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

Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05385484
• Other study ID #: 849897
• Secondary ID: 1R01HD103563-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 18, 2022
• Est. completion date: June 2025

Study information

• Verified date: January 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Alcohol Consumption
• Alcohol Drinking
• Behavior
• HIV Infections
• Human Immunodeficiency Virus
• Incentives
• STI

Intervention

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.

Locations

Country	Name	City	State
Kenya	Impact Research and Development Organization	Kisumu

Sponsors (6)

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

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Expenditures on alcohol	Money spent on alcohol.	6 month intervals
Secondary	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
Secondary	Expenditures on gambling	Money spent on gambling.	6 month intervals
Secondary	Number of sexual partners	Number of sexual partners participant had in the past 3 months.	6 month intervals
Secondary	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
Secondary	Number of transactional sex partners	Total number of transactional sex partners participant had in the past 3 months.	6 month intervals
Secondary	Number of transactional sex encounters	Number of transactional sex encounters participant engaged in during the past 3 months.	6 month intervals
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Expenditures on food	Money spent on food items.	6 month intervals
Secondary	Expenditures on household needs	Money spent on household needs (e.g., utilities).	6 month intervals
Secondary	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
Secondary	Total formal savings	The sum of savings balances in all formal bank accounts.	6 month intervals
Secondary	Total household assets	Value of all assets.	6 month intervals
Secondary	Expenditure on human capital investment	Money spent on human capital investment (e.g., spending on children's education).	6 month intervals
Secondary	Expenditure on productive assets	Money spent on productive assets (e.g., spending on agricultural equipment).	6 month intervals
Secondary	Expenditure on housing improvement	Money spent on structure of dwelling.	6 month intervals