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Innovative Behavioral Economics Incentives Strategies for Health (IBIS-Health)

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Prize incentive - Low
Prize incentive - High
Escalating payment incentive
Travel Voucher
Standard care
Fixed Incentive - Prize
Loss Aversion - Prize
Lottery - Prize
Fixed Incentive - Voucher
Loss Aversion - Deposit
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HIV/AIDS focused on measuring HIV, incentives, behavioral economics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

AIM 1 - TESTING TRIAL

Inclusion Criteria:

  • Male
  • ≥18 years
  • Resident (≥6 months) in one of 4 study communities

Exclusion Criteria:

  • Plan to move <6 months from study start

AIM 2 - TREATMENT TRIAL

Inclusion Criteria:

  • ≥18 years
  • Resident (≥6 months) in one of 4 study communities
  • HIV positive

Exclusion Criteria:

  • Plan to move <6 months from study start

AIM 3 - REPEAT TESTING PILOT

Inclusion Criteria:

  • HIV-negative by rapid HIV antibody testing at pilot trial baseline,
  • Ages 18 - 59 years old,
  • Attendee of high-risk site of HIV acquisition (e.g. bars, trading centers, etc.) in the region

Exclusion Criteria:

  • Intention to move away from the community in the 3 months from time of recruitment

AIM 3 - REPEAT TESTING TRIAL

Inclusion Criteria:

  • HIV-negative by rapid HIV antibody testing at time of recruitment,
  • Ages 18 - 59 years old,
  • Reported willingness to retest for HIV in the six months following recruitment,
  • Sexual risk behavior, defined as at least one of the following self-reported risks in the 12 months prior to recruitment:

    1. >1 sexual partner, or
    2. known HIV-infected sexual partner, or
    3. sexually transmitted infection, or
    4. paid or received compensation or gifts for sex.

Exclusion Criteria:

  • Intention to move away from the community for >=4 consecutive months during the six months following recruitment
  • A history of testing for HIV >=3 times in the 12 months prior to recruitment

Sites / Locations

  • Infectious Diseases Research Collaboration

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Active Comparator

Experimental

Experimental

Active Comparator

Experimental

Experimental

Experimental

No Intervention

Experimental

Experimental

No Intervention

Arm Label

Aim 1 - Fixed Incentive

Aim 1 - Loss Aversion

Aim 1 - Lottery

Aim 2 - Standard Care

Aim 2 - Enhanced Care (Intervention)

Aim 3 Pilot - Loss Aversion

Aim 3 Pilot - Fixed Incentive

Aim 3 Pilot - No incentive

Aim 3 Trial - Loss Aversion

Aim 3 Trial - Fixed Incentive

Aim 3 Trial - No incentive

Arm Description

Fixed Incentive - Prize Prize incentive - Low Prize incentive - High

Loss Aversion - Prize Prize incentive - Low Prize incentive - High

Lottery - Prize Prize incentive - Low Prize incentive - High

Standard care Travel voucher

Escalating payment incentive Travel voucher

Loss Aversion - Deposit

Fixed Incentive - Voucher

Participants will be encouraged to come for repeat HIV testing, but no incentive will be offered.

Loss Aversion - Deposit

Fixed Incentive - Voucher

Participants will be encouraged to come for repeat HIV testing, but no incentive will be offered.

Outcomes

Primary Outcome Measures

Proportion of participants who receive an HIV test at a community health campaign between intervention groups
Aim 1 (IBIS HIV Testing Trial) primary outcome
Proportion of participants with HIV RNA <400 copies/mL between intervention groups
Aim 2 (IBIS Treatment Trial) primary outcome
Proportion of participants randomized to loss aversion trial who make a deposit
Aim 3 Pilot (IBIS Repeat HIV Testing Trial) primary outcome
Proportion of participants who complete all HIV retest visits at study venue
Aim 3 Trial (IBIS Repeat HIV Testing Trial) primary outcome

Secondary Outcome Measures

Proportion of participants who have HIV positive result between intervention groups
Aim 1 (IBIS HIV Testing Trial) secondary outcome
Proportion of participants who receive an HIV test at a testing site between intervention groups
Aim 3 Pilot (IBIS Repeat HIV Testing Trial) secondary outcome
Proportion of participants who retest for HIV at study venue at 3 months
Aim 3 Trial (IBIS Repeat HIV Testing Trial) secondary outcome
Proportion of participants who retest for HIV at study venue at 6 months
Aim 3 Trial (IBIS Repeat HIV Testing Trial) secondary outcome
Proportion of participants who retest for HIV at 3 months among those who made deposits
Aim 3 Trial (IBIS Repeat HIV Testing Trial) secondary outcome
Proportion of participants who retest for HIV at 6 months among those who made deposits
Aim 3 Trial (IBIS Repeat HIV Testing Trial) secondary outcome
Cumulative incidence of HIV seroconversion
Aim 3 Trial (IBIS Repeat HIV Testing Trial) secondary outcome

