480 Participants Needed

Communication + Substance Use Interventions for HIV

(4Us Trial)

Recruiting at 1 trial location
TJ
CC
Overseen ByChristine Cowles
Age: < 65
Sex: Male
Trial Phase: Academic
Sponsor: Hunter College of City University of New York
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of this treatment for reducing drug use in people with HIV?

Research shows that using technology like HealthCall, which includes self-monitoring and feedback, can help reduce drug and alcohol use in people with HIV. Additionally, improving communication skills in healthcare providers can enhance patient motivation and adherence to treatment plans.12345

Is the Communication + Substance Use Interventions for HIV treatment safe for humans?

The research articles provided do not contain specific safety data for the Communication + Substance Use Interventions for HIV treatment or its related modules. Therefore, no relevant safety information is available from these sources.26789

How does the Communication + Substance Use Interventions treatment for HIV differ from other treatments?

This treatment is unique because it combines communication strategies with substance use interventions, focusing on improving patient-provider communication and using motivational interviewing techniques enhanced by smartphone technology to support medication adherence and reduce substance use among people living with HIV.210111213

What is the purpose of this trial?

This study utilizes a randomized controlled trial design to evaluate the efficacy of two intervention components for couples HIV testing and counseling (CHTC): a communication skills training video and a substance use module. Participants are randomized in a full-factorial design to one of 4 conditions: CHTC as usual; CHTC + communication skills training videos; CHTC + substance use module; or CHTC plus both adjunct components.

Eligibility Criteria

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.

Inclusion 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.
See 7 more

Exclusion Criteria

I have experienced intimate partner violence and feel unsafe in my current relationship.
You have severe mental illness or problems with thinking and memory.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Couples HIV Testing and Counseling (CHTC) with potential adjunct modules including communication skills training and substance use module

12 months
Quarterly and bi-annual assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Communication skills training video
  • Drug use module
Trial Overview 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

Hunter College of City University of New York

Lead Sponsor

Trials
43
Recruited
10,000+

University of Michigan

Collaborator

Trials
1,891
Recruited
6,458,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Findings from Research

The addition of an educational component to a community outreach program aimed at reducing HIV transmission behaviors among injecting drug users did not lead to significant differences in risk reduction compared to the standard intervention.
The study highlights the need for more effective interventions that focus on maximizing healthcare service utilization and strengthening social support networks for injecting drug users, given their chronic drug use and high HIV infection rates.
Effects of a HIV risk reduction education program among injection drug users in Puerto Rico.Colón, HM., Robles, RR., Freeman, D., et al.[2007]
The MI+HealthCall intervention, which combines Motivational Interviewing with smartphone technology, showed high feasibility with a 95% daily use rate and excellent patient satisfaction (4.5 out of 5) among adults living with HIV.
Participants using MI+HealthCall experienced significantly greater reductions in drug use and spending compared to those receiving only Motivational Interviewing, indicating its potential effectiveness in addressing substance use issues that can hinder HIV treatment adherence.
HealthCall delivered via smartphone to reduce co-occurring drug and alcohol use in HIV-infected adults: A randomized pilot trial.Aharonovich, E., Stohl, M., Cannizzaro, D., et al.[2020]
The adherence intervention for antiretroviral therapy (ART) significantly improved patients' information and motivation scores, indicating enhanced understanding and willingness to adhere to treatment, but it also led to a decrease in behavioral skills related to adherence.
Better patient-provider communication was linked to higher motivation and overall information scores for ART adherence, suggesting that effective communication can play a crucial role in improving treatment adherence among patients.
An EMR-based alert with brief provider-led ART adherence counseling in Haiti: effects on information, motivation, and behavioral skills (IMB) and patient-provider communication (PPC).Wang, L., Ramaiya, MK., Puttkammer, N., et al.[2023]

References

Effects of a HIV risk reduction education program among injection drug users in Puerto Rico. [2007]
HealthCall delivered via smartphone to reduce co-occurring drug and alcohol use in HIV-infected adults: A randomized pilot trial. [2020]
An EMR-based alert with brief provider-led ART adherence counseling in Haiti: effects on information, motivation, and behavioral skills (IMB) and patient-provider communication (PPC). [2023]
Improving oncology nurses' communication skills for difficult conversations. [2018]
Characterizing and improving HIV/AIDS knowledge among cocaine-dependent outpatients. [2007]
Preliminary Evidence for Feasibility, Use, and Acceptability of Individualized Texting for Adherence Building for Antiretroviral Adherence and Substance Use Assessment among HIV-Infected Methamphetamine Users. [2022]
Implementation of a fidelity monitoring process to assess delivery of an evidence-based adherence counseling intervention in a multi-site biomedical HIV prevention study. [2021]
Start Talking About Risks: development of a Motivational Interviewing-based safer sex program for people living with HIV. [2022]
Program targets HIV+ injection drug users. [2005]
10.United Statespubmed.ncbi.nlm.nih.gov
Integrated Care Models: HIV and Substance Use. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Patient-Provider Communication and Information, Motivation, and Behavioral Skills in HIV-Positive Adults Initiating Antiretroviral Therapy in Haiti. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Substance use service availability in HIV treatment programs: Data from the global IeDEA consortium, 2014-2015 and 2017. [2023]
A pilot randomized clinical trial of two medication adherence and drug use interventions for HIV+ crack cocaine users. [2021]
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