Barriers, Facilitators and Opportunities for HIV Status Disclosure Among Young Men Who Have Sex With Men: Qualitative Findings from the Tough Talks Intervention.

Disclosing one's HIV status can involve complex individual and interpersonal processes interacting with discriminatory societal norms and institutionalized biases. To support disclosure decision-making among young men who have sex with men (YMSM) living with HIV, we developed Tough Talks™, an mHealth intervention that uses artificially intelligent-facilitated role-playing disclosure scenarios and informational activities that build disclosure skills and self-efficacy. Qualitative interviews were conducted with 30 YMSM living with HIV (mean age 24 years, 50% Black) who were enrolled in a randomized controlled trial assessing Tough Talks™ to understand their experiences with HIV status disclosure. Interviews were recorded, transcribed, and thematically coded. Barriers to disclosure focused on fear, anxiety, stigma, and trauma. Facilitators to disclosure are described in the context of these barriers including how participants built comfort and confidence in disclosure decisions and ways the Tough Talks™ intervention helped them. Participants' narratives identified meaning-making within disclosure conversations including opportunities for educating others and advocacy. Findings revealed ongoing challenges to HIV status disclosure among YMSM and a need for clinical providers and others to support disclosure decision-making and affirm individuals' autonomy over their decisions to disclose. Considering disclosure as a process rather than discrete events could inform future intervention approaches.

HIV risk and prevention among clients of a delivery-based harm reduction service during an HIV outbreak among people who use drugs in northern rural Minnesota, USA.

BACKGROUND: Since 2019, multiple HIV outbreaks occurred among people who inject drugs (PWID) in Minnesota. Syringe service programs (SSPs) are evidence-based programs that reduce the spread of HIV. We conducted an assessment of characteristics and HIV risk and prevention among clients of a delivery-based SSP near an HIV outbreak in rural, northern Minnesota. METHODS: In the fall of 2021, we conducted a cross-sectional survey of clients of a mobile SSP based in Duluth, Minnesota. Survey topics included demographics, drug use, sexual behavior, HIV testing history, and HIV status. We conducted descriptive analyses and used univariate logistic regression to identify correlates of syringe sharing. The analysis was limited to PWID in the last six months. RESULTS: A total of 125 people were surveyed; 77 (62%) were PWID in the last six months. Among these participants, 52% were female and 50% were homeless. Thirty-two percent reported sharing syringes and 45% reported sharing injecting equipment. Approximately one-half (49%) of participants had been tested for HIV in the past year, and none reported being HIV-positive. Individuals reported low condom usage (88% never used), and 23% of participants reported engaging in some form of transactional sex in the last six months. Incarceration in the last year was associated with sharing syringes (odds ratio = 1.4, 95% confidence interval 1.1-1.8). CONCLUSION: HIV risk was high among PWID receiving services at this SSP. These data highlight a rural SSP that is engaged with people at risk for HIV and needs additional support to expand harm reduction services.

Tough Talks Virtual Simulation HIV Disclosure Intervention for Young Men Who Have Sex With Men: Development and Usability Testing.

BACKGROUND: HIV status disclosure is an important decision with barriers specific to young men who have sex with men (YMSM), who have the highest rates of new HIV infections in the United States. Behavioral and social determinants of the difficulty to disclose can include fear of rejection, stigma, loss of financial stability, and lack of communication skills. Once able to disclose, a person may have increased access to social support and improved informed risk reduction conversations and medication adherence. Despite the known challenges and advantages of disclosure, there are few effective tools supporting this behavior. OBJECTIVE: To address this gap in disclosure interventions, the Tough Talks (TT) app, an mHealth intervention using artificial intelligence (AI)-facilitated role-playing scenarios, was developed for YMSM. This paper reports stages of development of the integrated app and results of the usability testing. METHODS: Building on the successful development and testing of a stand-alone interactive dialogue feature in phases 1-3, we conducted additional formative research to further refine and enhance the disclosure scenarios and develop and situate them within the context of a comprehensive intervention app to support disclosure. We assessed the new iteration for acceptability and relevance in a usability study with 8 YMSM with HIV. Participants completed a presurvey, app modules, and a semistructured qualitative interview. RESULTS: TT content and activities were based on social cognitive theory and disclosure process model framework and expanded to a 4-module curriculum. The AI-facilitated scenarios used dialogue from an utterance database developed using language crowdsourced through a comic book contest. In usability testing, YMSM reported high satisfaction with TT, with 98% (31/33) of activities receiving positive ratings. Participants found the AI-facilitated scenarios and activities to be representative and relevant to their lived experiences, although they noted difficulty having nuanced disclosure conversations with the AI. CONCLUSIONS: TT was an engaging and practical intervention for self-disclosure among YMSM with HIV. Facilitating informed disclosure decisions has the potential to impact engagement in sexual risk behaviors and HIV care. More information is needed about the ideal environment, technical assistance, and clinical support for an mHealth disclosure intervention. TT is being tested as a scalable intervention in a multisite randomized controlled trial to address outstanding questions on accessibility and effect on viral suppression. TRIAL REGISTRATION: ClinicalTrials.gov NCT03414372; https://clinicaltrials.gov/ct2/show/NCT03414372.