Full Information

First Posted
August 10, 2016
Last Updated
February 22, 2022
Sponsor
University of California, San Francisco
Collaborators
University of Pennsylvania, Makerere University, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02890459
Brief Title
Innovative Behavioral Economics Incentives Strategies for Health
Acronym
IBIS-Health
Official Title
Innovative Incentive Strategies for Sustainable HIV Testing and Antiretroviral Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
August 21, 2019 (Actual)
Study Completion Date
January 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
University of Pennsylvania, Makerere University, National Institute of Mental Health (NIMH)

4. Oversight

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

5. Study Description

Brief Summary
The success of combination HIV prevention efforts, including HIV treatment as prevention, hinges on universal, routine HIV testing with effective treatment after HIV diagnosis. The proposed study will evaluate the comparative effectiveness and sustainability of innovative incentive strategies, informed directly by behavioral economics and decision psychology, to promote HIV testing among men and HIV treatment among HIV-infected adults in rural Uganda.
Detailed Description
[INTRODUCTION] The success of combination HIV prevention efforts, including HIV treatment as prevention, hinges on universal, routine HIV testing with linkage to care and antiretroviral treatment initiation after HIV diagnosis. The proposed study will evaluate the comparative effectiveness and sustainability of innovative incentive strategies, informed directly by behavioral economics and decision psychology, to promote HIV testing among men and HIV and treatment among HIV-infected adults in rural Uganda. [OBJECTIVES] AIM 1: Adult men living in the study communities in rural Uganda (N=3,000) will be randomized to one of three (fixed, loss aversion, and lottery) incentive approaches and different incentive amounts that encourage HIV testing. The hypothesis is that lottery and loss aversion incentives will result in significantly higher testing uptake than fixed incentives. The investigators also hypothesize that the proportion of testers in each arm who are HIV-infected (secondary outcome) will be highest with lottery-based incentives. In sub-samples of men who do and do not test, the investigators will conduct in-depth interviews to assess perceptions, attitudes and preferences related to incentives that may affect how incentives influence testing. AIM 2: Adult men and women living in the study communities (N=400) who obtained an HIV-positive result at a community health campaign will be randomized into one of two incentive approaches that encourage HIV treatment adherence. The investigators hypothesize that a financial incentive will be more effective than no incentive in promoting HIV virologic suppression (a measure of success in ART adherence and navigation of the HIV treatment cascade) as incentives capitalize on present bias by drawing attention to a salient, immediate benefit of initiating and/or maintaining treatment, and leverage loss aversion by generating implicit loss as a result of delaying the decision to initiate ART. AIM 3 - Pilot: In order to assess the feasibility of leveraging loss aversion to increase repeat HIV testing, HIV-negative adults who are at high risk of HIV acquisition and have just tested for HIV will be randomized into one of several different incentive strategies that encourage repeat HIV testing. The incentive arms will either: a) leverage loss-aversion by requesting participants to make an initial voluntary deposit that they will lose if they do not test for HIV at a later date; or b) use a standard gain-framed incentive strategy, in which participants are told they will receive an incentive for testing again for HIV at a later date. We will compare these two types of incentive strategies to a no incentive arm as well. Results from this pilot study will also be used to inform how best to implement loss aversion-based incentives in a larger trial, and provide preliminary data to guide sample size estimates for a larger trial comparing loss aversion vs. gain-framed incentive-based strategies vs. no incentive, on the outcome of repeat HIV testing. We hypothesize that loss aversion incentives will be feasible (i.e. ≥50% of eligible adults will be willing to participate), and will result in significantly higher testing uptake than either gain-framed incentives or no incentives. Aim 3 - Trial. Assess the comparative effectiveness of deposit contracts (a form of incentives that leverages loss aversion) vs. gain-framed incentives, compared to no incentives (control), to promote repeat HIV testing among high-risk HIV-uninfected adults. In our Aim 3 pilot trial, we assessed the feasibility and acceptability of deposit contracts: a loss aversion-based strategy to incentivize retesting for HIV. As deposit contracts were found to be highly acceptable and feasible in our Aim 3 pilot in August-December 2017 (>90% of participants in the deposit contract group made deposits into the study contracts), we will now proceed with a larger trial of sufficient sample size to compare the effectiveness of loss aversion and gain-framed incentive approaches vs. no incentives, on the outcome of repeat HIV testing. We hypothesize that deposit contracts (loss aversion-based incentives) will result in significantly higher HIV retesting uptake 3- and 6-months after enrollment than either gain-framed incentives or no incentives.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
HIV, incentives, behavioral economics

