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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
Have a main partner who is another male and have been in a relationship for 3 month or longer
· 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
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been in a relationship with another man for at least 3 months.
Select...
I have been in a relationship with another man for at least 3 months.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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?

University of MichiganOTHER
1,852 Previous Clinical Trials
6,432,262 Total Patients Enrolled
Hunter College of City University of New YorkLead Sponsor
40 Previous Clinical Trials
8,434 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,582 Previous Clinical Trials
3,326,560 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
~157 spots leftby May 2026