Polysubstance AddictionPRISMNCT05973838

Peer Recovery to Improve Polysubstance Use and Mobile Telemedicine Retention

A study testing Peer-Delivered Behavioral Activation ("Peer Activate") in people with Polysubstance Addiction and Opioid Medication Assisted Treatment, run by University of Maryland, College Park at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Polysubstance Addiction, Opioid Medication Assisted Treatment, Treatment Adherence
What is being tested?: Peer-Delivered Behavioral Activation ("Peer Activate")
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 4 sitesUnited States
Study dates: 15 Jun 2023to 1 Sep 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient participants in the RCT must be 18 or older; receive OUD treatment as part of the telemedicine program; and exhibit polysubstance use within the past three-months (i.e., use of one or more non-prescribed substances (excluding opioids and/or tobacco) by urine toxicology or self-report.

Who cannot join

Demonstrating active, unstable or untreated psychiatric symptoms, including mania and/or psychosis that would interfere with study participation
Inability to understand the study and provide informed consent in English

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Morgan S Anvari, BA contact

3014055095

manvari@umd.edu

United States4 sites, 4 recruiting

University of Maryland Baltimore (UMD Drug Treatment Center)
Baltimore, Maryland, 21223
Heather Fitzsimons, 443-462-3400, hfitzsimons@som.umaryland.edu
Sarah M Kattakuzhy, MD
Not yet recruiting
University of Maryland, College Park
College Park, Maryland, 20742
Morgan S Anvari, BA, 3014055095, manvari@umd.edu
Jessica F Magidson, PhD, 301-405-5095, jmagidso@umd.edu
Not yet recruiting
Caroline County Behavioral Health
Denton, Maryland, 21629
Jessica Tuel, MSW, 410-479-8172, jessicam.tuel@maryland.gov
Recruiting
HIPS Clinic
Washington D.C., District of Columbia, 20002
Sarah M. Kattakuzhy, MD, 443-691-4638, skattakuzhy@ihv.umaryland.edu
Not yet recruiting

Other trials in United States

About this study

Official title: Peer-Delivered, Behavioral Activation Intervention to Improve Polysubstance Use and Retention in Mobile Telemedicine OUD Treatment in an Underserved, Rural Area

The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led, brief, behavioral intervention to improve adherence to medication for opioid use disorder (MOUD) and reduce polysubstance use among patients with OUD and polysubstance use in underserved areas. The intervention is based on behavioral activation (BA) and is specifically designed to be implemented by a trained peer recovery specialist. In this hybrid, Type-1 effectiveness-implementation randomized controlled trial (RCT), the investigators will evaluate the effectiveness and implementation of Peer Activate vs. treatment as usual (TAU) over twelve months.

Read the detailed description

There is a significant burden of opioid and polysubstance use within the US. Yet many communities are poorly equipped to meet the pressing need for addiction treatment, including medications for OUD (MOUD) and evidence-based interventions (EBIs) to address the rise in opioid use disorder (OUD) and co-occurring stimulant use. The availability of telemedicine has helped fill the void of practitioners by providing buprenorphine for OUD treatment in underserved areas, however, OUD treatment retention remains an ongoing challenge, with polysubstance use and stimulant use exacerbating this. Peer recovery specialists (PRSs), trained individuals with their own lived experience with substance use disorder (SUD) and recovery, are a promising strategy to improve OUD treatment retention and polysubstance use at these sites using a reinforcement-based approach.

Behavioral activation (BA) may be a feasible, scalable, reinforcement-based approach for improving OUD treatment retention and reducing polysubstance use in underserved areas. By targeting increases in positive reinforcement, BA has been found to be effective for improving SUD treatment retention, preventing future relapse, including for stimulant use specifically, and improving medication adherence (i.e., for HIV) among low-income, minority populations with SUD as well as depression, which is a barrier to MOUD retention. BA has been shown to be feasibly delivered by peers and community health workers.

