Communication + Substance Use Interventions for HIV
(4Us Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: < 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, IPV history, others
Stay on your current meds
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
16789How 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.
110111213Eligibility 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.
+8 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.
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
University of MichiganAnn Arbor, MI
Hunter CollegeNew York, NY
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Who Is Running the Clinical Trial?
Hunter College of City University of New YorkLead Sponsor
University of MichiganCollaborator
National Institute on Drug Abuse (NIDA)Collaborator
References
HealthCall delivered via smartphone to reduce co-occurring drug and alcohol use in HIV-infected adults: A randomized pilot trial. [2020]Co-occurrence of drug and alcohol use among people living with HIV is linked to poor medication adherence and lack of viral suppression. HealthCall, a technological enhancement of brief Motivational Interviewing (MI), involves brief daily self-monitoring, positive reinforcement, and personalized feedback. This randomized pilot study among people living with HIV investigated the feasibility and efficacy of reducing non-injection drug and alcohol use with MI+HealthCall as adapted for smartphone technology.
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]We examined the secondary effects of an antiretroviral therapy (ART) adherence intervention on information, motivation, and behavioral skills (IMB) and patient-provider communication (PPC). Data were from a sample of 116 patients enrolled in a quasi-experimental mixed-methods study at two large ART clinics in Haiti. We examined changes in IMB and PPC scores after the intervention and the association between baseline PPC and endline IMB.The intervention was associated with increased scores in information (ß = 0.89, 95% CI [0.07, 1.70]) and motivation (ß = 2.55, 95% CI [0.38, 4.72]) but a decreased score in behavioral skills (ß = -2.39, 95% CI [-4.29, -0.49]), after controlling for demographic and clinical variables. Baseline PPC was associated with higher endline IMB total scores (ß = 0.17, 95% CI [0.02, 0.31]), controlling for demographic variables, clinical variables, and baseline IMB score. At the subscale level, baseline PPC was associated with higher endline motivation score (ß = 0.09, 95% CI [0.01, 0.17]), marginally associated with higher endline information score (ß = 0.04, 95% CI [0.00, 0.08]), after controlling for demographic and clinical variables.The intervention was beneficial to patients' adherence related motivation. Favorable patient-provider communication is associated with more motivation to adhere to ART.
Improving oncology nurses' communication skills for difficult conversations. [2018]When oncology nurses have strong communication skills, they play a pivotal role in influencing patient satisfaction, adherence to plans of care, and overall clinical outcomes. However, research studies indicate that nurses tend to keep communication with patients and families at a superficial, nontherapeutic level. Processes for teaching goals-of-care communication skills and for implementing skills into clinical practice are not clearly defined. Nurses at a large comprehensive cancer center recognized the need for help with this skill set and sought out communication experts to assist in providing the needed education. An educational project was developed to improve therapeutic communication skills in oncology nurses during goals-of-care discussions and giving bad news. The program was tailored to nurses and social workers providing care to patients in a busy, urban, academic, outpatient oncology setting. Program topics included exploring the patient's world, eliciting hopes and concerns, and dealing with conflict about goals. Sharing and discussing specific difficult questions and scenarios were encouraged throughout the program. The program was well attended and well received by oncology nurses and social workers. Participants expressed interest in the continuation of communication programs to further enhance skills.
Characterizing and improving HIV/AIDS knowledge among cocaine-dependent outpatients. [2007]The present study was an experimental test of efficacy of a brief education intervention for increasing HIV/AIDS knowledge among cocaine-dependent outpatients. Participants were randomly assigned to an HIV/AIDS education intervention (experimental condition) or a sham intervention (control condition). Control participants were subsequently crossed over to the HIV/AIDS education intervention. Experimental participants had higher scores on tests of HIV/AIDS knowledge after receiving the education intervention than did control participants. Further supporting the intervention's efficacy, control participant scores also increased once participants were crossed over and received the education intervention. Scores at follow-up were lower than at postintervention but remained higher than baseline scores. Results support the intervention's efficacy for increasing HIV/AIDS knowledge among cocaine-dependent outpatients. This intervention is brief, inexpensive, and easily implemented.
Effects of a HIV risk reduction education program among injection drug users in Puerto Rico. [2007]This report examines the extent to which an educational component enhanced the efficacy of a community outreach program in reducing HIV transmission behaviors among injecting drug users (IDUs). The experimental enhancement comprised three group educational sessions where detailed information on HIV risk and protective behaviors was conveyed, protective behaviors were shown and practiced, and a problem solving perspective guided discussion of serostatus results. Substantial risk reduction in behaviors were prospectively measured. However, IDUs assigned on a random basis to the enhanced intervention showed no significant differences in levels of risk reduction when compared to those assigned to the standard-only intervention. The chronic and intensive use of injected drugs among the IDUs studied and their high level of HIV infection suggest the need of interventions geared to maximize the utilization of health care services and enhance the supportive functions of familial and social networks of IDUs.
