Geographic variations of pre-exposure prophylaxis reversal and abandonment among United States counties.

OBJECTIVE: In the United States, one in five newly insurer-approved pre-exposure prophylaxis (PrEP) prescriptions are reversed with over 70% of those reversed, being abandoned. Given the Ending the HIV Epidemic (EHE) initiative's goals, we assessed geographic variations of PrEP reversal and abandonment across EHE and non-EHE counties in the United States. DESIGN: This was a cross-sectional analysis of secondary data. METHODS: Data were collected from Symphony Analytics for adults 18 years and older, with a newly prescribed PrEP claim. Using the proportion of PrEP prescriptions by county, hotspot analysis was conducted utilizing Getis Ord Gi∗ statistics stratified by EHE and non EHE counties. Multivariable logistic regression was used to identify factors associated with residing in hotspots of PrEP reversal or PrEP abandonments. RESULTS: Across 516 counties representing 36,204 patients, the overall PrEP reversal rate was 19.4%, whereas the PrEP abandonment rate was 13.7%. Reversals and abandonments were higher for non-EHE (22.7 and 17.1%) than EHE (15.6 and 10.5%) counties. In both EHE and non-EHE counties, younger age, less education, females, and an out-of-pocket cost of greater than $100, were significantly associated with greater likelihood of residing in hotspots of PrEP reversal or abandonment, while Hispanics, Medicaid recipients, and an out-of-pocket cost of $10 or less had lower likelihood of residing in hotspots of reversal and abandonment. CONCLUSION: Findings indicate the need for implementation of focused interventions to address disparities observed in PrEP reversal and abandonment. Moreover, to improve primary PrEP adherence, national PrEP access programs should streamline and improve PrEP accessibility across different geographic jurisdictions.

"Make it more than a pill, make it an experience of health:" results from an open pilot intervention to retain young African American men who have sex with men in PrEP care.

Uptake and retention in clinical care for pre-exposure prophylaxis (PrEP) is suboptimal, particularly among young African American men who have sex with men (MSM) in the Deep South. We conducted a two-phase study to develop and implement an intervention to increase PrEP persistence. In Phase I, we conducted focus groups with 27 young African American MSM taking PrEP at a community health center in Jackson, Mississippi to elicit recommendations for the PrEP persistence intervention. We developed an intervention based on recommendations in Phase I, and in Phase II, ten participants were enrolled in an open pilot. Eight participants completed Phase II study activities, including a single intervention session, phone call check-ins, and four assessments (Months 0, 1, 3, and 6). Exit interviews demonstrated a high level of acceptability and satisfaction with the intervention. These formative data demonstrate the initial promise of a novel intervention to improve PrEP persistence among young African American MSM.

Increasing Spiritual Beliefs are Associated With Lower HIV Incidence Among Black Men Who Have Sex With Men: Results From HPTN 061 Longitudinal Study.

BACKGROUND: There is a limited understanding about the impact of spiritual beliefs and activities on HIV seroconversion among black men who have sex with men (BMSM), which we investigate in this study. SETTING: United States. METHODS: The HIV Prevention Trials Network Study 061 collected demographic and biomedical assessments among BMSM across 6 United States cities for longitudinal analysis. Spiritual beliefs and spiritual activities are constructed composite scales. Bivariate analyses among 894 who provided data at 12-month follow-up compared men who seroconverted to HIV between baseline and 6 months with those who remained uninfected with HIV at 12 months. Cox proportional hazard regression among 944 men tested spiritual beliefs and activities on the longitudinal risk of HIV seroconversion adjusting for age and any sexually transmitted infection (STI). RESULTS: Among this sample, HIV incidence between baseline and 6 months was 1.69%, (95% confidence intervals [CI]: 1.04 to 2.77). Men who seroconverted to HIV were significantly younger than those who remained uninfected at the 12-month follow-up: (mean age 27, SD = 11 vs 37, SD = 12) and a higher proportion reported any STI (46.67% vs 11.39%, P < 0.01). A one-unit increase in spiritual beliefs was associated with lower hazard rate of seroconverting to HIV at follow-up [adjusted hazard ratio (aHR) = 0.37, 95% CI: = (0.16 to 0.87)]. Religious service attendance and spiritual activities were unrelated to seroconverting. CONCLUSIONS: Spirituality is important in the lives of BMSM. Biomedical and behavioral HIV prevention interventions should consider assessing spiritual beliefs in HIV care among BMSM.

