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

Primary Purpose

Human Immunodeficiency Virus, STI, Alcohol Consumption

Status
Recruiting
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Receives mobile banking account with incentives to save
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Immunodeficiency Virus

Eligibility Criteria

18 Years - 39 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Impact Research and Development OrganizationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mobile banking account with incentives to save

Basic health and financial education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Expenditures on alcohol
Money spent on alcohol.
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).
Expenditures on gambling
Money spent on gambling.
Number of sexual partners
Number of sexual partners participant had in the past 3 months.
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.
Number of transactional sex partners
Total number of transactional sex partners participant had in the past 3 months.
Number of transactional sex encounters
Number of transactional sex encounters participant engaged in during the past 3 months.
Condom use at most recent sexual encounter
Whether participant used a condom or not at most recent sexual encounter in the past 3 months.
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
HIV, CT, and NG incidence between 0-12 months and 12-24 months
More temporally granular measures of incidence for HIV, CT, and NG.
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.
Expenditures on food
Money spent on food items.
Expenditures on household needs
Money spent on household needs (e.g., utilities).
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.
Total formal savings
The sum of savings balances in all formal bank accounts.
Total household assets
Value of all assets.
Expenditure on human capital investment
Money spent on human capital investment (e.g., spending on children's education).
Expenditure on productive assets
Money spent on productive assets (e.g., spending on agricultural equipment).
Expenditure on housing improvement
Money spent on structure of dwelling.

Full Information

First Posted
May 17, 2022
Last Updated
March 16, 2023
Sponsor
University of Pennsylvania
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT05385484
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus, STI, Alcohol Consumption, Incentives, Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mobile banking account with incentives to save
Arm Type
Experimental
Arm Description
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.
Arm Title
Basic health and financial education
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Receives mobile banking account with incentives to save
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of HIV and other STIs
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Expenditures on alcohol
Description
Money spent on alcohol.
Time Frame
6 month intervals
Title
Expenditures on transactional sex
Description
Money, goods, and services spent on transactional sex (defined broadly to include financial and non-financial transfers to commercial and non-commercial sexual partners).
Time Frame
6 month intervals
Title
Expenditures on gambling
Description
Money spent on gambling.
Time Frame
6 month intervals
Title
Number of sexual partners
Description
Number of sexual partners participant had in the past 3 months.
Time Frame
6 month intervals
Title
Recent engagement in transactional sex
Description
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.
Time Frame
6 month intervals
Title
Number of transactional sex partners
Description
Total number of transactional sex partners participant had in the past 3 months.
Time Frame
6 month intervals
Title
Number of transactional sex encounters
Description
Number of transactional sex encounters participant engaged in during the past 3 months.
Time Frame
6 month intervals
Title
Condom use at most recent sexual encounter
Description
Whether participant used a condom or not at most recent sexual encounter in the past 3 months.
Time Frame
6 month intervals
Title
Alcohol use
Description
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
Time Frame
6 month intervals
Title
HIV, CT, and NG incidence between 0-12 months and 12-24 months
Description
More temporally granular measures of incidence for HIV, CT, and NG.
Time Frame
Up to 24 months
Title
Engagement in care among those who are HIV-positive
Description
Whether or not participants who are HIV-positive are currently engaged in care for their HIV.
Time Frame
6 month intervals
Title
Expenditures on food
Description
Money spent on food items.
Time Frame
6 month intervals
Title
Expenditures on household needs
Description
Money spent on household needs (e.g., utilities).
Time Frame
6 month intervals
Title
Savings and investment
Description
Total savings and investment, defined as the money value of formal and informal savings as well as investments in physical and human capital.
Time Frame
6 month intervals
Title
Total formal savings
Description
The sum of savings balances in all formal bank accounts.
Time Frame
6 month intervals
Title
Total household assets
Description
Value of all assets.
Time Frame
6 month intervals
Title
Expenditure on human capital investment
Description
Money spent on human capital investment (e.g., spending on children's education).
Time Frame
6 month intervals
Title
Expenditure on productive assets
Description
Money spent on productive assets (e.g., spending on agricultural equipment).
Time Frame
6 month intervals
Title
Expenditure on housing improvement
Description
Money spent on structure of dwelling.
Time Frame
6 month intervals

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teniola Egbe, MPH, MBE
Phone
215-898-2939
Email
tegbe@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Harsha Thirumurthy, PhD
Phone
215-746-0410
Email
hthirumu@upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harsha Thirumurthy, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Impact Research and Development Organization
City
Kisumu
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kawango Agot, PhD, MPH
Phone
+254-(0)57-2020132
Email
kawango@impact-rdo.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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