This study proposes to evaluate the effectiveness, implementation, and cost-effectiveness of an adapted PRS-delivered BA approach on the TM-MTU ("Peer Activate-MTU") compared to enhanced treatment as usual (ETAU; facilitated referrals and general PRS support) for patients with OUD and other polysubstance use receiving telemedicine buprenorphine. The investigators propose a randomized Type 1 hybrid effectiveness-implementation trial (n=160) to evaluate Peer Activate-MTU compared to ETAU. Specific aims are to evaluate the effectiveness of Peer Activate-MTU over 12-months on OUD treatment retention and polysubstance use. The investigators will also evaluate the implementation of Peer-Active-MTU, including feasibility, acceptability, fidelity, and adoption guided by RE-AIM.

Conditions: Polysubstance Addiction, Opioid Medication Assisted Treatment, Treatment Adherence, Retention in Care, Substance-Related Disorders
Being tested: Peer-Delivered Behavioral Activation ("Peer Activate")
Keywords: Substance-Related Disorders, Opioid-Related Disorders, Polysubstance Use, Mental disorders
Medical subject headings: Treatment Adherence and Compliance, Substance-Related Disorders, Opioid-Related Disorders, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Peer-Delivered Behavioral Activation ("Peer Activate")Behavioural
The PRS-delivered Peer Activate intervention will consist of approximately six weekly "core" sessions (approximately 30 minutes-1 hour), and then 6 optional "booster" sessions to reinforce skill practice. In Peer Activate sessions, participants will learn behavioral activation and problem-solving skills to reduce barriers to medication nonadherence and incorporate value-driven, substance-free, rewarding activities into their daily life to reduce polysubstance use and improve retention.

Study groups in NCT05973838
Study group	Role	What they receive
Peer-Delivered Behavioral Activation ("Peer Activate")	Experimental	Participants in the Peer Activate intervention will receive a PRS-delivered behavioral activation intervention to address barriers to retention in methadone treatment and increase substance-free, positive reinforcement to support retention and reduce polysubstance use. Receives: Behavioral: Peer-Delivered Behavioral Activation ("Peer Activate")
Treatment As Usual	No intervention	Participants in the TAU group will receive enhanced treatment as usual, defined as MTU services as usual enhanced with additional community referrals and follow-ups on those referrals, in addition to regular meetings with an addiction medicine physician and PRS on the MTU. Standard PRS contact typically includes connection to local resources and general peer support as needed.

What is being measured

The primary outcome is the main question the study is designed to answer.

Six-Month Polysubstance Use Urinalysis
Polysubstance use will be assessed using urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine.
Measured: Measured from baseline to 6-month follow-up
Six-Month Polysubstance Use Self Report
The New York University (NYU) polysubstance use measurement tool will be utilized to assess polysubstance frequency.
Measured: Assessed between the baseline assessment 6-month follow-up

Secondary outcomes (7)

Six-month OUD Treatment Retention
Retention is measured using chart review of clinic records of appointment attendance. Retention will be assessed measured as dichotomous retention (yes/no) at six months post MOUD initiation.
Measured: Measured from intake through 6-month follow up
Six-month Buprenorphine Adherence
Buprenorphine adherence will be assessed through urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine. Continuity of pharmacy for MOUD through 6 months will be assessed and calculated via the percent retained on MT for at least 6 months, defined as having one or more additional MOUD-related visits for each 30-day period up to 6 months.
Measured: Measured from intake to six-month follow-up
Six-month Self-Report Buprenorphine Adherence
The IRA Wilson will be utilized to assess self-report buprenorphine adherence
Measured: Assessed between the baseline assessment and 6-month follow-up
Six-Month Problems Associated with Substance Use
Problems associated with use will be assessed using the Short Inventory of Problems (SIP), a 15-item measure that will be used to assess five domains of impairment related to polysubstance use.
Measured: Assessed between the baseline assessment and 6-month follow-up
Intervention Uptake
Feasibility, defined as the suitability and practicability of the approach, will be measured quantitatively as the % of patients who agree to participate in the intervention.
Measured: Assessed between the baseline assessment and 6-month follow-up
Intervention Session Attendance
Acceptability, defined as satisfaction with or tolerability of the proposed approach, will be measured quantitatively by session attendance. Specifically, % of patients enrolled who attend ≥75% sessions will be measured.
Measured: Assessed between the baseline assessment 6-month follow-up
Intervention Fidelity
Fidelity, defined as the delivery of the intervention as intended, will be measured based on PRS adherence to the intervention delivery. A random selection of 20% of sessions will be rated for fidelity by an independent rater, and % of intervention components delivered as intended will be measured.
Measured: Assessed at the acute post-treatment follow-up (approximately 3-months post-baseline assessment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 20231 Sep 2027