Perspectives on long-acting formulations of pre-exposure prophylaxis (PrEP) among men who have sex with men who are non-adherent to daily oral PrEP in the United States.

INTRODUCTION: Pre-exposure prophylaxis (PrEP) persistence among men who have sex with men (MSM) in real world clinical settings for HIV prevention is suboptimal. New longer-acting formulations of PrEP are becoming available, including injectables, subdermal implants, and other oral medications. These longer-acting formulations have the potential to improve retention among those who have challenges remaining adherent to daily oral PrEP. METHODS: We interviewed 49 MSM who had initiated but discontinued oral PrEP at three diverse clinics across the United States. We examined participants' perspectives about long-acting PrEP formulations and how long-acting options could affect PrEP use using thematic analysis. RESULTS: Participants were not very knowledgeable about long-acting formulations of PrEP but were open to learning about them and considering use. Participants were concerned about safety and efficacy of products given that they were still newer and/or in development. Finally, participants had clear preferences for oral pills, injectables, and then subdermal implants and were most interested in options that reduced the number of visits to the clinic. CONCLUSION: Long-acting formulations of PrEP are acceptable to MSM with suboptimal PrEP persistence and have the potential to improve PrEP persistence. However, many felt they needed more information on safety, efficacy, and use to consider these options. As these long-acting formulations are implemented, public health campaigns and clinical interventions to encourage may maximize uptake particularly among those who are not currently adherent to daily oral PrEP.

A randomized trial of acceptance-based behavioral therapy to improve mental health outcomes for LGBTQ+ persons: Study protocol.

BACKGROUND: During the COVID-19 pandemic, public health measures limited social interactions as an effective and protective intervention for all. For many, however, this social isolation exacerbated mental health symptoms. People who identify as lesbian, gay, bisexual, transgender, and queer (LGBTQ+) were already at elevated risk of anxiety and depression, relative to cisgender and heterosexual populations, and pandemic-related social isolation likely heightened these disparities. In our prior work with sexual and gender minorities, we developed and established feasibility and acceptability of a novel acceptance-based behavioral therapy (ABBT) intervention for HIV treatment. ABBT showed promise in improving social support and reducing mental health symptoms. In the current study, we investigate the efficacy of ABBT, compared to a treatment-as-usual control condition, in a full-scale randomized controlled trial to improve social support for LGBTQ+ persons living with anxiety and depression. METHODS: Two hundred forty LGBTQ+ adults with anxiety and/or depressive symptoms will be recruited and equally randomized to receive: (a) the ABBT intervention, consisting of two 30-40 min sessions plus treatment-as-usual (TAU), or (b) TAU only. Primary outcomes are interviewer-assessed anxiety and depressive symptoms. Secondary outcomes are self-reported anxiety and depressive symptoms. Experiential avoidance and social support are hypothesized mediators and presence of an anxiety and/or depressive disorder is a hypothesized moderator. CONCLUSIONS: ABBT represents a novel, identify-affirming real-world approach to promoting social support as a means of improving mental health among individuals who identify as LGBTQ+. This study will contribute actionable data establishing the impact, mediational mechanisms, and effect modifiers of ABBT. CLINICALTRIALS: govregistration: NCT05540067.

Factors associated with suboptimal retention in HIV pre-exposure prophylaxis care among men who have sex with men.

