opening bank account)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
This randomized control trial will test an economic intervention to reduce Kenyan men's engagement in behaviors that increase the risk of HIV/STIs. Participants randomized to the intervention group will be able to open accounts with a partner bank and will be incentivized to save with lottery-based rewards.
Read the detailed description
This project will evaluate an innovative, theoretically-motivated economic intervention to reduce men's engagement in transactional sex and other risky behaviors. Leveraging innovations in mobile financial services and research on savings behavior in low-income countries, the investigators propose to test an intervention that seeks to motivate high-risk, income-earning men in western Kenya to reduce their spending on risky behaviors and instead save their disposable income in local bank accounts. These bank accounts will include additional incentives to save in the form of lottery-based rewards linked to amounts saved. The intervention will also encourage participants to develop savings goals and strategies, and provide periodic reminders about saving regularly. Through a direct economic mechanism (incentives to shift expenditures from the present to the future) and a psychological mechanism (increasing future orientation), the investigators hypothesize that the intervention will result in increased savings, reduced spending on transactional sex and alcohol, less risky sexual behavior, and reduced risk of HIV and sexually transmitted infections (STIs).
The investigators will conduct a randomized controlled trial among men who are at high risk of HIV and STI infection and determine the effects of a savings intervention on health and economic outcomes. Specific aims of the project are as follows. Aim 1: Determine the impact of the intervention on savings and investment behavior, self-reported sexual behavior, and incidence of HIV/STIs. Aim 2: Quantitatively and qualitatively assess mechanisms of behavior change among participants and a sample of their female partners.
- Conditions
- Human Immunodeficiency Virus, STI, Alcohol Consumption, Incentives, Behavior
- Being tested
- Receives mobile banking account with incentives to save, Basic Health and financial education
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases, Alcohol Drinking, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receives mobile banking account with incentives to saveBehavioural
Participants will receive assistance in opening and using a mobile savings account, will be given education emphasizing saving practices and will be told about lottery-based incentives opportunities.
Basic Health and financial educationOther
Participants in the control group will be given basic information on the importance of saving for the future. In addition, health education curriculum developed by Impact Research \& Development Organization (IRDO) will be provided to participants with standard health education on places to seek services for HIV and STI prevention and treatment, including information on alcohol and transactional sex as risk factors for HIV transmission.
| Study group | Role | What they receive |
|---|---|---|
| Mobile banking account with incentives to save | Experimental | Participants in the savings intervention group will be provided with basic information on the importance of saving for the future, as well as (a) lottery-based incentives to save, (b) opportunities to develop savings goals, and (c) periodic reminders about the savings incentives and goals. Participants will receive assistance in opening and using a mobile savings account and will receive an education session that emphasizes the importance of saving for the future. Participants will be told about lottery-based incentives for saving money in their account. Receives: Behavioral: Receives mobile banking account with incentives to save |
| Basic health and financial education | Other | Participants in the control group will be given basic information on the importance of saving for the future. In addition, health education curriculum developed by Impact Research \& Development Organization (IRDO) will be provided to participants with standard health education on places to seek services for HIV and STI prevention and treatment, including information on alcohol and transactional sex as risk factors for HIV transmission. Receives: Other: Basic Health and financial education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of HIV and Other STIs
Composite incidence of at least one of HIV or other STIs (herpes simplex virus type 2 (HSV-2), Neisseria gonorrhoeae (NG), and Chlamydia trachomatis (CT)) over 24 months. The investigators will combine all STIs (including HIV) into a composite variable, with each participant counting once. For participants who are HIV-positive at baseline or HSV-2-positive, the outcome will be defined over all STIs other than HIV.
Measured: 24 months
Secondary outcomes (27)
Expenditures on Alcohol (Self and Others)
Money spent on alcohol during a 6 month period (2022 USD, winsorized at the 95th percentile)
Measured: 24 months
Expenditures on Transactional Sex
Money, goods, and services spent on transactional sex (defined broadly to include financial and non-financial transfers to commercial and non-commercial sexual partners) during a 6 month period (2022 USD, winsorized at the 95th percentile)
Measured: 24 month
Expenditures on Gambling
Money spent on gambling during a 6 month period (2022 USD, winsorized at the 95th percentile)
Measured: 24 month
Number of Sexual Partners
Number of sexual partners participant had in the past 3 months.