Mass Spectroscopy Imaging of Hair Strands Captures Short-Term and Long-Term Changes in Emtricitabine Adherence.

Most measures of adherence to antiretroviral therapy require a blood sample, and none capture longitudinal daily adherence. A new noninvasive method for measuring daily adherence to antiretroviral regimens containing emtricitabine (FTC) was developed for intact hair strands using infrared matrix-assisted laser desorption electrospray ionization (IR-MALDESI) mass spectrometry imaging (MSI). A directly observed therapy study of daily and intermittent (3, 1, and 0 doses/week) FTC dosing (n = 12) benchmarked adherence in hair, revealing distinct accumulation patterns and median FTC signal abundance (1,702, 495, 352, and 0, respectively) with each dosing frequency. A threshold value of FTCsignal abundance of 500 differentiated daily dosing from 3 or fewer doses/week (specificity, 100%; sensitivity, 100% over 30 days and 80% over 60 days). Using these criteria, daily FTC hair adherence was classified in young men (n = 8) who have sex with men (YMSM) engaged in or initiating preexposure prophylaxis (PrEP). Four types of adherence profiles were observed in sequential 30-day periods: consistently high, occasional missed doses, improvement following study initiation, and intermittent. Discrete days of nonadherence were identified across the 60-day window, with the average number of consecutive days classified as nonadherent increasing across the four profile types (1, 2, 19, and 58 days, respectively). Additionally, cumulative FTC response in hair (60-day average) significantly correlated with dried blood spot tenofovir diphosphate concentrations collected simultaneously (rs = 0.79, P = 0.03). Based on these data, IR-MALDESI FTC adherence classification in hair strands can better delineate short-term changes in adherence behaviors over a long retrospective window, offering great potential for noninvasive adherence monitoring and quick supportive interventions.

Is your syringe services program cost-saving to society? A methodological case study.

BACKGROUND: While there is a general acceptance among public health officials and policy-makers that syringe services programs can be effective in reducing HIV transmission among persons who inject drugs, local syringe services programs are often asked to provide economic justifications for their activities. A cost-effectiveness study, estimating the cost of preventing one HIV infection, would be the preferred methods for addressing this economic question, but few local syringe services programs have the needed data, staff and epidemiologic modeling resources needed for a cost-effectiveness study. We present a method for estimating a threshold value for the number of HIV infections prevented above which the program will be cost-saving to society. An intervention is considered "cost-saving" when it leads to a desirable health outcome a lower cost than the alternative. METHODS: The research literature on the effectiveness of syringe services programs in controlling HIV transmission among persons who inject drugs and guidelines for syringe services program that are "functioning very well" were used to estimate the cost-saving threshold at which a syringe services program becomes cost-saving through preventing HIV infections versus lifetime treatment of HIV. Three steps are involved: (1) determining if HIV transmission in the local persons who inject drugs (PWID) population is being controlled, (2) determining if the local syringe services program is functioning very well, and then (3) dividing the annual budget of the syringe services program by the lifetime cost of treating a single HIV infection. RESULTS: A syringe services program in an area with controlled HIV transmission (with HIV incidence of 1/100 person-years or less), functioning very well (with high syringe coverage, linkages to other services, and monitoring the local drug use situation), and an annual budget of $500,000 would need to prevent only 3 new HIV infections per year to be cost-saving. CONCLUSIONS: Given the high costs of treating HIV infections, syringe services programs that are operating according to very good practices ("functioning very well") and in communities in which HIV transmission is being controlled among persons who inject drugs, will almost certainly be cost-saving to society.