Despite the efficacy of HIV pre-exposure prophylaxis (PrEP), retention in care in the United States remains suboptimal. The goal of this study was to explore factors that lead to suboptimal retention in PrEP care for men who have sex with men (MSM) in real-world clinical settings in the United States. Trained interviewers conducted semi-structured interviews with MSM (N = 49) from three clinics who had been engaged in PrEP care in the Midwest (n = 15), South (n = 15), and Northeast (n = 19) geographic regions and had experienced a lapse in PrEP use. Factors that emerged as related to suboptimal retention in PrEP care included structural factors such as transportation and out-of-pocket costs; social factors such as misinformation on media and in personal networks; clinical factors such as frequency and timing of appointments; and behavioral factors such as changes in sexual behavior and low perceived risk for HIV. Participants suggested reducing the out-of-pocket costs of medications and lab visits, having flexible appointment times, culturally responsive services, and comprehensive patient navigation to help retention in care. These findings leveraged real-world experiences and opinions of patients to inform gaps in current services and how to make changes to optimize PrEP care.

Barriers and facilitators to HIV care engagement: Recommendations from people with HIV in rural Arkansas.

PURPOSE: Little is known about factors affecting HIV care engagement and retention among rural people with HIV (PWH) in the South. About half of PWH in Arkansas reside in rural areas. The purpose of this study was to explore factors affecting engagement and retention in HIV care among PWH in rural areas of Arkansas. METHODS: We conducted an exploratory qualitative study in 2020 and completed individual interviews (N = 11) with PWH in rural counties in Arkansas. FINDINGS: Content analysis revealed the following themes: (1) Barriers to HIV care included long distances to the nearest HIV clinic and transportation issues along with anticipating and/or experiencing HIV-related stigma; (2) facilitators of HIV care included having a helpful HIV care provider and Ryan White case manager and a social support network that aided them in prioritizing their own health; (3) participants had the most favorable reactions to Ryan White case management, peer navigators, and telemedicine for HIV treatment/care; and (4) participants demonstrated resilience overcoming various obstacles as they worked toward being healthy mentally and physically while living with HIV. CONCLUSION: Interventions need to address multilevel factors, including hiring PWH as peer navigators and/or caseworkers and offering HIV care via telemedicine, to improve HIV care engagement and retention among rural populations.

Pre-exposure Prophylaxis Discontinuation During the COVID-19 Pandemic Among Men Who Have Sex With Men in a Multisite Clinical Cohort in the United States.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic continues to put strain on health systems in the United States, leading to significant shifts in the delivery of routine clinical services, including those offering HIV pre-exposure prophylaxis (PrEP). We aimed to assess whether individuals discontinued PrEP use at higher rates during the COVID-19 pandemic and the extent to which disruptions to usual clinical care were mitigated through telehealth. METHODS: Using data from an ongoing prospective cohort of men who have sex with men (MSM) newly initiating PrEP in 3 mid-sized cities (n = 195), we calculated the rate of first-time discontinuation of PrEP use in the period before the COVID-19 pandemic and during the COVID-19 pandemic and compared these rates using incidence rate ratios (IRRs). Furthermore, we compared the characteristics of patients who discontinued PrEP use during these periods with those who continued to use PrEP during both periods. RESULTS: Rates of PrEP discontinuation before the COVID pandemic and during the COVID-19 pandemic were comparable [4.29 vs. 5.20 discontinuations per 100 person-months; IRR: 1.95; 95% confidence interval (CI): 0.83 to 1.77]. Although no significant differences in the PrEP discontinuation rate were observed in the overall population, the rate of PrEP discontinuation increased by almost 3-fold among participants aged 18-24 year old (IRR: 2.78; 95% CI: 1.48 to 5.23) and by 29% among participants covered by public insurance plans at enrollment (IRR: 1.29; 95% CI: 1.03 to 5.09). Those who continued to use PrEP were more likely to have had a follow-up clinical visit by telehealth in the early months of the pandemic (45% vs. 17%). CONCLUSIONS: In this study, rates of PrEP discontinuation were largely unchanged with the onset of the COVID-19 pandemic. The use of telehealth likely helped retain patients in PrEP care and should continue to be offered in the future.

Findings From Talking Tech: A Technology Training Pilot Intervention to Reduce Loneliness and Social Isolation Among Homebound Older Adults.

