- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05385484
A Savings Intervention to Reduce Men's Engagement in HIV Risk Behaviors
Study Overview
Status
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kisumu, Kenya
- Impact Research and Development Organization
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- 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)
Exclusion Criteria:
- None
Study Plan
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 |
|---|---|
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Experimental: Mobile banking account with incentives to save
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.
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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.
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Other: Basic health and financial education
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of HIV and Other STIs
Time Frame: 24 months
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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.
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24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Expenditures on Alcohol (Self and Others)
Time Frame: 24 months
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Money spent on alcohol during a 6 month period (2022 USD, winsorized at the 95th percentile)
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24 months
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Expenditures on Transactional Sex
Time Frame: 24 month
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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)
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24 month
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Expenditures on Gambling
Time Frame: 24 month
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Money spent on gambling during a 6 month period (2022 USD, winsorized at the 95th percentile)
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24 month
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Number of Sexual Partners
Time Frame: 24 month
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Number of sexual partners participant had in the past 3 months.
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24 month
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Participant Engaged in Transactional Sex in the Last 3 Months
Time Frame: 24 month
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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?"
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24 month
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Number of Transactional Sex Partners
Time Frame: 24 month
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Total number of transactional sex partners participant had in the past 3 months.
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24 month
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Number of Transactional Sex Encounters
Time Frame: 24 month
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Number of transactional sex encounters participant engaged in during the past 3 months (winsorized at the 95th percentile).
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24 month
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Participant Used Condom at Most Recent Sexual Encounter in the Past 3 Months
Time Frame: 24 month
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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?"
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24 month
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Alcohol Use (Hazardous Drinking)
Time Frame: 24 month
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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.
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24 month
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Expenditures on Food
Time Frame: 24 month
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Money spent on food items during a 6-month period (2022 USD, winsorized at the 95th percentile)
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24 month
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Expenditures on Household Needs
Time Frame: 24 month
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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)
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24 month
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Savings and Investment
Time Frame: 24 months
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Total savings and investment, defined as the money value of formal and informal savings as well as investments in physical and human capital.
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24 months
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Total Informal Savings
Time Frame: 24 month
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The sum of savings held outside of formal institutions, including savings groups and money saved at home or elsewhere
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24 month
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Total Formal Savings
Time Frame: 24 month
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The sum of savings balances in all formal bank accounts.
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24 month
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Total Household Assets
Time Frame: 24 month
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Value of all assets (2022 USD, winsorized at the 95th percentile).
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24 month
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Expenditure on Human Capital Investment
Time Frame: 24 month
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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)
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24 month
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Housing Improved in the Past 6 Months
Time Frame: 24 months
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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?"
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24 months
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Perpetuation Intimate Partner Violence
Time Frame: 24 month
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Perpetuation of physical, psychological, or sexual IPV
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24 month
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Experienced Intimate Partner Violence
Time Frame: 24 month
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Experienced physical, psychological, or sexual IPV
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24 month
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Perceived Financial Security
Time Frame: 24 month
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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.
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24 month
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Food Security
Time Frame: 24 month
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3 item scale from Household Food Insecurity Access Scale.
0 to 9 with higher scores indicating higher food insecurity
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24 month
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Stress
Time Frame: 24 month
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Cohen's Perceived Stress Scale, PSS.
0 to 40 with higher scores indicating higher perceived stress
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24 month
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Stress, Helplessness
Time Frame: 24 month
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Perceived helplessness score (subscale of PSS).
0 to 24 with higher scores indicating higher helplessness
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24 month
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Stress, Self-efficacy
Time Frame: 24 month
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Perceived self-efficacy score (subscale of PSS).
0 to 16 with higher scores indicating higher self-efficacy
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24 month
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Most Future Oriented
Time Frame: 24 month
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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).
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24 month
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Future Orientation, Well Being
Time Frame: 24 month
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Cantril scale which measures participant's well-being.
0 to 10 with higher scores indicating higher well being
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24 month
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Future Orientation, Longevity
Time Frame: 24 month
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11-point scale that assesses participant's expectations about their longevity.
0 to 10 with higher scores indicating higher expectations about longevity
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24 month
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Harsha Thirumurthy, PhD, UNIVERSITY of PENNSYLVANIA
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Blood-Borne Infections
- Urogenital Diseases
- Genital Diseases
- Pathologic Processes
- Disease Attributes
- Immune System Diseases
- Infections
- RNA Virus Infections
- Virus Diseases
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Drinking Behavior
- Slow Virus Diseases
- HIV Infections
- Pathological Conditions, Signs and Symptoms
- Alcohol Drinking
- Acquired Immunodeficiency Syndrome
- Sexually Transmitted Diseases
- Behavior
Other Study ID Numbers
- 849897
- 1R01HD103563-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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