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]Pre-Exposure Prophylaxis (PrEP) trials often implement counseling to support product adherence. Counseling fidelity can vary significantly across providers and time. Fidelity monitoring can ensure that counseling is delivered as designed. We describe the process, feasibility, and outcomes of monitoring Options counseling fidelity in an open-label study of the dapivirine vaginal ring MTN-025/HOPE. After initial training, 63 counselors from 14 sites in Sub-Sahara Africa audio-recorded counseling sessions with study participants. Sessions were rated by a New York-based team that included bilingual emigres from the study countries. Completed session rating forms were sent to counselors to provide feedback and counseling difficulties were discussed during monthly calls. Of 1456 study participants, 85.7% consented to at least one session, and 20% to all sessions, being audio-recorded. Among 9926 study visits in which Options was expected to occur, 5366 (54.1%) Options sessions were audio-recorded, of which 1238 (23.1%) were reviewed; 1039 (83.9%) were rated as "good" or "fair." Eleven counselors who failed to consistently deliver the intervention were reassigned to back-up status. This study demonstrates the feasibility and benefits of monitoring counseling fidelity using audio-recordings in a multi-site, multi-language, multi-country PrEP trial. Given the investment necessary to conduct such trials, providing counseling oversight is highly warranted.
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.
Program targets HIV+ injection drug users. [2005]A large intervention program designed specifically for HIV-positive injection drug users may provide HIV programs with a workable way to teach this population about safety measures.
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]The feasibility, use, and acceptability of text messages to track methamphetamine use and promote antiretroviral treatment (ART) adherence among HIV-infected methamphetamine users was examined. From an ongoing randomized controlled trial, 30-day text response rates of participants assigned to the intervention (individualized texting for adherence building (iTAB), n = 20) were compared to those in the active comparison condition (n = 9). Both groups received daily texts assessing methamphetamine use, and the iTAB group additionally received personalized daily ART adherence reminder texts. Response rate for methamphetamine use texts was 72.9% with methamphetamine use endorsed 14.7% of the time. Text-derived methamphetamine use data was correlated with data from a structured substance use interview covering the same time period (P
Integrated Care Models: HIV and Substance Use. [2023]Behaviors and practices associated with substance use contribute to lack of HIV virologic suppression and onward transmission. In the USA, many recent HIV outbreaks have been connected with substance use. Evidence-based strategies for integrating care of those at risk for and living with HIV and who use substances continue to evolve. This review, based on scientific and medical literature through March 2023, provides an overview and evaluation of initiatives for integrated care aimed to serve patients at risk for and with HIV and a substance use disorder.
Patient-Provider Communication and Information, Motivation, and Behavioral Skills in HIV-Positive Adults Initiating Antiretroviral Therapy in Haiti. [2021]While Haiti has scaled up use of antiretroviral therapy (ART), current studies suggest sub-optimal adherence threatens long-term viral suppression in this understudied setting. Patient-provider communication (PPC) and information, motivation, and behavioral skills (IMB) have been implicated in ART adherence globally. However, no studies have examined their relevance in Haiti. The present mixed-methods study utilized cross-sectional survey data from 128 ART-initiating patients at 2 large HIV treatment sites in Haiti, as well as observational data from 12 clinic visits, to document associations between adherence-related PPC and IMB. Multivariate regression analyses suggested that PPC is associated with IMB constructs. At the bivariate level, more effective PPC was associated with higher levels of adherence-related information and motivation, but not behavioral skills. Observational findings indicate infrequent and non-collaborative adherence support. Taken together, findings lay the groundwork for additional research in the area of PPC, IMB, and ART adherence in Haiti.
Substance use service availability in HIV treatment programs: Data from the global IeDEA consortium, 2014-2015 and 2017. [2023]Substance use is common among people living with HIV and has been associated with suboptimal HIV treatment outcomes. Integrating substance use services into HIV care is a promising strategy to improve patient outcomes.
A pilot randomized clinical trial of two medication adherence and drug use interventions for HIV+ crack cocaine users. [2021]Crack cocaine use undermines adherence to highly active antiretroviral therapy (HAART). This pilot randomized clinical trial tested the feasibility and efficacy of 2 interventions based on the Information-Motivation-Behavioral Skill model to improve HAART adherence and reduce crack cocaine problems.