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Behavioral Intervention

Emotion Regulation Program for HIV+ Individuals with Substance Use Disorder (iSTRIVE Trial)

N/A

Recruiting

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 12 weeks after intervention completion

Awards & highlights

iSTRIVE Trial Summary

This trial tests if an emotion regulation program can help people living with HIV+ and substance use better manage their health care. #HIV #substanceuse

Who is the study for?

This trial is for HIV-positive adults who have used injection drugs in the past 6 months and are not fully managing their HIV (viral load over 200 copies/mL or no test results in the past year). Participants must be able to consent, speak English, and be at least 18 years old. Those who don't inject drugs or are HIV-negative cannot join.Check my eligibility

What is being tested?

The study tests a new program called Project iSTRIVE with incentivized Directly Observed Therapy (iDOT) to see if it helps people manage their HIV better by improving emotion control and communication skills. It's a small-scale study where participants are randomly chosen to receive this intervention.See study design

What are the potential side effects?

Since this trial focuses on behavioral interventions rather than medications, traditional side effects like those seen with drugs aren't expected. However, participants may experience emotional discomfort when discussing personal issues during therapy sessions.

iSTRIVE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 12 weeks after intervention completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 12 weeks after intervention completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 12 weeks after intervention completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of intervention

Feasibility of iDOT intervention

Feasibility of iSTRIVE intervention

Secondary outcome measures

HIV Viral Load

Injection Drug Use Behaviors

Substance Use

iSTRIVE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment2 Interventions

This intervention includes 6 face-to-face therapy sessions with a trained clinician plus an incentivized directly observed therapy (iDOT) intervention facilitated via a mobile application.

Group II: incentivized Directly Observed Therapy (iDOT)Active Control1 Intervention

Participants in the iDOT condition will be provided a mobile application to facilitate video recording of their daily medication adherence in order to receive small, escalating monetary incentives for HIV medication adherence.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Fenway Community HealthOTHER

34 Previous Clinical Trials

5,831,674 Total Patients Enrolled

National Institute of Drug AbuseFED

9 Previous Clinical Trials

14,449 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,941 Previous Clinical Trials

13,200,598 Total Patients Enrolled

Media Library

Project iSTRIVE (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05819411 — N/A

Substance Use Disorder Research Study Groups: Intervention, incentivized Directly Observed Therapy (iDOT)

Substance Use Disorder Clinical Trial 2023: Project iSTRIVE Highlights & Side Effects. Trial Name: NCT05819411 — N/A

Project iSTRIVE (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05819411 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to join this research endeavor currently?

"As per information on clinicaltrials.gov, this medical trial has opened its recruitment window and is currently accepting patients. The initial posting date was September 1st 2021 with the most recent amendment done on April 5th 2023."

Answered by AI

What is the maximum number of individuals who can participate in this experiment?

"Affirmative. According to the information published on clinicaltrials.gov, this research project is currently searching for participants. This medical trial was posted online on September 1st 2021 and has since been updated twice; most recently on April 5th 2023. The study requires 70 patients from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intervention to Improve HIV Self-care Among People Who Inject Drugs

Abigail Batchelder, Ph.D., M.P.H. 2021. "Intervention to Improve HIV Self-care Among People Who Inject Drugs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05819411.