Habits, HIV/AIDS, Medication Adherence
Conditions
Keywords
Behavioral: Daily Text Messages, Behavioral: Incentivization based on
Brief summary
Low medication adherence when initiating antiretroviral treatment (ART) is a key barrier to HIV virologic suppression, resulting in avoidable cases of drug resistance, death, and viral transmission. Routinized pill-taking can lead to successful long-term ART adherence, and short-term behavioral economics-based supports are a novel way to overcome the limited success of existing routinization interventions. This study proposes to test this combined approach for promoting long-term ART adherence using a Stage III Sequential, Multiple Assignment, Randomized Trial (SMART) design in one of the largest HIV clinics in Uganda to identify the most cost-effective adaptive intervention that if found effective is generalizable to other settings and other chronic diseases.
Detailed description
Building on a previous R34 study, the investigators will adapt and deliver the INMIND approach to 550 ART initiators at Mildmay. Participants will initially be randomized to receive either usual care (Control, n=275) or daily text messages (Messages, n=275) to support adherence routines. At months 1 and 2, participants may revise their adherence plans. Those showing \<80% adherence in month 3 will be re-randomized to receive either monthly or monthly escalated prize incentives for the next three months. Adherence will be monitored for an additional 12 months (total follow-up: 18 months) to assess long-term routine maintenance and recovery after interruptions. The SMART design will help identify the most cost-effective intervention sequencing. A cost-effectiveness analysis and stakeholder dissemination will support future scale-up. The investigators hypothesize that Messages will be more effective than Control as a first-stage treatment; that monthly escalated prizes will be more effective than monthly prizes as a second-stage treatment; and that the mechanisms of lack of Salience and Present Bias will mediate the effect of INMIND on our primary and secondary outcomes.
Interventions
BEHAVIORALDaily Text Messages
Participants will receive daily text message reminders to use their routine behavior to trigger medication adherence.
Participants will be eligible to (draw a prize in monthly prize group) or get a monthly prize (monthly escalated group) if they take their medication within +/-one hour of the stated existing routine to which pill-taking is anchored on at least 80% of days for 3-months.
Sponsors
RAND
Arizona State University
National Institute of Mental Health (NIMH)
Mildmay Uganda Limited
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
At recruitment, participants will be randomized to one of two low-intensity components (Control or Messages). Those not showing progress towards routinization (defined as pill-taking in line with their anchoring plan on fewer than 80% of days during study month three) will be re-randomized to one of two higher-intensity components (monthly or monthly escalated prizes), ensuring that even participants who do not show routinization progress at month three will have a full three months in the second stage to form a strong ART adherence routine. The second-stage incentives will be given out as prize drawings, as BE shows that they leverage the bias of overestimation of small probabilities and take advantage of the motivational power and joy of games of chance.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female clients age 18 and older. * Started ART at Mildmay or another clinic within the preceding 2 months * Able to speak and understand either English or Luganda. * Have their own cell phone or have consistent access to someone else's phone. * Willing to receive daily text messages for the 6 months of intervention duration. * Willing and able to use the WisePill device distributed for adherence verification for the duration of the study.
Exclusion criteria
* Not mentally fit to consent. * Language other than Luganda or English. * Not willing to consistently use the Wisepill device for adherence measurement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electronically measured mean medication adherence | 24 months | We will collect Wisepill data continuously over the 24-month study period to calculate the primary outcome variable of mean adherence (# of actual bottle openings /# of prescribed bottle openings) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retention in Care. | 24 months | Retention in care will be measured as the fraction of participants recruited who are still active clients at the clinic at month 24. |
| Viral Suppression | 24 months | HIV RNA (viral load) is the secondary outcome measure, and we will also examine intervention effects on mean change in log-transformed viral load. Viral loads are now part of routine clinical care in Uganda and will be chart abstracted. |
| Routinization of ART adherence | 24 months | We will calculate the fraction of scheduled pills taken within a one-hour window around the typical time that participants report completing their existing routine behavior that anchors their pill-taking. |
Countries
Uganda
Contacts
CONTACTYvonne Karamagi Site Principal Investigator
CONTACTLillian Lukuse
PRINCIPAL_INVESTIGATORSebastian Linnemayr, Ph.D
RAND
PRINCIPAL_INVESTIGATORChad Stecher, Ph.D
Arizona State University
Outcome results
None listed