Measured: 24 month
Participant Engaged in Transactional Sex in the Last 3 Months
Participant engaged in transactional sex (defined broadly to include renumerating someone via financial and non-financial transfers for sexual activities), in the past 3 months (binary yes=1/no=0). The question from the survey: "In the past 3 months, have you exchanged money, goods, gifts, food (including fish), housing or services for sex?"
Measured: 24 month
Number of Transactional Sex Partners
Total number of transactional sex partners participant had in the past 3 months.
Measured: 24 month
Number of Transactional Sex Encounters
Number of transactional sex encounters participant engaged in during the past 3 months (winsorized at the 95th percentile).
Measured: 24 month
Participant Used Condom at Most Recent Sexual Encounter in the Past 3 Months
Participant used a condom at most recent sexual encounter in the past 3 months (binary: yes=1/no=0). The question from the survey: "In your last sexual encounter in the past 3 months, did you use a condom?"
Measured: 24 month
Alcohol Use (Hazardous Drinking)
As measured by the Alcohol Use Disorders Identification Test-Concise (AUDIT-C) scale. The AUDIT-C is scored on a scale of 0-12, and higher values mean worse outcomes. We measure hazardous drinking, as indicated by an AUDIT-C score >=4.
Measured: 24 month
Expenditures on Food
Money spent on food items during a 6-month period (2022 USD, winsorized at the 95th percentile)
Measured: 24 month
Expenditures on Household Needs
Money spent on household needs (including personal items; clothing and shoes; household items; utilities; and transport) during a 6-month period (2022 USD, winsorized at the 95th percentile)
Measured: 24 month
Savings and Investment
Total savings and investment, defined as the money value of formal and informal savings as well as investments in physical and human capital.
Measured: 24 months
Total Informal Savings
The sum of savings held outside of formal institutions, including savings groups and money saved at home or elsewhere
Measured: 24 month
Total Formal Savings
The sum of savings balances in all formal bank accounts.
Measured: 24 month
Total Household Assets
Value of all assets (2022 USD, winsorized at the 95th percentile).
Measured: 24 month
Expenditure on Human Capital Investment
Money spent on human capital investment (e.g., spending on children's education) during a 6-month period (2022 USD, winsorized at the 95th percentile)
Measured: 24 month
Housing Improved in the Past 6 Months
Housing was improved in the past 6 months, e,g, repaired or constructed home's walls, roof, floor, toilet source, or drinking water source (yes=1/no=0). The question from the survey: "Have you made any additions or improvements to your house in the last 6 months? For example, have you repaired or constructed your home's walls, roof, floor, toilet source, drinking water source?"
Measured: 24 months
Perpetuation Intimate Partner Violence
Perpetuation of physical, psychological, or sexual IPV
Measured: 24 month
Experienced Intimate Partner Violence
Experienced physical, psychological, or sexual IPV
Measured: 24 month
Perceived Financial Security
Financial wellbeing scale is a 10 item scale (Fu, J. (2020). Ability or opportunity to act: what shapes financial well-being?. World Development, 128, 104843). The scale is called the financial wellbeing scale. The total score ranges from 1 to 8 with lower values indicating poorer financial wellbeing.
Measured: 24 month
Food Security
3 item scale from Household Food Insecurity Access Scale. 0 to 9 with higher scores indicating higher food insecurity
Measured: 24 month
Stress
Cohen's Perceived Stress Scale, PSS. 0 to 40 with higher scores indicating higher perceived stress
Measured: 24 month
Stress, Helplessness
Perceived helplessness score (subscale of PSS). 0 to 24 with higher scores indicating higher helplessness
Measured: 24 month
Stress, Self-efficacy
Perceived self-efficacy score (subscale of PSS). 0 to 16 with higher scores indicating higher self-efficacy
Measured: 24 month
Most Future Oriented
Assessed by a commonly-used scale that asks participants to make hypothetical choices between money received at two different times (e.g., 1,000 Shillings in 1 month vs. 1,100 Shillings in 2 months). Based on their responses participants are grouped into one of four ordinal groups that range from least to most future oriented. This was then binarized into the most future oriented group (category 4) versus less future oriented (categories 1 through 3).
