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

Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT05385484
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), Impact Research & Development Organization (Other), University of California, San Francisco (Other), University of Washington (Other), RTI International (Other)
1,500
1
2
28.5
52.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Receives mobile banking account with incentives to save
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Savings Intervention to Reduce Men's Engagement in HIV Risk Behaviors
Actual Study Start Date :
Jul 18, 2022
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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.

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

  1. Incidence of HIV and other STIs [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 Outcome Measures

  1. Expenditures on alcohol [6 month intervals]

    Money spent on alcohol.

  2. Expenditures on transactional sex [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).

  3. Expenditures on gambling [6 month intervals]

    Money spent on gambling.

  4. Number of sexual partners [6 month intervals]

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

  5. Recent engagement in transactional sex [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.

  6. Number of transactional sex partners [6 month intervals]

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

  7. Number of transactional sex encounters [6 month intervals]

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

  8. Condom use at most recent sexual encounter [6 month intervals]

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

  9. Alcohol use [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

  10. HIV, CT, and NG incidence between 0-12 months and 12-24 months [Up to 24 months]

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

  11. Engagement in care among those who are HIV-positive [6 month intervals]

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

  12. Expenditures on food [6 month intervals]

    Money spent on food items.

  13. Expenditures on household needs [6 month intervals]

    Money spent on household needs (e.g., utilities).

  14. Savings and investment [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.

  15. Total formal savings [6 month intervals]

    The sum of savings balances in all formal bank accounts.

  16. Total household assets [6 month intervals]

    Value of all assets.

  17. Expenditure on human capital investment [6 month intervals]

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

  18. Expenditure on productive assets [6 month intervals]

    Money spent on productive assets (e.g., spending on agricultural equipment).

  19. Expenditure on housing improvement [6 month intervals]

    Money spent on structure of dwelling.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 39 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Impact Research and Development Organization Kisumu Kenya

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Harsha Thirumurthy, PhD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT05385484
Other Study ID Numbers:
  • 849897
  • 1R01HD103563-01A1
First Posted:
May 23, 2022
Last Update Posted:
Jul 25, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 25, 2022