HIV/AIDSIBIS-HealthNCT02890459
Innovative Behavioral Economics Incentives Strategies for Health
A study testing Prize incentive - Low, Prize incentive - High and Escalating payment incentive in people with HIV/AIDS, run by University of California, San Francisco at 1 site in Uganda.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Prize incentive - Low, Prize incentive - High and Escalating payment incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,580 participants
- Where
- 1 siteUganda
- Study dates
- Apr 2016to 3 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- ≥18 years
- Resident (≥6 months) in one of 4 study communities
- ≥18 years
- Resident (≥6 months) in one of 4 study communities
- HIV positive
Show all 17Show fewer
- 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
- 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.
Who cannot join
- Plan to move <6 months from study start
- AIM 2 - TREATMENT TRIAL
- Plan to move <6 months from study start
- AIM 3 - REPEAT TESTING PILOT
- Intention to move away from the community in the 3 months from time of recruitment
- AIM 3 - REPEAT TESTING TRIAL
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Innovative Incentive Strategies for Sustainable HIV Testing and Antiretroviral Treatment
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.
Read the 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.
- Conditions
- HIV/AIDS
- Being tested
- Prize incentive - Low, Prize incentive - High, Escalating payment incentive, Travel Voucher, Standard care
- Keywords
- HIV, incentives, behavioral economics
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prize incentive - LowOther
Low expected prize value.
Prize incentive - HighOther
High expected prize value.
Escalating payment incentiveOther
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.
Travel VoucherOther
Travel voucher to assist with linkage to care.
Standard careOther
Includes HIV viral load and treatment adherence counseling.
Fixed Incentive - PrizeBehavioural
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.
Loss Aversion - PrizeBehavioural
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.
Lottery - PrizeBehavioural
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.
Fixed Incentive - VoucherBehavioural
A standard gain-framed incentive arm in which participants will be offered a voucher for coming for a repeat HIV test in the future.
Loss Aversion - DepositBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Aim 1 - Fixed Incentive | Active comparator | Fixed Incentive - Prize Prize incentive - Low Prize incentive - High Receives: Other: Prize incentive - Low; Other: Prize incentive - High; Behavioral: Fixed Incentive - Prize |
| Aim 1 - Loss Aversion | Experimental | Loss Aversion - Prize Prize incentive - Low Prize incentive - High Receives: Other: Prize incentive - Low; Other: Prize incentive - High; Behavioral: Loss Aversion - Prize |
| Aim 1 - Lottery | Experimental | Lottery - Prize Prize incentive - Low Prize incentive - High Receives: Other: Prize incentive - Low; Other: Prize incentive - High; Behavioral: Lottery - Prize |
| Aim 2 - Standard Care | Active comparator | Standard care Travel voucher Receives: Other: Travel Voucher; Other: Standard care |
| Aim 2 - Enhanced Care (Intervention) | Experimental | Escalating payment incentive Travel voucher Receives: Other: Escalating payment incentive; Other: Travel Voucher; Other: Standard care |
| Aim 3 Pilot - Loss Aversion | Experimental | Loss Aversion - Deposit Receives: Behavioral: Loss Aversion - Deposit |
| Aim 3 Pilot - Fixed Incentive | Experimental | Fixed Incentive - Voucher Receives: Behavioral: Fixed Incentive - Voucher |
| Aim 3 Pilot - No incentive | No intervention | Participants will be encouraged to come for repeat HIV testing, but no incentive will be offered. |
| Aim 3 Trial - Loss Aversion | Experimental | Loss Aversion - Deposit Receives: Behavioral: Loss Aversion - Deposit |
| Aim 3 Trial - Fixed Incentive | Experimental | Fixed Incentive - Voucher Receives: Behavioral: Fixed Incentive - Voucher |
| Aim 3 Trial - No incentive | No intervention | Participants will be encouraged to come for repeat HIV testing, but no incentive will be offered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who receive an HIV test at a community health campaign between intervention groups
Aim 1 (IBIS HIV Testing Trial) primary outcome
Measured: 6-8 weeks after enrollment; annually
Proportion of participants with HIV RNA <400 copies/mL between intervention groups
Aim 2 (IBIS Treatment Trial) primary outcome
Measured: 6 months after enrollment
Proportion of participants randomized to loss aversion trial who make a deposit
Aim 3 Pilot (IBIS Repeat HIV Testing Trial) primary outcome
Measured: At enrollment
Proportion of participants who complete all HIV retest visits at study venue