Background and Objectives: Social isolation and loneliness are common among older adults and associated with negative health outcomes including cognitive decline, depression, suicide ideation, and mortality. Information and communication technology interventions are often used to combat loneliness and social isolation; however, homebound older adults face barriers to access. This study reports findings from a novel pilot intervention, called Talking Tech, designed to reduce loneliness and social isolation in homebound older adults by providing one-on-one, in-home technology training, a tablet, and the internet, to promote digital literacy and participation in a virtual senior center. Research Design and Methods: Twenty-one homebound older adults participated in this 14-week, volunteer-delivered program. We used qualitative interviews with participants, volunteers, and program staff, weekly progress reports from volunteers, and quantitative pre- and postintervention surveys with participants to examine experiences and to evaluate the impact of the intervention on loneliness and social isolation. Qualitative data were analyzed using content analysis and pre- and postintervention survey data were compared. Results: Participants reported increased technological literacy and use, increased access to online activities, and improved facilitation of social connections to existing and new networks. Additionally, during interviews, many participants reported that participating in Talking Tech alleviated their loneliness. While not statistically significant, our quantitative analysis revealed trends toward decreased participant feelings of loneliness and increased technology use. Additionally, intervention adoption and retention were high, with only one participant withdrawing from the intervention. Discussion and Implications: This evaluation of the novel Talking Tech pilot intervention provides critical insights into strategies to reduce loneliness and isolation for older adults, with implications for future research, policy, and practice. Findings demonstrate that individualized technology training may be an acceptable way to improve well-being for homebound older adults.

Projected Effects of Disruptions to Human Immunodeficiency Virus (HIV) Prevention Services During the Coronavirus Disease 2019 Pandemic Among Black/African American Men Who Have Sex With Men in an Ending the HIV Epidemic Priority Jurisdiction.

Background: Disruptions in access to in-person human immunodeficiency virus (HIV) preventive care during the coronavirus disease 2019 (COVID-19) pandemic may have a negative impact on our progress towards the Ending the HIV Epidemic goals in the United States. Methods: We used an agent-based model to simulate HIV transmission among Black/African American men who have sex with men in Mississippi over 5 years to estimate how different reductions in access affected the number of undiagnosed HIV cases, new pre-exposure prophylaxis (PrEP) starts, and HIV incidence. Results: We found that each additional 25% decrease in HIV testing and PrEP initiation was associated with decrease of 20% in the number of cases diagnosed and 23% in the number of new PrEP starts, leading to a 15% increase in HIV incidence from 2020 to 2022. Conclusions: Unmet need for HIV testing and PrEP prescriptions during the COVID-19 pandemic may temporarily increase HIV incidence in the years immediately after the disruption period.

A Pilot Study of a Patient Navigation Intervention to Improve HIV Pre-exposure Prophylaxis Persistence Among Black/African American Men Who Have Sex With Men.

BACKGROUND: Suboptimal HIV pre-exposure prophylaxis (PrEP) care outcomes among Black/African American men who have sex with men (MSM) limits its population-level effects on HIV incidence. We conducted a pilot study of a brief patient navigation intervention aimed at improving PrEP initiation and persistence among Black/African American MSM in the Southern United States. SETTING: Community health center in Jackson, MS. METHODS: We recruited 60 Black/African American MSM aged 18-34 years who were newly prescribed PrEP. Participants were randomized to receive the clinic's current standard of care or an intervention condition including a single patient navigation session to discuss and address perceived barriers to initiating and maintaining access to PrEP and biweekly check-ins. Participants were followed over 6 months using survey assessments, medical chart review, and pharmacy purchase records to ascertain PrEP initiation and persistence. RESULTS: Participants in the intervention condition were more likely to pick up their initial PrEP prescription [RR: 1.47; 95% confidence interval (CI): 1.10 to 1.97], be retained in PrEP care at 3 months (RR: 1.62; 95% CI: 1.01 to 2.59) and 6 months (RR: 1.38; 95% CI: 0.64 to 2.93), and have access to PrEP medications greater than 80% of all study days based on pharmacy fill records (RR: 3.00; 95% CI: 1.50 to 5.98). CONCLUSION: A brief patient navigation intervention demonstrated proof-of-concept in improving PrEP initiation and persistence among Black/African American MSM in the Southern United States.