First posted3 Aug 2023
Study start15 Jun 2023
Primary completion1 Jul 2027 (estimated)
Study completion1 Sep 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Polysubstance AddictionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be randomized in parallel to receive either the Peer Activate intervention on the MTU or enhanced treatment as usual (TAU: treatment as usual services on the MTU in addition to referral to other available services in the community through study contact). Assessments will take place for both groups at baseline, at a midpoint (1-month), and follow ups at 3-month, 6-month and 12-months following the baseline assessment. Follow up assessments will be conducted by a blinded assessor.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 160 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05973838
Sponsor's protocol ID: 1953327
Other IDs: R01DA057443
Acronym: PRISM
Status last verified: Apr 2026
First submitted: 7 Jun 2023
Last updated: 27 Apr 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: After all primary analyses are complete, de-identified data will be uploaded to an NIH-supported data repository and/or available by request to the MPIs.

Publications

Ghertner R. U.S. trends in the supply of providers with a waiver to prescribe buprenorphine for opioid use disorder in 2016 and 2018. Drug Alcohol Depend. 2019 Nov 1;204:107527. doi: 10.1016/j.drugalcdep.2019.06.029. Epub 2019 Aug 30.
PubMed 31525570
Magidson JF, Gorka SM, MacPherson L, Hopko DR, Blanco C, Lejuez CW, Daughters SB. Examining the effect of the Life Enhancement Treatment for Substance Use (LETS ACT) on residential substance abuse treatment retention. Addict Behav. 2011 Jun;36(6):615-623. doi: 10.1016/j.addbeh.2011.01.016. Epub 2011 Jan 21.
PubMed 21310539
Mimiaga MJ, Reisner SL, Pantalone DW, O'Cleirigh C, Mayer KH, Safren SA. A pilot trial of integrated behavioral activation and sexual risk reduction counseling for HIV-uninfected men who have sex with men abusing crystal methamphetamine. AIDS Patient Care STDS. 2012 Nov;26(11):681-93. doi: 10.1089/apc.2012.0216. Epub 2012 Oct 3.
PubMed 23030605
Mimiaga MJ, Pantalone DW, Biello KB, Hughto JMW, Frank J, O'Cleirigh C, Reisner SL, Restar A, Mayer KH, Safren SA. An initial randomized controlled trial of behavioral activation for treatment of concurrent crystal methamphetamine dependence and sexual risk for HIV acquisition among men who have sex with men. AIDS Care. 2019 Sep;31(9):1083-1095. doi: 10.1080/09540121.2019.1595518. Epub 2019 Mar 19.
PubMed 30887824
Daughters SB, Magidson JF, Anand D, Seitz-Brown CJ, Chen Y, Baker S. The effect of a behavioral activation treatment for substance use on post-treatment abstinence: a randomized controlled trial. Addiction. 2018 Mar;113(3):535-544. doi: 10.1111/add.14049. Epub 2017 Nov 19.
PubMed 28963853
Magidson JF, Seitz-Brown CJ, Safren SA, Daughters SB. Implementing Behavioral Activation and Life-Steps for Depression and HIV Medication Adherence in a Community Health Center. Cogn Behav Pract. 2014 Nov 1;21(4):386-403. doi: 10.1016/j.cbpra.2013.10.002.
PubMed 25419102
Magidson JF, Joska JA, Regenauer KS, Satinsky E, Andersen LS, Seitz-Brown CJ, Borba CPC, Safren SA, Myers B. "Someone who is in this thing that I am suffering from": The role of peers and other facilitators for task sharing substance use treatment in South African HIV care. Int J Drug Policy. 2019 Aug;70:61-69. doi: 10.1016/j.drugpo.2018.11.004. Epub 2019 May 10.
PubMed 31082664
Daughters SB, Magidson JF, Schuster RM, Safren SA. ACT HEALTHY: A Combined Cognitive-Behavioral Depression and Medication Adherence Treatment for HIV-Infected Substance Users. Cogn Behav Pract. 2010 Aug 1;17(3):309-321. doi: 10.1016/j.cbpra.2009.12.003.
PubMed 21709737
Tull MT, Berghoff CR, Bardeen JR, Schoenleber M, Konkle-Parker DJ. An Initial Open Trial of a Brief Behavioral Activation Treatment for Depression and Medication Adherence in HIV-Infected Patients. Behav Modif. 2018 Mar;42(2):196-209. doi: 10.1177/0145445517723901. Epub 2017 Aug 11.
PubMed 28799413
Carroll KM. Lost in translation? Moving contingency management and cognitive behavioral therapy into clinical practice. Ann N Y Acad Sci. 2014 Oct;1327(1):94-111. doi: 10.1111/nyas.12501. Epub 2014 Sep 9.
PubMed 25204847
Magidson JF, Lejuez CW, Kamal T, Blevins EJ, Murray LK, Bass JK, Bolton P, Pagoto S. Adaptation of community health worker-delivered behavioral activation for torture survivors in Kurdistan, Iraq. Glob Ment Health (Camb). 2015 Dec;2:e24. doi: 10.1017/gmh.2015.22.
PubMed 27478619
Richards DA, Ekers D, McMillan D, Taylor RS, Byford S, Warren FC, Barrett B, Farrand PA, Gilbody S, Kuyken W, O'Mahen H, Watkins ER, Wright KA, Hollon SD, Reed N, Rhodes S, Fletcher E, Finning K. Cost and Outcome of Behavioural Activation versus Cognitive Behavioural Therapy for Depression (COBRA): a randomised, controlled, non-inferiority trial. Lancet. 2016 Aug 27;388(10047):871-80. doi: 10.1016/S0140-6736(16)31140-0. Epub 2016 Jul 23.
PubMed 27461440
Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.
PubMed 10474547
Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
PubMed 20957426
Mack KA, Jones CM, Ballesteros MF. Illicit Drug Use, Illicit Drug Use Disorders, and Drug Overdose Deaths in Metropolitan and Nonmetropolitan Areas-United States. Am J Transplant. 2017 Dec;17(12):3241-3252. doi: 10.1111/ajt.14555.
PubMed 29145698

