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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alcohol Consumption; Human Immunodeficiency Virus; Behavior; STI; Incentives
• Intervention / Treatment: Behavioral: Receives mobile banking account with incentives to save; Other: Basic Health and financial education

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: Interventional
• Enrollment (Actual): 1500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Kisumu, Kenya
    • Impact Research and Development Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes

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)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Receives 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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 month intervals
Expenditures on gambling	Money spent on gambling.	6 month intervals
Number of sexual partners	Number of sexual partners participant had in the past 3 months.	6 month intervals
Recent engagement in transactional sex	Whether participant engaged in transactional sex (defined broadly to include financial and non-financial transfers to commercial and non-commercial sexual partners), or not in the past 3 months.	6 month intervals
Number of transactional sex partners	Total number of transactional sex partners participant had in the past 3 months.	6 month intervals
Number of transactional sex encounters	Number of transactional sex encounters participant engaged in during the past 3 months.	6 month intervals
Condom use at most recent sexual encounter	Whether participant used a condom or not at most recent sexual encounter in the past 3 months.	6 month intervals
Alcohol use	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	6 month intervals
HIV, CT, and NG incidence between 0-12 months and 12-24 months	More temporally granular measures of incidence for HIV, CT, and NG.	Up to 24 months
Engagement in care among those who are HIV-positive	Whether or not participants who are HIV-positive are currently engaged in care for their HIV.	6 month intervals
Expenditures on food	Money spent on food items.	6 month intervals
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.	6 month intervals
Total formal savings	The sum of savings balances in all formal bank accounts.	6 month intervals
Total household assets	Value of all assets.	6 month intervals
Expenditure on human capital investment	Money spent on human capital investment (e.g., spending on children's education).	6 month intervals
Expenditures on alcohol (self only)	Money spent on alcohol.	6 month intervals
Expenditures on alcohol (self and others)	Money spent on alcohol.	6 month intervals
Expenditures on household needs	Money spent on household needs (including personal items; clothing and shoes; household items; utilities; and transport)	6 month intervals
Total informal savings	The sum of savings held outside of formal institutions, including savings groups and money saved at home or elsewhere	6 month intervals
Any housing improvements	Any improvement to house (yes/no)	6 month intervals
Perpetuation Intimate partner violence	Perpetuation of physical, psychological, or sexual IPV	6 month intervals
Experienced Intimate partner violence	Experienced physical, psychological, or sexual IPV	6 month intervals
Perceived financial security	10 item scale by Fu 2020 World Development	6 month interval
Future orientation	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)	6 month interval
Food security	3 item scale from Household Food Insecurity Access Scale. 0 to 9 with higher scores indicating higher food insecurity	6 month interval
Stress	Cohen's Perceived Stress Scale, PSS. 0 to 40 with higher scores indicating higher perceived stress	6 month interval
Stress, helplessness	Perceived helplessness score (subscale of PSS). 0 to 24 with higher scores indicating higher helplessness	6 month interval
Stress, self-efficacy	Perceived self-efficacy score (subscale of PSS). 0 to 16 with higher scores indicating higher self-efficacy	6 month interval
Future orientation, well being	Cantril scale which measures participant's well-being. 0 to 10 with higher scores indicating higher well being	6 month interval
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	6 month interval

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Washington; University of California, San Francisco; RTI International; Impact Research & Development Organization
• Investigators: Principal Investigator: Harsha Thirumurthy, PhD, University of Pennsylvania

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2022
• Primary Completion (Actual): June 26, 2025
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

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)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No