What side effects are associated with this type of intervention?

Positive Affect Regulation and Contingency Management, as behavioral interventions, generally do not have pharmacological side effects. However, potential challenges may include emotional discomfort during therapy sessions, frustration with the contingency management process, and the possibility of inconsistent adherence to the intervention protocols. These interventions aim to improve medication adherence through psychological and behavioral support, minimizing the risk of traditional medication side effects.

What prior FDA approvals exist?

The FDA has approved various interventions aimed at improving medication adherence, particularly for chronic conditions. While specific drugs for adherence are not typically approved, behavioral interventions like Contingency Management (CM) have shown efficacy. CM uses positive reinforcement, such as vouchers or rewards, to encourage adherence to treatment regimens. This approach is similar to the PARTI+CM trial, which combines CM with Positive Affect Regulation to enhance adherence to PrEP among high-risk populations. Other related interventions include digital health tools and reminder systems, which have been used to support adherence across various treatments.

What other types of research exist?

Promising novel alternatives to PARTI+CM for enhancing medication adherence in 2024 include: 1) Digital health interventions such as smartphone apps and telehealth platforms that provide reminders, education, and support; 2) Pharmacotherapy options like long-acting injectable medications to reduce the burden of daily dosing; 3) Behavioral interventions including Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT) tailored to individual needs; 4) Integrated care models that combine medical, psychological, and social support services to address multifaceted barriers to adherence.

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Emotion Management Counseling + App for HIV Prevention (PARTI Trial)

N/A

Recruiting

Led By Adam W Carrico, PhD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

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

Must have

Reports condomless anal sex (CAS) with men in the past 6 months

Age 18 or older

Must not have

Unable to provide informed consent

Unwilling to participate in smartphone-based CM for directly observed PrEP doses

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new program called PARTI, which combines mood-boosting sessions with a smartphone app that helps men who use stimulants take their HIV prevention medication regularly. The goal is to see if this approach can lower their risk of getting HIV.

Who is the study for?

This trial is for sexual minority men in California or Florida who use stimulants, are HIV negative, have had condomless anal sex recently, and are on PrEP but may not adhere to it strictly. They must be 18+, speak English, own a smartphone, and identify as male or gender minority. Those assigned female at birth or planning to move soon cannot join.

What is being tested?

The study tests the PARTI program—a positive affect intervention—combined with Contingency Management (CM) for taking PrEP doses against an attention-control condition with CM. The goal is to see if PARTI+CM better prevents HIV by encouraging consistent use of PrEP.

What are the potential side effects?

Since this trial focuses on behavioral interventions rather than medications directly administered during the study, there aren't typical medication side effects; however, participants will continue their usual PrEP regimen which can include side effects like nausea and headaches.

Eligibility Criteria

Inclusion Criteria

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

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I have had unprotected anal sex with men in the last 6 months.

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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:

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I am unable to understand and agree to the study's details on my own.

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I am not willing to use a smartphone app for monitoring my medication.

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I am not on a daily PrEP regimen.

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I was assigned female at birth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up 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

Percentage of Participants Engaging HIV Acquisition Risk

Secondary study objectives

Positive Affect

PrEP Persistence

Retention in PrEP Care

+1 more

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: PARTI and CM (Contingency Management)Experimental Treatment2 Interventions

The PARTI intervention will be delivered in five individual sessions during a 12-week contingency management protocol for PrEP adherence

Group II: Attention-Control and CM (Contingency Management)Active Control2 Interventions

The attention-control condition will consist of five individual sessions where participants complete self-report measures and neutral writing exercises during a 12-week contingency management protocol for PrEP adherence

0 / 7Eligibility 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

Common treatments for medication adherence, such as Positive Affect Regulation and Contingency Management, work by enhancing positive emotions and providing rewards for adherence behaviors. Positive Affect Regulation improves motivation and coping strategies, while Contingency Management reinforces adherence through a system of rewards. These approaches are important because they address both emotional and behavioral factors, increasing the likelihood that patients will consistently follow their prescribed treatment plans.

Pre COVID-19 Pandemic Use of Telemedicine for Adherence Promotion in Patients with Psychotic Disorders: A Literature Review.Does adherence therapy improve medication adherence among patients with schizophrenia? A systematic review.