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Active, Not Recruiting

NCT Number: NCT05385484

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Alcohol Consumption Alcohol Drinking Behavior Blood-Borne Infections Communicable Diseases Disease Attributes Drinking Behavior Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Incentives Infections Lentivirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections STI Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–39 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Impact Research and Development Organization

Kisumu, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Basic Health and financial education

Other

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.

Primary outcomes

  1. Incidence of HIV and other STIs

    Time frame: 24 months

    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.

Secondary outcomes

  1. Expenditures on alcohol (self only)

    Time frame: 6 month intervals

    Money spent on alcohol.

  2. Expenditures on alcohol (self and others)

    Time frame: 6 month intervals

    Money spent on alcohol.

  3. Expenditures on transactional sex

    Time frame: 6 month intervals

    Money, goods, and services spent on transactional sex (defined broadly to include financial and non-financial transfers to commercial and non-commercial sexual partners).

  4. Expenditures on gambling

    Time frame: 6 month intervals

    Money spent on gambling.

  5. Number of sexual partners

    Time frame: 6 month intervals

    Number of sexual partners participant had in the past 3 months.

  6. Recent engagement in transactional sex

    Time frame: 6 month intervals

    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.

  7. Number of transactional sex partners

    Time frame: 6 month intervals

    Total number of transactional sex partners participant had in the past 3 months.

  8. Number of transactional sex encounters

    Time frame: 6 month intervals

    Number of transactional sex encounters participant engaged in during the past 3 months.

  9. Condom use at most recent sexual encounter

    Time frame: 6 month intervals

    Whether participant used a condom or not at most recent sexual encounter in the past 3 months.

  10. Alcohol use

    Time frame: 6 month intervals

    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

  11. HIV, CT, and NG incidence between 0-12 months and 12-24 months

    Time frame: Up to 24 months

    More temporally granular measures of incidence for HIV, CT, and NG.

  12. Engagement in care among those who are HIV-positive

    Time frame: 6 month intervals

    Whether or not participants who are HIV-positive are currently engaged in care for their HIV.

  13. Expenditures on food

    Time frame: 6 month intervals

    Money spent on food items.

  14. Expenditures on household needs

    Time frame: 6 month intervals

    Money spent on household needs (including personal items; clothing and shoes; household items; utilities; and transport)

  15. Savings and investment

    Time frame: 6 month intervals

    Total savings and investment, defined as the money value of formal and informal savings as well as investments in physical and human capital.

  16. Total informal savings

    Time frame: 6 month intervals

    The sum of savings held outside of formal institutions, including savings groups and money saved at home or elsewhere

  17. Total formal savings

    Time frame: 6 month intervals

    The sum of savings balances in all formal bank accounts.

  18. Total household assets

    Time frame: 6 month intervals

    Value of all assets.

  19. Expenditure on human capital investment

    Time frame: 6 month intervals

    Money spent on human capital investment (e.g., spending on children's education).

  20. Any housing improvements

    Time frame: 6 month intervals

    Any improvement to house (yes/no)

  21. Perpetuation Intimate partner violence

    Time frame: 6 month intervals

    Perpetuation of physical, psychological, or sexual IPV

  22. Experienced Intimate partner violence

    Time frame: 6 month intervals

    Experienced physical, psychological, or sexual IPV

  23. Perceived financial security

    Time frame: 6 month interval

    10 item scale by Fu 2020 World Development

  24. Food security

    Time frame: 6 month interval

    3 item scale from Household Food Insecurity Access Scale. 0 to 9 with higher scores indicating higher food insecurity

  25. Stress

    Time frame: 6 month interval

    Cohen's Perceived Stress Scale, PSS. 0 to 40 with higher scores indicating higher perceived stress

  26. Stress, helplessness

    Time frame: 6 month interval

    Perceived helplessness score (subscale of PSS). 0 to 24 with higher scores indicating higher helplessness

  27. Stress, self-efficacy

    Time frame: 6 month interval

    Perceived self-efficacy score (subscale of PSS). 0 to 16 with higher scores indicating higher self-efficacy

  28. Future orientation

    Time frame: 6 month interval

    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)

  29. Future orientation, well being

    Time frame: 6 month interval

    Cantril scale which measures participant's well-being. 0 to 10 with higher scores indicating higher well being

  30. Future orientation, longevity

    Time frame: 6 month interval

    11-point scale that assesses participant's expectations about their longevity. 0 to 10 with higher scores indicating higher expectations about longevity

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • 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

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
May 23, 2022
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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