Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:10 AM
Study NCT ID:
NCT07414459
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combining Social Network Strategies and Routine Substance Use Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D040261', 'term': 'Harm Reduction'}, {'id': 'D057545', 'term': 'Social Stigma'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Viral suppression and SUD reduction will be monitored via chart review and used to parameterize an agent-based model (ABM) examining the potential population-level impact of implementing the SUD screener and SNI across Chicago on the local HIV epidemic. Control data will consist of standard intake data on new patients and patients returning to care at HBH. Standard intake data will be collected corresponding to the same timeframe as the recruitment period for the SNI.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Substance Use Disorder (SUD) Detection', 'timeFrame': 'Baseline through 24 months', 'description': 'The number and proportion of patients who screen positive for substance use disorder using the routine SUD screening tool (NIDA Quick Screen) compared with the number identified through existing electronic medical record (EMR) documentation. This outcome measures whether routine screening increases the detection of individuals with possible SUD.'}, {'measure': 'Number of Individuals Identified as Viremic and/or Having SUD Through the Social Network Intervention (SNI)', 'timeFrame': 'Baseline through 24 months', 'description': 'The number of people identified through the Social Network Intervention who have unsuppressed HIV (viremia), substance use disorder, or both. This will be compared to a functional control group (new or re-engaged clinic patients during the same time period) to determine whether the SNI is more effective at finding high-priority individuals needing care.'}, {'measure': 'Linkage to HIV Care or Substance Use Services', 'timeFrame': 'Baseline through 24 months', 'description': 'The proportion of individuals identified through SUD screening or the SNI who successfully link to harm reduction, HIV care, or substance use treatment services. This outcome assesses early engagement in care following identification.'}], 'secondaryOutcomes': [{'measure': 'Viral Suppression Among Individuals Identified Through Screening or SNI', 'timeFrame': 'Baseline through 24 months', 'description': 'The proportion of people identified with HIV who achieve viral suppression after being linked to care. This measures the downstream impact of improved identification and engagement.'}, {'measure': 'Time to Linkage to HIV Care or Substance Use Services', 'timeFrame': 'Baseline through 24 months', 'description': 'The number of days from identification (via SUD screen or SNI) to the first attended HIV care appointment, harm reduction service, or substance use treatment visit.'}, {'measure': 'Number of New HIV Diagnoses Identified Through the SNI', 'timeFrame': 'Baseline through 24 months', 'description': 'The number of individuals identified by SNI participants who test positive for HIV and were previously undiagnosed.'}, {'measure': 'Substance Use Treatment Initiation', 'timeFrame': 'Baseline through 24 months', 'description': 'The proportion of people identified with SUD who initiate counseling, medication-assisted treatment, or other substance use services.'}, {'measure': 'Re-engagement in HIV Care', 'timeFrame': 'Baseline through 24 months', 'description': 'The number and proportion of individuals previously out of care for ≥6 months who return for at least one HIV medical visit after identification.'}, {'measure': 'Acceptability of SUD Screening and the SNI', 'timeFrame': 'Measured at Months 6, 12, 18, and 24', 'description': 'Acceptability scores based on surveys and interviews with clinic staff and participants, assessing satisfaction, perceived burden, and overall fit within the clinical setting.'