Clinical trial NCT05385484: A Savings Intervention to Reduce Men's Engagement in HIV Risk Behaviors
Official title: A Savings Intervention to Reduce Men's Engagement in HIV Risk Behaviors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Human Immunodeficiency Virus
STI
Alcohol Consumption
Incentives
Behavior
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Impact Research & Development Organization
name: University of California, San Francisco
name: University of Washington
name: RTI International
First posted: 2022-05-23
Enrollment: 1500
Sex: MALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of HIV and other STIs
timeFrame: 24 months
Secondary outcomes:
measure: Expenditures on alcohol (self only)
timeFrame: 6 month intervals
measure: Expenditures on alcohol (self and others)
timeFrame: 6 month intervals
measure: Expenditures on transactional sex
timeFrame: 6 month intervals
measure: Expenditures on gambling
timeFrame: 6 month intervals
measure: Number of sexual partners
timeFrame: 6 month intervals
measure: Recent engagement in transactional sex
timeFrame: 6 month intervals
measure: Number of transactional sex partners
timeFrame: 6 month intervals
measure: Number of transactional sex encounters
timeFrame: 6 month intervals
measure: Condom use at most recent sexual encounter
timeFrame: 6 month intervals
measure: Alcohol use
timeFrame: 6 month intervals
measure: HIV, CT, and NG incidence between 0-12 months and 12-24 months
timeFrame: Up to 24 months
measure: Engagement in care among those who are HIV-positive
timeFrame: 6 month intervals
measure: Expenditures on food
timeFrame: 6 month intervals
measure: Expenditures on household needs
timeFrame: 6 month intervals
measure: Savings and investment
timeFrame: 6 month intervals
measure: Total informal savings
timeFrame: 6 month intervals
measure: Total formal savings
timeFrame: 6 month intervals
measure: Total household assets
timeFrame: 6 month intervals
measure: Expenditure on human capital investment
timeFrame: 6 month intervals
measure: Any housing improvements
timeFrame: 6 month intervals
measure: Perpetuation Intimate partner violence
timeFrame: 6 month intervals
measure: Experienced Intimate partner violence
timeFrame: 6 month intervals
measure: Perceived financial security
timeFrame: 6 month interval
measure: Food security
timeFrame: 6 month interval
measure: Stress
timeFrame: 6 month interval
measure: Stress, helplessness
timeFrame: 6 month interval
measure: Stress, self-efficacy
timeFrame: 6 month interval
measure: Future orientation
timeFrame: 6 month interval
measure: Future orientation, well being
timeFrame: 6 month interval
measure: Future orientation, longevity
timeFrame: 6 month interval
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Impact Research and Development Organization
Study officials:
affiliation: University of Pennsylvania
name: Harsha Thirumurthy, PhD
role: PRINCIPAL_INVESTIGATOR
References: