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Drug Use Module for HIV Infection(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 be HIV negative (as confirmed by rapid test)

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)

Must not have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up12 months

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Human Immunodeficiency Virus (HIV) Infection
Substance Abuse

4Us Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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You have engaged in risky behavior that could lead to transmitting diseases in the last 90 days.

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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.

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You have had unprotected anal sex with a casual partner or with a non-monogamous or serodiscordant main partner in the last 90 days.

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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).

4Us Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Awards & Highlights

No Placebo-Only Group

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

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.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hunter College of City University of New YorkLead Sponsor

37 Previous Clinical Trials

8,237 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,397 Previous Clinical Trials

2,059,964 Total Patients Enrolled

University of MichiganOTHER

1,744 Previous Clinical Trials

6,584,461 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