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Peer-Delivered, Behavioral Activation Intervention to Improve Polysubstance Use and Retention in Mobile Telemedicine OUD Treatment in an Underserved, Rural Area
ClinicalTrials.gov ID: NCT05973838
Acronym / sponsor ID: PRISM / 1953327
Conditions: Polysubstance Addiction, Opioid Medication Assisted Treatment, Treatment Adherence, Retention in Care, Substance-Related Disorders
Keywords: Substance-Related Disorders, Opioid-Related Disorders, Polysubstance Use, Mental disorders
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 160 participants (estimated)
Lead sponsor: University of Maryland, College ParkUniversity, hospital or other
Collaborators: University of Maryland, Baltimore, Weill Medical College of Cornell University, National Institute on Drug Abuse (NIDA)
Study start: 15 Jun 2023 (actual)
Primary completion: 1 Jul 2027 (estimated)
Study completion: 1 Sep 2027 (estimated)
First posted: 3 Aug 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Participants will be randomized in parallel to receive either the Peer Activate intervention on the MTU or enhanced treatment as usual (TAU: treatment as usual services on the MTU in addition to referral to other available services in the community through study contact). Assessments will take place for both groups at baseline, at a midpoint (1-month), and follow ups at 3-month, 6-month and 12-months following the baseline assessment. Follow up assessments will be conducted by a blinded assessor.