}, {'measure': 'Feasibility of Implementing the SUD Screener and SNI', 'timeFrame': 'Baseline through 24 months', 'description': 'Assessment of whether the interventions can be carried out in the clinic as intended, measured by workflow fit, completion rates, and staff-reported ease of implementation.'}, {'measure': 'Sustainability of Screening and SNI Workflows (EPIS: Sustainment Phase)', 'timeFrame': 'Measured at 24 months', 'description': 'Indicators of ongoing use of SUD screening and SNI processes without external study support, including continued staff utilization and workflow integration.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['social networks', 'HIV', 'substance use disorder', 'HIV testing', 'HIV prevention', 'harm reduction', 'social stigma', 'programs', 'testing', 'treatment', 'mental health', 'community clinic', 'intervention', 'color', 'Chicago', 'drug abuse', 'addiction'], 'conditions': ['HIV', 'Substance Use Disorder (SUD)']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Proctor E, Silmere H, Raghavan R, et al. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health 2011; 38(2): 65-76.'}, {'type': 'BACKGROUND', 'citation': 'Aarons GA, Hurlburt M, Horwitz SM. Advancing a conceptual model of evidence-based practice implementation in public service sectors. Adm Policy Ment Health 2011; 38(1): 4-23.'}, {'type': 'BACKGROUND', 'citation': 'Oehler C, Rajagopal A, Songster T, et al. Partner Notification Services for Patients with Established and New HIV Infection Leads to Diagnosis and Linkage of HIV-Positive Partners. AIDS Behav 2021; 25(3): 809-13.'}, {'type': 'BACKGROUND', 'citation': 'Cummins B, Johnson K, Schneider JA, et al. Leveraging social networks for identification of people with HIV who are virally unsuppressed. Aids; 38(2): 245-54. doi: 10.1097/QAD.0000000000003767. Epub 2023 Oct 26.'}, {'type': 'BACKGROUND', 'citation': 'Skaathun B, Pho MT, Pollack HA, et al. Comparison of effectiveness and cost for different HIV screening strategies implemented at large urban medical centre in the United States. J Int AIDS Soc 2020; 23(10): e25554.'}, {'type': 'BACKGROUND', 'citation': 'Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care 2012; 50(3): 217-26.'}, {'type': 'BACKGROUND', 'citation': 'McPherson M, Smith-Lovin L, Cook JM. Birds of a Feather: Homophily in Social Networks. Annual Review of Sociology 2001; 27(1): 415-44.'}, {'type': 'BACKGROUND', 'citation': 'Shrader CA-O, Borquez A, Vasylyeva TI, et al. Network-level HIV risk norms are associated with individual-level HIV risk and harm reduction behaviors among people who inject drugs: a latent profile analysis. (1573-3254 (Electronic)).'}, {'type': 'BACKGROUND', 'citation': 'Nikolopoulos GK, Pavlitina E, Muth SQ, et al. A network intervention that locates and intervenes with recently HIV-infected persons: The Transmission Reduction Intervention Project (TRIP). Scientific Reports 2016; 6(1): 38100.'}, {'type': 'BACKGROUND', 'citation': 'Morgan E, Skaathun B, Nikolopoulos GK, et al. A network intervention to locate newly HIV infected persons within MSM networks in Chicago. AIDS and Behavior 2019; 23(1): 15-20.'}, {'type': 'BACKGROUND', 'citation': 'Prevention CfDCa. Use of social networks to identify persons with undiagnosed HIV infection-seven U.S. Cities, October 2003-September., 2005.'}, {'type': 'BACKGROUND', 'citation': 'Jones E, Rieckmann T. Substance Use Disorder Screening Capacity Lags Behind Depression Screening Capacity in Community Health Centers. Journal of Drug Issues 2017.'}, {'type': 'BACKGROUND', 'citation': 'Dawson-Rose C, Draughon JE, Cuca Y, Huang E, Freeborn K, Lum PJ. Prevalence of Substance Use in an HIV Primary Care Safety Net Clinic: A Call for Screening. Journal of the Association of Nurses in Aids Care 2017.'}, {'type': 'BACKGROUND', 'citation': 'Lucas GM, Gebo KA, Chaisson RE, Moore RD. Longitudinal assessment of the effects of drug and alcohol abuse on HIV-1 treatment outcomes in an urban clinic. AIDS 2002; 16(5).'