IMB-MI Technique for HIV

(HARP Trial)

Overseen By Amy C Justice, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Yale University

Must be taking: Benzodiazepines, Opioids, Muscle relaxants, SSRIs

Disqualifiers: Inpatient, Alcohol use disorder, others

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

Compensation: Varies

Number of Visits: 5

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for people living with HIV who also drink alcohol and take multiple medications. The study examines how alcohol and other substances affect falls and cognitive issues, using Information Motivation Behavioral and Motivational Interviewing (IMB-MI). Trained clinical pharmacists lead the trial, guiding participants through this method. Ideal candidates have HIV, have recently visited a local VA site, drink alcohol, and take five or more medications, including sleep aids or antidepressants. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to experience this new approach.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should be taking 5 or more non-ART medications, including certain types like benzodiazepines and opioids, so it seems you may continue your current medications.

What prior data suggests that the IMB-MI technique is safe for use in this trial?

Research has shown that the Information Motivation Behavioral and Motivational Interviewing (IMB-MI) technique is generally easy for people to manage. Various studies have used this method to help individuals improve their health habits. For instance, motivational interviewing (MI) increased confidence in practicing safer behaviors among people living with HIV. It also helped them adhere to treatments like PrEP, a medicine that prevents HIV.

Reports of major side effects from these techniques are not specific. The focus on talking and guidance, rather than medication, makes it a safe option for most people. As this trial is in its early phase, researchers continue to learn about its potential effects in different situations. However, existing evidence supports its safety as a talking-based approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the IMB-MI technique for HIV because it offers a personalized, behavior-focused approach led by trained clinical pharmacists. Unlike standard HIV treatments that primarily focus on medication adherence and viral suppression, the IMB-MI technique emphasizes motivation and behavior change, potentially leading to more sustainable health outcomes. This method integrates motivational interviewing with the Information-Motivation-Behavioral skills model, providing a holistic strategy to address the psychological and social factors influencing HIV management. By equipping pharmacists with specialized training and a detailed manual, the intervention ensures consistent support and guidance for patients, which could transform how HIV care is delivered.

What evidence suggests that the IMB-MI technique is effective for falls and neurocognitive symptoms in HIV?

Research has shown that the Information Motivation Behavioral and Motivational Interviewing (IMB-MI) technique, which participants will experience through a pharmacist-led intervention, can improve behaviors related to preventing HIV. Motivational interviewing, a key component of this method, has enhanced HIV prevention behaviors and increased the use of counseling services. The IMB model also aids in understanding and improving adherence to HIV prevention methods like PrEP. Studies have found that this model effectively promotes the right information, motivation, and skills needed for better health outcomes. While there is less direct evidence of its effects on falls and neurocognitive symptoms, this approach has shown promise in changing behaviors that might indirectly help manage these issues. ^{1 2 6 7 8}

Who Is on the Research Team?

Amy C Justice, MD, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for individuals with HIV who also consume alcohol, may use cannabis, and are concerned about falling or cognitive symptoms. Participants should be using medications that could interact with their alcohol or cannabis use.

Inclusion Criteria

HIV+

Have visited a local VA site within the past year

Had an AUDIT-C indicating current alcohol use

Exclusion Criteria

Patients with an Alcohol Use Disorder (AUD) diagnosis in the past 12 months

Patients who test positive on the Alcohol Symptom Checklist for moderate or severe AUD during the screening process

I am currently hospitalized.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (phone call)

Enrollment and Pre-Intervention

Participants are enrolled, screened for alcohol use, and complete medication reconciliation

2 weeks

1 visit (phone call), home test kit sent

Intervention

Participants receive a pharmacist-led intervention focusing on alcohol use and medication management

4 weeks

1 visit (phone call)

Follow-up

Participants are monitored for progress and complete post-intervention surveys

6 months

1 visit (phone call), home test kit sent

Qualitative Interviews

Participants provide feedback on the intervention through qualitative interviews

1 month

1 visit (phone call or Microsoft Teams)

What Are the Treatments Tested in This Trial?

Interventions

• Information Motivation Behavioral and Motivational Interviewing (IMB-MI) technique

Trial Overview The study tests the Information Motivation Behavioral and Motivational Interviewing (IMB-MI) technique to see if it can reduce falls and improve neurocognitive function in people mixing alcohol, cannabis, and certain medications.

How Is the Trial Designed?

Group I: Pharmacist lead intervention Experimental Treatment 1 Intervention

Clinical pharmacists will be trained by a team with expertise in behavioral and HIV clinical care, and participate in a 10-hour training course with coaching sessions offered over the course of the study to ensure effective and consistent performance. Pharmacists will be guided by a manual designed to provide and walk them through the necessary skills to perform the pilot intervention easily and effectively. The manual will provide background information, study goals, and describe the critical components of the IMB-MI model and the HARP pilot interventions. An easy to follow, step-by-step approach to performing the intervention will be included. The study protocol to be followed by the clinical pharmacists will be included in the manual along with additional motivational and troubleshooting strategies. Systematic feedback regarding intervention fidelity will be provided by the Evaluation Team.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10575988/

Using Motivational Interviewing to Increase HIV PrEP ... Motivational interviewing (MI) can improve HIV prevention behaviors. However, limited research identifies how MI impacts PrEP uptake and ...

2. researchprotocols.org researchprotocols.org/2022/7/e36655/

Adapting a Motivational Interviewing Intervention to ... A motivational interviewing behavioral intervention that successfully and simultaneously increased community-based HIV testing and prevention counseling and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9167713/

Assessing the Information-Motivation-Behavioral Skills Model ... In the current study, the IMB Model was used to understand factors that predict adherence to PrEP among a community-based cohort of 204 Black men who have sex ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1976131714000504

Intervention Strategies Based on Information-Motivation ... This study systematically reviewed research on behavioral interventions based on the information-motivation-behavioral skills (IMB) model

5. researchgate.net researchgate.net/profile/Jeffrey-Fisher-2/publication/23302517_The_Information-Motivation-Behavioral_Skills_model_of_antiretroviral_adherence_and_its_applications/links/57a8d18108ae0107eee71351/The-Information-Motivation-Behavioral-Skills-model-of-antiretroviral-adherence-and-its-applications.pdf?origin=journalDetail

The-Information-Motivation-Behavioral-Skills-model-of- ... There are 20 highly engaging interventions targeting information, motivation, and behavioral skills deficits; these interventions range from simulated interac-.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0738399111003880

Does motivational interviewing counseling time influence ... This study examined the impact of motivational interviewing (MI) counseling time on self-efficacy to practice safer sex for people living with HIV/AIDS ...

7. researchgate.net researchgate.net/publication/230842974_Motivational_interviewing_for_improving_outcomes_in_youth_living_with_HIV

Motivational interviewing for improving outcomes in youth ... The results of this review examining correlational studies demonstrated a larger association between MHSU and retention in HIV care than reports ...

8. nmac.org nmac.org/wp-content/uploads/2018/06/Motivational_Interviewing_Manual_KJ-edits-6-7-18-Final.pdf

MOTIVATIONAL INTERVIEWING AND HIV: A GUIDE ... - NMAC The navigator helps the client identify skills and abilities, emphasizes client strengths, and de-emphasizes the client's accounting of all the things s/he has ...