Aim 3 Trial (IBIS Repeat HIV Testing Trial) primary outcome
Measured: 6 months
Secondary outcomes (7)
Proportion of participants who have HIV positive result between intervention groups
Aim 1 (IBIS HIV Testing Trial) secondary outcome
Measured: 6-8 weeks after enrollment; annually
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
Measured: 1-3 months after enrollment
Proportion of participants who retest for HIV at study venue at 3 months
Aim 3 Trial (IBIS Repeat HIV Testing Trial) secondary outcome
Measured: 3-4 months after enrollment
Proportion of participants who retest for HIV at study venue at 6 months
Aim 3 Trial (IBIS Repeat HIV Testing Trial) secondary outcome
Measured: 6-7 months after enrollment
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
Measured: 3-4 months after enrollment
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
Measured: 6-7 months after enrollment
Cumulative incidence of HIV seroconversion
Aim 3 Trial (IBIS Repeat HIV Testing Trial) secondary outcome
Measured: 6-7 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startApr 2016
- Primary completion21 Aug 2019
- Study completion3 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,580 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Makerere University, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Gabriel Chamie, MD, MPH, Principal investigator, University of California, San FranciscoHarsha Thirumurthy, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890459
- Sponsor's protocol ID
- 15-16876
- Other IDs
- R01MH105254
- Acronym
- IBIS-Health
- Status last verified
- Feb 2022
- First submitted
- 10 Aug 2016
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: N/A. Individual data may be made available upon request.
Publications
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.
PubMed 29683850Thirumurthy 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.
PubMed 30660594Ndyabakira 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.
PubMed 31073946Ndyabakira 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.
PubMed 31888589Schaffer 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.
PubMed 31981135Chamie 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.
PubMed 32470089Kavanagh 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.
PubMed 33257417Marson 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.
PubMed 33172300Chamie 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.
PubMed 33794183Chamie 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.
PubMed 33945526Camlin 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.
PubMed 35749510
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Incentive Strategies for Sustainable HIV Testing and Antiretroviral Treatment
- ClinicalTrials.gov ID
- NCT02890459
- Acronym / sponsor ID
- IBIS-Health / 15-16876
- Conditions
- HIV/AIDS
- Keywords
- HIV, incentives, behavioral economics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,580 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Makerere University, National Institute of Mental Health (NIMH)
- Study start
- Apr 2016 (actual)
- Primary completion
- 21 Aug 2019 (actual)
- Study completion
- 3 Jan 2020 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Aim 1 - Fixed Incentive | Active comparator | Other: Prize incentive - Low, Other: Prize incentive - High, Behavioral: Fixed Incentive - PrizeFixed Incentive - Prize Prize incentive - Low Prize incentive - High |
| Aim 1 - Loss Aversion | Experimental | Other: Prize incentive - Low, Other: Prize incentive - High, Behavioral: Loss Aversion - PrizeLoss Aversion - Prize Prize incentive - Low Prize incentive - High |
| Aim 1 - Lottery | Experimental | Other: Prize incentive - Low, Other: Prize incentive - High, Behavioral: Lottery - PrizeLottery - Prize Prize incentive - Low Prize incentive - High |
| Aim 2 - Standard Care | Active comparator | Other: Travel Voucher, Other: Standard careStandard care Travel voucher |
| Aim 2 - Enhanced Care (Intervention) | Experimental | Other: Escalating payment incentive, Other: Travel Voucher, Other: Standard careEscalating payment incentive Travel voucher |
| Aim 3 Pilot - Loss Aversion | Experimental | Behavioral: Loss Aversion - DepositLoss Aversion - Deposit |
| Aim 3 Pilot - Fixed Incentive | Experimental | Behavioral: Fixed Incentive - VoucherFixed Incentive - Voucher |
| Aim 3 Pilot - No incentive | No intervention | –Participants will be encouraged to come for repeat HIV testing, but no incentive will be offered. |
| Aim 3 Trial - Loss Aversion | Experimental | Behavioral: Loss Aversion - DepositLoss Aversion - Deposit |
| Aim 3 Trial - Fixed Incentive | Experimental | Behavioral: Fixed Incentive - VoucherFixed Incentive - Voucher |