}, {'type': 'BACKGROUND', 'citation': 'Grov C, Westmoreland D, Morrison C, Carrico AW, Nash D. The Crisis We Are Not Talking About: One-in-Three Annual HIV Seroconversions Among Sexual and Gender Minorities Were Persistent Methamphetamine Users. JAIDS Journal of Acquired Immune Deficiency Syndromes 2020; 85(3).'}, {'type': 'BACKGROUND', 'citation': 'Comulada WS, Rotheram-Borus MJ, Pequegnat W, et al. Relationships over time between mental health symptoms and transmission risk among persons living with HIV. Psychol Addict Behav 2010; 24(1): 109-18.'}, {'type': 'BACKGROUND', 'citation': 'Korthuis PT, Zephyrin LC, Fleishman JA, et al. Health-Related Quality of Life in HIV-Infected Patients: The Role of Substance Use. AIDS Patient Care and STDs 2008; 22(11): 859-67.'}, {'type': 'BACKGROUND', 'citation': 'Chou FY, Armstrong HL, Wang L, et al. A longitudinal analysis of cannabis use and mental health symptoms among gay, bisexual, and other men who have sex with men in Vancouver, Canada. Journal of Affective Disorders 2019; 247: 125-33.'}, {'type': 'BACKGROUND', 'citation': 'Cristiani SA, Pukay-Martin ND, Bornstein RA. Marijuana Use and Cognitive Function in HIV-Infected People. The Journal of Neuropsychiatry and Clinical Neurosciences 2004; 16(3): 330-5.'}, {'type': 'BACKGROUND', 'citation': 'Skalski ML, Towe LS, Sikkema JK, Meade SC. The Impact of Marijuana Use on Memory in HIV- Infected Patients: A Comprehensive Review of the HIV and Marijuana Literatures. Current Drug Abuse Reviews 2016; 9(2): 126-41.'}, {'type': 'BACKGROUND', 'citation': 'Attonito JM, Dévieux JG, Lerner BDG, Hospital MM, Rosenberg R. Exploring Substance Use and HIV Treatment Factors Associated with Neurocognitive Impairment among People Living with HIV/AIDS. Frontiers in Public Health 2014; 2.'}, {'type': 'BACKGROUND', 'citation': 'Chao C, Jacobson LP, Tashkin D, et al. Recreational drug use and T lymphocyte subpopulations in HIV-uninfected and HIV-infected men. Drug and Alcohol Dependence 2008; 94(1): 165-71.'}, {'type': 'BACKGROUND', 'citation': 'Roth MD, Tashkin DP, Whittaker KM, Choi R, Baldwin GC. Tetrahydrocannabinol suppresses immune function and enhances HIV replication in the huPBL-SCID mouse. Life Sciences 2005; 77(14): 1711-22.'}, {'type': 'BACKGROUND', 'citation': 'Lee JT, Saag LA, Kipp AM, et al. Self-reported Cannabis Use and Changes in Body Mass Index, CD4 T-Cell Counts, and HIV-1 RNA Suppression in Treated Persons with HIV. AIDS and Behavior 2020; 24(4): 1275-80.'}, {'type': 'BACKGROUND', 'citation': 'Cherenack EM, Enders K, Rupp BM, Seña AC, Psioda M. Daily Predictors of ART Adherence Among Young Men Living with HIV Who Have Sex with Men: A Longitudinal Daily Diary Study. AIDS and Behavior 2022; 26(6): 1727-38.'}, {'type': 'BACKGROUND', 'citation': 'Kipp AM, Rebeiro PF, Shepherd BE, et al. Daily Marijuana Use is Associated with Missed Clinic Appointments Among HIV-Infected Persons Engaged in HIV Care. AIDS and Behavior 2017; 21(7): 1996- 2004.'}, {'type': 'BACKGROUND', 'citation': 'Montgomery L, Bagot K, Brown JL, Haeny AM. The Association Between Marijuana Use and HIV Continuum of Care Outcomes: a Systematic Review. Curr HIV/AIDS Rep 2019; 16(1): 17-28.'}, {'type': 'BACKGROUND', 'citation': 'Connolly MD, Dankerlui DN, Eljallad T, Dodard-Friedman I, Tang A, Joseph CLM. Outcomes of a PrEP Demonstration Project with LGBTQ Youth in a Community-Based Clinic Setting with Integrated Gender- Affirming Care. Transgend Health 2020; 5(2): 75-9.'}, {'type': 'BACKGROUND', 'citation': 'Serota DP, Rosenberg ES, Sullivan PS, et al. Pre-exposure Prophylaxis Uptake and Discontinuation Among Young Black Men Who Have Sex With Men in Atlanta, Georgia: A Prospective Cohort Study. Clin Infect Dis 2020; 71(3): 574-82.'