mHealth to Enhance & Sustain Drug Use Reduction of the QUIT BI in Primary Care

NCT04935606 | Active Not Recruiting DMC

• 1 other identifier: R01DA047386
• Study Type: interventional
• Target: 458
• Locations: 1 country
• Sites: 5

Brief Summary

The QUIT-Mobile study proposes to use mobile phone self-monitoring and feedback to enhance and sustain over 12-months the impacts of the Quit Using Drugs Intervention Trial (QUIT), an effective screening and brief intervention (SBI) previously successful in reducing risky drug use (i.e., moderate use) in low-income, diverse patients over a 3-month follow up. The investigators will conduct the QUIT-Mobile study for patients who receive care in clinics of federally qualified health centers (FQHC) in Southern California over 12-months follow up. The study is an Effectiveness-Implementation Hybrid Type 1 design consisting of a single-blind, 3-arm, RCT with adult, mostly Latino FQHC primary care patients with risky drug use (ASSIST score 4-26), randomized to 3 conditions (n=200/arm, n=600 total): 1) QUIT-Mobile; 2) standard QUIT; 3) Usual Care. Qualitative data on implementation facilitators and barriers will inform future scale-up and sustainability, in addition to cost data analyses. The aims are to examine effectiveness in reducing risky drug use and cost-effectiveness comparing the three arms over 3-, 6- and 12-months. Drug use measures include self-reports for past 30-days and urine drug screen validation for underreporting (acknowledging that people with moderate risk drug use have sporadic drug use patterns requiring longer self-report recalls for drug use that urine screens may not detect). The 3-arm study enables testing of the independent and synergistic effects of QUIT-Mobile compared to QUIT and both to Usual Care. The 12-month timeline reflects annual primary care visits when screening and brief intervention would be repeated routinely. The QUIT intervention contains 3 primary components: 1) patient screening with the WHO ASSIST, 2) brief clinician advice (\<3 minutes) including opioid overdose prevention education, and 3) 2- and 6-week telephone drug-use health coaching sessions utilizing motivational interviewing and cognitive behavioral techniques, delivered by paraprofessional health coaches. QUIT-Mobile tests the addition of mobile phone self-monitoring, automated feedback, and coach monitoring dashboard to enhance and sustain QUIT\'s drug use reductions using mobile-web app, text-messaging (SMS), or interactive voice response (IVR).

Conditions

Drug Use

Keywords

risky drug use; mobile phone; self-monitoring; automated feedback; SBIRT

Outcome Measures

Primary Outcomes (4)

• Drug Use

  30-day self-reports of drug use (due to sporadic use patterns of moderate/risky drug users) with urine screen to validate underreporting given detection windows of 1-3 days for most drugs (except cannabis) measured at baseline.

  Baseline

• Drug Use

  30-day self-reports of drug use (due to sporadic use patterns of moderate/risky drug users) with urine screen to validate underreporting given detection windows of 1-3 days for most drugs (except cannabis) measured at 3-month follow-up.

  3-month follow-up

• Drug Use

  30-day self-reports of drug use (due to sporadic use patterns of moderate/risky drug users) with urine screen to validate underreporting given detection windows of 1-3 days for most drugs (except cannabis) measured at 6-month follow-up.

  6-month follow-up

• Drug Use

  30-day self-reports of drug use (due to sporadic use patterns of moderate/risky drug users) with urine screen to validate underreporting given detection windows of 1-3 days for most drugs (except cannabis) measured at 12-month follow-up.

  12-month follow-up

Secondary Outcomes (20)

• Health-related Quality of Life Improvement Self-Reports (SF-12)

  Baseline

• Health-related Quality of Life Improvement Self-Reports (SF-12)

  3-month follow-up

• Health-related Quality of Life Improvement Self-Reports (SF-12)

  6-month follow-up

• Health-related Quality of Life Improvement Self-Reports (SF-12)

  12-month follow-up

• Health-related Quality of Life Improvement Self-Reports (MHI)

  Baseline

Study Arms (3)

Usual Care

EXPERIMENTAL

Usual Care participants will receive their standard medical care as usual (no provider advice or telephone coaching sessions) and all screening and study assessments. To reduce biases, Usual Care arm patients will be given a cancer screening booklet and will be shown a cancer screening Video Doctor. They will also receive 2 re-contact telephone sessions at weeks 2 and 6 corresponding to the timing of the coaching sessions for the QUIT and QUIT-Mobile arms. All participants will also receive re-contact calls monthly from 7-weeks to 12-months. The re-contact calls (5 min) provide attention control for the Usual Care arm, motivate continued trial participation by reminding them of the next research assessment, but do not provide an active intervention. At study end, the Usual Care arm will receive the QUIT video doctor and drug use reduction booklet brochure materials including overdose prevention materials and a list of clinic/community resources to help them reduce substance use.

