Emotion Management Counseling + App for HIV Prevention
(PARTI Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byAdam W Carrico, PhD
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of Miami
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
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.
What data supports the idea that Emotion Management Counseling + App for HIV Prevention is an effective treatment?
The available research shows that using digital tools and counseling can help people stick to their HIV prevention plans. For example, a study on a mobile app for medication adherence found that users improved their adherence to taking their HIV prevention medication. This suggests that similar approaches, like Emotion Management Counseling + App for HIV Prevention, could also be effective in helping people consistently follow their prevention plans. The research highlights the importance of using technology and counseling to support people in maintaining their health routines.12345
What safety data exists for Emotion Management Counseling + App for HIV Prevention?
The provided research does not directly address safety data for Emotion Management Counseling + App for HIV Prevention or its related interventions. The studies focus on adherence strategies, socio-behavioral factors, and digital interventions for PrEP adherence among men who have sex with men. While these studies provide insights into adherence and behavioral interventions, they do not specifically evaluate the safety of the mentioned treatment or its components.13467
Is the treatment 'Attention-Control, Contingency Management for PrEP Adherence, PARTI' a promising treatment for HIV prevention?
Eligibility Criteria
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.
See 7 more
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.
See 5 more
Treatment Details
Interventions
- Attention-Control (Behavioral Intervention)
- Contingency Management for PrEP Adherence (Behavioral Intervention)
- PARTI (Behavioral Intervention)
Trial OverviewThe 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.
Participant Groups
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Miami Miller School of MedicineMiami, FL
University of MiamiMiami, FL
University of California, San FranciscoSan Francisco, CA
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Who Is Running the Clinical Trial?
University of MiamiLead Sponsor
Florida International UniversityLead Sponsor
University of California, San FranciscoCollaborator
National Institute on Drug Abuse (NIDA)Collaborator
References
Socio-behavioral factors related to PrEP non-adherence among gay male PrEP users living in California and New York: A behavioral theory informed approach. [2022]One effective preventative measure to reduce the number of new HIV infections is through the uptake of daily oral HIV pre-exposure prophylaxis (PrEP). Although previous clinical trials have proven the effectiveness of on-demand PrEP uptake, daily PrEP uptake is the most popular prevention method among PrEP users and is still recommended by most healthcare professionals and organizations. Informed by the integrative model of behavioral prediction, the current study examined the socio-behavioral factors associated with PrEP non-adherence. The present study conducted a cross-sectional survey of 210 gay male daily PrEP users living in California and New York. The results showed more than two-thirds of the sample indicated that they had skipped taking PrEP within the last 30 days, averaging around four to five missed doses. General attitudes toward desirable and undesirable outcomes, perceived behavioral control, and social-level barriers were associated with daily PrEP uptake non-adherence. The findings highlight providers' role in PrEP adherence and the importance of habit-forming, which can be enhanced by cost-effective strategies and technological innovations.
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. [2021]In 2010, the iPrEx study demonstrated efficacy of daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) pre-exposure prophylaxis (PrEP) in reducing HIV acquisition among men who have sex with men. Adherence to study product was critical for PrEP efficacy, and varied considerably, with FTC/TDF detection rates highest in the United States. We conducted a qualitative study to gain insights into the experiences of iPrEx participants in San Francisco (SF) where there was high confirmed adherence, to understand individual and contextual factors influencing study product use in this community. In 2009 and 2011, we conducted focus groups and in-depth interviews in 36 and 16 SF iPrEx participants, respectively. Qualitative analyses indicate that participants joined the study out of altruism. They had a clear understanding of study product use, and pill taking was facilitated by establishing or building on an existing routine. Participants valued healthcare provided by the study and relationships with staff, whom they perceived as nonjudgmental, and found client-centered counseling to be an important part of the PrEP package. This facilitated pill taking and accurate reporting of missed doses. Adherence barriers included changes in routine, side effects/intercurrent illnesses, and stress. Future PrEP adherence interventions should leverage existing routines and establish client-centered relationships/ environments to support pill taking and promote accurate reporting.
Identifying Strategies for Improving Pre-exposure Prophylaxis Adherence: Perspectives from a Sample of Highly Adherent Young Men Who have Sex with Men. [2023]Most research on pre-exposure prophylaxis (PrEP) adherence and persistence uses a deficit-based approach to identify negative influences on PrEP adherence; however, an alternative set of approaches (such as resilience, asset-based, and positive variation) may identify equally important positive influences on PrEP adherence. Thus, the current study presents qualitative perspectives of PrEP adherence strategies from a sample of adherent YMSM. PrEP-using YMSM living in the Chicago area from a larger cohort study were recruited into a 90-day diary study that measured sexual health behaviors including PrEP use. A subset (n = 28) were then recruited for in-depth interviews between April and September 2020 covering topics of PrEP use and adherence. Thematic analysis was used to interpret patterns within the data. The analytic sample (n = 19) consistently reported high levels of adherence. Adherence strategies were organized into three broader categories: psychological (e.g. mindfulness, pill auditing), technical/instrumental (e.g. automated reminders, pill organizers), and social strategies (e.g. checking in with friends, or getting suggestions from friends). The majority of participants described using multiple strategies and changing strategies to respond to barriers to adherence. Other themes that were related to adherence included having a daily medication history and a generally positive outlook toward the PrEP regimen. Those who had medication histories were able to draw from experience to develop strategies for PrEP adherence. Findings suggest the need for pre-emptive counseling for PrEP-initiators on the use of multiple strategies, how to prepare for PrEP adherence, to adapt to challenges, and to adopt a range of potential strategies for adherence.
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. [2023]The efficacy of pre-exposure prophylaxis (PrEP) for HIV prevention in men who have sex with men (MSM) is contingent upon consistent adherence. Digital pill systems (DPS) provide real-time, objective measurement of ingestions and can inform behavioral adherence interventions. Qualitative feedback was solicited from MSM who use stimulants to optimize a cognitive behavioral therapy (CBT)-based intervention (LifeSteps), used in conjunction with a DPS, to promote PrEP adherence (PrEPSteps). Seven focus groups and one individual qualitative interview were conducted in Boston, MA with cisgender, HIV-negative MSM who reported stimulant use and current PrEP use or interest. Focus groups and interviews explored reactions to the DPS and PrEPSteps messaging components: contingent reinforcement (CR), corrective feedback (CF), LifeSteps, and substance use Screening, Brief Intervention, and Referral to Treatment (SBIRT). Quantitative assessments were administered. Qualitative data were analyzed using applied thematic analysis. Twenty MSM participated. Most were White (N = 12), identified as homosexual or gay (N = 15), and college-educated (N = 15). Ages ranged from 24 to 68 years (median 35.5). Participants were willing to engage with the DPS and viewed it as beneficial for promoting adherence. Confirmatory CR messages were deemed acceptable, and a neutral tone was preferred. CF messages were viewed as most helpful and as promoting individual responsibility. LifeSteps was perceived as useful for contextualizing nonadherence. However, SBIRT was a barrier to DPS use; concerns around potential substance use stigma were reported. MSM who use stimulants were accepting of the DPS and PrEPSteps intervention. CR, CF, and LifeSteps messages were viewed as helpful, with modifications pertaining to tone and content; SBIRT messages were not preferred.
Feasibility, Acceptability, and Preliminary Efficacy of a Gamified Mobile Health Contingency Management Intervention for PrEP Adherence Among Black MSM. [2023]Oral HIV pre-exposure prophylaxis (PrEP) is effective at preventing HIV. However, low adherence is common and undermines these protective effects. This is particularly relevant for groups with disproportionately higher rates of HIV, including Black men who have sex with men (MSM). The current study tested the feasibility, acceptability, and preliminary efficacy of a gamified mobile health contingency management intervention for PrEP adherence-called mSMART (Mobile App-Based Personalized Solutions for Medication Adherence of Rx Pill Tool). Fifteen Black MSM already prescribed PrEP in the community completed baseline and follow-up assessments separated by 8 weeks of using mSMART. Regarding feasibility, there was no study attrition, no mSMART functional difficulties that significantly interfered with use, and a mean rate of 82% daily mSMART use. Acceptability ratings were in the moderately to extremely satisfied range for factors such as willingness to recommend mSMART to others and user-friendliness, and in the low range for ratings on difficulty learning how to use mSMART. Scores on a system usability measure were in the acceptable range for 73% of the sample. Qualitative analysis of follow-up interviews identified individual components of mSMART that could be modified in future iterations to make it more engaging. PrEP composite adherence scores from biomarkers indicated an improvement from baseline to follow-up with a medium effect size, as well as a decrease in the number of perceived barriers to medication adherence. Findings indicate a future efficacy trial is needed to examine the effects of this gamified mobile health contingency management intervention on PrEP adherence.
