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Telehealth Counseling for Alcohol Misuse in HIV (ReACH3 Trial)

N/A

Recruiting

Led By Christopher Kahler, PhD

Research Sponsored by Brown University

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 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a counseling program delivered via text messaging and videoconferencing can help reduce alcohol use and improve HIV viral control among people with HIV who drink heavily.

Who is the study for?

This trial is for people with HIV who are receiving care at one of the participating health centers and have a history of heavy drinking, defined as having at least one day with 4+ drinks or averaging more than 7 drinks per week in the last month. Those needing supervised detox due to severe withdrawal symptoms cannot participate.

What is being tested?

The study is testing if telehealth counseling can help reduce alcohol use and improve HIV viral control. Participants will either get a single session of brief alcohol counseling or that plus a referral to an extended telehealth program with videoconferencing and text support.

What are the potential side effects?

Since this trial involves counseling services rather than medication, there are no direct physical side effects from the interventions being tested. However, participants may experience emotional discomfort discussing personal habits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Alcoholics drinks consumed per week

Number of heavy drinking days

Proportion of participants with a detectable HIV viral load

Secondary study objectives

Condomless sex with non-steady partners

Proportion of the past 30 days adherent to antiretroviral therapy

Veterans Aging Cohort Study (VACS) index total score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Brief Intervention plus Telehealth CounselingExperimental Treatment3 Interventions

A brief alcohol intervention followed by referral to a telehealth counseling protocol including 5 sessions of counseling based on Motivational Interviewing and delivered by videoconferencing. Telehealth counseling extends for up to two years and also includes a text messaging intervention to encourage reductions in drinking.

Group II: Brief interventionActive Control1 Intervention

A brief alcohol intervention lasting about 10 minutes, delivered after the baseline assessments.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brief Intervention

2008

Completed Phase 3

~5860

Text messaging

2013