Behavioral: Usual Care

QUIT

EXPERIMENTAL

The QUIT brief intervention protocol will consist of 5 steps corresponding to the 5A's approach for assisting behavior change in the clinic setting (Ask, Advise, Assess, Assist, and Arrange) that will focus on patients' HSD (highest scoring drug on the baseline ASSIST) use in the past 30 days.

Behavioral: QUIT Intervention (doctor brief advice, video doctor, health coaching sessions at 2- and 6-weeks)

QUIT-Mobile

EXPERIMENTAL

QUIT-Mobile will include a mobile platform with self-monitoring surveys and feedback message and robust data transfer protocols across three mobile technology platforms to meet diverse patient's preferences and needs regardless of literacy and phone type: a mobile-optimized web-app (using any smart phone's web-browser, not "native" apps), SMS (text-messaging), and IVR (automated voice calls for low literacy patients). Data collected during this study on patient platform preferences and exploratory analyses on intervention efficacy across platform types will inform the development of future effectiveness trials that can evaluate effectiveness of different mobile platforms.

Behavioral: QUIT-Mobile (QUIT Intervention plus weekly mobile-web app or text message weekly self-monitoring, automated feedback over 12 months)

Interventions

Usual Care BEHAVIORAL

Usual Care participants will receive their standard medical care as usual and all study assessments. Providers will not receive information about their drug use. To reduce Hawthorne effect biases and to mask the study's purpose, RAs will provide the Usual Care arm patients with a cancer screening booklet and have them view a cancer screening Video Doctor. Participants will receive re-contact calls (5 min) to provide attentional control for the Usual Care arm, motivate continued trial participation by reminding next research assessment and study incentives, update contact information, and address participation barriers, but do not provide intervention. At study end, Usual Care will receive the QUIT video doctor and drug use reduction booklet materials including overdose prevention materials and a list of clinic/community resources to help them reduce substance use.

Usual Care

QUIT Intervention (doctor brief advice, video doctor, health coaching sessions at 2- and 6-weeks) BEHAVIORAL

QUIT's core components include: 1. patient screening with the WHO Alcohol Smoking and Substance Involvement Screening Test (ASSIST, score 4-26); 2. face-to-face brief clinician advice on reducing drug use (2-3 minutes); 3. video doctor reinforcing the clinician message; 4. drug use reduction brochure; 5. 2- and 6-week telephone health coaching sessions to enhance self-efficacy in reducing drug use, via motivational interviewing and cognitive behavior therapy (CBT) techniques (20-30 minutes).

QUIT

QUIT-Mobile (QUIT Intervention plus weekly mobile-web app or text message weekly self-monitoring, automated feedback over 12 months) BEHAVIORAL

The QUIT-Mobile intervention includes QUIT's core components and adds: 1. SMS/IVR/mobile-app self-monitoring survey prompts twice-weekly during the QUIT coaching through 6 weeks, and then weekly self-monitoring and automated feedback via SMS/IVR/app through 12-months. 2. Web-based dashboards will be used by coaches for monitoring of patients' self-monitoring data to enhance 2- and 6-week coaching sessions and for monitoring during the post-coaching self-management and monitoring period from 7-weeks to 12-months and intervening accordingly. The mobile platform will provide the same intervention functions (self-monitoring surveys and feedback messages) and robust data transfer protocols across three mobile technology platforms.

QUIT-Mobile

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years old and older receiving care at study clinics.
• Have a phone number at which they can be contacted over time during the study (to conduct follow-up health education phone calls).
• Have a primary care visit with a regular clinic provider on the date of recruitment and enrollment.
• English or Spanish-speaking.
• ASSIST score between 4 and 26 indicating risky (moderate) drug use, and used the substance in the past 30 days.
• Able (not cognitively impaired) and willing to cooperate with data collection and research procedures, including and 2-week, 6-week, and 3, 6, 12-month follow-up assessments.
• Planning to be in the Los Angeles area for the next 12 months so they can complete the study period.

You may not qualify if:

• Repeaters: All patients will be asked a set of repeater questions. This includes a question on whether they have ever been involved in our UCLA study at the clinic before. We will create a unique identifier based on a set of questions that we have used in our prior studies that combines aspects about the potential subject (mother's first name, father's first name, month and day of birth) that will screen them out if they screen again in the future.
• ASSIST Score above 26 indicating high use and potential serious SUD needing referral to specialty treatment: The RA will receive a message that the subject scored 27+ on alcohol or any drugs on the WHO ASSIST (i.e. indication of possible severe substance use disorder). The RA will inform the patient that they are at risk for certain health behaviors and ask the patient if they want to disclose this information to their doctor. If they agree to disclose information to their doctor then we will fill out a letter informing the doctor of patient's potential more serious substance use disorder. We will also provide the patient with a list of local substance use disorder treatment referrals.
• ASSIST Score below 4 (low use): These patients are not eligible for enrollment in the trial.
• Subject Enrolled in a Substance Use Treatment Program: Subjects enrolled in a treatment program are excluded from the study.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute on Drug Abuse (NIDA): collaborator
• University of Arkansas: collaborator
• Medical University of South Carolina: collaborator

