Peer Supported Collaborative Care Mental Health and Substance Use Disorder Care

HIV Infections Clinical Trial

Official title:

Peer Supported Collaborative Care to Increase Engagement in Mental Health and Substance Use Disorder Care in HIV Care Settings

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04601064
• Other study ID #: IRB00264580
• Secondary ID: R01DA052297
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2022
• Est. completion date: December 15, 2026

Study information

• Verified date: February 2024
• Source: Johns Hopkins University
• Contact: Oluwaseun Falade-Nwulia, MBBS, MPH
• Phone: 410-287-1964
• Email: ofalade1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a research study to assess the effectiveness of a peer-led collaborative care model for integrating treatment for substance use and or mental health disorders into HIV care settings.

Depending on whether or not participants enroll in this study, participants will be assigned randomly (by chance, like drawing a number from a hat) to one of two groups. In group 1, participants would receive usual clinical care. In group 2, participants would work with a peer-case manager who would help support participants to engage in substance use or mental health disorder care. Regardless of the group participants are in, participants will fill out a survey when first enrolled in the study, and then again 12 months later.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 15, 2026
• Est. primary completion date: December 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Individuals 18-99 years old

• accessing HIV care at the Bartlett HIV clinic

• Screened positive for a Mental health disorder or substance use disorder based on a computerized self-administered screen with Patient Health Questionnaire (PHQ-9)(score>10), General Anxiety Disorder (GAD-7) (score>10), National Institute on Drug Abuse Drug Use Screening Tool: 3 Question Quick Screen (Response of "Yes" to one or more heavy drinking days or "Yes" to use of illegal drugs or prescription drugs for non-medical reasons.

• Does not currently have a Mental Health or Substance Use Disorder treatment provider and or not receiving any current treatment (psychotherapy or pharmacotherapy) for Mental Health or Substance Use Disorder.

• English speaking

Exclusion Criteria:

• Individuals lacking the capacity to consent

Related Conditions & MeSH terms

• Addiction
• Drug Use
• HIV Infections
• Mental Disorders
• Mental Health Disorder
• Opioid Use
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Collaborative Care Model
Collaborative care (CC) is an evidence-based model of integrated mental health and substance use disorder care endorsed by the American Psychiatric Association for the integration of mental health and substance use disorder care into primary care settings. CC includes the following components: 1) A collaborative care team of multidisciplinary health care providers consisting of the primary physician, a care manager and a consulting psychiatrist, providing care in a coordinated fashion; 2) A population focus with the team working together to provide care and continuously measure and track health outcomes of a defined population of patients; 3) A measurement-guided approach with systematic use of disease specific patient reported outcome measures, such as symptom rating scales like the PHQ-9 to drive clinical decision making; and 4) Evidence-based practices with the team adapting scientifically proven treatments within an individual clinical context to achieve improved health outcomes.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (25)

Archer J, Bower P, Gilbody S, Lovell K, Richards D, Gask L, Dickens C, Coventry P. Collaborative care for depression and anxiety problems. Cochrane Database Syst Rev. 2012 Oct 17;10:CD006525. doi: 10.1002/14651858.CD006525.pub2. — View Citation

Ashman JJ, Conviser R, Pounds MB. Associations between HIV-positive individuals' receipt of ancillary services and medical care receipt and retention. AIDS Care. 2002 Aug;14 Suppl 1:S109-18. doi: 10.1080/09540120220149993a. — View Citation

Azar MM, Springer SA, Meyer JP, Altice FL. A systematic review of the impact of alcohol use disorders on HIV treatment outcomes, adherence to antiretroviral therapy and health care utilization. Drug Alcohol Depend. 2010 Dec 1;112(3):178-93. doi: 10.1016/j.drugalcdep.2010.06.014. Epub 2010 Aug 11. — View Citation

Campo RE, Alvarez D, Santos G, Latorre J. Antiretroviral treatment considerations in Latino patients. AIDS Patient Care STDS. 2005 Jun;19(6):366-74. doi: 10.1089/apc.2005.19.366. — View Citation

Chander G, Himelhoch S, Fleishman JA, Hellinger J, Gaist P, Moore RD, Gebo KA. HAART receipt and viral suppression among HIV-infected patients with co-occurring mental illness and illicit drug use. AIDS Care. 2009 May;21(5):655-63. doi: 10.1080/09540120802459762. — View Citation