Predictors of Event-Driven Regimen Choice in Current PrEP Users and Sexual Behavior Characteristics of MSM Receiving Sexual Health Services in New York City. [2022]While daily PrEP is undeniably effective, broad-based adoption remains low. Non-daily PrEP modalities, like event-driven PrEP (ED PrEP), offer an efficient way to deliver PrEP's protection to priority populations. We carried out an at-home survey with patients receiving sexual health services in a LGBTQ-clinic in New York (n = 147). Participants answered questions on ED PrEP awareness and preferences, sexual behavior, and sexual preparatory practices. Only 50% of our sample were aware of ED PrEP, about 30% met eligibility for ED PrEP, and 35% chose ED PrEP as a good HIV prevention option for them. In a robust Poisson model (n = 128), endorsement of ED PrEP as a good prevention choice was significantly more common in participants who were uninsured, preferred taking PrEP only when needed, and those who had concerns about side-effects. Furthermore, participants reported many sexual behaviors patterns and preparatory practices compatible with use of ED PrEP.
Medication adherence among men who have sex with men at risk for HIV infection in the United States: implications for pre-exposure prophylaxis implementation. [2018]Pre-exposure prophylaxis (PrEP) is a promising HIV prevention approach for men who have sex with men (MSM), however non-adherence could limit its effectiveness. Understanding the experiences of HIV-uninfected MSM taking routine medications can provide valuable insights into open label PrEP adherence in real world settings and guide development of PrEP adherence interventions. In this study, we examined self-reported medication-taking experiences and facilitators and barriers of medication adherence among a geographically-diverse online sample of HIV-uninfected US MSM. Among 1480 participants, 806 (54%) reported taking medications regularly, of whom 80% reported taking medications for treatment and 55% for prevention purposes. Facilitators of medication adherence included establishing a routine, keeping medication visible, and using a pill-box; barriers included forgetting, changes in routine, and being busy or away from home. Only 45% rated their medication-taking ability as excellent, and 36% reported not missing any doses in the past 30 days. In multivariable analyses, older men and those not reporting any adherence barriers were more likely to report excellent adherence, and men willing to use PrEP were more likely to report perfect 30-day adherence. Counseling strategies to build pill-taking routines and support younger MSM are suggested to maximize the public health impact of PrEP.
Smartphone-based incentives for promoting adherence to antiretroviral therapy: A randomized controlled trial. [2021]Antiretroviral therapy can improve the lives of people living with HIV and reduce the rate of transmission. However, high levels of adherence are required. Some people living with HIV, including people who use drugs, are at elevated risk for non-adherence. Contingency management is a promising intervention for promoting adherence to antiretroviral therapy. Barriers to adoption of contingency management include lack of provider expertise and implementation effort. To address these barriers, a smartphone-based adherence intervention was developed. HIV + people with a substance use disorder were required to submit video selfies of medication consumption that met validity criteria. Monetary incentives were delivered to participants via reloadable debit cards, contingent upon a valid video. The intervention was evaluated in a small (n = 50) randomized controlled trial. Intervention participants submitted 75% of possible videos, and 81% of videos met validity criteria, indicating a high level of usability. Participants also rated the intervention as highly acceptable. Adherence was measured as the percent of participants who achieved a 95% adherence threshold, and also as the overall percent of days in which participants were adherent to their antiretroviral therapy. The former showed a significant effect for group, (p = .034) but this was not maintained when adjusting for stratification variables as covariates (p = .094). The latter measure showed a significant group × time interaction. Smartphone-based contingency management is a promising method for promoting adherence to antiretroviral therapy. Assessing the cost-benefit of the intervention and development of strategies for long-term adherence are priorities for future research.
Assessing determinants of pre-exposure prophylaxis (PrEP) adherence among a sample of rural Midwestern men who have sex with men (MSM). [2021]Pre-exposure prophylaxis (PrEP) efficacy in preventing HIV among gay, bisexual, and other men who have sex with men (MSM) is dependent upon adherence. Little is known about the PrEP adherence experiences among MSM who live in rural areas of the US. This qualitative study was informed by a modified version of Straussian Grounded Theory. Thirty-four 34 rural Midwestern MSM participated in telephone interviews that assessed their PrEP adherence factors. Overall, participants adhered to the PrEP regimen, ranging from missing none to a couple of doses per month. Participants had high self-efficacy (competence) and self-reliance (autonomy) in taking PrEP daily. Participants incorporated PrEP into their already existing routines. Participants were motivated to adhere to prevent HIV acquisition and be financially responsible. All participants mentioned their PrEP provider discussed the importance of adherence with PrEP's effectiveness, but future patient-provider PrEP adherence communication varied among participants. Future PrEP adherence interventions should address counseling strategies that leverage these constructs to support pill taking. Future research should explore patient-provider conversations surrounding PrEP adherence to inform provider- and patient-level interventions.