Novel population-level proxy measures for suboptimal HIV preexposure prophylaxis initiation and persistence in the USA.

OBJECTIVE: In the United States (USA), HIV preexposure prophylaxis (PrEP) use is suboptimal. Population-level metrics on PrEP use are limited and focus on prescriptions issued rather than how much prescriptions are picked up. We introduce PrEP reversals, defined as when patients fail to pick up PrEP prescriptions at the pharmacy point-of-sale, as a proxy for PrEP initiation and persistence. DESIGN: We analysed PrEP pharmacy claims and HIV diagnoses from a Symphony Health Solutions dataset across all US states from 1 October 2015 to 30 September 2019. METHODS: We calculated the percentage of individuals who were newly prescribed PrEP and who reversed (i.e. patient did not pick up an insurance-approved prescription and pharmacy withdrew the claim), delayed (reversed and then picked up within 90 days), very delayed (reversed and then picked up between 90 and 365 days) or abandoned (not picked up within 365 days), and subsequent HIV diagnosis within 365 days. RESULTS: Of 59 219 individuals newly prescribed PrEP, 19% reversed their index prescription. Among those, 21% delayed initiation and 8% had very delayed initiation. Seventy-one percent of patients who reversed their initial prescription abandoned it, 6% of whom were diagnosed with HIV---three times higher than those who persisted on PrEP. CONCLUSION: Nearly one in five patients newlyprescribed PrEP reversed initial prescriptions, leading to delayed medication access, being lost to PrEP care, and dramatically higher HIV risk. Reversals could be used for real-time nationwide PrEP population-based initiation and persistence tracking, and for identifying patients that might otherwise be lost to care.

Loss to Follow-Up and Re-Engagement in HIV Pre-Exposure Prophylaxis Care in the United States, 2013-2019.

Retention in HIV pre-exposure prophylaxis (PrEP) care is critical for effective PrEP implementation. Few studies have reported long-term lost to follow-up (LTFU) and re-engagement in PrEP care in the United States. Medical record data for all cisgender patients presenting to the major Rhode Island PrEP clinic from 2013 to 2019 were included. LTFU was defined as no PrEP follow-up appointment within 98 days. Re-engagement in care was defined as individuals who were ever LTFU and later attended a follow-up appointment. Recurrent event survival analysis was performed to explore factors associated with PrEP retention over time. Of 654 PrEP patients, the median age was 31 years old [interquartile range (IQR): 25, 43]. The majority were male (96%), White (64%), non-Hispanic (82%), and insured (97%). Overall, 72% patients were ever LTFU and 27% of those ever LTFU re-engaged in care. Female patients were 1.37 times [crude hazard ratio (cHR): 1.37; 95% confidence interval (CI): 0.86-2.18] more likely to be LTFU than male patients, and a 1-year increase in age was associated with a 1% lower hazard of being LTFU (cHR: 0.99; CI: 0.98-0.99). Being either heterosexual (aHR: 2.25, 95% (CI): 1.70-2.99] or bisexual (aHR: 2.35, 95% CI: 1.15-4.82) was associated with a higher hazard of loss to follow-up compared with having same-sex partners only. The majority of PrEP users were LTFU, especially at the first 6 months of PrEP initiation. Although a significant number were re-engaged in care, targeted interventions are needed to improve retention in PrEP care. This study characterized the natural projection of loss to follow-up and re-engagement in HIV PrEP care using a longitudinal clinic cohort data and explored associated factors for guiding future interventions to improve retention in PrEP care.

Gay and Bisexual Men's Recommendations for Effective Digital Social Marketing Campaigns to Enhance HIV Prevention and Care Continuity.

