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A Savings Intervention to Reduce Men's Engagement in HIV Risk Behaviors

A Savings Intervention to Reduce Men's Engagement in HIV Risk Behaviors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05385484
Enrollment
1500
Registered
2022-05-23
Start date
2022-07-18
Completion date
2027-03-01
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Consumption, Behavior, Human Immunodeficiency Virus, Incentives, STI

Brief 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.

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.

Interventions

BEHAVIORALReceives mobile banking account with incentives to save

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.

OTHERBasic 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.

Sponsors

University of Pennsylvania
Lead SponsorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Impact Research & Development Organization
CollaboratorOTHER
University of California, San Francisco
CollaboratorOTHER
University of Washington
CollaboratorOTHER
RTI International
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
MALE
Age
18 Years to 39 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of HIV and Other STIs24 monthsComposite 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.

Secondary

MeasureTime frameDescription
Expenditures on Alcohol (Self and Others)24 monthsMoney spent on alcohol during a 6 month period (2022 USD, winsorized at the 95th percentile)
Expenditures on Transactional Sex24 monthMoney, 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)
Expenditures on Gambling24 monthMoney spent on gambling during a 6 month period (2022 USD, winsorized at the 95th percentile)
Number of Sexual Partners24 monthNumber of sexual partners participant had in the past 3 months.
Participant Engaged in Transactional Sex in the Last 3 Months24 monthParticipant 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?"
Number of Transactional Sex Partners24 monthTotal number of transactional sex partners participant had in the past 3 months.
Number of Transactional Sex Encounters24 monthNumber of transactional sex encounters participant engaged in during the past 3 months (winsorized at the 95th percentile).
Participant Used Condom at Most Recent Sexual Encounter in the Past 3 Months24 monthParticipant 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?"
Alcohol Use (Hazardous Drinking)24 monthAs 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.
Expenditures on Food24 monthMoney spent on food items during a 6-month period (2022 USD, winsorized at the 95th percentile)
Expenditures on Household Needs24 monthMoney 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)
Savings and Investment24 monthsTotal savings and investment, defined as the money value of formal and informal savings as well as investments in physical and human capital.
Total Informal Savings24 monthThe sum of savings held outside of formal institutions, including savings groups and money saved at home or elsewhere
Total Formal Savings24 monthThe sum of savings balances in all formal bank accounts.
Total Household Assets24 monthValue of all assets (2022 USD, winsorized at the 95th percentile).
Expenditure on Human Capital Investment24 monthMoney spent on human capital investment (e.g., spending on children's education) during a 6-month period (2022 USD, winsorized at the 95th percentile)
Housing Improved in the Past 6 Months24 monthsHousing 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?"
Perpetuation Intimate Partner Violence24 monthPerpetuation of physical, psychological, or sexual IPV
Experienced Intimate Partner Violence24 monthExperienced physical, psychological, or sexual IPV
Perceived Financial Security24 monthFinancial 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.
Food Security24 month3 item scale from Household Food Insecurity Access Scale. 0 to 9 with higher scores indicating higher food insecurity
Stress24 monthCohen's Perceived Stress Scale, PSS. 0 to 40 with higher scores indicating higher perceived stress
Stress, Helplessness24 monthPerceived helplessness score (subscale of PSS). 0 to 24 with higher scores indicating higher helplessness
Stress, Self-efficacy24 monthPerceived self-efficacy score (subscale of PSS). 0 to 16 with higher scores indicating higher self-efficacy
Most Future Oriented24 monthAssessed 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).
Future Orientation, Well Being24 monthCantril scale which measures participant's well-being. 0 to 10 with higher scores indicating higher well being
Future Orientation, Longevity24 month11-point scale that assesses participant's expectations about their longevity. 0 to 10 with higher scores indicating higher expectations about longevity

Countries

Kenya

Contacts

PRINCIPAL_INVESTIGATORHarsha Thirumurthy, PhD

University of Pennsylvania

Participant flow

Pre-assignment details

Participants completed the baseline survey after screening and were randomized at the end of the survey.

Baseline characteristics

Characteristic
Age, Continuous27.9 years
STANDARD_DEVIATION 5.1
Married or living as married466 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Kenya
749 participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
749 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
5 / 75111 / 749
other
Total, other adverse events
0 / 7510 / 749
serious
Total, serious adverse events
0 / 7510 / 749

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026