Study Sites (5)

The Children's Clinic (TCC) Family Health

Long Beach, California, 90806, United States

Location

South Central Family Health Clinic

Los Angeles, California, 90011, United States

Location

Wesley Health Centers

Los Angeles, California, 90013, United States

Location

Saban Community Clinic

Los Angeles, California, 90038, United States

Location

UMMA Community Clinic

Los Angeles, California, 90044, United States

Location

Related Publications (10)

• Swendeman D, Sumstine S, Aguilar E, Gorbach PM, Comulada WS, Gelberg L. Feasibility and Acceptability of Mobile Phone Self-monitoring and Automated Feedback to Enhance Telephone Coaching for People With Risky Substance Use: The QUIT-Mobile Pilot Study. J Addict Med. 2021 Apr 1;15(2):120-129. doi: 10.1097/ADM.0000000000000707.

  PMID: 32732684 BACKGROUND

• Gelberg L, Andersen RM, Afifi AA, Leake BD, Arangua L, Vahidi M, Singleton K, Yacenda-Murphy J, Shoptaw S, Fleming MF, Baumeister SE. Project QUIT (Quit Using Drugs Intervention Trial): a randomized controlled trial of a primary care-based multi-component brief intervention to reduce risky drug use. Addiction. 2015 Nov;110(11):1777-90. doi: 10.1111/add.12993.

  PMID: 26471159 BACKGROUND

• Singleton KW, Lan M, Arnold C, Vahidi M, Arangua L, Gelberg L, Bui AA. Wireless data collection of self-administered surveys using tablet computers. AMIA Annu Symp Proc. 2011;2011:1261-9. Epub 2011 Oct 22.

  PMID: 22195187 BACKGROUND

• Baumeister SE, Gelberg L, Leake BD, Yacenda-Murphy J, Vahidi M, Andersen RM. Effect of a primary care based brief intervention trial among risky drug users on health-related quality of life. Drug Alcohol Depend. 2014 Sep 1;142:254-61. doi: 10.1016/j.drugalcdep.2014.06.034. Epub 2014 Jul 4.

  PMID: 25042213 BACKGROUND

• Bone C, Gelberg L, Vahidi M, Leake B, Yacenda-Murphy J, Andersen RM. Under-reporting of Risky Drug Use Among Primary Care Patients in Federally Qualified Health Centers. J Addict Med. 2016 Nov/Dec;10(6):387-394. doi: 10.1097/ADM.0000000000000246.

  PMID: 27753718 BACKGROUND

• Reddy AT, Andersen RM, Gelberg L. Clinicians' Beliefs and Practices Regarding Drug Use Care of Their Community Health Center Patients. J Addict Med. 2015 Nov-Dec;9(6):447-53. doi: 10.1097/ADM.0000000000000158.

  PMID: 26441402 BACKGROUND

• Padwa H, Ni YM, Barth-Rogers Y, Arangua L, Andersen R, Gelberg L. Barriers to drug use behavior change among primary care patients in urban United States community health centers. Subst Use Misuse. 2014 May;49(6):743-51. doi: 10.3109/10826084.2013.866962. Epub 2013 Dec 20.

  PMID: 24354547 BACKGROUND

• Bone CW, Goodfellow AM, Vahidi M, Gelberg L. Prevalence of Sexual Violence and its Association with Depression among Male and Female Patients with Risky Drug Use in Urban Federally Qualified Health Centers. J Urban Health. 2018 Feb;95(1):111-115. doi: 10.1007/s11524-017-0213-7.

  PMID: 29340911 BACKGROUND

• Gelberg L, Andersen RM, Rico MW, Vahidi M, Natera Rey G, Shoptaw S, Leake BD, Serota M, Singleton K, Baumeister SE. A pilot replication of QUIT, a randomized controlled trial of a brief intervention for reducing risky drug use, among Latino primary care patients. Drug Alcohol Depend. 2017 Oct 1;179:433-440. doi: 10.1016/j.drugalcdep.2017.04.022. Epub 2017 Jun 13.

  PMID: 28844733 BACKGROUND

• Gelberg L, Natera Rey G, Andersen RM, Arroyo M, Bojorquez-Chapela I, Rico MW, Vahidi M, Yacenda-Murphy J, Arangua L, Serota M. Prevalence of Substance Use Among Patients of Community Health Centers in East Los Angeles and Tijuana. Subst Use Misuse. 2017 Feb 23;52(3):359-372. doi: 10.1080/10826084.2016.1227848. Epub 2016 Dec 21.

  PMID: 28001094 BACKGROUND

Study Officials

• Lillian Gelberg, MD, MSPH

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Dallas Swendeman, PhD, MPH

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 3-arm single blind RCT that compares: QUIT-Mobile, QUIT, and Usual Care, to assess the effectiveness among these interventions in reducing highest scoring risky drug use across time (at 3, 6 and 12 months follow-up).

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: June 23, 2021
• Study Start: June 1, 2021
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations

US (5)