Couples Motivational Interviewing for Substance Abuse and HIV Risk
(CHP Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18 - 65
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Hunter College of City University of New York
Disqualifiers: Serious mental illness, Suicidal ideations, IPV history, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This study utilizes a randomized controlled trial design to evaluate the efficacy of couples motivational interviewing (MI) to reduce the frequency and severity of illicit drug use and frequency of HIV transmission risk behavior (TRB). Participants are randomized to one of two conditions: couples MI or standard couples HIV testing and counseling (CHTC).
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 data supports the effectiveness of the treatment Couples Motivational Interviewing for Substance Abuse and HIV Risk?
Research shows that motivational interviewing (MI) is effective in reducing substance use and improving health-related behaviors. Studies have found that MI can help couples improve their relationship dynamics and communication, which are important for addressing substance use and HIV risk.
12345Is Couples Motivational Interviewing safe for humans?
Motivational Interviewing (MI), including when used with couples, is generally considered safe as it is a non-judgmental, client-centered counseling style. The studies reviewed did not report any safety concerns, suggesting it is safe for use in humans.
12678How is the Couples Motivational Interviewing treatment different from other treatments for substance abuse and HIV risk?
Couples Motivational Interviewing is unique because it treats the couple as a unit rather than focusing on an individual, addressing both substance use and HIV risk by improving communication and resolving conflicts between partners. This approach leverages the dynamics of the relationship to facilitate change, which is particularly relevant for male couples where substance use and sexual health are interconnected.
128910Eligibility Criteria
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.
I am between 18 and 34 years old.
+4 more
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.
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Active Control
Group I: Behavioral: Couples Health ProjectActive Control1 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 usualActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of VirginiaCharlottesville, VA
Wayne State UniversityDetroit, MI
Hunter CollegeNew York, NY
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Who Is Running the Clinical Trial?
Hunter College of City University of New YorkLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
References
Development of Motivational Interviewing Treatment Integrity (MITI) Fidelity Codes Assessing Motivational Interviewing with Couples. [2023]This study evaluated preliminary reliability and validity evidence for novel scores that extend the motivational interviewing treatment integrity (MITI) coding system to assess elements unique to motivational interviewing (MI) with couples. We recruited 20 cismale couples where at least one partner was aged 18-29; reported substance use; and was HIV-negative. Couples were randomized to a three-session MI or attention-matched education control. Four coders rated audio-recordings of initial sessions in both conditions. Novel global scores had high nearly-exact percent agreement (Decreasing Dyadic Ambivalence = 100%; Facilitating Dyadic Functioning = 94%). Consistency for novel behavior counts was good (ICCdyadic reflections = .72) and above minimum thresholds (nearly-exact agreement for Relationship Affirmations = 78%). MI sessions generated novel and established MITI codes that were significantly better than education sessions, providing preliminary evidence of validity. Findings provided initial support for the use of these novel scores in future research evaluating MI-based substance use and HIV risk reduction studies with couples.
Motivational interviewing with male couples to reduce substance use and HIV risk: Manifestations of partner discord and strategies for facilitating dyadic functioning. [2021]The efficacy of motivational interviewing (MI) to reduce substance use is well established; however, its use with couples has met with mixed results. The development of such interventions is particularly relevant for male couples, as rates of substance use in this population are comparatively high and use is associated with aspects of sexual relationship functioning. One challenge noted in conducting MI with couples is how to respond to situations in which partners disagree with one another or argue against change. Guided by the couples interdependence theory, we conceptualized conflicts within session as failures in the accommodation process. We used qualitative analysis to examine manifestations of conflict in session and to identify effective provider response strategies. The sample included 14 cis-male couples with at least 1 partner was aged 18-29 years, reported substance use, and was HIV negative. All couples completed 3 MI sessions lasting 60-75 min each. Manifestations of conflict included conflation of thoughts/feelings, vague or indirect communication, and inaccurate assumptions. Effective provider responses included correcting assumptions, shifting focus, relationship repair, "common ground" reflections, and relationship affirmations. Observed conflicts aligned with conceptualizations of destructive resolutions to the accommodation process (i.e., exit and neglect). Effective provider responses to conflict facilitated dyadic functioning and catalyzed constructive accommodation. These results provide an initial compendium of provider skills and strategies that may be particularly relevant in work with sexual minority male couples, for whom achieving accommodation around drug use and sexual health goals is often viewed as a key mechanism of intervention. (PsycINFO Database Record (c) 2020 APA, all rights reserved).
Motivational Interviewing Skills in Health Care Encounters (MISHCE): Development and psychometric testing of an assessment tool. [2015]Motivational interviewing (MI) has demonstrated a significant impact as an intervention strategy for addiction management, change in lifestyle behaviors, and adherence to prescribed medication and other treatments. Key elements to studying MI include training in MI of professionals who will use it, assessment of skills acquisition in trainees, and the use of a validated skills assessment tool.
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. [2022]Motivational interviewing (MI) is a counseling technique that has been used effectively to change a number of health-related behaviors. We sought to assess the impact on patients' antiretroviral therapy (ART) adherence of a multicomponent, MI-based ART adherence intervention compared with that of an HIV informational control program.
Mechanisms of change in motivational interviewing: a review and preliminary evaluation of the evidence. [2021]Motivational interviewing (MI) is an efficacious treatment for substance use disorders. However, little is known about how MI exerts its therapeutic effects. This review is a first attempt to summarize and evaluate the evidence for purported within-session mechanisms of change. The primary question of interest was: which MI constructs and variables appear to be the most promising candidates for mechanisms of change?