Measured: 24 month
Future Orientation, Well Being
Cantril scale which measures participant's well-being. 0 to 10 with higher scores indicating higher well being
Measured: 24 month
Future Orientation, Longevity
11-point scale that assesses participant's expectations about their longevity. 0 to 10 with higher scores indicating higher expectations about longevity
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start18 Jul 2022
- Primary completion26 Jun 2025
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Model description
- In Kenyan communities with high HIV/STI prevalence, men will be randomized to two groups: a control group that receives basic health and financial education or a savings intervention group that receives a mobile banking account with incentives to save.
- Masking
- None (open label)
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Impact Research & Development Organization, University of California, San Francisco, University of Washington, RTI International
- Responsible party
- Sponsor
- Investigators
- Harsha Thirumurthy, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385484
- Sponsor's protocol ID
- 849897
- Other IDs
- 1R01HD103563-01A1
- Status last verified
- Aug 2026
- First submitted
- 17 May 2022
- Last updated
- 10 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Egbe TI, Omollo OD, Wesonga JO, Bair EF, Chakrabarti A, Putt ME, Celum CL, Camlin CS, Napierala S, Agot K, Thirumurthy H. A savings intervention to reduce men's engagement in HIV risk behaviors: study protocol for a randomized controlled trial. Trials. 2022 Dec 16;23(1):1018. doi: 10.1186/s13063-022-06927-0.
PubMed 36527120
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Savings Intervention to Reduce Men's Engagement in HIV Risk Behaviors
- ClinicalTrials.gov ID
- NCT05385484
- Acronym / sponsor ID
- 849897
- Conditions
- Human Immunodeficiency Virus, STI, Alcohol Consumption, Incentives, Behavior
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Impact Research & Development Organization, University of California, San Francisco, University of Washington, RTI International
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- Mar 2027 (estimated)
- First posted
- 23 May 2022 (actual)
- Results
- Posted 10 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized control trial will test an economic intervention to reduce Kenyan men's engagement in behaviors that increase the risk of HIV/STIs. Participants randomized to the intervention group will be able to open accounts with a partner bank and will be incentivized to save with lottery-based rewards.
Detailed description
This project will evaluate an innovative, theoretically-motivated economic intervention to reduce men's engagement in transactional sex and other risky behaviors. Leveraging innovations in mobile financial services and research on savings behavior in low-income countries, the investigators propose to test an intervention that seeks to motivate high-risk, income-earning men in western Kenya to reduce their spending on risky behaviors and instead save their disposable income in local bank accounts. These bank accounts will include additional incentives to save in the form of lottery-based rewards linked to amounts saved. The intervention will also encourage participants to develop savings goals and strategies, and provide periodic reminders about saving regularly. Through a direct economic mechanism (incentives to shift expenditures from the present to the future) and a psychological mechanism (increasing future orientation), the investigators hypothesize that the intervention will result in increased savings, reduced spending on transactional sex and alcohol, less risky sexual behavior, and reduced risk of HIV and sexually transmitted infections (STIs).
The investigators will conduct a randomized controlled trial among men who are at high risk of HIV and STI infection and determine the effects of a savings intervention on health and economic outcomes. Specific aims of the project are as follows. Aim 1: Determine the impact of the intervention on savings and investment behavior, self-reported sexual behavior, and incidence of HIV/STIs. Aim 2: Quantitatively and qualitatively assess mechanisms of behavior change among participants and a sample of their female partners.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In Kenyan communities with high HIV/STI prevalence, men will be randomized to two groups: a control group that receives basic health and financial education or a savings intervention group that receives a mobile banking account with incentives to save.
