Emotion Management Counseling + App for HIV Prevention

(PARTI Trial)

Not currently recruiting at 2 trial locations

Overseen By Adam W. Carrico, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Miami

Must be taking: PrEP

Disqualifiers: Transfeminine, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help sexual minority men who use stimulants adhere to their HIV prevention routine, known as PrEP (a daily pill to prevent HIV). It compares two groups: one receives emotion management sessions with smartphone support to encourage PrEP adherence, while the other receives general support sessions (Attention-Control). The goal is to determine which method more effectively reduces the risk of HIV by monitoring pill-taking habits and sexual activity. Men who have used PrEP for at least two months, occasionally skip doses, and engage in condomless sex with men may be suitable candidates. Participants should also regularly use stimulants and own a smartphone. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance HIV prevention strategies for sexual minority men.

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

The trial does not specify if you need to stop taking your current medications. However, you must be currently taking daily oral PrEP and willing to participate in smartphone-based Contingency Management for directly observed PrEP doses.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must have an active prescription for daily oral PrEP and be willing to upload videos of taking it.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Contingency Management (CM) is generally easy for people to handle. This approach uses rewards to help individuals adhere to their medication plans. Studies have found that CM improves medication adherence, such as with PrEP. For instance, one study found that participants took PrEP as prescribed 91% of the time with CM support, suggesting that people manage CM well without major issues.

However, specific safety information for the PrEP Affect Regulation Treatment Innovation (PARTI) is limited. Without clear safety data from research, it is difficult to assess how well people tolerate PARTI. Since this trial lacks a specific phase, the available safety information might be limited. This should be considered when deciding to join the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Emotion Management Counseling combined with a mobile app for HIV prevention because it targets emotional well-being and behavior management alongside traditional medical adherence. Unlike standard PrEP adherence methods that focus solely on medication, this approach includes the PARTI intervention, which provides personalized emotional support and coping strategies through five individual sessions. Additionally, the use of Contingency Management introduces a reward-based system to encourage consistent PrEP usage, offering a unique motivational boost to stick with the treatment plan. This holistic strategy aims to improve adherence by addressing both emotional and behavioral factors, potentially leading to better outcomes in HIV prevention.

What evidence suggests that this trial's treatments could be effective for HIV prevention?

Research has shown that PrEP (pre-exposure prophylaxis) can lower the risk of HIV by 86% when taken regularly. However, its effectiveness decreases if taken less than 40% of the time. In this trial, participants may receive the PARTI (PrEP Affect Regulation Treatment Innovation) program, which uses positive thinking techniques to help maintain a medication schedule. Alternatively, participants may receive Contingency Management (CM), which offers rewards to encourage regular medication use. Studies have found CM effective, with some individuals reporting medication adherence as high as 91%. Both methods in this trial aim to help people take PrEP consistently, maximizing its protection against HIV. ^{1 2 3 4 6}

Who Is on the Research Team?

Adam W Carrico, PhD

Principal Investigator

Florida International University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Screens positive for a moderate or severe stimulant use disorder with an abbreviated version of the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) (total score of 4 or more) OR reports weekly use of either methamphetamine or cocaine

I identify as male or gender non-conforming.

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

Exclusion Criteria

I switched from Truvada to Descovy within the last 5 months.

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 5-session positive affect intervention delivered during a 12-week smartphone-based Contingency Management (CM) protocol for PrEP adherence

12 weeks

Follow-up

Participants are monitored for HIV acquisition risk and PrEP adherence

Up to 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Attention-Control
• Contingency Management for PrEP Adherence
• PARTI

Trial Overview

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.

How Is the Trial Designed?

Group I: PARTI and CM (Contingency Management) Experimental Treatment 2 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 Control 2 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

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Florida International University

Lead Sponsor

Trials

114

Recruited

19,400+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

A study involving 19 young men who have sex with men (YMSM) in Chicago revealed that successful PrEP adherence strategies include psychological techniques like mindfulness, technical tools such as automated reminders, and social support from friends.

Participants reported using multiple strategies and adapting them to overcome challenges, highlighting the importance of pre-emptive counseling for new PrEP users to prepare for adherence and utilize a variety of strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying Strategies for Improving Pre-exposure Prophylaxis Adherence: Perspectives from a Sample of Highly Adherent Young Men Who have Sex with Men. Xavier Hall, CD., Bundy, C., Foran, JE., et al.[2023]

The iPrEx study showed that daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) is effective in reducing HIV acquisition among men who have sex with men, with adherence being crucial for its efficacy.

Qualitative insights from San Francisco participants revealed that strong adherence was supported by established routines, positive relationships with nonjudgmental healthcare staff, and client-centered counseling, while barriers included routine changes and side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participant experiences and facilitators and barriers to pill use among men who have sex with men in the iPrEx pre-exposure prophylaxis trial in San Francisco. Gilmore, HJ., Liu, A., Koester, KA., et al.[2021]

A study involving 20 HIV-negative men who have sex with men (MSM) showed that participants found a digital pill system (DPS) helpful for promoting adherence to pre-exposure prophylaxis (PrEP), indicating its potential as a supportive tool in HIV prevention.

