Behavioral Economics Incentives to Support HIV Treatment Adherence in Sub-Saharan Africa

NCT03494777 | Completed

• 2 other identifiers: R01MH1103501R01MH110350-01A1
• Study Type: interventional
• Target: 331
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Keywords

ART adherence

Outcome Measures

Primary Outcomes (4)

• Electronically measured adherence

  Number of ART doses taken / number of doses prescribed

  12 months

• Electronically measured adherence

  Number of ART doses taken / number of doses prescribed

  24 months

• Viral suppression

  Viral load \<=200 copies/mL

  At month 12

• Viral suppression

  Viral load \<=200 copies/mL

  At month 24

Study Arms (3)

Adherence-based incentivization

EXPERIMENTAL

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.

Behavioral: Incentivization based on high adherence; Behavioral: Annual adherence prize drawing; Behavioral: Year 2 booster

Viral suppression-based incentivization

EXPERIMENTAL

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'.

Behavioral: Incentivization based on timely clinic visit; Behavioral: Annual viral suppression-based prize drawing; Behavioral: Year 2 booster

Control

NO INTERVENTION

This arm will receive care as usual, including the adherence support mechanisms that are part of usual care practices.

Interventions

Incentivization based on high adherence BEHAVIORAL

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.

Adherence-based incentivization

Incentivization based on timely clinic visit BEHAVIORAL

When a participant comes for a regular clinic visit on the day s/he is scheduled, s/he will participate in a prize drawing.

Viral suppression-based incentivization

Annual adherence prize drawing BEHAVIORAL

Participants will have a chance to take part in an annual drawing where eligibility is based on the average adherence during that year.

Adherence-based incentivization

Annual viral suppression-based prize drawing BEHAVIORAL

Participants will have a chance to take part in an annual drawing where eligibility is based on showing viral suppression.

Viral suppression-based incentivization

Year 2 booster BEHAVIORAL

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.

Adherence-based incentivization; Viral suppression-based incentivization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• at Mildmay clinic on ART for at least two years
• adherence problems in the last six months
• years of age or older
• started on ART at Mildmay clinic within the last six months

You may not qualify if:

• 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

Sponsors & Collaborators

• RAND: lead
• National Institute of Mental Health (NIMH): collaborator
• Mildmay Uganda Limited: collaborator

Study Sites (1)

Mildmay Uganda

Kampala, Uganda

Location

Related Publications (8)

• Wagner Z, Wang Z, Stecher C, Karamagi Y, Odiit M, Haberer JE, Linnemayr S. The association between adherence to antiretroviral therapy and viral suppression under dolutegravir-based regimens: an observational cohort study from Uganda. J Int AIDS Soc. 2024 Aug;27(8):e26350. doi: 10.1002/jia2.26350.

  PMID: 39155425 DERIVED

• Linnemayr S, Wagner Z, Saya UY, Stecher C, Lunkuse L, Wabukala P, Odiit M, Mukasa B. Behavioral Economic Incentives to Support HIV Care: Results From a Randomized Controlled Trial in Uganda. J Acquir Immune Defic Syndr. 2024 Jul 1;96(3):250-258. doi: 10.1097/QAI.0000000000003420.

  PMID: 38534162 DERIVED

• MacCarthy S, Wagner Z, Saya U, Ghai I, Karamagi Y, Odiit M, Mukasa B, Linnemayr S. Food Insecurity During the COVID-19 Pandemic: A Longitudinal Mixed-Methods Study from a Cohort of HIV Clients in Uganda. AIDS Behav. 2023 Jul;27(7):2216-2225. doi: 10.1007/s10461-022-03953-6. Epub 2023 Jan 11.

  PMID: 36629972 DERIVED

• 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.

  PMID: 35619119 DERIVED

• 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.

  PMID: 34802344 DERIVED

• 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.

  PMID: 34757973 DERIVED

• 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.

  PMID: 32513192 DERIVED

• 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.

  PMID: 31900193 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Sebastian Linnemayr, PhD

  RAND

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator and outcomes assessor will be blinded to treatment assignment of study participants.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 11, 2018
• Study Start: April 11, 2018
• Primary Completion: October 2, 2023
• Study Completion: October 2, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

UG (1)