Arm	Type	Receives
Peer-Delivered Behavioral Activation ("Peer Activate")	Experimental	Behavioral: Peer-Delivered Behavioral Activation ("Peer Activate")Participants in the Peer Activate intervention will receive a PRS-delivered behavioral activation intervention to address barriers to retention in methadone treatment and increase substance-free, positive reinforcement to support retention and reduce polysubstance use.
Treatment As Usual	No intervention	–Participants in the TAU group will receive enhanced treatment as usual, defined as MTU services as usual enhanced with additional community referrals and follow-ups on those referrals, in addition to regular meetings with an addiction medicine physician and PRS on the MTU. Standard PRS contact typically includes connection to local resources and general peer support as needed.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patient participants in the RCT must be 18 or older; receive OUD treatment as part of the telemedicine program; and exhibit polysubstance use within the past three-months (i.e., use of one or more non-prescribed substances (excluding opioids and/or tobacco) by urine toxicology or self-report.

Key exclusion criteria (2 listed)

Demonstrating active, unstable or untreated psychiatric symptoms, including mania and/or psychosis that would interfere with study participation
Inability to understand the study and provide informed consent in English

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Peer-Delivered Behavioral Activation ("Peer Activate")The PRS-delivered Peer Activate intervention will consist of approximately six weekly "core" sessions (approximately 30 minutes-1 hour), and then 6 optional "booster" sessions to reinforce skill practice. In Peer Activate sessions, participants will learn behavioral activation and problem-solving skills to reduce barriers to medication nonadherence and incorporate value-driven, substance-free, rewarding activities into their daily life to reduce polysubstance use and improve retention.	Behavioural	Peer-Delivered Behavioral Activation ("Peer Activate")

Primary outcome

Six-Month Polysubstance Use Urinalysis
Time frame: Measured from baseline to 6-month follow-up
Polysubstance use will be assessed using urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine.
Six-Month Polysubstance Use Self Report
Time frame: Assessed between the baseline assessment 6-month follow-up
The New York University (NYU) polysubstance use measurement tool will be utilized to assess polysubstance frequency.

