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

NCT05385484 | Active Not Recruiting DMC

• 2 other identifiers: 8498971R01HD103563-01A1
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (30)

• Expenditures on alcohol (self only)

  6 month intervals

• Expenditures on alcohol (self and others)

  6 month intervals

• Expenditures on transactional sex

  6 month intervals

• Expenditures on gambling

  6 month intervals

• Number of sexual partners

  6 month intervals

Study Arms (2)

Mobile banking account with incentives to save

EXPERIMENTAL

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

Basic health and financial education

NO INTERVENTION

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.

Interventions

Receives mobile banking account with incentives to save BEHAVIORAL

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.

Mobile banking account with incentives to save

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• None

Sponsors & Collaborators

• University of Pennsylvania: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Impact Research & Development Organization: collaborator
• University of California, San Francisco: collaborator
• University of Washington: collaborator
• RTI International: collaborator

Study Sites (1)

Impact Research and Development Organization

Kisumu, Kenya

Location

Related Publications (1)

• 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.

  PMID: 36527120 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases; Alcohol Drinking; Behavior

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drinking Behavior

Study Officials

• Harsha Thirumurthy, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 23, 2022
• Study Start: July 18, 2022
• Primary Completion: June 26, 2025
• Study Completion: March 1, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)