What is the mechanism of action of this treatment?

The most common treatments for HIV/AIDS include antiretroviral therapy (ART) and non-pharmacological interventions like Cognitive Behavioral Therapy (CBT). ART works by inhibiting the replication of the HIV virus, reducing viral load, and improving immune function. CBT, on the other hand, helps patients develop adaptive coping mechanisms to manage the stigma and psychological stress associated with HIV/AIDS. This dual approach is crucial as it addresses both the biological and psychosocial aspects of the disease, leading to improved overall health outcomes for patients.

What side effects are associated with this type of intervention?

The most common treatment for HIV/AIDS is antiretroviral therapy (ART), which can have side effects such as nausea, diarrhea, fatigue, and headaches. Long-term use of ART may also lead to more serious side effects like liver or kidney damage, cardiovascular issues, and bone density loss. Cognitive Behavioral Therapy (CBT), used to improve coping responses to stigma associated with HIV, generally has fewer physical side effects but may cause emotional discomfort as patients confront challenging thoughts and feelings. Overall, CBT is well-tolerated and can significantly improve mental health and adherence to ART.

What prior FDA approvals exist?

FDA-approved treatments for HIV/AIDS primarily include antiretroviral therapies (ART) such as protease inhibitors, integrase inhibitors, and reverse transcriptase inhibitors, which work to suppress the viral load in patients. While these medications are crucial for managing the disease, cognitive behavioral therapy (CBT) is also being studied to improve HIV outcomes by helping patients cope with stigma and other psychological challenges. This holistic approach aims to enhance medication adherence and overall well-being, complementing the pharmacological treatments.

What other types of research exist?

Promising, novel alternatives to Cognitive Behavioral Therapy (CBT) for HIV/AIDS patients in 2024 may include Acceptance and Commitment Therapy (ACT), Mindfulness-Based Stress Reduction (MBSR), and other integrative therapies that focus on improving coping responses to stigma and enhancing mental health outcomes.

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Behavioral Intervention

Cognitive Behavioral Therapy for HIV Prevention in Latinx Sexual Minority Men

N/A

Recruiting

Led By Laura Bogart, PhD

Research Sponsored by RAND

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

report having sex with men in the past 12 months

identify as male

Must not have

transgender women

cisgender women

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 12-months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to support Latinx sexual minority men by teaching them ways to manage challenges and improve their health.

Who is the study for?

This trial is for Latinx sexual minority men who were biologically male at birth, are immigrants, have had sex with men in the past year, and expect to be available for monthly study visits over the next year. They must be HIV-negative or of unknown status, at least 18 years old, and able to communicate in Spanish or English.

What is being tested?

The trial is testing a cognitive behavior therapy (CBT) group intervention designed to help participants cope better with stigma related to their ethnicity, immigration status, sexual orientation, and PrEP use. The goal is to increase HIV testing and PrEP adoption among these individuals.

What are the potential side effects?

As this is a psychological intervention focusing on coping strategies rather than medication or medical procedures, traditional physical side effects are not expected. Participants may experience emotional discomfort discussing personal topics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had sexual relations with men in the past year.

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I identify as male.

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I am 18 years old or older.

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I was assigned male at birth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am a transgender woman.

Select...

I am a cisgender woman.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 12-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 12-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 12-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants who are HIV tested at least annually

Proportion of participants who have taken PrEP in the past 12 months

Secondary study objectives

Change in average level of adaptive coping, measured by the Brief COPE

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CBT Coping InterventionExperimental Treatment1 Intervention

The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP among Latinx sexual minority men (SMM). The intervention sessions will address topics such as: understanding and coping with intersectional stigma, multiple identities (e.g., race/ethnicity, sexual orientation), medical mistrust, social support, and structural stigma. Intervention groups will be led by a trained facilitator (with expertise in group therapy with Latinx SMM) and a trained peer co-facilitator matched in identities with participants (Latinx SMM).

Group II: ControlActive Control1 Intervention

Participants who are randomized to the control condition will be referred to the standard of care program at Bienestar, which includes an ongoing weekly open wellness-oriented support group available to all clients.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for HIV/AIDS include antiretroviral therapy (ART) and non-pharmacological interventions like Cognitive Behavioral Therapy (CBT). ART works by inhibiting the replication of the HIV virus, reducing viral load, and improving immune function. CBT, on the other hand, helps patients develop adaptive coping mechanisms to manage the stigma and psychological stress associated with HIV/AIDS. This dual approach is crucial as it addresses both the biological and psychosocial aspects of the disease, leading to improved overall health outcomes for patients.

Cultural Adaptation of 2 Evidence-Based Alcohol Interventions for Antiretroviral Treatment Clinic Patients in Vietnam.