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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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 moreSecondary study objectives
Binge drinking
PrEP Uptake
PrEP adherence
+1 moreAwards & 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
1,863 Previous Clinical Trials
6,441,093 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
2,606 Previous Clinical Trials
3,329,389 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had unprotected anal sex with someone who is not your regular partner or with a partner who has a different HIV status than you.I have used a drug like cocaine or ecstasy in the last 90 days.I have been in a relationship with another man for at least 3 months.You have engaged in risky behavior that could lead to transmitting diseases in the last 90 days.I am between 17 and 29 years old, or my main partner is over 17.I have experienced intimate partner violence and feel unsafe in my current relationship.I am between 17 and 29 years old, or my main partner is over 17.I have been in a relationship with another man for at least 3 months.You have severe mental illness or problems with thinking and memory.You have had unprotected anal sex with a casual partner or with a non-monogamous or serodiscordant main partner in the last 90 days.
Research Study Groups:
This trial has the following groups:- Group 1: CHTC as usual
- Group 2: CHTC and communications skills training video
- Group 3: CHTC and substance use module
- Group 4: CHTC, communications skills training and substance use module
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.