Chander G, Himelhoch S, Moore RD. Substance abuse and psychiatric disorders in HIV-positive patients: epidemiology and impact on antiretroviral therapy. Drugs. 2006;66(6):769-89. doi: 10.2165/00003495-200666060-00004. — View Citation

Chander G, Lau B, Moore RD. Hazardous alcohol use: a risk factor for non-adherence and lack of suppression in HIV infection. J Acquir Immune Defic Syndr. 2006 Dec 1;43(4):411-7. doi: 10.1097/01.qai.0000243121.44659.a4. — View Citation

DeGroote NP, Korhonen LC, Shouse RL, Valleroy LA, Bradley H. Unmet Needs for Ancillary Services Among Men Who Have Sex with Men and Who Are Receiving HIV Medical Care - United States, 2013-2014. MMWR Morb Mortal Wkly Rep. 2016 Sep 23;65(37):1004-1007. doi: 10.15585/mmwr.mm6537a4. — View Citation

Falade-Nwulia O, Sutcliffe CG, Mehta SH, Moon J, Chander G, Keruly J, Katzianer J, Thomas DL, Moore RD, Sulkowski MS. Hepatitis C Elimination in People With HIV Is Contingent on Closing Gaps in the HIV Continuum. Open Forum Infect Dis. 2019 Sep 30;6(10):ofz426. doi: 10.1093/ofid/ofz426. eCollection 2019 Oct. — View Citation

Giordano TP, Visnegarwala F, White AC Jr, Troisi CL, Frankowski RF, Hartman CM, Grimes RM. Patients referred to an urban HIV clinic frequently fail to establish care: factors predicting failure. AIDS Care. 2005 Aug;17(6):773-83. doi: 10.1080/09540120412331336652. — View Citation

Kaaya S, Eustache E, Lapidos-Salaiz I, Musisi S, Psaros C, Wissow L. Grand challenges: Improving HIV treatment outcomes by integrating interventions for co-morbid mental illness. PLoS Med. 2013;10(5):e1001447. doi: 10.1371/journal.pmed.1001447. Epub 2013 May 21. — View Citation

Korhonen LC, DeGroote NP, Shouse RL, Valleroy LA, Prejean J, Bradley H. Unmet Needs for Ancillary Services Among Hispanics/Latinos Receiving HIV Medical Care - United States, 2013-2014. MMWR Morb Mortal Wkly Rep. 2016 Oct 14;65(40):1104-1107. doi: 10.15585/mmwr.mm6540a3. — View Citation

Korthuis PT, Josephs JS, Fleishman JA, Hellinger J, Himelhoch S, Chander G, Morse EB, Gebo KA; HIV Research Network. Substance abuse treatment in human immunodeficiency virus: the role of patient-provider discussions. J Subst Abuse Treat. 2008 Oct;35(3):294-303. doi: 10.1016/j.jsat.2007.11.005. Epub 2008 Mar 7. — View Citation

Low AJ, Mburu G, Welton NJ, May MT, Davies CF, French C, Turner KM, Looker KJ, Christensen H, McLean S, Rhodes T, Platt L, Hickman M, Guise A, Vickerman P. Impact of Opioid Substitution Therapy on Antiretroviral Therapy Outcomes: A Systematic Review and Meta-Analysis. Clin Infect Dis. 2016 Oct 15;63(8):1094-1104. doi: 10.1093/cid/ciw416. Epub 2016 Jun 25. — View Citation

Lucas GM, Chaudhry A, Hsu J, Woodson T, Lau B, Olsen Y, Keruly JC, Fiellin DA, Finkelstein R, Barditch-Crovo P, Cook K, Moore RD. Clinic-based treatment of opioid-dependent HIV-infected patients versus referral to an opioid treatment program: A randomized trial. Ann Intern Med. 2010 Jun 1;152(11):704-11. doi: 10.7326/0003-4819-152-11-201006010-00003. — View Citation

Monroe AK, Lau B, Mugavero MJ, Mathews WC, Mayer KH, Napravnik S, Hutton HE, Kim HS, Jabour S, Moore RD, McCaul ME, Christopoulos KA, Crane HC, Chander G. Heavy Alcohol Use Is Associated With Worse Retention in HIV Care. J Acquir Immune Defic Syndr. 2016 Dec 1;73(4):419-425. doi: 10.1097/QAI.0000000000001083. — View Citation