Participants responded positively to cognitive behavioral therapy (CBT)-based messaging components of the intervention, particularly corrective feedback and contingent reinforcement, but expressed concerns about stigma related to substance use screening, which could hinder the use of the DPS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a digital pill and respondent behavioral intervention (PrEPSteps) for HIV pre-exposure prophylaxis adherence among stimulant using men who have sex with men. Chai, PR., Mohamed, Y., Goodman, G., et al.[2023]

The mSMART mobile health intervention showed high feasibility and acceptability among 15 Black men who have sex with men (MSM) already prescribed PrEP, with an impressive 82% daily usage rate and positive feedback on user-friendliness.

Participants demonstrated improved PrEP adherence, as indicated by biomarker scores, suggesting that gamified interventions like mSMART could effectively enhance medication adherence and reduce barriers to taking PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Preliminary Efficacy of a Gamified Mobile Health Contingency Management Intervention for PrEP Adherence Among Black MSM. Mitchell, JT., Burns, CM., Atkinson, B., et al.[2023]

A qualitative study involving 34 rural Midwestern MSM revealed that participants generally adhered well to their PrEP regimen, with some missing only a few doses per month, indicating a positive trend in adherence among this population.

Participants reported high self-efficacy and motivation to take PrEP daily to prevent HIV, suggesting that integrating PrEP into their existing routines and enhancing patient-provider communication could further improve adherence strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing determinants of pre-exposure prophylaxis (PrEP) adherence among a sample of rural Midwestern men who have sex with men (MSM). Owens, C., Hubach, RD., Lester, JN., et al.[2021]

A study of 210 gay male daily PrEP users revealed that over two-thirds had missed doses in the past month, averaging four to five missed doses, indicating a significant issue with adherence to daily PrEP.

Factors influencing non-adherence included attitudes towards outcomes, perceived control over taking the medication, and social barriers, suggesting that healthcare providers can play a crucial role in improving adherence through supportive strategies and technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Socio-behavioral factors related to PrEP non-adherence among gay male PrEP users living in California and New York: A behavioral theory informed approach. Dai, M., Calabrese, C.[2022]

Only 50% of participants in a survey of 147 patients at a New York LGBTQ clinic were aware of event-driven PrEP (ED PrEP), highlighting a significant gap in knowledge about this effective HIV prevention method.

Participants who were uninsured, preferred taking PrEP only when needed, and had concerns about side effects were more likely to endorse ED PrEP as a suitable option, suggesting that targeted education could improve adoption among these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Event-Driven Regimen Choice in Current PrEP Users and Sexual Behavior Characteristics of MSM Receiving Sexual Health Services in New York City. Carneiro, PB., Rincon, C., Golub, S.[2022]

In a study of 1480 HIV-uninfected men who have sex with men (MSM), 54% reported taking medications regularly, with adherence influenced by factors like routine establishment and visibility of medications.

Only 45% of participants rated their medication-taking ability as excellent, highlighting the need for targeted counseling strategies to improve adherence, especially among younger MSM and those facing barriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication adherence among men who have sex with men at risk for HIV infection in the United States: implications for pre-exposure prophylaxis implementation. Liu, AY., Hessol, NA., Vittinghoff, E., et al.[2018]

A smartphone-based intervention using contingency management showed high usability, with participants submitting 75% of required video selfies for medication adherence, and 81% of those meeting validity criteria.

The intervention demonstrated promise in promoting adherence to antiretroviral therapy among HIV+ individuals with substance use disorders, although significant effects on adherence measures were not consistently maintained after adjusting for other variables.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-based incentives for promoting adherence to antiretroviral therapy: A randomized controlled trial. DeFulio, A., Devoto, A., Traxler, H., et al.[2021]

Citations

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pmc.ncbi.nlm.nih.gov

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Contingency management (CM), an incentive-based intervention to encourage target behaviors, effectively promotes medication adherence.

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clinicaltrials.gov

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Contingency Management for PrEP Adherence and/or ...

The goal of the current research is to use CM as a platform to integrate HIV prevention with substance use treatment among MA-using MSM to transform population- ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714422003639

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We describe the rationale and study design for a new study, “Contingency Management and Pre-Exposure Prophylaxis (PrEP) Adherence Support Services (CoMPASS),” ...

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mhealth.jmir.org

mhealth.jmir.org/2018/9/e10456/

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Participants reported mean PrEP adherence rates of 91% via daily entries in mSMART. At the end of the 4-week period, participants indicated ...

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researchprotocols.org

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Harm Reduction Contingency Management for Stimulant ...

Abstract. Background: Stimulant use disorder has been linked with medication nonadherence and mortality among people living with HIV.