Communication + Substance Use Interventions for HIV

(4Us Trial)

Recruiting at 1 trial location

Overseen By Christine Cowles

Age: < 65

Sex: Male

Trial Phase: Academic

Sponsor: Hunter College of City University of New York

Disqualifiers: Serious mental illness, IPV history, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

480 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to improve Couples HIV Testing and Counseling sessions. It examines whether adding a communication skills training video or a drug use module (known as the Substance Use Module or Adjunct Module for Reducing Drug Use) can better support couples. Participants will join one of four groups: the usual counseling session, counseling plus the video, counseling plus the substance module, or both additional components. Eligibility requires participants to have been in a same-sex relationship for at least three months, live in NYC or Detroit, speak English, and meet specific health and behavior criteria. As an unphased trial, this study explores innovative approaches to enhance support for couples, offering participants a chance to contribute to meaningful advancements in HIV counseling.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that video-based training for communication skills is safe. Studies involving diverse groups, such as women in Africa and men in U.S. cities, found these videos effective in preventing HIV. No reports of harm have emerged from using these videos.

For the substance use module, early studies suggest it is safe and may quickly reduce drug use, even within a month of completion. This module aims to decrease risky behaviors, and no serious side effects have been reported.

Overall, available research indicates that both methods are well-received. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions because they aim to enhance standard HIV care by integrating communication and substance use components. Unlike conventional approaches that focus solely on medical aspects, these treatments emphasize improving communication between partners, which can strengthen relationships and reinforce mutual support in managing HIV. Additionally, the substance use module directly addresses drug-related behaviors that can impact HIV treatment adherence and transmission. By targeting these behavioral factors, the interventions have the potential to improve overall outcomes for couples dealing with HIV.

What evidence suggests that this trial's interventions could be effective for HIV?

This trial will compare different interventions to enhance traditional Couples HIV Testing and Counseling (CHTC). Participants in one arm will watch a communication skills training video, which research has shown can effectively boost knowledge about HIV. For instance, studies have found that these videos helped both parents and teens learn more about HIV, which is important for prevention.

Another arm will involve a substance use module. Research suggests this module can help reduce risky behaviors related to drug use and HIV spread. One study showed that motivational interviewing, a technique used in these modules, effectively encouraged people to change their substance use habits.

Additionally, some participants will receive both the communication skills training video and the substance use module, aiming to improve traditional CHTC by offering extra tools for better communication and managing substance use. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: CHTC as usual Active Control 1 Intervention

Participants complete the standard Couples HIV Testing and Counseling session (CHTC).

Group II: CHTC and communications skills training video Active Control 1 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 module Active Control 1 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 module Active Control 2 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.

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study involving 128 patients starting antiretroviral therapy (ART) in Haiti, effective patient-provider communication (PPC) was linked to better information and motivation regarding ART adherence, highlighting its importance in treatment success.

Observational data revealed that adherence support during clinic visits was infrequent and non-collaborative, suggesting a need for improved communication strategies to enhance ART adherence in this setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Provider Communication and Information, Motivation, and Behavioral Skills in HIV-Positive Adults Initiating Antiretroviral Therapy in Haiti. Ramaiya, MK., Haight, E., Simoni, JM., et al.[2021]

A brief education intervention significantly increased HIV/AIDS knowledge among cocaine-dependent outpatients, as evidenced by higher test scores in the experimental group compared to the control group.

The effectiveness of the intervention was further confirmed when control participants, after receiving the education, also showed improved knowledge scores, indicating that the intervention is both effective and easily implementable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing and improving HIV/AIDS knowledge among cocaine-dependent outpatients. Heil, SH., Sigmon, SC., Mongeon, JA., et al.[2007]

Integrated care services that combine treatment for HIV and substance use disorders can significantly improve health outcomes, such as enhancing HIV viral suppression, particularly through opioid use disorder treatment.

Innovative delivery methods, including mobile healthcare clinics, telehealth, and technology like mobile apps, are effective in providing integrated care to communities at risk for HIV and substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Care Models: HIV and Substance Use. Hill, K., Kuo, I., Shenoi, SV., et al.[2023]

A survey of 286 HIV care sites in 45 countries showed that from 2014-2015 to 2017, there was a notable increase in the provision of substance use education (up 9%), screening (up 16%), and referrals (up 8%) for patients, indicating a positive trend in integrating substance use services into HIV care.

Despite these improvements, significant gaps remain, especially in screening and referral services for children and adolescents, and in lower-income countries, highlighting the need for continued efforts to enhance these services in resource-constrained settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Substance use service availability in HIV treatment programs: Data from the global IeDEA consortium, 2014-2015 and 2017. Parcesepe, AM., Lancaster, K., Edelman, EJ., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A targeted educational program was developed to enhance therapeutic communication skills among oncology nurses, focusing on goals-of-care discussions and delivering bad news, addressing a recognized gap in their training.

The program was well-received by participants, indicating a strong interest in ongoing education to improve communication skills, which are crucial for patient satisfaction and clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving oncology nurses' communication skills for difficult conversations. Baer, L., Weinstein, E.[2018]

In a study involving 1456 participants across 14 sites in Sub-Saharan Africa, monitoring the fidelity of counseling for the dapivirine vaginal ring was feasible and effective, with 54.1% of expected counseling sessions being audio-recorded.

The majority of reviewed sessions (83.9%) were rated as 'good' or 'fair', indicating that consistent and high-quality counseling can be maintained, which is crucial for supporting adherence to PrEP interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a fidelity monitoring process to assess delivery of an evidence-based adherence counseling intervention in a multi-site biomedical HIV prevention study. Balán, IC., Lentz, C., Giguere, R., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 HIV epidemic in the US, particularly in the southeast, has increasingly impacted women and minorities, highlighting the need for tailored interventions in diverse patient populations.

The Start Talking About Risks (STAR) program utilizes Motivational Interviewing (MI) to provide a client-centered approach to safer sex counseling for people living with HIV/AIDS, aiming to effectively reduce risky behaviors by addressing individual circumstances rather than using standardized prevention messages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Start Talking About Risks: development of a Motivational Interviewing-based safer sex program for people living with HIV. Golin, CE., Patel, S., Tiller, K., et al.[2022]

In a pilot study involving 54 adults with crack cocaine use and HIV, both Motivational Interviewing plus feedback and skills building (MI+) and Video information plus debriefing (Video+) interventions significantly improved adherence to HAART and reduced drug problems over 6 months, with medium effect sizes observed.

No significant differences were found between the two intervention groups, indicating that both methods are effective and may be scalable for improving treatment adherence among individuals with substance use issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized clinical trial of two medication adherence and drug use interventions for HIV+ crack cocaine users. Ingersoll, KS., Farrell-Carnahan, L., Cohen-Filipic, J., et al.[2021]

The individualized texting for adherence building (iTAB) intervention showed a high response rate of 72.9% for tracking methamphetamine use, indicating that text messaging can be an effective tool for monitoring substance use among HIV-infected individuals.

Participants in the iTAB group reported a 69.0% response rate to ART adherence reminders, with 81.8% confirming they took their medication, suggesting that personalized text messages can significantly enhance adherence to antiretroviral treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Moore, DJ., Montoya, JL., Blackstone, K., et al.[2022]

A targeted intervention program for HIV-positive injection drug users can effectively educate them about safety measures related to their health and drug use.

This program offers a practical approach for HIV programs to engage and inform this high-risk population, potentially improving their health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Program targets HIV+ injection drug users. [2005]

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A videotape-based, HIV prevention intervention is a feasible and effective approach to HIV prevention among female military personnel from sub-Saharan Africa.

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