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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02890459
Recruitment Status : Active, not recruiting
First Posted : September 7, 2016
Last Update Posted : August 9, 2019
Sponsor:
Collaborators:
University of Pennsylvania
Makerere University
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Gabriel Chamie, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Other: Prize incentive - Low Other: Prize incentive - High Other: Escalating payment incentive Other: Travel Voucher Other: Standard care Behavioral: Fixed Incentive - Prize Behavioral: Loss Aversion - Prize Behavioral: Lottery - Prize Behavioral: Fixed Incentive - Voucher Behavioral: Loss Aversion - Deposit Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Innovative Incentive Strategies for Sustainable HIV Testing and Antiretroviral Treatment
Actual Study Start Date : April 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Aim 1 - Fixed Incentive
Fixed Incentive - Prize Prize incentive - Low Prize incentive - High
Other: Prize incentive - Low
Low expected prize value.

Other: Prize incentive - High
High expected prize value.

Behavioral: Fixed Incentive - Prize
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.

Experimental: Aim 1 - Loss Aversion
Loss Aversion - Prize Prize incentive - Low Prize incentive - High
Other: Prize incentive - Low
Low expected prize value.

Other: Prize incentive - High
High expected prize value.

Behavioral: Loss Aversion - Prize
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.

Experimental: Aim 1 - Lottery
Lottery - Prize Prize incentive - Low Prize incentive - High
Other: Prize incentive - Low
Low expected prize value.

Other: Prize incentive - High
High expected prize value.

Behavioral: Lottery - Prize
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.

Active Comparator: Aim 2 - Standard Care
Standard care Travel voucher
Other: Travel Voucher
Travel voucher to assist with linkage to care.

Other: Standard care
Includes HIV viral load and treatment adherence counseling.

Experimental: Aim 2 - Enhanced Care (Intervention)
Escalating payment incentive Travel voucher
Other: Escalating payment incentive

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.


Other: Travel Voucher
Travel voucher to assist with linkage to care.

Other: Standard care
Includes HIV viral load and treatment adherence counseling.

Experimental: Aim 3 Pilot - Loss Aversion
Loss Aversion - Deposit
Behavioral: Loss Aversion - Deposit
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)

Experimental: Aim 3 Pilot - Fixed Incentive
Fixed Incentive - Voucher
Behavioral: Fixed Incentive - Voucher
A standard gain-framed incentive arm in which participants will be offered a voucher for coming for a repeat HIV test in the future.

No Intervention: Aim 3 Pilot - No incentive
Participants will be encouraged to come for repeat HIV testing, but no incentive will be offered.
Experimental: Aim 3 Trial - Loss Aversion
Loss Aversion - Deposit
Behavioral: Loss Aversion - Deposit
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)

Experimental: Aim 3 Trial - Fixed Incentive
Fixed Incentive - Voucher
Behavioral: Fixed Incentive - Voucher
A standard gain-framed incentive arm in which participants will be offered a voucher for coming for a repeat HIV test in the future.

No Intervention: Aim 3 Trial - No incentive
Participants will be encouraged to come for repeat HIV testing, but no incentive will be offered.



Primary Outcome Measures :
  1. Proportion of participants who receive an HIV test at a community health campaign between intervention groups [ Time Frame: 6-8 weeks after enrollment; annually ]
    Aim 1 (IBIS HIV Testing Trial) primary outcome

  2. Proportion of participants with HIV RNA <400 copies/mL between intervention groups [ Time Frame: 6 months after enrollment ]
    Aim 2 (IBIS Treatment Trial) primary outcome

  3. Proportion of participants randomized to loss aversion trial who make a deposit [ Time Frame: At enrollment ]
    Aim 3 Pilot (IBIS Repeat HIV Testing Trial) primary outcome

  4. Proportion of participants who complete all HIV retest visits at study venue [ Time Frame: 6 months ]
    Aim 3 Trial (IBIS Repeat HIV Testing Trial) primary outcome


Secondary Outcome Measures :
  1. Proportion of participants who have HIV positive result between intervention groups [ Time Frame: 6-8 weeks after enrollment; annually ]
    Aim 1 (IBIS HIV Testing Trial) secondary outcome

  2. Proportion of participants who receive an HIV test at a testing site between intervention groups [ Time Frame: 1-3 months after enrollment ]
    Aim 3 Pilot (IBIS Repeat HIV Testing Trial) secondary outcome

  3. Proportion of participants who retest for HIV at study venue at 3 months [ Time Frame: 3-4 months after enrollment ]
    Aim 3 Trial (IBIS Repeat HIV Testing Trial) secondary outcome

  4. Proportion of participants who retest for HIV at study venue at 6 months [ Time Frame: 6-7 months after enrollment ]
    Aim 3 Trial (IBIS Repeat HIV Testing Trial) secondary outcome

  5. Proportion of participants who retest for HIV at 3 months among those who made deposits [ Time Frame: 3-4 months after enrollment ]
    Aim 3 Trial (IBIS Repeat HIV Testing Trial) secondary outcome

  6. Proportion of participants who retest for HIV at 6 months among those who made deposits [ Time Frame: 6-7 months after enrollment ]
    Aim 3 Trial (IBIS Repeat HIV Testing Trial) secondary outcome

  7. Cumulative incidence of HIV seroconversion [ Time Frame: 6-7 months after enrollment ]
    Aim 3 Trial (IBIS Repeat HIV Testing Trial) secondary outcome



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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. >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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890459


Locations
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Uganda
Infectious Diseases Research Collaboration
Mbarara, Uganda
Sponsors and Collaborators
University of California, San Francisco
University of Pennsylvania
Makerere University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Gabriel Chamie, MD, MPH University of California, San Francisco
Principal Investigator: Harsha Thirumurthy, PhD University of Pennsylvania

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gabriel Chamie, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02890459     History of Changes
Other Study ID Numbers: 15-16876
R01MH105254 ( U.S. NIH Grant/Contract )
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gabriel Chamie, University of California, San Francisco:
HIV
incentives
behavioral economics

Additional relevant MeSH terms:
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Denatonium
Aversive Agents
Molecular Mechanisms of Pharmacological Action
Abuse-Deterrent Formulations
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents