NCT02890459

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,580

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2020

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

3.4 years

First QC Date

August 10, 2016

Last Update Submit

February 22, 2022

Conditions

Keywords

HIVincentivesbehavioral economics

Outcome Measures

Primary Outcomes (4)

  • Proportion of participants who receive an HIV test at a community health campaign between intervention groups

    Aim 1 (IBIS HIV Testing Trial) primary outcome

    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

    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

    At enrollment

  • Proportion of participants who complete all HIV retest visits at study venue

    Aim 3 Trial (IBIS Repeat HIV Testing Trial) primary outcome

    6 months

Secondary Outcomes (7)

  • Proportion of participants who have HIV positive result between intervention groups

    6-8 weeks after enrollment; annually

  • Proportion of participants who receive an HIV test at a testing site between intervention groups

    1-3 months after enrollment

  • Proportion of participants who retest for HIV at study venue at 3 months

    3-4 months after enrollment

  • Proportion of participants who retest for HIV at study venue at 6 months

    6-7 months after enrollment

  • Proportion of participants who retest for HIV at 3 months among those who made deposits

    3-4 months after enrollment

  • +2 more secondary outcomes

Study Arms (11)

Aim 1 - Fixed Incentive

ACTIVE COMPARATOR

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

Other: Prize incentive - LowOther: Prize incentive - HighBehavioral: Fixed Incentive - Prize

Aim 1 - Loss Aversion

EXPERIMENTAL

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

Other: Prize incentive - LowOther: Prize incentive - HighBehavioral: Loss Aversion - Prize

Aim 1 - Lottery

EXPERIMENTAL

Lottery - Prize Prize incentive - Low Prize incentive - High

Other: Prize incentive - LowOther: Prize incentive - HighBehavioral: Lottery - Prize

Aim 2 - Standard Care

ACTIVE COMPARATOR

Standard care Travel voucher

Other: Travel VoucherOther: Standard care

Aim 2 - Enhanced Care (Intervention)

EXPERIMENTAL

Escalating payment incentive Travel voucher

Other: Escalating payment incentiveOther: Travel VoucherOther: Standard care

Aim 3 Pilot - Loss Aversion

EXPERIMENTAL

Loss Aversion - Deposit

Behavioral: Loss Aversion - Deposit

Aim 3 Pilot - Fixed Incentive

EXPERIMENTAL

Fixed Incentive - Voucher

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

Behavioral: Loss Aversion - Deposit

Aim 3 Trial - Fixed Incentive

EXPERIMENTAL

Fixed Incentive - Voucher

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.

Interventions

Low expected prize value.

Aim 1 - Fixed IncentiveAim 1 - Loss AversionAim 1 - Lottery

High expected prize value.

Aim 1 - Fixed IncentiveAim 1 - Loss AversionAim 1 - Lottery

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.

Aim 2 - Enhanced Care (Intervention)

Travel voucher to assist with linkage to care.

Aim 2 - Enhanced Care (Intervention)Aim 2 - Standard Care

Includes HIV viral load and treatment adherence counseling.

Aim 2 - Enhanced Care (Intervention)Aim 2 - Standard Care

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.

Aim 1 - Fixed Incentive

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.

Aim 1 - Loss Aversion
Lottery - PrizeBEHAVIORAL

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.

Aim 1 - Lottery

A standard gain-framed incentive arm in which participants will be offered a voucher for coming for a repeat HIV test in the future.

Aim 3 Pilot - Fixed IncentiveAim 3 Trial - Fixed Incentive

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)

Aim 3 Pilot - Loss AversionAim 3 Trial - Loss Aversion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Plan to move \<6 months from study start
  • AIM 2 - TREATMENT TRIAL
  • ≥18 years
  • Resident (≥6 months) in one of 4 study communities
  • HIV positive
  • Plan to move \<6 months from study start
  • AIM 3 - REPEAT TESTING PILOT
  • 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
  • Intention to move away from the community in the 3 months from time of recruitment
  • AIM 3 - REPEAT TESTING TRIAL
  • 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,
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Infectious Diseases Research Collaboration

Mbarara, Uganda

Location

Related Publications (11)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Gabriel Chamie, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
  • Harsha Thirumurthy, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2016

First Posted

September 7, 2016

Study Start

April 1, 2016

Primary Completion

August 21, 2019

Study Completion

January 3, 2020

Last Updated

February 24, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

N/A. Individual data may be made available upon request.

Locations