| Arm | Type | Receives |
|---|---|---|
| Mobile banking account with incentives to save | Experimental | Behavioral: Receives mobile banking account with incentives to saveParticipants in the savings intervention group will be provided with basic information on the importance of saving for the future, as well as (a) lottery-based incentives to save, (b) opportunities to develop savings goals, and (c) periodic reminders about the savings incentives and goals. Participants will receive assistance in opening and using a mobile savings account and will receive an education session that emphasizes the importance of saving for the future. Participants will be told about lottery-based incentives for saving money in their account. |
| Basic health and financial education | Other | Other: Basic Health and financial educationParticipants in the control group will be given basic information on the importance of saving for the future. In addition, health education curriculum developed by Impact Research \& Development Organization (IRDO) will be provided to participants with standard health education on places to seek services for HIV and STI prevention and treatment, including information on alcohol and transactional sex as risk factors for HIV transmission. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male
- Age 18-39 years
- Resides in study community and plans to remain for the next 2 years
- Used alcohol or other substances in the past month
- Engagement in any transactional sex (defined as payment of money, goods, or services in exchange for sex) in the past 3 months
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Receives mobile banking account with incentives to saveParticipants will receive assistance in opening and using a mobile savings account, will be given education emphasizing saving practices and will be told about lottery-based incentives opportunities. | Behavioural | Mobile banking account with incentives to save |
| Basic Health and financial educationParticipants in the control group will be given basic information on the importance of saving for the future. In addition, health education curriculum developed by Impact Research \& Development Organization (IRDO) will be provided to participants with standard health education on places to seek services for HIV and STI prevention and treatment, including information on alcohol and transactional sex as risk factors for HIV transmission. | Other | Basic health and financial education |
Primary outcome
Incidence of HIV and Other STIs
Time frame: 24 months
Composite incidence of at least one of HIV or other STIs (herpes simplex virus type 2 (HSV-2), Neisseria gonorrhoeae (NG), and Chlamydia trachomatis (CT)) over 24 months. The investigators will combine all STIs (including HIV) into a composite variable, with each participant counting once. For participants who are HIV-positive at baseline or HSV-2-positive, the outcome will be defined over all STIs other than HIV.
27 secondary outcomes
Expenditures on Alcohol (Self and Others)
Time frame: 24 months
Expenditures on Transactional Sex
Time frame: 24 month
Expenditures on Gambling
Time frame: 24 month
Number of Sexual Partners
Time frame: 24 month
Participant Engaged in Transactional Sex in the Last 3 Months
Time frame: 24 month
Number of Transactional Sex Partners
Time frame: 24 month
Number of Transactional Sex Encounters
Time frame: 24 month
Participant Used Condom at Most Recent Sexual Encounter in the Past 3 Months
Time frame: 24 month
Alcohol Use (Hazardous Drinking)
Time frame: 24 month
Expenditures on Food
Time frame: 24 month
Expenditures on Household Needs
Time frame: 24 month
Savings and Investment
Time frame: 24 months
Total Informal Savings
Time frame: 24 month
Total Formal Savings
Time frame: 24 month
Total Household Assets
Time frame: 24 month
Expenditure on Human Capital Investment
Time frame: 24 month
Housing Improved in the Past 6 Months
Time frame: 24 months
Perpetuation Intimate Partner Violence
Time frame: 24 month
Experienced Intimate Partner Violence
Time frame: 24 month
Perceived Financial Security
Time frame: 24 month
Food Security
Time frame: 24 month
Stress
Time frame: 24 month
Stress, Helplessness
Time frame: 24 month
Stress, Self-efficacy
Time frame: 24 month
Most Future Oriented
Time frame: 24 month
Future Orientation, Well Being
Time frame: 24 month
Future Orientation, Longevity
Time frame: 24 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36527120Egbe TI, Omollo OD, Wesonga JO, Bair EF, Chakrabarti A, Putt ME, Celum CL, Camlin CS, Napierala S, Agot K, Thirumurthy H. A savings intervention to reduce men's engagement in HIV risk behaviors: study protocol for a randomized controlled trial. Trials. 2022 Dec 16;23(1):1018. doi: 10.1186/s13063-022-06927-0.
- Individual participant dataSharing planned: No
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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.
Harsha Thirumurthy, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Receives mobile banking account with incentives to save and Basic Health and financial education in people with Human Immunodeficiency Virus and STI, run by University of Pennsylvania at 1 site in Kenya.
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 10 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. 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 Kenya. 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?
Yes. Results are posted in the registry (first posted 10 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of HIV and Other STIs (time frame: 24 months). 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 NCT05385484, which also lists 1 linked publication.
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 10 Sep 2026.