- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03494777
Behavioral Economics Incentives to Support HIV Treatment Adherence in Sub-Saharan Africa
Study Overview
Status
Conditions
Detailed Description
It is imperative to find ways to boost ART adherence in sub-Saharan Africa where adherence rates have been found to decline over time, and where treatment options such as second-line regimens are limited. A promising tool is the use of incentives based on insights from behavioral economics (BE) for healthy HIV-related behavior. The proposed R01 study is based on the results of the PI's R34 'Rewarding Adherence Program (RAP)' [R34 MH096609] that demonstrated feasibility and acceptability of incentives allocated by a drawing for HIV-related behaviors, and established preliminary efficacy. The current R01 study builds on these promising results with the aim to a) use viral loads as biological endpoints that were not included in the R34 for cost reasons; b) establish efficacy in a fully powered intervention as well as comparative efficacy of two different ways of implementing the incentives including one arm that has been adapted to changing clinical guidelines and can be implemented with readily available data from clinic records; and c) assess the cost effectiveness of these two implementation modes as a further input for policy-makers. The intervention is targeted at increasing the motivation of HIV clients who have been on ART for several years through the benefit and joy of prize drawings, thereby attempting to overcome the treatment 'fatigue' that can develop in the context of mundane, daily pill taking over the course of life-long treatment. Insights from behavioral economics suggest that such an intervention may be particularly effective for people with present bias (those who have a tendency to give in to short-term temptation at the cost of more long-term benefits) that was found to be prevalent among HIV clients in the R34 study. The intervention will be implemented among 330 adult clients in three groups: for the first intervention group, timely clinic attendance will constitute the eligibility criteria for participating in a prize drawing at each scheduled clinic visit; participants are also eligible for an annual prize drawing based on showing viral suppression. The second treatment group will be incentivized on demonstrated high ART adherence between clinic visits that also determine the winning chances at an annual prize drawing. The control group will receive the usual standard of care. All participants will receive MEMS caps to record adherence and assessments over 24 months (at baseline and every 6 months thereafter). The first Specific Aim will be to evaluate the effectiveness of the intervention; the second aim is to compare the relative effectiveness of the adherence-based arm and the arm directly incentivizing viral suppression that uses only data readily available in the clinic. The third Specific Aim is to perform a comparative cost-effectiveness analysis of the two intervention arms as a further policy input. If proven efficacious, the intervention as implemented in the newly adapted arm based on viral load suppression can be readily taken over by the clinic and scaled at low cost to other clinics.
In the study also 70 treatment initiating clients (in addition to the 330 treatment mature clients described above) will be recruited, but they will be excluded from the main analysis. [Note on 9/7/2019: due to funding, we will not recruit this additional sample of treatment initiating clients]
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Kampala, Uganda
- Mildmay Uganda
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years of age or older
- at Mildmay clinic on ART for at least two years
- adherence problems in the last six months
Note: for the 70 treatment initiators to be recruited in addition to the main sample of 330 treatment-mature clients (on which the main analysis will focus), the inclusion criteria are:
- 18 years of age or older
- started on ART at Mildmay clinic within the last six months
Exclusion Criteria:
- not able to understand the consent form and study procedures
- language other than Luganda or English
- not willing to consistently use the MEMS caps device for adherence measurement
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adherence-based incentivization
Participants will be eligible for prize drawings at every regular clinic visit based on high adherence as measured by MEMS-caps. In addition there will be an annual prize drawing that is conditional on showing high adherence over the course of the year. This arm will receive the intervention 'Incentivization based on high adherence' and the intervention 'Annual adherence prize drawing' and (if eligible) the intervention 'Year 2 booster'. Note: the 70 treatment initiating clients will all be assigned to this arm to receive preliminary data as to whether incentives may work for this group. |
When a participant comes for a regular clinic visit, s/he will have the MEMS data extracted, and if adherence over the previous month >=90%, will participate in a prize drawing.
Participants will have a chance to take part in an annual drawing where eligibility is based on the average adherence during that year.
Those participants not showing viral suppression at month 12 will be randomized in a 1:1 fashion to receive an additional intervention component or continue receiving the same intervention arm as in Year 1.
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Experimental: Viral suppression-based incentivization
Participants will be able to participate in prize drawings at every clinic visit where eligibility will be based on timely drug refills (that coincide with the clinic visits). Participants will also have a chance to enter a prize drawing at the end of every year if they show viral suppression. This arm will receive the intervention 'Incentivization based on timely clinic visit' and the intervention 'Annual viral suppression-based prize drawing', and (if eligible) the intervention 'Year 2 booster'. |
Those participants not showing viral suppression at month 12 will be randomized in a 1:1 fashion to receive an additional intervention component or continue receiving the same intervention arm as in Year 1.
When a participant comes for a regular clinic visit on the day s/he is scheduled, s/he will participate in a prize drawing.
Participants will have a chance to take part in an annual drawing where eligibility is based on showing viral suppression.
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No Intervention: Control
This arm will receive care as usual, including the adherence support mechanisms that are part of usual care practices.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Electronically measured adherence
Time Frame: 12 months
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Number of ART doses taken / number of doses prescribed
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12 months
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Electronically measured adherence
Time Frame: 24 months
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Number of ART doses taken / number of doses prescribed
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24 months
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Viral suppression
Time Frame: At month 12
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Viral load <=200 copies/mL
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At month 12
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Viral suppression
Time Frame: At month 24
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Viral load <=200 copies/mL
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At month 24
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sebastian Linnemayr, PhD, RAND
Publications and helpful links
General Publications
- Saya U, MacCarthy S, Mukasa B, Wabukala P, Lunkuse L, Wagner Z, Linnemayr S. "The one who doesn't take ART medication has no wealth at all and no purpose on Earth" - a qualitative assessment of how HIV-positive adults in Uganda understand the health and wealth-related benefits of ART. BMC Public Health. 2022 May 27;22(1):1056. doi: 10.1186/s12889-022-13461-w.
- Wagner Z, Mukasa B, Nakakande J, Stecher C, Saya U, Linnemayr S. Impact of the COVID-19 Pandemic on Use of HIV Care, Antiretroviral Therapy Adherence, and Viral Suppression: An Observational Cohort Study From Uganda. J Acquir Immune Defic Syndr. 2021 Dec 15;88(5):448-456. doi: 10.1097/QAI.0000000000002811.
- Jennings Mayo-Wilson L, Devoto B, Coleman J, Mukasa B, Shelton A, MacCarthy S, Saya U, Chemusto H, Linnemayr S. Habit formation in support of antiretroviral medication adherence in clinic-enrolled HIV-infected adults: a qualitative assessment using free-listing and unstructured interviewing in Kampala, Uganda. AIDS Res Ther. 2020 Jun 8;17(1):30. doi: 10.1186/s12981-020-00283-2.
- Linnemayr S, Stecher C, Saya U, MacCarthy S, Wagner Z, Jennings L, Mukasa B. Behavioral Economics Incentives to Support HIV Treatment Adherence (BEST): Protocol for a randomized controlled trial in Uganda. Trials. 2020 Jan 3;21(1):9. doi: 10.1186/s13063-019-3795-4.
- MacCarthy S, Mendoza-Graf A, Jennings Mayo-Wilson L, Wagner Z, Saya U, Chemusto H, Mukasa B, Linnemayr S. A qualitative exploration of health-related present bias among HIV-positive adults in Uganda. AIDS Care. 2023 Jun;35(6):883-891. doi: 10.1080/09540121.2021.2004298. Epub 2021 Nov 21.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- R01MH110350 (U.S. NIH Grant/Contract)
- 1R01MH110350-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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