[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06799702":3,"trial-entities:NCT06799702":107,"trial-summary:NCT06799702":111},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":44,"secondary_outcomes":55,"sex":71,"minimum_age":72,"maximum_age":73,"healthy_volunteers":15,"eligibility_criteria":74,"std_ages":85,"locations":88,"central_contacts":98,"overall_officials":104,"references":105,"see_also_links":106},"NCT06799702","PROJECT000009015","Trauma-informed, Resilience-based Telehealth Intervention for Improving HIV Prevention and HCV Care for Persons Who Inject Drugs in the Deep South (Pilot Testing: Aim3)","Trauma-informed, Resilience-based Telehealth Intervention for Improving HIV Prevention and HCV Care for Persons Who Inject Drugs in the Deep South","NOT_YET_RECRUITING","2028-07-31","2025-12","2025-12-18","2026-08-01","University of Georgia","OTHER",true,"Evaluate the feasibility, acceptability, and usability of the intervention (primary outcomes) and coping skills and resilience (secondary outcomes) of the telehealth intervention over two months (8 weekly sessions) in a waitlist-controlled, randomized pilot trial using a cross-over design among 40 PWID. The primary outcomes will be feasibility, acceptability, and usability of the intervention. Secondary outcomes will be increased coping skills and resilience, which in turn, will increase status neutral HIV and HCV care and MOUD uptake (longer-term outcomes). Outcomes will be assessed using pre- and post-intervention surveys.","The telehealth intervention will include components from the LIFT intervention: identifying and expressing emotion related to stressors; identifying different stressors and coping difficulties; and developing adaptive strategies to reduce stress. The intervention will also include developing health goals and a health plan on PrEP, DAA, and MOUD, as well as components from RISE-UP: baseline assessment of individual assets (e.g., self-esteem, emotion regulation, positive future orientation), coping with addictive behavior (stress reduction, avoiding unsafe sexual and injection practices, self-care), building relationships (with peers, family, provider), and social support (finding and seeking social support). It will consist of 8 sessions (4 addressing stress and 4 addressing stigma). Each session will last an hour and be conducted weekly for eight consecutive weeks.",[19,20,21],"HIV Pre-exposure Prophylaxis","HEPATITIS C (HCV)","Opioid Use Disorder",[23,24,25,26,27,28],"HIV Pre-Exposure Prophylaxis","Hepatitis C Virus","Medications for Opioid Use Disorder","People who inject drugs (PWID)","Deep South","Telehealth Intervention","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[32],"NA",{"count":34,"type":35},50,"ESTIMATED",[37],{"type":38,"name":39,"description":40,"armGroupLabels":41},"BEHAVIORAL","Telehealth Behavioral Intervention for promoting HIV and HCV care and MOUD among Persons who inject drugs (PWID)","The telehealth intervention will include components from the LIFT intervention: identifying and expressing emotion related to stressors; identifying different stressors and coping difficulties; and developing adaptive strategies to reduce stress. The intervention will also include developing health goals and a health plan on PrEP, DAA, and MOUD, as well as components from RISE-UP: baseline assessment of individual assets (e.\n\ng., self-esteem, emotion regulation, positive future orientation), coping with addictive behavior (stress reduction, avoiding unsafe sexual and injection practices, self-care), building relationships (with peers, family, provider), and social support (finding and seeking social support). It will consist of 8 sessions (4 addressing stress and 4 addressing stigma). Each session will last an hour and be conducted weekly for eight consecutive weeks.",[42,43],"Intervention","Waitlist Control",[45,49,52],{"measure":46,"description":47,"timeFrame":48},"Feasibility of the Intervention","Feasibility of the telehealth intervention will be assessed during baseline, at 2-months, and 4-months among both PWID and interventionists. Feasibility will be assessed by the completion rates of the interventionist training sessions and the participation\u002Fdrop-out rates of the PWID.","Months 31-60",{"measure":50,"description":51,"timeFrame":48},"Acceptability of the telehealth intervention","Acceptability of the telehealth intervention will be assessed during baseline, at 2-months, and 4-months among both PWID and interventionists. Acceptability will be examined by Likert scale like responses, e.g., \"convenient,\" \"a nuisance,\" \"easy to use,\" and \"time-consuming.\"",{"measure":53,"description":54,"timeFrame":48},"Usability of the telehealth intervention","Usability of the telehealth intervention will be assessed during baseline, at 2-months, and 4-months among both PWID and interventionists. Usability will be assessed with the USE questionnaire, which captures the perceived usefulness, satisfaction, and ease of use.",[56,59,62,65,68],{"measure":57,"description":58,"timeFrame":48},"Depressive symptoms","The Center for Epidemiologic Studies Depression (CES-D) Scale (20 items) will be used to measure depressive symptoms. CES-D Scores range from 0 to 60, with high scores indicating greater depressive symptoms.",{"measure":60,"description":61,"timeFrame":48},"Resilience","The 10-item Connor-Davidson Resilience Scale (CD-RISC) scale will be used to measure resilience. Scores range from 0-40, where higher scores indicate greater resilience.",{"measure":63,"description":64,"timeFrame":48},"Intersecting stigma of HIV, HCV, and drug use","The 16-item Anticipated HIV Stigma Scale will be used to measure HIV stigma. Scores range from 16-64, where higher scores reflect higher stigma. The 33-item HCV Stigma Scale (HCV-SS) will be used to measure HCV-related stigma. The total score range for this scale is 33 to 132, with higher scores indicating greater perceived stigma. The 8-item Perceived Stigma of Substance Abuse Scale (PSAS) will be used to measure the drug use stigma. Scores range from 8-32, where a higher score reflects higher stigma. Intersectional stigma scores will be calculated using the formula, d = square root of (a-squared + b-squared + c-squared), where d is the intersectional stigma score, and a is the HIV-related stigma score, b is the HCV-related stigma score, and c is the drug use stigma score. The score ranges from 37.5-150.2, and the higher the score, the higher the intersecting stigma.",{"measure":66,"description":67,"timeFrame":48},"Sexual behavior","Sexual practices like protected sex, risky sex (sex under the influence, sex in return of drugs\u002Fmoney, unprotected anal\u002Fvaginal sex, multiple partners, not knowing partnmer's HIV status)",{"measure":69,"description":70,"timeFrame":48},"Risky Injection Bheavior","Risky injection behavior includes the sharing of syringes, using same syringe multiple times","ALL","18 Years",null,{"inclusion":75,"exclusion":80,"raw_text":84},[76,77,78,79],"People who actively inject drugs verified by visible injection stigmata (needle tracks)","HIV negative","Adult (≥18 years)","lives in rural areas",[81,82,83],"Living with HIV","Lives in urban areas","Not proficient in English","Inclusion Criteria:\n\n* People who actively inject drugs verified by visible injection stigmata (needle tracks)\n* HIV negative\n* Adult (≥18 years)\n* lives in rural areas\n\nExclusion Criteria:\n\n* Living with HIV\n* Lives in urban areas\n* Not proficient in English",[86,87],"ADULT","OLDER_ADULT",[89],{"facility":90,"city":91,"state":92,"zip":93,"country":94,"geoPoint":95},"MedLink Georgia","Colbert","Georgia","30628","United States",{"lat":96,"lon":97},34.03789,-83.21265,[99],{"name":100,"role":101,"phone":102,"email":103},"Mohammad Rifat Haider, Ph.D.","CONTACT","803-477-4289","haider@uga.edu",[],[],[],{"nct_id":4,"conditions":108,"biomarkers":110},[109,21],"Hepatitis C Infection",[],{"nct_id":4,"found":15,"summary":112,"prompt_version":122},{"design":113,"status":114,"heading":115,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is an interventional study with a waitlist-controlled, randomized pilot trial design, involving about 40 participants. It uses a cross-over design.","completed","Telehealth Intervention for HIV Prevention and HCV Care in the Deep South","This study is testing a telehealth (virtual healthcare) program for people who inject drugs in the Deep South. The program, called \"Trauma-informed, Resilience-based Telehealth Intervention,\" aims to improve HIV prevention (using PrEP), Hepatitis C (HCV) care, and treatment for opioid use disorder (MOUD). It helps you identify and manage stress, develop coping skills, and build resilience. We want to see if this program is practical, well-liked, and easy to use. You might be able to join if you are at least 18 years old, inject drugs, are HIV negative, and live in a rural area. The study plans to enroll 50 participants.","The primary outcomes (feasibility, acceptability, usability) are measured at Months 31-60. Secondary outcomes are assessed using pre- and post-intervention surveys.",102,"You would participate in 8 weekly telehealth sessions, each lasting one hour, over eight consecutive weeks. You will also complete surveys before and after the intervention.","Not stated in the trial record.",[],"v2"]