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Communication + Substance Use Interventions for HIV (4Us Trial)

N/A
Recruiting
Research Sponsored by Hunter College of City University of New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
One participant must have used at least 1 drug in the past 90 days (cocaine/crack, opiates, misuse of prescription medication, stimulants, psychedelics, ecstasy, ketamine, GHB)
Have a main partner who is another male and have been in a relationship for 3 month or longer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

4Us Trial Summary

This trial is testing whether adding a communication skills training video or a substance use module to couples HIV testing and counseling makes the intervention more effective.

Who is the study for?
This trial is for male couples where one partner is aged 17-29, living in NYC or Detroit areas. They must speak English and have been together for at least 3 months. One should be HIV negative and have used drugs like cocaine or ecstasy recently. They're ineligible if they show serious mental illness, cognitive deficits, or a history of intimate partner violence.Check my eligibility
What is being tested?
The study tests the effectiveness of adding a drug use module and communication skills training video to standard Couples HIV Testing and Counseling (CHTC). Participants are randomly assigned to receive just CHTC, CHTC with either adjunct component, or both additional components.See study design
What are the potential side effects?
Since this trial focuses on counseling modules rather than medication, traditional side effects aren't expected. However, participants may experience emotional discomfort discussing personal topics during sessions.

4Us Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have used a drug like cocaine or ecstasy in the last 90 days.
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I have been in a relationship with another man for at least 3 months.
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I have used a drug like cocaine or ecstasy in the last 90 days.
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I am between 17 and 29 years old, or my main partner is over 17.
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I am between 17 and 29 years old, or my main partner is over 17.
Select...
I have been in a relationship with another man for at least 3 months.

4Us Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bacterial STI's
CAS with casual partners
Drug use frequency
+1 more
Secondary outcome measures
Binge drinking
PrEP Uptake
PrEP adherence
+1 more

4Us Trial Design

4Treatment groups
Active Control
Group I: CHTC as usualActive Control1 Intervention
Participants complete the standard Couples HIV Testing and Counseling session (CHTC).
Group II: CHTC and communications skills training videoActive Control1 Intervention
Participants complete the standard Couples HIV Testing and Counseling session and also watch a communication skills training video together.
Group III: CHTC and substance use moduleActive Control1 Intervention
Participants complete the standard Couples HIV Testing and Counseling session and also complete a substance use module together.
Group IV: CHTC, communications skills training and substance use moduleActive Control2 Interventions
Participants complete the standard Couples HIV Testing and Counseling session and watch a communication skills training video and complete a substance use module together.

Find a Location

Who is running the clinical trial?

Hunter College of City University of New YorkLead Sponsor
38 Previous Clinical Trials
8,597 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,455 Previous Clinical Trials
2,596,484 Total Patients Enrolled
University of MichiganOTHER
1,787 Previous Clinical Trials
6,365,054 Total Patients Enrolled

Media Library

CHTC and communications skills training video Clinical Trial Eligibility Overview. Trial Name: NCT05000866 — N/A
Human Immunodeficiency Virus Infection Research Study Groups: CHTC as usual, CHTC and communications skills training video, CHTC and substance use module, CHTC, communications skills training and substance use module
Human Immunodeficiency Virus Infection Clinical Trial 2023: CHTC and communications skills training video Highlights & Side Effects. Trial Name: NCT05000866 — N/A
CHTC and communications skills training video 2023 Treatment Timeline for Medical Study. Trial Name: NCT05000866 — N/A

Frequently Asked Questions

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

What are the eligibility requirements for participating in this trial?

"This clinical trial is seeking 480 individuals between the ages of 17 and 29 that present with an HIV diagnosis. In addition to age requirements, participants must have used at least one illicit drug within 90 days prior (e.g., cocaine/crack, opiates, misused prescription medication); be in a relationship with another male for 3 months or longer; and partaken in Transmission Risk Behavior (TRB) during the last 90 day period such as Condom-less Anal Sex (CAS) with either casual partners or non-monogamous/serodiscordant main partner(s)."

Answered by AI

Are there any vacancies left in this clinical trial that people can join?

"According to the latest update on clinicaltrials.gov, this medical trial is still recruiting patients; it was initially posted on October 13th 2021 and updated November 24th 2021."

Answered by AI

How many subjects have enrolled in the research thus far?

"Affirmative. According to records on clinicaltrials.gov, this medical research was first posted on October 13th 2021 and is now recruiting 480 patients from two distinct sites."

Answered by AI

Is eligibility for this experiment limited to those over 35 years of age?

"The requirements for taking part in this trial dictate that the youngest enrollees must be 17 years old, while 30 is the cutoff age."

Answered by AI

What is the central goal of this experiment?

"This research project, spanning a period of one year, seeks to measure the primary outcome of CAS with casual partners. Additional objectives include evaluating Prep Uptake (self-reported receipt of prescription), PrEP Adherence (4+ doses weekly as prescribed) and Syphilis infection (based on bi-annual RPR testing)."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Hunter College
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

You rarely see clinical trials hiv+ and substance abuse. Hoping I can stop be sober again. People violate me when I'm using.
PatientReceived 1 prior treatment
~137 spots leftby Apr 2025