1  Overview of Research Design and Methods

1.1 Study Procedure Chronology

  1. Recruitment. Participants recruited (e.g., via VA, MAT clinic, craigslist, reddit, or Facebook ads)
  2. Screening. Participants fill out a screening survey; if eligible, they are directed to a Doodle poll to schedule an Onboarding/Consent call
  3. Consent and onboarding. Participants are walked though the study procedures and consent form. Once they give consent, they provide demographic information and are assigned a subID, and are walked through installing the app. They are instructed to watch a set of video tutorials to learn to use the STAR app. They are scheduled for a 1-week check in phone call. They are mailed a set of onboarding materials including a payment card.
  4. One-week check-in. Enrolled participants meet with study staff after 1 week via video call to troubleshoot any technical issues and otherwise ensure that they have what they need to participate fully. Specifically ask if they have been recording their faces in the daily video check-ins / if that has been comfortable.
  5. Monthly payment. Every month participants will be issued a bonus in the form of a reload on a debit card. They will be sent a confirmation of this payment with a summary of the length of their participation, acknowledgement of their scheduled end date, a summary of their compliance over the month, and a statement of the bonus amount being issued.
  6. Debriefing. At the end of the study enrollment period, whether this is after one year or earlier (e.g., for participants to discontinue and who we are able to get in touch with) meet briefly with study staff for a debriefing session.
  7. Documentation of participant issues & activities. Each participant has an admin thread in the proj-risk2-admin slack channel. Study activities and participant communication are recorded here. Additionally, There is a Web Log (WOG) where issues with participant data are recorded. There is also a Date Log where participant visit dates and changes in study status are documented.

1.2 Subject Selection

  1. Participant who is interested in the study fills out the screening form (the link to which will be made available on the study website)

    • Screening Survey
    • Note. If they qualify, they are asked to enter information (name, /and contact preference (call, text, or email)

  2. Participants are then redirected to a Doodle bookable calendar to schedule consent/onboarding session Doodle Bookable Calendar

1.2.1 Inclusion Criteria for Study Enrollment

  1. Participants must be aged 18 or older

  2. Participants must be able to read, write, and speak in English

  3. Participants must be currently receiving medication for opioid addiction within an opioid treatment program (OTP) or office based opioid treatment (OBOT) program; OR be enrolled in or have recently completed a day treatment program (DTP, also known as a partial hospitalization program or PHP:

    • Participants on MAT must have been enrolled for a minimum of 1 month and no longer than 12 months at study intake.

    • Participants must have adhered to their MAT plan over the last month (i.e., must have taken monthly medication for two consecutive months; must have taken daily medication ‘most days’ or ‘every day’)

  4. Participants must have an Android smart phone and an active cellular plan that they are able and willing to maintain while enrolled in the study. They must also be able and willing to use the phone as their personal phone for the duration of the study.

1.2.2 Criteria for Study Withdrawal

Missing data/noncompliance with study procedures

If one or more of the following conditions is met, participants will be withdrawn from the study with no option of re-enrolling (unless they have been incarcerated or enrolled in inpatient treatment).

  • < 20 complete daily updates in any four-week period; > 2 missing lapse questions among completed daily updates in the same period.

  • Failing to complete a total of three monthly updates.

  • Failing to provide location data consistently by disabling location sharing for more than 12 hours in a four-week period.

  • Failing to provide SMS and phone log data consistently by disabling SMS and phone log sharing for more than 12 hours in a four-week period. NOTE: We tell participants this but can’t enforce this criterion b/c STAR does not allow us to record SMC/phone call sharing.

  • Failing to provide SMS content data by disabling SMS content sharing for more than 12 hours in a four-week period. NOTE: We tell participants this but can’t enforce this criterion b/c STAR does not allow us to record SMC/phone call sharing.

Simplified version from Consent form:

For each month, you must:

  • Complete 20 daily updates without missing questions.

  • Complete 1 monthly update, with less than 5 missing questions. Must not miss 3 monthly updates total.

  • Share GPS location data consistently. You must not disable location sharing for more than 12 hours in a single month.

  • Share phone log data consistently. You must not disable phone log sharing for more than 12 hours in a single month.

  • Share SMS log data consistently. You must not disable SMS log sharing for more than 12 hours in a single month.

Additionally, If a participant becomes incarcerated during their study participation, no data will be collected during the period of their incarceration, and they will be considered withdrawn unless they contact us after their incarceration to re-establish participation.

Violation of app guidelines

Participants may be withdrawn if their behavior on the STAR App or in communication with staff violates App Guidelines. Study staff will discuss guideline violations on a case-by-case basis - with John having the final say.