CBT for HIV with Mental Health Issues

(Synk2b Trial)

Overseen By Elliott R Weinstein, MPH, M.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Severe mental illness, Untreated psychosis, Mania, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how Cognitive Behavioral Therapy (CBT) can assist people living with HIV in managing their health and mental well-being. The focus is on using CBT to support individuals facing mental health challenges or struggling with substance use. Those living with HIV who have recently had difficulty controlling the virus, and who are either men who have sex with men using stimulants, transgender women, or emerging adults aged 18 to 26, might be suitable for this study. Participants will engage in 14 CBT sessions over four months.

As an unphased trial, this study offers a unique opportunity to contribute to understanding how CBT can enhance the lives of those living with HIV.

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

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

What prior data suggests that this CBT is safe for people living with HIV?

Research has shown that cognitive-behavioral therapy (CBT) has been tested in people with HIV who also face mental health issues like depression and substance use. In studies using CBT to aid adherence to HIV treatment and manage depression, participants generally tolerated the therapy well. No major reports of serious side effects directly linked to CBT have emerged.

CBT helps people change negative thoughts and behaviors. This therapy is generally considered safe because it doesn't involve medication, instead using structured sessions to teach coping skills. In the context of HIV and mental health, CBT has helped people better manage their health and emotional well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Cognitive Behavioral Therapy (CBT) for HIV patients with mental health issues because it specifically targets syndemics and adherence factors, which are often overlooked by standard treatments. Unlike typical medications that primarily focus on controlling HIV or managing mental health separately, this approach integrates mental health support to improve adherence to HIV treatment regimens. This holistic method not only addresses the mental health challenges faced by individuals with HIV but also enhances their ability to stick with their treatment plans, potentially leading to better health outcomes.

What evidence suggests that CBT for Syndemics and Adherence Factors is effective for supporting people living with HIV?

Research has shown that Cognitive Behavioral Therapy (CBT) can help people with HIV take their medication more consistently. A review of several studies found that CBT significantly improved adherence to antiretroviral therapy (ART), which is essential for managing HIV. This trial will evaluate the effectiveness of CBT for Syndemics and Adherence Factors, delivered to participants over 14 sessions in 4 months. This therapy helps change thought patterns, benefiting mental health and reducing substance use issues. Early findings suggest that CBT supports better health by addressing these connected challenges. Overall, CBT appears promising in helping people with HIV manage both their treatment and mental well-being. ^{2 6 7 8 9}

Who Is on the Research Team?

Steven A Safren, Ph.D.

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for HIV-positive adults with uncontrolled virus levels in the past year. It includes men who have sex with men (MSM) using stimulants, transgender women, and young adults aged 18-26. Participants must not be severely ill or impaired at consent time, nor currently/recently in CBT treatment.

Inclusion Criteria

The study is looking for three specific groups of people: (1) men who have sex with men and have used stimulants in the past 4 months, (2) transgender women, and (3) young adults between the ages of 18 and 26.

Evidence of uncontrolled virus (e.g., > 200 copies/ml) within the past 12 months as verified by medical record

HIV positive

Exclusion Criteria

You have a severe mental illness that is not being treated and could affect your ability to take part in the study.

Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview

Opinion of the PI that the participant would be at risk for harm to self or others

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Cognitive Behavioral Therapy (CBT) for Syndemics and Adherence Factors intervention for a total of 14 sessions

4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

What Are the Treatments Tested in This Trial?

Interventions

• CBT for Syndemics and Adherence Factors

Trial Overview The study tests Cognitive Behavioral Therapy (CBT) tailored to address both mental health issues and medication adherence among people living with HIV. The goal is to improve their ability to manage HIV treatment alongside coping with psychological and substance use challenges.

How Is the Trial Designed?

Group I: Cognitive Behavioral Therapy (CBT) for Syndemic and Adherence Factors Group Experimental Treatment 1 Intervention

Participants in this group will receive the CBT for Syndemics and Adherence Factors intervention for a total of 14 sessions over 4 months.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. withpower.com withpower.com/trial/phase-mental-health-issue-4-2022-eff51

CBT for HIV with Mental Health Issues (Synk2b Trial) The purpose of this study is to learn about ways to better support people living with HIV with their HIV treatment and cope with mental health challenges ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12352344/

a systematic review and meta-analysis - PMC - PubMed Central Our results provide evidence, with moderate certainty, that CBT has a significant positive impact on ART adherence. The effect of CBT on ART ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06152003

Intervention Development for Syndemics Among PWH in SA This study proposes to: 1) explore how syndemic problems work together to make health worse for people with HIV (PWH) and explore what people think about a ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06152003/intervention-development-for-syndemics-among-pwh-in-sa

Intervention Development for Syndemics Among PWH in SA This study proposes to: 1) explore how syndemic problems work together to make health worse for people with HIV (PWH) and explore what people ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722999800522

Applying cognitive behavioral therapy to HIV medication ... This paper describes a new cognitive-behavioral intervention in which education, problem solving, and rehearsal strategies are used to help patients develop ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6193852/

Learning to address multiple syndemics for people living with ... In one trial of cognitive-behavioral therapy for HIV medication adherence and depression (CBT-AD) in individuals in treatment for injection drug use (PWIDU) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3365619/

Cognitive Behavioral Therapy for Adherence and ... The present study tested cognitive-behavioral therapy for adherence and depression (CBT-AD) in patients with HIV and depression in active substance abuse ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02696681?tab=history&a=5

Record History | ver. 5: 2017-03-17 | NCT02696681 Syndemics are co-occurring psychosocial problems that interact with each other and with health behavior such as HIV sexual transmission risk behavior and ...

9. scholarship.miami.edu scholarship.miami.edu/view/pdfCoverPage?instCode=01UOML_INST&filePid=13386078490002976&download=true

Does Problematic Substance Use Moderate Efficacy of ... Methods: The present study used data from a completed randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) ...