Moral practices shaping HIV disclosure among young gay and bisexual men living with HIV in the context of biomedical advance.

Biomedical advances in diagnostics, treatment and prevention increase the means available to reduce HIV transmission risk. Subsequent shifts in HIV status disclosure obligation and ethics may impact how those living with HIV view, enact and experience disclosure. We analysed focus group and interview data to explore how these changes are reflected in disclosure decision-making to sexual partners among young gay and bisexual men living with HIV in the USA. Three interrelated themes were identified: engaging with partners' varying HIV knowledge; attribution of blame; and negotiating disclosure-related harms. Participants experienced blame from partners that questioned the timing of HIV testing, status disclosure and sex events without regards for viral suppression or use of pre-exposure prophylaxis. Substantial HIV stigma was described in response to disclosure, mitigated in some cases by partners' higher HIV knowledge. Overall, an uneven diffusion of HIV treatment and prevention knowledge and continuing HIV stigma seemed to limit the translation of biomedical advances into improved disclosure experiences. Our findings suggest that young gay and bisexual men living with HIV may continue to perform much of the moral labour involved in disclosure by managing others' reactions, correcting inaccurate sexual health information, and negotiating the risks of disclosure-related harm.

Testing the Efficacy of a Social Networking Gamification App to Improve Pre-Exposure Prophylaxis Adherence (P3: Prepared, Protected, emPowered): Protocol for a Randomized Controlled Trial.

BACKGROUND: HIV prevalence is high among young men who have sex with men (YMSM) and young transgender women who have sex with men (YTWSM), particularly among minorities. Despite its proven efficacy and safety, the uptake of and adherence to pre-exposure prophylaxis (PrEP) among YMSM and YTWSM is currently limited. To date, evidence-based interventions to promote and sustain PrEP adherence have been limited and not shown to be highly efficacious. Given the widespread adoption of smartphones, mobile apps can be utilized to increase PrEP adherence for many YMSM and YTWSM. OBJECTIVE: The study consists of a formative research phase to develop an app-based intervention, P3 (Prepared, Protected, emPowered), to increase PrEP adherence, and a randomized controlled trial (RCT) to test its efficacy. P3 is a mobile app built on an established health platform, which includes social networking and game-based components to encourage PrEP adherence among YMSM and YTWSM. P3+ includes all P3 features plus adherence counseling delivered via two-way text messaging (short message service, SMS) through the app. METHODS: The formative research phase includes usability testing to assess users' comprehension of P3's educational content, understanding and use of intervention features, and overall impressions of app functionality, followed by app refinements. A subsequent field trial will identify and resolve any remaining technical challenges. A three-arm RCT (P3, P3+, and standard of care) will then be conducted at 6 iTech subject recruitment venues to assess intervention efficacy and to conduct a comparison of costs to deliver the 2 intervention arms. RESULTS: This is an ongoing research project with initial results from the formative work expected in 2020 and those from the RCT in 2021. CONCLUSIONS: P3 aims to provide an engaging, interactive experience that is highly appealing for the target population, leveraging technology already heavily integrated into the lives of young people, and thus meeting users' needs in a familiar, stimulating way. If efficacious, P3 could be a sustainable, easily disseminated, lower-cost PrEP intervention for YMSM and YTWSM. Further, the research aims to determine the processes that are essential to developing and implementing future health-related gamification interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT03320512; https://clinicaltrials.gov/ct2/show/NCT03320512 (Archived by WebCite at http://www.webcitation.org/74OVZkICl). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/10448.

"I DIDN'T TELL YOU SOONER BECAUSE I DIDN'T KNOW HOW TO HANDLE IT MYSELF." DEVELOPING A VIRTUAL REALITY PROGRAM TO SUPPORT HIV-STATUS DISCLOSURE DECISIONS.

HIV status disclosure is associated with increased sorcial support and protective behaviors against HIV transmission. Yet disclosure poses significant challenges in the face of persistent societal stigma. Few interventions focus on decision-making self-efficacy, and communication skills to support disclosing HIV status to an intimate partner. Virtual reality (VR) and artifcial intelligence (AI) technologies offer poweful tools to address this gap. Informed by Social Cognitive Theory, we created the Tough Talks VR program for HIV-positive young men who have sex with men (YMSM) to practice status disclosure safely and confidentially. Fifty-eight YMSM (ages 18 - 30, 88% HIV-positive) contributed 132 disclosure dialogues to develop the prototype through focus groups, usability testing, and a technical pilot. The prototype includes three disclosure scenarios (neutral, sympathetic, and negative response) and a database of 125 virtual character utterances. Participants select a VR scenario and realistic virtual character with whom to practice. In a pilot test of the fully automated neutral response scenario, the AI system responded appropriately to 71% of participant utterances. Most pilot study participants agreed Tough Talks was easy to use (9/11) and that they would like to use the system frequently (9/11). Tough Talks demonstrates that VR can be used to practice HIV status disclosure and lessons learned from program development offer insights for the use of AI systems for other areas of health and education.