}, {'type': 'BACKGROUND', 'citation': 'Okafor CN, Hucks-Ortiz C, Hightow-Weidman LB, et al. Associations between Self-Reported Substance Use Behaviors and PrEP Acceptance and Adherence among Black MSM in the HPTN 073 Study. J Acquir Immune Defic Syndr 2020.'}, {'type': 'BACKGROUND', 'citation': 'Cain D, Samrock S, Jones SS, et al. Marijuana and illicit drugs: Correlates of condomless anal sex among adolescent and emerging adult sexual minority men. Addictive Behaviors 2021; 122: 107018.'}, {'type': 'BACKGROUND', 'citation': 'Firkey M, Sheinfil A, Ramos J, Woolf-King SE. Cannabis and Alcohol Co-Use and Condomless Anal Sex Among Men Who have Sex with Men Living with HIV: An Event-Level Analysis. AIDS and Behavior 2021; 25(11): 3770-81.'}, {'type': 'BACKGROUND', 'citation': 'Mauro PM, Philbin MM, Greene ER, Diaz JE, Askari MS, Martins SS. Daily cannabis use, cannabis use disorder, and any medical cannabis use among US adults: Associations within racial, ethnic, and sexual minoritized identities in a changing policy context. Preventive Medicine Reports 2022; 28: 101822.'}, {'pmid': '30306433', 'type': 'BACKGROUND', 'citation': 'Grov C, Rendina HJ, John SA, Parsons JT. Determining the Roles that Club Drugs, Marijuana, and Heavy Drinking Play in PrEP Medication Adherence Among Gay and Bisexual Men: Implications for Treatment and Research. AIDS Behav. 2019 May;23(5):1277-1286. doi: 10.1007/s10461-018-2309-9.'}, {'pmid': '33733310', 'type': 'BACKGROUND', 'citation': 'Firkey M, Sheinfil A, Ramos J, Woolf-King SE. Cannabis and Alcohol Co-Use and Condomless Anal Sex Among Men Who have Sex with Men Living with HIV: An Event-Level Analysis. AIDS Behav. 2021 Nov;25(11):3770-3781. doi: 10.1007/s10461-021-03228-6. Epub 2021 Mar 18.'}, {'pmid': '35066459', 'type': 'BACKGROUND', 'citation': 'Bustamante MJ, Palfai TP, Luehring-Jones P, Maisto SA, Simons JS. Cannabis use and sexual risk among MSM who drink: Understanding why more frequent cannabis users may engage in higher rates of condomless sex. Drug Alcohol Depend. 2022 Mar 1;232:109282. doi: 10.1016/j.drugalcdep.2022.109282. Epub 2022 Jan 10.'}, {'pmid': '34289278', 'type': 'BACKGROUND', 'citation': 'Compton WM, Jones CM. Substance Use among Men Who Have Sex with Men. N Engl J Med. 2021 Jul 22;385(4):352-356. doi: 10.1056/NEJMra2033007. No abstract available.'}, {'type': 'BACKGROUND', 'citation': 'Prevention CfDCa. Estimated HIV incidence and prevalence in the United States, 2017-2021: National Profile, HIV Surveillance Supplemental Report 2023. 3, 2023.'}, {'pmid': '30897075', 'type': 'BACKGROUND', 'citation': 'Li Z, Purcell DW, Sansom SL, Hayes D, Hall HI. Vital Signs: HIV Transmission Along the Continuum of Care - United States, 2016. MMWR Morb Mortal Wkly Rep. 2019 Mar 22;68(11):267-272. doi: 10.15585/mmwr.mm6811e1.'}, {'pmid': '37698755', 'type': 'BACKGROUND', 'citation': 'Hill K, Kuo I, Shenoi SV, Desruisseaux MS, Springer SA. Integrated Care Models: HIV and Substance Use. Curr HIV/AIDS Rep. 2023 Oct;20(5):286-295. doi: 10.1007/s11904-023-00667-9. Epub 2023 Sep 12.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to improve health care for people who may have HIV or substance use disorders by bringing two services to a large community health center in Chicago. First, the clinic will begin offering routine screening for substance use to all patients. Second, the study will offer a social network-based program that helps people identify friends or partners who may need support and link them to care. The goal is to help more people learn their HIV status, reduce HIV levels in the community, and connect people with substance use treatment when needed. The study will also look at how well these services can be added into everyday clinic practice and what is needed to keep them going over time.', 'detailedDescription': 'This project will take place in a network of federally qualified health centers that serves communities in Chicago that experience some of the highest rates of new HIV infections. The study has two main parts: Routine Substance Use Screening and a Social Network Intervention (SNI).