7 secondary outcomes

Six-month OUD Treatment Retention
Time frame: Measured from intake through 6-month follow up
Six-month Buprenorphine Adherence
Time frame: Measured from intake to six-month follow-up
Six-month Self-Report Buprenorphine Adherence
Time frame: Assessed between the baseline assessment and 6-month follow-up
Six-Month Problems Associated with Substance Use
Time frame: Assessed between the baseline assessment and 6-month follow-up
Intervention Uptake
Time frame: Assessed between the baseline assessment and 6-month follow-up
Intervention Session Attendance
Time frame: Assessed between the baseline assessment 6-month follow-up
Intervention Fidelity
Time frame: Assessed at the acute post-treatment follow-up (approximately 3-months post-baseline assessment)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
Background: PubMed 31525570Ghertner R. U.S. trends in the supply of providers with a waiver to prescribe buprenorphine for opioid use disorder in 2016 and 2018. Drug Alcohol Depend. 2019 Nov 1;204:107527. doi: 10.1016/j.drugalcdep.2019.06.029. Epub 2019 Aug 30.
Background: PubMed 21310539Magidson JF, Gorka SM, MacPherson L, Hopko DR, Blanco C, Lejuez CW, Daughters SB. Examining the effect of the Life Enhancement Treatment for Substance Use (LETS ACT) on residential substance abuse treatment retention. Addict Behav. 2011 Jun;36(6):615-623. doi: 10.1016/j.addbeh.2011.01.016. Epub 2011 Jan 21.
Background: PubMed 23030605Mimiaga MJ, Reisner SL, Pantalone DW, O'Cleirigh C, Mayer KH, Safren SA. A pilot trial of integrated behavioral activation and sexual risk reduction counseling for HIV-uninfected men who have sex with men abusing crystal methamphetamine. AIDS Patient Care STDS. 2012 Nov;26(11):681-93. doi: 10.1089/apc.2012.0216. Epub 2012 Oct 3.
Background: PubMed 30887824Mimiaga MJ, Pantalone DW, Biello KB, Hughto JMW, Frank J, O'Cleirigh C, Reisner SL, Restar A, Mayer KH, Safren SA. An initial randomized controlled trial of behavioral activation for treatment of concurrent crystal methamphetamine dependence and sexual risk for HIV acquisition among men who have sex with men. AIDS Care. 2019 Sep;31(9):1083-1095. doi: 10.1080/09540121.2019.1595518. Epub 2019 Mar 19.
Background: PubMed 28963853Daughters SB, Magidson JF, Anand D, Seitz-Brown CJ, Chen Y, Baker S. The effect of a behavioral activation treatment for substance use on post-treatment abstinence: a randomized controlled trial. Addiction. 2018 Mar;113(3):535-544. doi: 10.1111/add.14049. Epub 2017 Nov 19.
Background: PubMed 25419102Magidson JF, Seitz-Brown CJ, Safren SA, Daughters SB. Implementing Behavioral Activation and Life-Steps for Depression and HIV Medication Adherence in a Community Health Center. Cogn Behav Pract. 2014 Nov 1;21(4):386-403. doi: 10.1016/j.cbpra.2013.10.002.
Background: PubMed 31082664Magidson JF, Joska JA, Regenauer KS, Satinsky E, Andersen LS, Seitz-Brown CJ, Borba CPC, Safren SA, Myers B. "Someone who is in this thing that I am suffering from": The role of peers and other facilitators for task sharing substance use treatment in South African HIV care. Int J Drug Policy. 2019 Aug;70:61-69. doi: 10.1016/j.drugpo.2018.11.004. Epub 2019 May 10.
Background: PubMed 21709737Daughters SB, Magidson JF, Schuster RM, Safren SA. ACT HEALTHY: A Combined Cognitive-Behavioral Depression and Medication Adherence Treatment for HIV-Infected Substance Users. Cogn Behav Pract. 2010 Aug 1;17(3):309-321. doi: 10.1016/j.cbpra.2009.12.003.
Background: PubMed 28799413Tull MT, Berghoff CR, Bardeen JR, Schoenleber M, Konkle-Parker DJ. An Initial Open Trial of a Brief Behavioral Activation Treatment for Depression and Medication Adherence in HIV-Infected Patients. Behav Modif. 2018 Mar;42(2):196-209. doi: 10.1177/0145445517723901. Epub 2017 Aug 11.
Background: PubMed 25204847Carroll KM. Lost in translation? Moving contingency management and cognitive behavioral therapy into clinical practice. Ann N Y Acad Sci. 2014 Oct;1327(1):94-111. doi: 10.1111/nyas.12501. Epub 2014 Sep 9.
Background: PubMed 27478619Magidson JF, Lejuez CW, Kamal T, Blevins EJ, Murray LK, Bass JK, Bolton P, Pagoto S. Adaptation of community health worker-delivered behavioral activation for torture survivors in Kurdistan, Iraq. Glob Ment Health (Camb). 2015 Dec;2:e24. doi: 10.1017/gmh.2015.22.
Background: PubMed 27461440Richards DA, Ekers D, McMillan D, Taylor RS, Byford S, Warren FC, Barrett B, Farrand PA, Gilbody S, Kuyken W, O'Mahen H, Watkins ER, Wright KA, Hollon SD, Reed N, Rhodes S, Fletcher E, Finning K. Cost and Outcome of Behavioural Activation versus Cognitive Behavioural Therapy for Depression (COBRA): a randomised, controlled, non-inferiority trial. Lancet. 2016 Aug 27;388(10047):871-80. doi: 10.1016/S0140-6736(16)31140-0. Epub 2016 Jul 23.
Individual participant dataSharing planned: Yes. After all primary analyses are complete, de-identified data will be uploaded to an NIH-supported data repository and/or available by request to the MPIs.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Morgan S Anvari, BA contact

3014055095

manvari@umd.edu

Jessica F Magidson, PhD principal investigator

University of Maryland, College Park

Sarah M Kattakuzhy, MD principal investigator

University of Maryland, Baltimore

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Morgan S Anvari, BA (3014055095, manvari@umd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Six-Month Polysubstance Use Urinalysis (time frame: Measured from baseline to 6-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05973838, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.