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3580 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aim 1 - Fixed Incentive
Arm Type
Active Comparator
Arm Description
Fixed Incentive - Prize Prize incentive - Low Prize incentive - High
Arm Title
Aim 1 - Loss Aversion
Arm Type
Experimental
Arm Description
Loss Aversion - Prize Prize incentive - Low Prize incentive - High
Arm Title
Aim 1 - Lottery
Arm Type
Experimental
Arm Description
Lottery - Prize Prize incentive - Low Prize incentive - High
Arm Title
Aim 2 - Standard Care
Arm Type
Active Comparator
Arm Description
Standard care Travel voucher
Arm Title
Aim 2 - Enhanced Care (Intervention)
Arm Type
Experimental
Arm Description
Escalating payment incentive Travel voucher
Arm Title
Aim 3 Pilot - Loss Aversion
Arm Type
Experimental
Arm Description
Loss Aversion - Deposit
Arm Title
Aim 3 Pilot - Fixed Incentive
Arm Type
Experimental
Arm Description
Fixed Incentive - Voucher
Arm Title
Aim 3 Pilot - No incentive
Arm Type
No Intervention
Arm Description
Participants will be encouraged to come for repeat HIV testing, but no incentive will be offered.
Arm Title
Aim 3 Trial - Loss Aversion
Arm Type
Experimental
Arm Description
Loss Aversion - Deposit
Arm Title
Aim 3 Trial - Fixed Incentive
Arm Type
Experimental
Arm Description
Fixed Incentive - Voucher
Arm Title
Aim 3 Trial - No incentive
Arm Type
No Intervention
Arm Description
Participants will be encouraged to come for repeat HIV testing, but no incentive will be offered.
Intervention Type
Other
Intervention Name(s)
Prize incentive - Low
Intervention Description
Low expected prize value.
Intervention Type
Other
Intervention Name(s)
Prize incentive - High
Intervention Description
High expected prize value.
Intervention Type
Other
Intervention Name(s)
Escalating payment incentive
Intervention Description
The incentives will increase in value when participants are found to meet the pre-specified virologic suppression criteria at 6 weeks, 3 months and 6 months. If the virologic threshold for an incentive is missed at the 6 week or 3 month time-point, the subsequent incentive for an undetectable HIV viral load will be reset to the initial incentive value.
Intervention Type
Other
Intervention Name(s)
Travel Voucher
Intervention Description
Travel voucher to assist with linkage to care.
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Includes HIV viral load and treatment adherence counseling.
Intervention Type
Behavioral
Intervention Name(s)
Fixed Incentive - Prize
Intervention Description
Men are informed that if they come for HIV testing, they will receive a specific prize (gain framing). The prize will be an item worth the same amount in US dollars as loss aversion and the expected value of a lottery prize. This gain-framed incentive resembles the form that incentives usually take in most studies and serves as a comparison to the lottery-based and loss-framed incentives.
Intervention Type
Behavioral
Intervention Name(s)
Loss Aversion - Prize
Intervention Description
The prizes are worth approximately the same amount as the fixed incentive and expected value of a lottery prize. At the time of randomization, study staff will inform the participant that he has won a prize. Staff will ask the participant to choose a specific prize from several choices, and then provide an opportunity for the participant to see the prize. Study staff will then tell participants that they will lose the prize if they do not participate in HIV testing. In this way, the incentive is framed as a loss rather than a gain, thereby leveraging loss aversion while not requiring men in very low-income settings to experience an actual loss.
Intervention Type
Behavioral
Intervention Name(s)
Lottery - Prize
Intervention Description
Men are entered in a lottery that offers a chance to win high-value prizes after testing for HIV at a community health campaign. Staff will emphasize that only those who come for HIV testing will be entered into the lottery and that not everyone will win a prize. Participants were informed at enrollment about the list of prizes and corresponding probabilities of winning them, in terms that are understandable to men with low numeracy (e.g., "1 in 20" rather than 5%). The probabilities of winning prizes varied between 1-5%, with higher value prizes having lower probability.
Intervention Type
Behavioral