A Gamified Smartphone App to Support Engagement in Care and Medication Adherence for HIV-Positive Young Men Who Have Sex With Men (AllyQuest): Development and Pilot Study.

BACKGROUND: HIV disproportionately impacts young men who have sex with men (YMSM) who experience disparities across the HIV care continuum. Addressing antiretroviral therapy (ART) adherence among YMSM is an urgent public health priority. Technology-based interventions-particularly mobile health platforms-can provide tailored adherence interventions and allow YMSM to engage and connect with others. OBJECTIVE: The objective of this study was to describe the development of AllyQuest, a novel, theoretically-based, smartphone app designed to improve engagement in care and ART adherence and social support among HIV-positive YMSM. METHODS: AllyQuest was built on an established platform for patient engagement that embeds social networking and fundamental game mechanics, such as challenges, points, and rewards. A medication tracker provides reminders to promote ART adherence via personalized adherence strategies that are user and context specific; a calendar allows for reflection on adherence over time. After iterative development with input from two youth advisory boards, usability testing was conducted to assess app functionality, comprehension of the educational content, use of intervention features, and overall impressions of app relevance and appeal. A 28-day pilot trial was conducted with 20 HIV+ YMSM to evaluate intervention feasibility and acceptability. RESULTS: Mean age of participants was 21.8 years (range 19-24), and 95% (19/20) of the participants were nonwhite. The mean time of app use was 158.4 min (SD 114.1), with a range of 13 to 441 min. There was a mean of 21.2 days of use (out of a total possible 28 days). There were 222 posts to the daily discussion social wall. Feasibility and acceptability ratings were high. Overall, participants found the app easy to use and navigate, not intrusive, and had few reported technical issues. Higher levels of app usage were positively correlated with HIV self-management outcomes, and there was a statistically significant (P<.05) positive association between the number of days logged into the app and knowledge and confidence in ability to reliably take HIV medications. CONCLUSIONS: AllyQuest represents a new, highly scalable solution that is well-suited to meet the specific prevention and care needs of HIV+ YMSM. The development of this intervention is both timely and vital, given the urgency of the ongoing HIV epidemic among YMSM.

Epic Allies: Development of a Gaming App to Improve Antiretroviral Therapy Adherence Among Young HIV-Positive Men Who Have Sex With Men.

BACKGROUND: In the United States, the human immunodeficiency virus (HIV) disproportionately affects young men who have sex with men (YMSM). For HIV-positive individuals, adherence to antiretroviral therapy (ART) is critical for achieving optimal health outcomes and reducing secondary transmission of HIV. However, YMSM often struggle with ART adherence. Novel mobile phone apps that incorporate game-based mechanics and social networking elements represent a promising intervention approach for improving ART adherence among YMSM. OBJECTIVE: This study used a multiphase, iterative development process to create an ART adherence app for YMSM. METHODS: The three-phase development process included: (1) theory-based concept development jointly by public health researchers and the technology team, (2) assessment of the target population's ART adherence needs and app preferences and development and testing of a clickable app prototype, and (3) development and usability testing of the final app prototype. RESULTS: The initial theory-based app concept developed in Phase One included medication reminders, daily ART adherence tracking and visualization, ART educational modules, limited virtual interactions with other app users, and gamification elements. In Phase Two, adherence needs, including those related to information, motivation, and behavioral skills, were identified. Participants expressed preferences for an ART adherence app that was informational, interactive, social, and customizable. Based on the findings from Phase Two, additional gaming features were added in Phase Three, including an interactive battle, superhero app theme, and app storyline. Other features were modified to increase interactivity and customization options and integrate the game theme. During usability testing of the final prototype, participants were able to understand and navigate the app successfully and rated the app favorably. CONCLUSIONS: An iterative development process was critical for the development of an ART adherence game app that was viewed as highly acceptable, relevant, and useful by YMSM.