\n\nRoutine screening at the clinics will introduce a consistent, standardized way to ask patients about substance use during regular visits. Patients who screen positive will be offered help, referrals, and follow-up services.\n\nThe social network intervention asks patients to think about people in their social networks (such as partners, friends, or peers) who may have untreated HIV, may have fallen out of care, or may have substance use concerns. Participants will receive support and tools to help connect people in their network to HIV testing, care, and treatment or substance use services at these clinics.\n\nTogether, these activities aim to:\n\n* Identify people who have HIV but are not in care\n* Reduce HIV viral load levels in the community\n* Identify people with substance use disorders and link them to treatment\n* Improve access to supportive services in the community\n\nThe study will also examine how easy or hard it is for clinics to use these two strategies in everyday practice. Researchers will gather feedback from clinic staff and patients to understand what helps or gets in the way of using these services in the long term. The goal is to create a package of tools and processes that other clinics can adopt in the future.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Assigned male sex at birth and have sex with men; speaks English or Spanish\n\nExclusion Criteria:\n\n* Institutionalized individuals; women; non-Hispanic whites;'}, 'identificationModule': {'nctId': 'NCT07414459', 'acronym': 'SNS SUS', 'briefTitle': 'Combining Social Network Strategies and Routine Substance Use Screening', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Combining Social Network Strategies and Routine Substance Use Screening', 'orgStudyIdInfo': {'id': '813457'}, 'secondaryIdInfos': [{'id': 'R37DA063274', 'link': 'https://reporter.nih.gov/quickSearch/R37DA063274', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Routine SUD screening', 'interventionNames': ['Behavioral: Substance use disorder screening']}, {'type': 'EXPERIMENTAL', 'label': 'Social Network Intervention', 'interventionNames': ['Behavioral: Social network intervention']}], 'interventions': [{'name': 'Substance use disorder screening', 'type': 'BEHAVIORAL', 'description': 'Implement a routine SUD screening at the FQHC.', 'armGroupLabels': ['Routine SUD screening']}, {'name': 'Social network intervention', 'type': 'BEHAVIORAL', 'description': 'Social network intervention (SNI) to identify individuals who are viremic, have SUD, or both and link them to harm reduction and HIV continuum of care services. There are three main activities that make up the SNI: 1) recruiting, screening, and interviewing "index participants"; 2) training the index participants to recruit others; 3) screening and interviewing persons who present a valid recruitment voucher given to them by an index participant.', 'armGroupLabels': ['Social Network Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60657', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'contacts': [{'name': 'Aniruddha (Anu) Hazra, MD', 'role': 'CONTACT', 'email': 'ahazra2@bsd.uchicago.edu', 'phone': '773-388-1600'}], 'facility': 'Howard Brown Health', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Britt Skaathun, PhD', 'role': 'CONTACT', 'email': 'bskaathun@health.ucsd.edu', 'phone': '619-543-5011'}, {'name': 'Nicole Carter, MPH', 'role': 'CONTACT', 'email': 'nscarter@health.ucsd.edu', 'phone': '619-471-0796'}], 'overallOfficials': [{'name': 'Britt Skaathun', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'Howard Brown Health Center', 'class': 'OTHER'}, {'name': 'University of Chicago', 'class': 'OTHER'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Adjunct Professor', 'investigatorFullName': 'Britt Skaathun', 'investigatorAffiliation': 'University of California, San Diego'}}}}