Because use of geosocial-networking smartphone applications ('apps') is ubiquitous among men who have sex with men (MSM), online-to-offline service models that include advertisements on these apps may improve engagement with effective HIV prevention and treatment services. Through our formative qualitative study, we conducted individual in-depth interviews (n = 30) and focus group discussions (n = 18) with MSM in Rhode Island to develop a digital social marketing campaign aimed at increasing HIV testing, including how best to reach men by advertising on apps. Qualitative data analysis revealed that participants were frequently exposed to pop-up advertisements on apps. These advertisements are viewed as invasive and, as such, many expressed a preference for other formats (e.g., direct messages, banner advertisements). Men expressed a preference for provocative images and phrases to catch their attention followed with fact-driven messaging to motivate them to engage with services offline. Findings from this study offer several practical recommendations for developing a social marketing campaign that uses advertisements on apps to increase HIV testing among MSM, including using formats other than pop-up advertisements and pairing fact-driven messaging with eye-catching images to direct them to trusted local clinical services.

Added Benefits of Pre-Exposure Prophylaxis Use on HIV Incidence with Minimal Changes in Efficiency in the Context of High Treatment Engagement Among Men Who Have Sex with Men.

Although there is ongoing debate over the need for substantial increases in pre-exposure prophylaxis (PrEP) use when antiretroviral treatment confers the dual benefits of reducing HIV-related morbidity and mortality and the risk of HIV transmission, no studies to date have quantified the potential added benefits of PrEP use and changes in its efficiency in the context of high treatment engagement across multiple US subpopulations. We used a previously published agent-based model to simulate HIV transmission in a dynamic network of Black/African American and White men who have sex with men (MSM) in Atlanta, Georgia (2015-2024) to understand how reductions in HIV incidence attributable to varying levels of PrEP use change when United Nations Joint Programme on HIV/AIDS (UNAIDS) "90-90-90" goals for HIV treatment are achieved and maintained. Even at achievement of "90-90-90" goals, 75% PrEP coverage further reduced incidence by 67.9% and 74.2% to 1.53 [simulation interval (SI): 1.39-1.70] and 0.355 (SI: 0.316-0.391) per 100 person-years for Black/African American and White MSM, respectively, compared with the same scenario with no PrEP use. Increasing PrEP coverage from 15% to 75% under "90-90-90" goals only increased the number of person-years of PrEP use per infection averted by 8.1% and 10.5% to 26.7 (SI: 25.6-28.0) and 73.3 (SI: 70.6-75.7) among Black/African American MSM and White MSM, respectively. Even with high treatment engagement, substantial expansion of PrEP use contributes to meaningful decreases in HIV incidence among MSM with minimal changes in efficiency.

Projecting the impact of equity-based preexposure prophylaxis implementation on racial disparities in HIV incidence among MSM.

BACKGROUND: It is unknown what levels of preexposure prophylaxis (PrEP) use are needed to reduce racial disparities in HIV incidence among men who have sex with men (MSM). Using an agent-based model, we quantified the impact of achieving PrEP coverage targets grounded in equity on racial disparities in HIV incidence among MSM in an urban setting in the Southeastern United States. METHODS: An agent-based model was adapted to simulate HIV transmission in a network of Black/African American and White MSM aged 18-39 years in the Atlanta-Sandy Springs-Roswell metropolitan area over 10 years (2015-2024). Scenarios simulated coverage levels consistent with targets based on the ratio of the number of individuals using PrEP to the number of individuals newly diagnosed in a calendar year (i.e., the 'PrEP-to-need ratio'), ranging from 1 to 10. Incidence rate ratios and differences were calculated as measures of disparities. RESULTS: Without PrEP, the model predicted a rate ratio of 3.82 and a rate difference of 4.50 comparing HIV incidence in Black/African American and White MSM, respectively. Decreases in the rate ratio of at least 50% and in the rate difference of at least 75% were observed in all scenarios in which the PrEP-to-need ratio among Black/African American MSM was 10, regardless of the value among White MSM. CONCLUSION: Significant increases in PrEP use are needed among Black/African American MSM to reduce racial disparities in HIV incidence. PrEP expansion must be coupled with structural interventions to address vulnerability to HIV infection among Black/African American MSM.