Does the quality of safetalk motivational interviewing counseling predict sexual behavior outcomes among people living with HIV? [2018]Although past research has demonstrated a link between the quality of motivational interviewing (MI) counseling and client behavior change, this relationship has not been examined in the context of sexual risk behavior among people living with HIV/AIDS. We studied MI quality and unprotected anal/vaginal intercourse (UAVI) in the context of SafeTalk, an evidence-based secondary HIV prevention intervention.
Start Talking About Risks: development of a Motivational Interviewing-based safer sex program for people living with HIV. [2022]The epidemiology of HIV infection in the US in general, and in the southeast, in particular, has shifted dramatically over the past two decades, increasingly affecting women and minorities. The site for our intervention was an infectious diseases clinic based at a university hospital serving over 1,300 HIV-infected patients in North Carolina. Our patient population is diverse and reflects the trends seen more broadly in the epidemic in the southeast and in North Carolina. Practicing safer sex is a complex behavior with multiple determinants that vary by individual and social context. A comprehensive intervention that is client-centered and can be tailored to each individual's circumstances is more likely to be effective at reducing risky behaviors among clients such as ours than are more confrontational or standardized prevention messages. One potential approach to improving safer sex practices among people living with HIV/AIDS (PLWHA) is Motivational Interviewing (MI), a non-judgmental, client-centered but directive counseling style. Below, we describe: (1) the development of the Start Talking About Risks (STAR) MI-based safer sex counseling program for PLWHA at our clinic site; (2) the intervention itself; and (3) lessons learned from implementing the intervention.
Pilot Randomized Controlled Trial of Motivational Interviewing with Sexual Minority Male Couples to Reduce Drug Use and Sexual Risk: The Couples Health Project. [2023]A randomized controlled trial evaluated the preliminary efficacy of a dyadically-delivered motivational interviewing (MI) intervention to reduce drug use and sexual risk in a sample of 50 sexual minority (cis)male (SMM) couples. In each couple, at least one partner was aged 18-29; reported drug use and sexual HIV transmission risk; and was HIV-negative. Couples were randomized to either the three-session MI intervention or an attention-matched control, with follow-up surveys completed at 3- and 6-months post-baseline. Between-group differences for all outcomes were non-significant in the overall sample. Subsequent moderation analyses indicated the intervention significantly reduced illicit drug use (excluding marijuana) at 3-month follow-up when either respondents (B = - 1.96; interval rate ratio-IRR 0.02-1.22; p = .001), their partners (B = - 2.60; IRR 0.01-0.64; p = .004), or both (B = - 2.38; IRR 0.01-0.80; p = .001) reported high levels of baseline use. The intervention also reduced condomless anal sex (CAS) with casual partners when both partners reported high frequency baseline CAS (B = - 2.54; IRR 0.01-0.83; p = .047). Findings provide initial evidence of the potential for MI to address drug use and sexual risk-taking among SMM couples at highest risk.Trial Registration ClinicalTrials.gov (NIH U.S. National Library of Medicine) Identifier: #NCT03386110.
Motivational interviewing with couples: A theoretical framework for clinical practice illustrated in substance use and HIV prevention intervention with gay male couples. [2023]Epidemiological data indicate the need to address substance use and sexual HIV transmission risk among gay and bisexual men in relationships. While brief Motivational Interviewing (MI) delivered to the individual has shown efficacy in reducing sexual HIV risk with casual partners and substance use, the application of MI with couples has received less attention. Most studies of MI with couples have conceptualized the "spouse" or partner as an adjunct participant in the treatment of an identified client. We propose a theoretical framework for conducting MI with a couple, which approaches the couple as the identified client, and may be adopted when either one or both partners engage in the target behavior. We then discuss similarities between MI-processes conceptualized with our proposed framework and those that are salient in existing couples therapies. We utilize case examples from brief MI sessions targeting substance use and sexual HIV risk in gay male couples to illustrate three phenomena unique to the implementation of MI with couples: 1) interpersonal ambivalence; 2) the role of dyadic functioning in tolerating and resolving interpersonal ambivalence; and 3) joint goal formation as a prerequisite to the planning phase of MI. Connecting these phenomena with the transformation of motivation and accommodation processes outlined in Couples Interdependence Theory, this paper suggests that brief MI may be a promising modality for substance use and HIV risk reduction interventions with couples generally and gay couples specifically.
A Pilot Randomized Trial of Intervention Components Addressing Drug Use in Couples HIV Testing and Counseling (CHTC) with Male Couples. [2020]Men who have sex with men (MSM) experience high rates of substance use and HIV infection. Main partners are the source of many (35-68%) of these new HIV infections. This study developed and examined the efficacy of two adjunct components to couples HIV testing and counseling (CHTC)-communication training (CT) videos and a substance use module (SUM)-to reduce drug use and sexual HIV transmission risk in MSM couples. Participants included 70 male couples randomized into one of four conditions: CHTC, CHTC + CT videos, CHTC + SUM, and CHTC + CT videos + SUM. Participants completed a survey pre-intervention and 1-, 3-, and 6-months later. Completion of the SUM in the absence of CT videos was associated with significant immediate decreases in drug use and related problems; however, at 3- and 6-month follow ups, the SUM was only associated with reductions in drug use and related problems among men who also viewed the CT videos. There were no between-condition differences in sexual behavior. CHTC may serve as a vehicle for the delivery of brief substance use intervention for MSM couples.ClinicalTrails.gov NCT # 03125915.