A savings intervention to reduce men’s engagement in HIV/STI risk behaviors

Last registered on May 21, 2024
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Pre-Trial

Trial Information

General Information

Title
A savings intervention to reduce men’s engagement in HIV/STI risk behaviors
RCT ID
AEARCTR-0009484
Initial registration date
May 20, 2024

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
May 21, 2024, 11:37 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

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Primary Investigator

Name
Harsha Thirumurthy
Affiliation
University of Pennsylvania
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Other Primary Investigator(s)

PI Name
Kawango Agot
PI Affiliation
Impact Research and Development Organization
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PI Name
Carol Camlin
PI Affiliation
University of California at San Francisco
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PI Name
Connie Celum
PI Affiliation
University of Washington
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PI Name
Sue Napierala
PI Affiliation
RTI International
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PI Name
Mary Putt
PI Affiliation
University of Pennsylvania
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Additional Trial Information

Status
On going
Start date
2022-07-18
End date
2025-08-31
Keywords
Behavior, Finance & Microfinance, Health
Additional Keywords
HIV, STI, Savings
JEL code(s)
I1, I12, D14, O10
Secondary IDs
ClinicalTrials.gov NCT05385484
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
This project will evaluate an theory-driven 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, we will test an intervention that seeks to motivate income-earning men in western Kenya to reduce their spending on high-risk health behaviors (transactional sex and alcohol use) and instead save their disposable income in local bank accounts. 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), we 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).

We will conduct a randomized controlled trial among men who are at high risk of HIV and others STIs 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 incidence of HIV and other STIs. Aim 2: Quantitatively and qualitatively assess mechanisms of behavior change among participants and a sample of their female partners. By testing an intervention to promote forward-looking behavior and reduce the risk of acquiring HIV and other STIs in a high HIV/STI burden setting, this project has great potential for scientific and public health impact.
External Link(s)

Registration Citation

Citation
Agot, Kawango et al. 2024. "A savings intervention to reduce men’s engagement in HIV/STI risk behaviors." AEA RCT Registry. May 21. https://doi.org/10.1257/rct.9484-1.0
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)
In Kenyan communities with high prevalence of HIV and other STIs, participants will be randomized to two groups: a control group that receives basic health education or a savings intervention group that receives a mobile banking account with incentives to save. The savings intervention group will receive bank accounts and (a) lottery-based incentives to save in the bank account, (b) opportunities to develop savings goals and strategies, and (c) periodic reminders about the savings incentives and goals.
Intervention Start Date
2022-07-22
Intervention End Date
2025-04-30

Primary Outcomes

Primary Outcomes (end points)
Composite incidence of HIV and other STIs over 24 months
Primary Outcomes (explanation)
The primary outcome is HIV/STI incidence, defined as the 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 combination of all STIs (including HIV) into a composite variable is justified as the risk factors for these STI’s are similar. Compared to a strategy of considering the individual infection as separate variables, using the composite variable (any HIV/STI infection) should increase the number of events and hence our ability to detect an effect of the intervention. For participants who are HIV-positive and/or HSV-2-positive at baseline, the outcome will be defined over all STIs other than HIV and/or HSV-2.

Secondary Outcomes

Secondary Outcomes (end points)
• The total amount of savings and investment
• Total formal savings, and total household assets
• Investment behavior such as housing improvements, and schooling expenditures
• Expenditures on food and household needs
• Expenditures on alcohol and transactional sex
• Expenditures on gambling
• Self-reported sexual behavior, including number of transactional sex partners, total number of sexual partners and condom use.
• Alcohol use
• Survey-based measures of future orientation
• Survey-based measures of stress
• Perpetration of intimate partner violence
Secondary Outcomes (explanation)
Alcohol use will be measured using the AUDIT-C scale. Future orientation will be measured using the Cantril scale. Stress will be measured using Cohen's Perceived Stress scale.

Experimental Design

Experimental Design
The Akiba study is a single-center two-arm parallel group trial designed to test the superiority of a behavioral intervention over control. To be eligible to participate in the study an individual must be a male aged 18-39 with a mobile phone and steady cash income source that results in earnings every week who also resides in study community and plans to remain for the next 2 years. The individual must have used alcohol or other substances in the past month and engaged in transactional sex (defined as payment of money, goods, or services in exchange for sex) in the past 3 months. And finally, they must have or be willing to open a bank account with partner financial institution, have a national identification card, and have or be willing to create a Kenya Revenue Authority PIN (the latter two criteria are required for opening bank account).

Eligible individuals who initially agree to participate will provide written informed consent before enrollment in the trial. This will be followed by a questionnaire and HIV/STI testing. Participants will be stratified on baseline HIV status, and within each stratum they will be randomized (1:1) to an intervention or control group using a computer-generated sequence.

Participants enrolled in the study will be administered a questionnaire at baseline, 6, 12,18, and 24 months. We will evaluate the
presence of HIV, NG, and CT at baseline, 12 months, and 24 months. We will also test for HSV-2 at baseline and 24 months.
Experimental Design Details
Not available
Randomization Method
We will use a computer-generated sequence with blocks of sizes of 10 that will be generated by the investigators before the start of enrollment. Treatment allocation will be revealed to participants and research assistants after completing the baseline questionnaire and obtaining the results of their HIV test by opening a sealed envelope that corresponds with the results of their HIV status (one set of envelopes for those that test negative and one for those that test positive/indeterminate). Each envelope will contain a sheet of paper that states whether a participant is in the control group or intervention group.
Randomization Unit
Individual
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
We will not be using clusters
Sample size: planned number of observations
1,500 participants
Sample size (or number of clusters) by treatment arms
Roughly 750 in control group and 750 in intervention group
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
With the expectation that annual HIV/STI incidence in the control group will be 15-20% (based on existing literature), a relative reduction of 21-25% in composite HIV/STI incidence is detectable with 80% power (two-sided, α=0.05) for ~1,500 participants (~750 per group). We included a conservative assumption of 20% attrition over 24 months (expected to be lower given our prior studies). Calculations are based on a two-group Chi-squared test of proportions.
Supporting Documents and Materials

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IRB

Institutional Review Boards (IRBs)

IRB Name
University of Pennsylvania Institutional Review Board
IRB Approval Date
2021-10-18
IRB Approval Number
849897
IRB Name
Maseno University Ethics Review Committee
IRB Approval Date
2021-11-17
IRB Approval Number
MUERC/01022/21
Analysis Plan