Couples Motivational Interviewing for Substance Abuse and HIV Risk

(CHP Trial)

Recruiting at 2 trial locations

Overseen By Demetria Cain, PHD

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: Hunter College of City University of New York

Disqualifiers: Serious mental illness, Suicidal ideations, IPV history, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 9 months

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a unique approach called Couples Motivational Interviewing to determine its effectiveness in reducing drug use and risky behaviors that could lead to HIV. Participants will be randomly assigned to either this new method or the usual couples HIV testing and counseling. The trial specifically seeks male couples where one partner has recently used drugs and engaged in risky sexual behaviors. This approach may suit couples aiming to improve communication and reduce health risks. As an unphased trial, it offers a unique opportunity for couples to contribute to innovative research that could enhance relationship dynamics and health outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this method is safe for reducing substance abuse and HIV risk?

Research shows that motivational interviewing (MI) is generally easy for people to handle. This counseling method helps individuals discuss their motivations and make positive changes. Studies have found that MI can effectively reduce substance use and improve health-related behaviors.

In couples motivational interviewing, the focus shifts to helping partners work through challenges together. Reports have not indicated any major negative effects from this approach. Instead, it often enhances communication and teamwork between partners.

This information suggests that couples motivational interviewing is a safe option for those looking to reduce drug use and HIV risk. For those considering joining a trial using this method, existing evidence supports its safety and potential benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Couples Motivational Interviewing because it offers a fresh approach to tackling substance abuse and HIV risk among couples. Unlike standard treatments that often focus on individuals, this intervention emphasizes couples communication skills, substance use management, and sexual agreements, all within a supportive partnership framework. The inclusion of couples HIV testing and counseling as part of the intervention's final session provides a holistic strategy that addresses both behavioral and health aspects, aiming to strengthen relationships while promoting healthier lifestyles.

What evidence suggests that Couples Motivational Interviewing is effective for reducing substance abuse and HIV risk?

Research shows that Couples Motivational Interviewing (MI), which participants in this trial may receive, can help reduce drug use and risky behaviors linked to HIV. Previous studies, particularly with young gay and bisexual men, have shown promise for this approach. These studies suggest that MI can enhance communication between couples and support healthier decision-making. Although results have varied, the method has been encouraging for certain groups. This treatment emphasizes improving communication and making agreements about substance use and sexual health, which are crucial for reducing risks. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for male couples where at least one partner has HIV and both are involved in drug use. They must be willing to participate together in interviews or counseling sessions aimed at reducing drug use and the risk of spreading HIV.

Inclusion Criteria

I have used a drug from the specified list in the past 30 days.

My main partner is a cisgender male and we've been together for 3+ months.

Live in the United States

Exclusion Criteria

Any signs of serious mental illness or cognitive deficit

Current suicidal/homicidal ideations

I have experienced intimate partner violence and feel unsafe in my current relationship.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a three-session intervention focusing on couples communication skills, substance use, and sexual agreements, including couples HIV testing and counseling

9 months

3 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments on drug use, sexual behavior, and PrEP uptake

9 months

Quarterly assessments

What Are the Treatments Tested in This Trial?

Interventions

• Couples Motivational Interviewing

Trial Overview The study is testing a program called Couples Health Project, which uses motivational interviewing techniques to help reduce drug use and risky behaviors that could spread HIV. Participants will either receive this special intervention or standard HIV testing and counseling.

How Is the Trial Designed?

Group I: Behavioral: Couples Health Project Active Control 1 Intervention

A three-session intervention for couples addressing couples communication skills, substance use, sexual agreements. The intervention also includes couples HIV testing and counseling in the final session.

Group II: No Intervention: CHTC as usual Active Control 1 Intervention

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

Couples Motivational Interviewing is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Motivational Interviewing for:

• Substance use reduction
• HIV risk reduction

Approved in Canada as Motivational Interviewing for:

• Substance use reduction
• HIV risk reduction

Approved in European Union as Motivational Interviewing for:

• Substance use reduction
• HIV risk reduction

Who Is Running the Clinical Trial?

Hunter College of City University of New York

Lead Sponsor

Trials

43

Recruited

10,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Motivational Interviewing (MI) can be effectively adapted for use with couples, treating both partners as the identified clients, which may enhance interventions aimed at reducing substance use and sexual HIV transmission risk.

The proposed framework highlights unique aspects of MI with couples, such as addressing interpersonal ambivalence and fostering joint goal formation, suggesting that this approach could improve outcomes for gay male couples facing these challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing with couples: A theoretical framework for clinical practice illustrated in substance use and HIV prevention intervention with gay male couples. Starks, TJ., Millar, BM., Doyle, KM., et al.[2023]

The study developed a reliable and valid assessment tool called the Motivational Interviewing Skills for Health Care Encounters (MISHCE) to evaluate healthcare providers' competence in motivational interviewing, which is crucial for effective patient interactions.

MISHCE demonstrated good internal consistency (Cronbach's alpha of 0.75) and strong reliability metrics, ensuring it can effectively measure both the skills of providers and the quality of the therapeutic alliance in brief healthcare encounters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational Interviewing Skills in Health Care Encounters (MISHCE): Development and psychometric testing of an assessment tool. Petrova, T., Kavookjian, J., Madson, MB., et al.[2015]

In a study examining motivational interviewing (MI) quality within the SafeTalk intervention for people living with HIV/AIDS, higher MI quality ratings were linked to a significant reduction in unprotected anal/vaginal intercourse (UAVI) acts at an 8-month follow-up.