Oldfield BJ, Munoz N, McGovern MP, Funaro M, Villanueva M, Tetrault JM, Edelman EJ. Integration of care for HIV and opioid use disorder. AIDS. 2019 Apr 1;33(5):873-884. doi: 10.1097/QAD.0000000000002125. — View Citation

Pyne JM, Fortney JC, Curran GM, Tripathi S, Atkinson JH, Kilbourne AM, Hagedorn HJ, Rimland D, Rodriguez-Barradas MC, Monson T, Bottonari KA, Asch SM, Gifford AL. Effectiveness of collaborative care for depression in human immunodeficiency virus clinics. Arch Intern Med. 2011 Jan 10;171(1):23-31. doi: 10.1001/archinternmed.2010.395. — View Citation

Rooks-Peck CR, Adegbite AH, Wichser ME, Ramshaw R, Mullins MM, Higa D, Sipe TA; Prevention Research Synthesis Project. Mental health and retention in HIV care: A systematic review and meta-analysis. Health Psychol. 2018 Jun;37(6):574-585. doi: 10.1037/hea0000606. — View Citation

Saag LA, Tamhane AR, Batey DS, Mugavero MJ, Eaton EF. Mental health service utilization is associated with retention in care among persons living with HIV at a university-affiliated HIV clinic. AIDS Res Ther. 2018 Jan 16;15(1):1. doi: 10.1186/s12981-018-0188-9. — View Citation

Sam TS, Hutton HE, Lau B, McCaul ME, Keruly J, Moore R, Chander G. Antiretroviral Therapy Use, Medication Adherence, and Viral Suppression Among PLWHA with Panic Symptoms. AIDS Behav. 2015 Nov;19(11):2049-56. doi: 10.1007/s10461-015-1064-4. — View Citation

Sherer R, Stieglitz K, Narra J, Jasek J, Green L, Moore B, Shott S, Cohen M. HIV multidisciplinary teams work: support services improve access to and retention in HIV primary care. AIDS Care. 2002 Aug;14 Suppl 1:S31-44. doi: 10.1080/09540120220149975. — View Citation

Vagenas P, Azar MM, Copenhaver MM, Springer SA, Molina PE, Altice FL. The Impact of Alcohol Use and Related Disorders on the HIV Continuum of Care: a Systematic Review : Alcohol and the HIV Continuum of Care. Curr HIV/AIDS Rep. 2015 Dec;12(4):421-36. doi: 10.1007/s11904-015-0285-5. — View Citation

Watkins KE, Ober AJ, Lamp K, Lind M, Setodji C, Osilla KC, Hunter SB, McCullough CM, Becker K, Iyiewuare PO, Diamant A, Heinzerling K, Pincus HA. Collaborative Care for Opioid and Alcohol Use Disorders in Primary Care: The SUMMIT Randomized Clinical Trial. JAMA Intern Med. 2017 Oct 1;177(10):1480-1488. doi: 10.1001/jamainternmed.2017.3947. — View Citation

Westergaard RP, Hess T, Astemborski J, Mehta SH, Kirk GD. Longitudinal changes in engagement in care and viral suppression for HIV-infected injection drug users. AIDS. 2013 Oct 23;27(16):2559-66. doi: 10.1097/QAD.0b013e328363bff2. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Participants with HIV Virologic Suppression	This is defined as a viral load < 200 copies/ml	Within a 3 month window of the 12 month follow-up (i.e. 3 months before or after the 12 month follow up)
Secondary	Number of Participants with Retention in HIV Care	At least 2 medical visit dates, specifically for HIV care, that are at least 90 days apart	Within 12 months of patient entrance into the study
Secondary	Number of Participants Who Obtain Treatment for Mental Health and Substance Use Disorder	Receipt of evidence-based treatment for Mental Health and Substance Use Disorder, including medication and brief psychotherapy	Within 12 month of patient entrance into the study
Secondary	Number of Participants with Change in Severity of Mental Health and Substance Use Disorder	The following changes in Mental Health and Substance Use Disorder outcomes from baseline to 12 month follow up: Depression- 50% reduction in PHQ 9, Anxiety- 50% reduction in GAD 7, Bipolar Disorder- 50% reduction in Altman Mania Scores, PTSD- 50% reduction in PTSD Checklist 5, and Substance Use Disorder- 50% reduction in severity of dependence scale score	Changes from baseline to 12 month follow up

External Links

•   Baltimore City HIV Fact Sheet. 2018
•   Diagnoses of HIV Infection in the United States and Dependent Areas, 2018 (Preliminary)