| Aim 3 Trial - No incentive | No intervention | –Participants will be encouraged to come for repeat HIV testing, but no incentive will be offered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male
- ≥18 years
- Resident (≥6 months) in one of 4 study communities
- ≥18 years
- Resident (≥6 months) in one of 4 study communities
Key exclusion criteria (8 listed)
- Plan to move <6 months from study start
- AIM 2 - TREATMENT TRIAL
- Plan to move <6 months from study start
- AIM 3 - REPEAT TESTING PILOT
- Intention to move away from the community in the 3 months from time of recruitment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prize incentive - LowLow expected prize value. | Other | Aim 1 - Fixed Incentive, Aim 1 - Loss Aversion, Aim 1 - Lottery |
| Prize incentive - HighHigh expected prize value. | Other | Aim 1 - Fixed Incentive, Aim 1 - Loss Aversion, Aim 1 - Lottery |
| Escalating payment incentiveThe 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 | Aim 2 - Enhanced Care (Intervention) |
| Travel VoucherTravel voucher to assist with linkage to care. | Other | Aim 2 - Enhanced Care (Intervention), Aim 2 - Standard Care |
| Standard careIncludes HIV viral load and treatment adherence counseling. | Other | Aim 2 - Enhanced Care (Intervention), Aim 2 - Standard Care |
| Fixed Incentive - PrizeMen 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. | Behavioural | Aim 1 - Fixed Incentive |
| Loss Aversion - PrizeThe 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. | Behavioural | Aim 1 - Loss Aversion |
| Lottery - PrizeMen 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. | Behavioural | Aim 1 - Lottery |
| Fixed Incentive - VoucherA standard gain-framed incentive arm in which participants will be offered a voucher for coming for a repeat HIV test in the future. | Behavioural | Aim 3 Pilot - Fixed Incentive, Aim 3 Trial - Fixed Incentive |
| Loss Aversion - DepositA 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) | Behavioural | Aim 3 Pilot - Loss Aversion, Aim 3 Trial - Loss Aversion |
Primary outcome
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
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
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
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
7 secondary outcomes
Proportion of participants who have HIV positive result between intervention groups
Time frame: 6-8 weeks after enrollment; annually
Proportion of participants who receive an HIV test at a testing site between intervention groups
Time frame: 1-3 months after enrollment
Proportion of participants who retest for HIV at study venue at 3 months
Time frame: 3-4 months after enrollment
Proportion of participants who retest for HIV at study venue at 6 months
Time frame: 6-7 months after enrollment
Proportion of participants who retest for HIV at 3 months among those who made deposits
Time frame: 3-4 months after enrollment
Proportion of participants who retest for HIV at 6 months among those who made deposits
Time frame: 6-7 months after enrollment
Cumulative incidence of HIV seroconversion
Time frame: 6-7 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Results publication: PubMed 29683850Chamie 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 publication: PubMed 30660594Thirumurthy 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 publication: PubMed 31073946Ndyabakira 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 publication: PubMed 31888589Ndyabakira 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 publication: PubMed 31981135Schaffer 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 publication: PubMed 32470089Chamie 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 publication: PubMed 33257417Kavanagh 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 publication: PubMed 33172300Marson 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 publication: PubMed 33794183Chamie 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 publication: PubMed 33945526Chamie 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.
- Derived from this study: PubMed 35749510Camlin 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.
- Individual participant dataSharing planned: No. N/A. Individual data may be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel Chamie, MD, MPH principal investigator
University of California, San Francisco
Harsha Thirumurthy, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prize incentive - Low, Prize incentive - High and Escalating payment incentive in people with HIV/AIDS, run by University of California, San Francisco at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who receive an HIV test at a community health campaign between intervention groups (time frame: 6-8 weeks after enrollment; annually). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02890459, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.