Intervention Name(s)
Fixed Incentive - Voucher
Intervention Description
A standard gain-framed incentive arm in which participants will be offered a voucher for coming for a repeat HIV test in the future.
Intervention Type
Behavioral
Intervention Name(s)
Loss Aversion - Deposit
Intervention Description
A loss-aversion framed incentive in which participants will be asked to voluntarily make a deposit that can be retrieved, with interest on the deposit, if they come for an HIV test in the future (i.e. for repeat testing)
Primary Outcome Measure Information:
Title
Proportion of participants who receive an HIV test at a community health campaign between intervention groups
Description
Aim 1 (IBIS HIV Testing Trial) primary outcome
Time Frame
6-8 weeks after enrollment; annually
Title
Proportion of participants with HIV RNA <400 copies/mL between intervention groups
Description
Aim 2 (IBIS Treatment Trial) primary outcome
Time Frame
6 months after enrollment
Title
Proportion of participants randomized to loss aversion trial who make a deposit
Description
Aim 3 Pilot (IBIS Repeat HIV Testing Trial) primary outcome
Time Frame
At enrollment
Title
Proportion of participants who complete all HIV retest visits at study venue
Description
Aim 3 Trial (IBIS Repeat HIV Testing Trial) primary outcome
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Proportion of participants who have HIV positive result between intervention groups
Description
Aim 1 (IBIS HIV Testing Trial) secondary outcome
Time Frame
6-8 weeks after enrollment; annually
Title
Proportion of participants who receive an HIV test at a testing site between intervention groups
Description
Aim 3 Pilot (IBIS Repeat HIV Testing Trial) secondary outcome
Time Frame
1-3 months after enrollment
Title
Proportion of participants who retest for HIV at study venue at 3 months
Description
Aim 3 Trial (IBIS Repeat HIV Testing Trial) secondary outcome
Time Frame
3-4 months after enrollment
Title
Proportion of participants who retest for HIV at study venue at 6 months
Description
Aim 3 Trial (IBIS Repeat HIV Testing Trial) secondary outcome
Time Frame
6-7 months after enrollment
Title
Proportion of participants who retest for HIV at 3 months among those who made deposits
Description
Aim 3 Trial (IBIS Repeat HIV Testing Trial) secondary outcome
Time Frame
3-4 months after enrollment
Title
Proportion of participants who retest for HIV at 6 months among those who made deposits
Description
Aim 3 Trial (IBIS Repeat HIV Testing Trial) secondary outcome
Time Frame
6-7 months after enrollment
Title
Cumulative incidence of HIV seroconversion
Description
Aim 3 Trial (IBIS Repeat HIV Testing Trial) secondary outcome
Time Frame
6-7 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
AIM 1 - TESTING TRIAL Inclusion Criteria: Male ≥18 years Resident (≥6 months) in one of 4 study communities Exclusion Criteria: Plan to move <6 months from study start AIM 2 - TREATMENT TRIAL Inclusion Criteria: ≥18 years Resident (≥6 months) in one of 4 study communities HIV positive Exclusion Criteria: Plan to move <6 months from study start AIM 3 - REPEAT TESTING PILOT Inclusion Criteria: HIV-negative by rapid HIV antibody testing at pilot trial baseline, Ages 18 - 59 years old, Attendee of high-risk site of HIV acquisition (e.g. bars, trading centers, etc.) in the region Exclusion Criteria: Intention to move away from the community in the 3 months from time of recruitment AIM 3 - REPEAT TESTING TRIAL Inclusion Criteria: HIV-negative by rapid HIV antibody testing at time of recruitment, Ages 18 - 59 years old, Reported willingness to retest for HIV in the six months following recruitment, Sexual risk behavior, defined as at least one of the following self-reported risks in the 12 months prior to recruitment: >1 sexual partner, or known HIV-infected sexual partner, or sexually transmitted infection, or paid or received compensation or gifts for sex. Exclusion Criteria: Intention to move away from the community for >=4 consecutive months during the six months following recruitment A history of testing for HIV >=3 times in the 12 months prior to recruitment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Chamie, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Harsha Thirumurthy, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Infectious Diseases Research Collaboration
City
Mbarara
Country
Uganda

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
N/A. Individual data may be made available upon request.
Citations:
PubMed Identifier
29683850
Citation
Chamie G, Schaffer EM, Ndyabakira A, Emperador DM, Kwarisiima D, Camlin CS, Havlir DV, Kahn JG, Kamya MR, Thirumurthy H. Comparative effectiveness of novel nonmonetary incentives to promote HIV testing. AIDS. 2018 Jul 17;32(11):1443-1451. doi: 10.1097/QAD.0000000000001833.
Results Reference
result
PubMed Identifier
30660594
Citation
Thirumurthy H, Ndyabakira A, Marson K, Emperador D, Kamya M, Havlir D, Kwarisiima D, Chamie G. Financial incentives for achieving and maintaining viral suppression among HIV-positive adults in Uganda: a randomised controlled trial. Lancet HIV. 2019 Mar;6(3):e155-e163. doi: 10.1016/S2352-3018(18)30330-8. Epub 2019 Jan 16.
Results Reference
result
PubMed Identifier
31073946
Citation
Ndyabakira A, Chamie G, Emperador D, Marson K, Kamya MR, Havlir DV, Kwarisiima D, Thirumurthy H. Men's Beliefs About the Likelihood of Serodiscordance in Couples with an HIV-Positive Partner: Survey Evidence from Rural Uganda. AIDS Behav. 2020 Mar;24(3):967-974. doi: 10.1007/s10461-019-02531-7.
Results Reference
result
PubMed Identifier
31888589
Citation
Ndyabakira A, Getahun M, Byamukama A, Emperador D, Kabageni S, Marson K, Kwarisiima D, Chamie G, Thirumurthy H, Havlir D, Kamya MR, Camlin CS. Leveraging incentives to increase HIV testing uptake among men: qualitative insights from rural Uganda. BMC Public Health. 2019 Dec 30;19(1):1763. doi: 10.1186/s12889-019-8073-6.
Results Reference
result
PubMed Identifier
31981135
Citation
Schaffer EM, Gonzalez JM, Wheeler SB, Kwarisiima D, Chamie G, Thirumurthy H. Promoting HIV Testing by Men: A Discrete Choice Experiment to Elicit Preferences and Predict Uptake of Community-based Testing in Uganda. Appl Health Econ Health Policy. 2020 Jun;18(3):413-432. doi: 10.1007/s40258-019-00549-5.
Results Reference
result
PubMed Identifier
32470089
Citation
Chamie G, Ndyabakira A, Marson KG, Emperador DM, Kamya MR, Havlir DV, Kwarisiima D, Thirumurthy H. A pilot randomized trial of incentive strategies to promote HIV retesting in rural Uganda. PLoS One. 2020 May 29;15(5):e0233600. doi: 10.1371/journal.pone.0233600. eCollection 2020.
Results Reference
result
PubMed Identifier
33257417
Citation
Kavanagh NM, Schaffer EM, Ndyabakira A, Marson K, Havlir DV, Kamya MR, Kwarisiima D, Chamie G, Thirumurthy H. Planning prompts to promote uptake of HIV services among men: a randomised trial in rural Uganda. BMJ Glob Health. 2020 Nov;5(11):e003390. doi: 10.1136/bmjgh-2020-003390.
Results Reference
result
PubMed Identifier
33172300
Citation
Marson K, Ndyabakira A, Kwarisiima D, Camlin CS, Kamya MR, Havlir D, Thirumurthy H, Chamie G. HIV retesting and risk behaviors among high-risk, HIV-uninfected adults in Uganda. AIDS Care. 2021 May;33(5):675-681. doi: 10.1080/09540121.2020.1842319. Epub 2020 Nov 10.
Results Reference
result
PubMed Identifier
33794183
Citation
Chamie G, Napierala S, Agot K, Thirumurthy H. HIV testing approaches to reach the first UNAIDS 95% target in sub-Saharan Africa. Lancet HIV. 2021 Apr;8(4):e225-e236. doi: 10.1016/S2352-3018(21)00023-0.
Results Reference
result
PubMed Identifier
33945526
Citation
Chamie G, Kwarisiima D, Ndyabakira A, Marson K, Camlin CS, Havlir DV, Kamya MR, Thirumurthy H. Financial incentives and deposit contracts to promote HIV retesting in Uganda: A randomized trial. PLoS Med. 2021 May 4;18(5):e1003630. doi: 10.1371/journal.pmed.1003630. eCollection 2021 May.
Results Reference
result
PubMed Identifier
35749510
Citation
Camlin CS, Marson K, Ndyabakira A, Getahun M, Emperador D, Byamukama A, Kwarisiima D, Thirumurthy H, Chamie G. Understanding the role of incentives for achieving and sustaining viral suppression: A qualitative sub-study of a financial incentives trial in Uganda. PLoS One. 2022 Jun 24;17(6):e0270180. doi: 10.1371/journal.pone.0270180. eCollection 2022.
Results Reference
derived

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Innovative Behavioral Economics Incentives Strategies for Health

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