Specifically, better MI quality, indicated by higher global ratings and a greater ratio of reflections to questions, predicted fewer UAVI incidents, suggesting that effective counseling can play a crucial role in promoting safer sexual behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the quality of safetalk motivational interviewing counseling predict sexual behavior outcomes among people living with HIV? Grodensky, C., Golin, C., Parikh, MA., et al.[2018]

Motivational interviewing (MI) is effective for treating substance use disorders, and this review identified key mechanisms of change, particularly client change talk/intention and the experience of discrepancy, which are linked to better treatment outcomes.

Therapist behaviors also play a crucial role; specifically, MI-Inconsistent behaviors were associated with worse outcomes, while the use of specific techniques like decisional balance exercises showed a strong positive correlation with treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms of change in motivational interviewing: a review and preliminary evaluation of the evidence. Apodaca, TR., Longabaugh, R.[2021]

The study involved 70 male couples and tested the effectiveness of adding communication training videos and a substance use module to couples HIV testing and counseling, finding that the substance use module alone led to immediate reductions in drug use.

However, sustained reductions in drug use over 3 and 6 months were only observed when the substance use module was combined with communication training videos, indicating that both components may be necessary for long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Trial of Intervention Components Addressing Drug Use in Couples HIV Testing and Counseling (CHTC) with Male Couples. Starks, TJ., Dellucci, TV., Gupta, S., et al.[2020]

Motivational interviewing (MI) can be effective in reducing substance use among male couples, but conflicts during sessions can hinder progress; this study analyzed 14 cis-male couples to identify these conflicts and effective responses.

Provider strategies such as correcting assumptions and focusing on relationship repair were found to help manage conflicts, promoting better communication and cooperation between partners, which is crucial for addressing substance use and sexual health goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing with male couples to reduce substance use and HIV risk: Manifestations of partner discord and strategies for facilitating dyadic functioning. Starks, TJ., Robles, G., Doyle, KM., et al.[2021]

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]

A study involving 140 adult HIV-infected patients found that a motivational interviewing (MI) intervention improved ART adherence by 4.5% compared to a control group, which experienced a decrease in adherence.

The MI group had 2.75 times higher odds of achieving over 95% adherence compared to controls, suggesting that MI may be a promising strategy for enhancing adherence to antiretroviral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 2-arm, randomized, controlled trial of a motivational interviewing-based intervention to improve adherence to antiretroviral therapy (ART) among patients failing or initiating ART. Golin, CE., Earp, J., Tien, HC., et al.[2022]

A randomized controlled trial involving 50 sexual minority male couples found that a motivational interviewing (MI) intervention significantly reduced illicit drug use (excluding marijuana) at the 3-month follow-up, particularly among couples with high baseline drug use.

The MI intervention also led to a reduction in condomless anal sex with casual partners when both partners reported high frequency of such behavior at baseline, indicating its potential effectiveness in addressing both drug use and sexual risk-taking in high-risk couples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Randomized Controlled Trial of Motivational Interviewing with Sexual Minority Male Couples to Reduce Drug Use and Sexual Risk: The Couples Health Project. Starks, TJ., Adebayo, T., Kyre, KD., et al.[2023]

The study tested new scoring methods for evaluating motivational interviewing (MI) with couples, showing high reliability in assessing key elements like Decreasing Dyadic Ambivalence and Facilitating Dyadic Functioning, with nearly perfect agreement rates of 100% and 94%, respectively.

MI sessions were found to be significantly more effective than educational sessions in generating both new and established coding scores, indicating that these novel scores could be useful for future research on MI interventions aimed at reducing substance use and HIV risk among couples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of Motivational Interviewing Treatment Integrity (MITI) Fidelity Codes Assessing Motivational Interviewing with Couples. Starks, TJ., Doyle, KM., Stewart, JL., et al.[2023]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11131189

Couples Motivational Interviewing to reduce drug use and HIV risk in ... To date, applications of Motivational Interviewing with couples were relatively rare and produced mixed results. Building on our successful pilot, we ...

2. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-20719-y

A protocol for a randomized controlled trial of couples ... A randomized controlled trial utilizing Motivational interviewing to reduce HIV risk and drug use in young gay and bisexual men. J Consult ...

3. trialx.com trialx.com/clinical-trials/listings/299172/couples-motivational-interviewing-to-reduce-drug-use-and-hiv-risk-in-vulnerable-male-couples/?&geo_lat=40.7830603&geo_lng=-73.9712488&radius=10&place=Manhattan&user_country=United%20States

Couples Motivational Interviewing to Reduce Drug Use ... This study utilizes a randomized controlled trial design to evaluate the efficacy of couples motivational interviewing (MI) to reduce the ...

4. taggs.hhs.gov taggs.hhs.gov/Detail/AwardDetail?arg_AwardNum=R01DA059272&arg_ProgOfficeCode=114

Award Information | HHS TAGGS Couples Motivational Interviewing to reduce drug use and HIV risk in vulnerable male couples. Award Number: R01DA059272. ORGANIZATION: NATIONAL INSTITUTE ON ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03386110

Couples-based Intervention to Reduce Drug Use and HIV ... A randomized controlled trial utilizing motivational interviewing to reduce HIV risk and drug use in young gay and bisexual men. J Consult Clin Psychol ...

6. reporter.nih.gov reporter.nih.gov/project-details/10757544

Couples Motivational Interviewing to reduce drug use and ... A protocol for a randomized controlled trial of couples motivational interviewing to reduce drug use and HIV transmission risk among male couples in the US: the ...

7. withpower.com withpower.com/trial/phase-hiv-infections-2-2024-b9c91

Couples Motivational Interviewing for Substance Abuse ... Research shows that motivational interviewing (MI) is effective in reducing substance use and improving health-related behaviors. Studies have found that MI can ...