Clinical trial NCT03494777: Behavioral Economics Incentives to Support HIV Treatment Adherence in Sub-Saharan Africa
Official title: Behavioral Economics Incentives to Support HIV Treatment Adherence in Sub-Saharan Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: ART adherence
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Mildmay Uganda Limited
First posted: 2018-04-11
Enrollment: 331
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Randomized controlled trial with two intervention arms and a control group will receive an intervention for twelve months; those not showing viral suppression at month 12 will be randomized to either continue receiving the year 1 intervention for another twelve months, or receive an additional intervention component for twelve months.

The main analysis will be based on the sample of 330 treatment mature clients, from which the 70 treatment initiating clients will be excluded.
Primary purpose: TREATMENT

Brief summary: This study will implement an intervention in a two-year randomized controlled trial (RCT) to establish efficacy on viral suppression as a biological endpoint, compare the effectiveness of two different modes of implementation (including one entirely based on readily available clinic data), and investigate cost-effectiveness. Participants in the first intervention group (T1, n=110) will be eligible for small lottery prizes based on timely clinic visits, and qualify for an annual lottery conditional if demonstrating viral suppression; those in the second group (T2, n=110) will draw prizes conditional on electronically measured adherence at each clinic visit, and also participate in an annual lottery that is conditional on high adherence throughout the year. The control group (n=110) will receive the usual standard of care. Assessments will be conducted at baseline and then every six months. Primary outcomes are undetectable viral load and electronically measured adherence.

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. \[Note on 9/7/2019: due to funding, we will not recruit this additional sample of treatment initiating clients\]

Eligibility criteria: 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

Primary outcomes:
measure: Electronically measured adherence
timeFrame: 12 months
measure: Electronically measured adherence
timeFrame: 24 months
measure: Viral suppression
timeFrame: At month 12
measure: Viral suppression
timeFrame: At month 24
Secondary outcomes:
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mildmay Uganda
Study officials:
affiliation: RAND
name: Sebastian Linnemayr, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.