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

• ClinicalTrials.gov Identifier: NCT02890459
• Recruitment Status: Completed
• First Posted: September 7, 2016
• Last Update Posted: February 16, 2021
• Sponsor: University of California, San Francisco
• Collaborators: University of Pennsylvania; Makerere University; National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): University of California, San Francisco

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.

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

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3580 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
• Actual Primary Completion Date: August 21, 2019
• Actual Study Completion Date: January 3, 2020

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Gabriel Chamie, MD, MPH; University of California, San Francisco
• Principal Investigator: Harsha Thirumurthy, PhD; University of Pennsylvania

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT02890459
• Other Study ID Numbers: 15-16876; R01MH105254 ( U.S. NIH Grant/Contract )
• First Posted: September 7, 2016
• Last Update Posted: February 16, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

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

Keywords provided by University of California, San Francisco:

HIV; incentives; behavioral economics

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome; HIV Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Slow Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Denatonium; Aversive Agents; Molecular Mechanisms of Pharmacological Action; Abuse-Deterrent Formulations; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents