Prepare Romania: study protocol for a randomized controlled trial of an intervention to promote pre-exposure prophylaxis adherence and persistence among gay, bisexual, and other men who have sex with men.

BACKGROUND: Gay, bisexual, and other men who have sex with men (GBMSM) represent a high-risk group for HIV transmission in Romania, yet they possess few resources for prevention. Despite having no formal access to pre-exposure prophylaxis (PrEP) through the health system, GBMSM in Romania demonstrate a high need for and interest in this medication. In anticipation of a national rollout of PrEP, this study tests the efficacy of a novel strategy, Prepare Romania, that combines two evidence-based PrEP promotion interventions for GBMSM living in Romania. METHODS: This study uses a randomized controlled trial design to examine whether GBMSM living in Romania receiving Prepare Romania, a culturally adapted counseling and mobile health intervention (expected n = 60), demonstrate greater PrEP adherence and persistence than those assigned to a PrEP education control arm (expected n = 60). Participants from two main cities in Romania are prescribed PrEP and followed-up at 3 and 6 months post-randomization. PrEP adherence data are obtained through weekly self-report surveys and dried blood spot testing at follow-up visits. Potential mediators (e.g., PrEP use motivation) of intervention efficacy are also assessed. Furthermore, Prepare Romania's implementation (e.g., proportion of enrolled participants attending medical visits, intervention experience) will be examined through interviews with participants, study implementers, and healthcare officials. DISCUSSION: The knowledge gained from this study will be utilized for further refinement and scale-up of Prepare Romania for a future multi-city effectiveness trial. By studying the efficacy of tools to support PrEP adherence and persistence, this research has the potential to lay the groundwork for PrEP rollout in Romania and similar contexts. Trial registration This study was registered on ClinicalTrials.gov, identifier NCT05323123 , on March 25, 2022.

Long-acting injectable ART to advance health equity: a descriptive analysis of US clinic perspectives on barriers, needed support and programme goals for implementation from applications to the ALAI UP Project.

INTRODUCTION: Approval of the first long-acting injectable antiretroviral therapy (LAI ART) medication heralded a new era of HIV treatment. However, the years since approval have been marked by implementation challenges. The "Accelerating Implementation of Multilevel Strategies to Advance Long-Acting Injectable for Underserved Populations (ALAI UP Project)" aims to accelerate the systematic and equitable delivery of LAI ART. METHODS: We coded and analysed implementation barriers according to the Consolidated Framework for Implementation Research (CFIR) domains, desired resources and programme goals from questionnaire short-answer responses by clinics across the United States responding to ALAI UP's solicitation to participate in the project between November 2022 and January 2023. RESULTS: Thirty-eight clinics responded to ALAI UP's solicitation. The characteristics of LAI ART as an innovation (cost, complexity of procurement, dosing interval, limited eligibility) precipitated and interacted with barriers in other CFIR domains. Barriers included obtaining coverage for the cost of medication (27/38 clinics) (outer setting); need for new workflows and staffing (12/38) and/or systems to support injection scheduling/coordination (16/38), transportation and expanded clinic hours (13/38) (inner setting); and patient (10/38) and provider (7/38) education (individuals). To support implementation, applicants sought: technical assistance to develop protocols and workflows (18/38), specifically strategies to address payor challenges (8/38); additional staff for care coordination and benefits navigation (17/38); opportunities to share experiences with other implementing clinics (12/38); patient-facing materials to educate and increase demand (7/38); and support engaging communities (6/38). Clinics' LAI ART programme goals varied. Most prioritized delivering LAI ART to their most marginalized patients struggling to achieve viral suppression on oral therapy, despite awareness that current US Food and Drug Administration approval is only for virally suppressed patients. The goal for LAI ART reach after 1 year of implementation ranged from ≤10% of patients with HIV on LAI ART (17/38) to ≥50% of patients (2/38). CONCLUSIONS: Diverse clinic types are interested in offering LAI ART and most aspire to use LAI ART to support their most vulnerable patients sustain viral suppression. Dedicated resources centred on equity and relevant to context and population are needed to support implementation. Otherwise, the introduction of LAI ART risks exacerbating, not ameliorating, health disparities.

Factors associated with PrEP-era HIV seroconversion in a 4-year U.S. national cohort of n = 6059 sexual and gender minority individuals who have sex with men, 2017-2022.

INTRODUCTION: Community-based cohort studies of HIV seroconversion can identify important avenues for enhancing HIV prevention efforts in the era of pre-exposure prophylaxis (PrEP). Within individuals, one can assess exposure and outcome variables repeatedly and with increased certainty regarding temporal ordering. This cohort study examined the association of several risk factors with subsequent HIV seroconversion. METHODS: We report data from a 4-year study (2017-2022) of 6059 HIV seronegative sexual and gender minority individuals who have sex with men who had indications for-, but were not using-, PrEP at enrolment. Participants completed repeat exposure assessments and self-collection of biospecimens for HIV testing. We examined the roles of race and ethnicity, socio-economic status, methamphetamine use and PrEP uptake over the course of follow-up in relation to HIV seroconversion. RESULTS: Over 4 years, 303 of the participants seroconverted across 18,421 person-years (incidence rate = 1.64 [95% CI: 1.59-1.70] per 100 person-years). In multivariable discrete-time survival analysis, factors independently associated with elevated HIV seroconversion risk included being Black/African American (adjusted risk ratio [aRR]: 2.44, 1.79-3.28), Hispanic/Latinx (1.53, 1.19-1.96), housing instability (1.58, 1.22-2.05) and past year methamphetamine use (3.82, 2.74-5.33). Conversely, time since study enrolment (24 vs. 12 months, 0.67, 0.51-0.87; 36 months, 0.60, 0.45-0.80; 48 months, 0.48, 0.35-0.66) and higher education (master's degree or higher vs. less than or equal to high school, 0.36, 0.17-0.66) were associated with reduced seroconversion risk. Compared to non-PrEP users in the past 2 years without a current clinical indication, those who started PrEP but then discontinued had higher seroconversion risk, irrespective of clinical indication (3.23, 1.74-6.46) or lack thereof (4.30, 1.85-9.88). However, those who initiated PrEP in the past year (0.14, 0.04-0.39) or persistently used PrEP in the past 2 years (0.33, 0.14-0.74) had a lower risk of seroconversion. Of all HIV seroconversions observed during follow-up assessments (12, 24, 36 and 48 months), methamphetamine was reported in the 12 months prior 128 (42.2%) times (overall). CONCLUSIONS: Interventions that acknowledge race and ethnicity, economic variables such as education and housing instability, and methamphetamine use are critically needed. Not only are interventions to engage individuals in PrEP care needed, but those that retain them, and re-engage those who may fall out of care are essential, given the exceptionally high risk of seroconversion in these groups.

Understanding Attitudes of Postpartum Cisgender Women Toward Integration of HIV Prevention Services into Routine Prenatal and Postpartum Sexual Health Discussions.

Oral pre-exposure prophylaxis (PrEP) is an effective, user-controlled method for HIV prevention. However, awareness, uptake, and adherence to PrEP remain low among cisgender women (CGW). The prenatal and postpartum periods present an opportunity for delivery of comprehensive sexual health services that include HIV prevention education and services. However, little is known about postpartum CGW's attitudes toward integration of HIV prevention education and services into obstetric care in the US. We conducted semistructured interviews with 20 postpartum CGW in the Bronx, NY from July to November 2022 to explore their experiences with prenatal and postpartum sexual health care, examine their attitudes toward integration of HIV prevention services into obstetric sexual health care, and identify components of future implementation strategies. Transcripts were analyzed thematically using a framework approach. Among CGW interviewed, fewer than half reported prior knowledge of PrEP. Ten participants preferred long-acting injectable PrEP relative to six who preferred daily oral PrEP. Most participants reported no discussion of sex with their provider during pregnancy, and when discussions occurred, they focused on permission or prohibition of sexual activity. Participants described a reliance on providers to lead prenatal sexual health discussions. Even when not perceived as personally relevant, most respondents valued education on HIV prevention and PrEP services. In the postpartum period, sexual health discussions were similarly limited despite participants describing complex experiential sexual health concerns. This study supports the potential for integration of HIV prevention education and services into routine prenatal and postpartum sexual health discussions in an area of high HIV prevalence in the US.

PrEP Discontinuation In A US National Cohort Of Sexual And Gender Minority Populations, 2017-22.

In the US, sexual and gender minority populations are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) is a key prevention method, but its effectiveness relies on consistent usage. Our four-year national cohort study explored PrEP discontinuation among sexual and gender minority people who initiated PrEP. We found a high annual rate of discontinuation (35-40 percent) after PrEP initiation. Multivariable analysis with 6,410 person-years identified housing instability and prior history of PrEP discontinuation as predictors of discontinuation. Conversely, older age, clinical indication for PrEP, and having health insurance were associated with ongoing PrEP use. To promote sustained PrEP use, strategies should focus on supporting those at high risk for discontinuation, such as younger people, those without stable housing or health insurance, and prior PrEP discontinuers.

HIV-1 Incidence, Adherence, and Drug Resistance in Individuals Taking Daily Emtricitabine/Tenofovir Disoproxil Fumarate for HIV-1 Pre-Exposure Prophylaxis: Pooled Analysis From 72 Global Studies.

BACKGROUND: Oral pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (F/TDF) has high efficacy against HIV-1 acquisition. Seventy-two prospective studies of daily oral F/TDF PrEP were conducted to evaluate HIV-1 incidence, drug resistance, adherence, and bone and renal safety in diverse settings. METHODS: HIV-1 incidence was calculated from incident HIV-1 diagnoses after PrEP initiation and within 60 days of discontinuation. Tenofovir concentration in dried blood spots (DBS), drug resistance, and bone/renal safety indicators were evaluated in a subset of studies. RESULTS: Among 17,274 participants, there were 101 cases with new HIV-1 diagnosis (0.77 per 100 person-years; 95% CI 0.63-0.94). In 78 cases with resistance data, 18 (23%) had M184I or V, one (1.3%) had K65R, and three (3.8%) had both mutations. In 54 cases with tenofovir concentration data from DBS, 45 (83.3%), 2 (3.7%), 6 (11.1%), and 1 (1.9%) had average adherence of <2, 2-3, 4-6, and ≥7 doses/week, respectively, and the corresponding incidence was 3.9 (95% CI 2.9-5.3), 0.24 (0.060-0.95), 0.27 (0.12-0.60), and 0.054 (0.008-0.38) per 100 person-years. Adherence was low in younger participants, Hispanic/Latinx and Black participants, cisgender women, and transgender women. Bone and renal adverse event incidence rates were 0.69 and 11.8 per 100 person-years, respectively, consistent with previous reports. CONCLUSIONS: Leveraging the largest pooled analysis of global PrEP studies to date, we demonstrate that F/TDF is safe and highly effective, even with less than daily dosing, in diverse clinical settings, geographies, populations, and routes of HIV-1 exposure.

PrEP Uptake and Methamphetamine Use Patterns in a 4-Year U.S. National Prospective Cohort Study of Sexual and Gender Minority People, 2017-2022.

Methamphetamine use is on the rise among sexual and gender minority people who have sex with men (SGMSM), escalating their HIV risk. Despite pre-exposure prophylaxis (PrEP) being an effective biomedical HIV prevention tool, its uptake in relation to methamphetamine use patterns in SGMSM has not been studied. In a U.S. cohort study from 2017 to 2022, 6,253 HIV-negative SGMSM indicated for but not using PrEP were followed for four years. Methamphetamine use was categorized (i.e., newly initiated, persistently used, never used, used but quit), and PrEP uptake assessed using generalized estimating equation (GEE), adjusted for attrition. Participants had a median age of 29, with 51.9% White, 11.1% Black, 24.5% Latinx, and 12.5% other races/ethnicities. Over the four years, PrEP use increased from 16.3 to 27.2%. GEE models identified risk factors including housing instability and food insecurity. In contrast, older age, health insurance, clinical indications, and prior PrEP use increased uptake. Notably, Latinx participants were more likely to use PrEP than Whites. Regarding methamphetamine use, those who newly initiated it were more likely to use PrEP compared to non-users. However, those who quit methamphetamine and those who persistently used it had PrEP usage rates comparable to those of non-users. Though PrEP uptake increased, it remained low in SGMSM. Methamphetamine use was associated with PrEP uptake. Healthcare providers should assess methamphetamine use for harm reduction. Prioritizing younger, uninsured SGMSM and addressing basic needs can enhance PrEP uptake and reduce HIV vulnerabilities.

Using audience segmentation to identify implementation strategies to improve PrEP uptake among at-risk cisgender women: a mixed-methods study protocol.

BACKGROUND: In the USA, 19% of new HIV infections occur among cisgender women (cis women); however, only 10% of eligible cis women have been prescribed pre-exposure prophylaxis (PrEP) for the prevention of HIV infection (an evidence-based intervention). A fundamental challenge for expanding HIV prevention to cis women is ensuring implementation strategies are tailored to the various healthcare settings in which cis women seek care and the heterogeneous providers nested within these settings. This project's specific aims are to (1) explore clinician-level characteristics and organizational climate factors that are related to variability in adoption of PrEP service delivery as an evidence-based intervention for cis women; (2) identify latent audience segments of women's health providers as the related to PrEP acceptability, adoption, and maintenance and analyze demographic correlates of these segments; and (3) identify audience segment-specific implementation strategies to facilitate the adoption of PrEP as an evidence-based intervention among at-risk cis women. METHODS: Using the i-PARIHS framework, this mixed-methods study examines three domains for guiding audience segmentation to facilitate PrEP implementation for cis women: innovation (degree of fit with existing practices, usability), recipient beliefs and knowledge and context factors (organizational culture, readiness for change), needs to determine appropriate facilitation methods. To achieve aim 1, qualitative interviews will be conducted with PrEP-eligible cis women, women's health providers, and other key stakeholders. Aim 2 will consist of a quantitative survey among 340 women's health providers. Latent class analysis will be used to facilitate audience segmentation. To achieve aim 3, a panel of 5-8 providers for each audience segment will meet and engage in iterative discussions guided by Fernandez's implementation mapping to identify (1) implementation outcomes and performance objectives, determinants, and change objectives and (2) determine and refine of implementation strategies for each audience segment. DISCUSSION: This exploratory mixed methods study will provide an empirical foundation to inform the development implementations strategies aimed at increasing PrEP delivery to cis women among heterogenous groups of providers.

Pathways Between Intersectional Stigma and HIV Treatment Engagement Among Men Who Have Sex with Men (MSM) in India.

In India and other low-and-middle-income countries, little is known about how intersectional stigma affects MSM engagement in ART. Informed by the Health Stigma and Discrimination Framework, we qualitatively examined how multiple stigmas influence ART engagement among Indian MSM. We conducted 3 focus groups (N = 22) with MSM living with HIV, aged 21-58 years, in Delhi and Hyderabad to identify potential intervention targets and solutions to improve treatment outcomes. Framework analysis and techniques were used to code and analyze translated audio-recordings. Findings revealed enacted stigma, associated with HIV and MSM identity, manifested as familial shame and healthcare discrimination, inhibiting access to support, and decreasing HIV care engagement. Anticipated stigma led to worry about disclosure and societal repercussions. Community-Based-Organizations, ART centers, and family members were primary sources of support, leading to increased ART initiation and retention. Potential solutions included using MSM peer-counselors, increasing social support, and providing HIV education to the general community.

Two Models for Increasing the Scope and Activities of Human Immunodeficiency Virus Partner Services Programs: Preliminary Findings From the Fast Track Project.

BACKGROUND: We sought to develop a novel strategy for expanding an existing human immunodeficiency virus (HIV) partner services (PS) model to provide comprehensive sexual health services, including sexually transmitted infection testing, a virtual telemedicine visit, and access to immediate start medication (antiretroviral treatment, preexposure or postexposure prophylaxis). Fast Track was a National Institutes of Health-funded implementation science trial in New York City to pilot and refine the new strategy, and examine its feasibility, acceptability, and impact. METHODS: Over the course of 1 year, health department staff collaborated with the academic research team to develop Fast Track protocols and workflows, create a cloud-based database to interview and track patients, and train disease intervention specialists to deliver the new program. The initial field-based program (Fast Track 1.0) was piloted March to December 2019. A modified telephone-based program (Fast Track 2.0) was developed in response to COVID-19 pandemic constraints and was piloted August 2020 to March 2021. RESULTS: These 2 pilots demonstrate the feasibility and acceptability of integrating comprehensive sexual health services into HIV PS programs. Disease intervention specialists were successfully trained to conduct comprehensive sexual health visits, and clients reported that the availability of comprehensive sexual health services made them more willing to engage with PS. Key lessons for scale-up include managing collaboration with a licensed provider, navigating technical and technological issues, and challenges in client engagement and retention. CONCLUSIONS: The success of this integrated strategy suggests that telehealth visits may be a critical gateway to care engagement for PS clients. This model is an innovative strategy for increasing engagement with HIV testing, prevention, and treatment for underserved populations.

Psychometric Evaluation and Predictive Validity of an Adapted Adherence Self-Efficacy Scale for PrEP.

Adherence to and sustainment of HIV pre-exposure prophylaxis (PrEP) are critical to its effectiveness. Adherence self-efficacy, i.e., confidence in one's ability to adhere to a particular medication, is a key psychological determinant of health behavior that strongly predicts HIV treatment adherence but has been understudied in PrEP research. This paper describes the psychometric evaluation and validation of the PrEP Adherence Self-Efficacy Scale (PrEP-ASES), adapted from the previously validated HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES). Data are drawn from two studies conducted at a community health center, one focused on gay and bisexual cisgender men and the other on transgender women. Factor analyses support a one-factor score (eigenvalue = 6.78) that explained 75.3% of the variance, with good test-retest reliability (rs > 0.40). In both studies, higher PrEP-ASES scores were associated with PrEP uptake, adherence, and sustainment. Findings support the utility of the PrEP-ASES in research and suggest the importance of addressing self-efficacy in PrEP programs and services.

Intersectional stigma and gender non-affirmation hinder HIV care engagement among transgender women living with HIV in India.

Among transgender women living with HIV (TGWLH) in India, little is understood about the mechanisms through which multiple intersecting stigmas impact HIV care engagement, or intervention strategies that might mitigate this impact. We conducted focus groups with TGWLH (N = 30) in three Indian cities and analysed data using theoretical frameworks related to HIV stigma, gender affirmation, and syndemics. Findings revealed that enacted and anticipated stigma due to transgender identity, HIV, or sex work status, and lack of gender affirmation (e.g., misgendering) in healthcare settings delayed ART initiation and promoted care disengagement. Having supportive physicians and counsellors within ART centres and peer outreach workers facilitated ART initiation, adherence, and retention. Findings also revealed that HIV stigma within TGW communities led to concealment of HIV status or syndemic conditions such as depression and alcohol use, thereby affecting care engagement. However, the TGW community itself was also described as a resilience resource, offering emotional, psychological and tangible support that decreased the impact of discrimination on care engagement. HIV care engagement efforts among Indian TGWLH could be strengthened by reducing intersecting stigmas in healthcare settings and within TGW communities, providing gender-affirming and culturally competent healthcare, addressing psychosocial syndemic conditions, and strengthening support within transgender communities.

Exploring Factors Affecting Patient-Provider Interactions and Healthcare Engagement Among a Diverse Sample of Women Who Have Sex with Women in New York City.

Women who have sex with women (WSW) have lower rates of engagement in health care and preventive screenings than women who have sex exclusively with men. Existing literature provides limited insight into how intersecting and overlapping identities, such as race, ethnicity, sexual orientation, gender identity, and identities related to gender expression, may shape individuals' experiences within health care. We conducted qualitative interviews in New York City with 30 people who identified as women, reported sex with people who identify as women, were age 18-65, and were diverse in race, ethnicity, and sexual orientation and gender identity. The semi-structured questionnaire asked participants about positive and negative healthcare experiences to elicit what could encourage or prevent seeking care, with a focus on provider-related factors. Factors that led to positive healthcare experiences included having a provider who was knowledgeable about LGBTQ experience and health and who affirmed their sexuality, gender identity, and other intersecting identities. Factors that contributed to negative healthcare experiences included poor interactions with providers, and providers' perceived heteronormativity and lack of awareness of WSW healthcare needs. WSW of different races, ethnicities, sexual orientations, and gender identities seek validating healthcare experiences that acknowledge and affirm their identities. We present a visual summary of the main thematic factors that contributed to positive and negative WSW healthcare experiences. Increasing access to care requires training providers on how to engage WSW patients, including WSW of diverse race/ethnicity and gender identity and expression.

The Long-Acting Cabotegravir Tail as an Implementation Challenge: Planning for Safe Discontinuation.

The long-acting feature of cabotegravir, an integrase-inhibitor highly effective in preventing acquisition of HIV in adolescents and adults, is both its greatest strength and a challenge to its implementation. Cab-LA is administered at 8-week intervals (after an initial loading dose) but has a long, variable drug "tail" that may leave users vulnerable to future drug resistance if they contract HIV during this critical period. The potential for cab-LA to meaningfully contribute to ending the HIV Epidemic is hindered by, among other factors, limited resources to guide patients and providers on how to safely discontinue injections. We suggest three key strategies to overcome this specific challenge: (1) Comprehensive patient education and counseling about the drug tail; (2) Training and coaching PrEP care teams, including clinical and non-clinical staff, on communication around the tail; (3) Adherence support strategies, including monitoring of cabotegravir drug levels after discontinuation, for a personalized medicine approach to safe discontinuation.

Ethical HIV research with transgender and non-binary communities in the United States.

INTRODUCTION: Because transgender individuals experience disproportionately high rates of HIV infection, this population is an increasing focus of epidemiological and implementation science research to combat the epidemic. However, study participants, providers and other advocates have become increasingly concerned about research practices that may alienate, objectify, exploit or even re-traumatize the communities they are designed to benefit. This commentary explores the common pitfalls of HIV research with transgender communities and provides a potential framework for ethical, community-engaged research practice. DISCUSSION: We review some of the critical challenges to HIV research with transgender and non-binary communities that limit the potential for such studies to improve practice. For example, scales that measure stigma perceptions/experiences often include activating language, while the consistent focus in research on risk and trauma can often feel judgemental and redundant. Because of limited employment opportunities, some participants may feel undue influence by research stipends; others may perceive their participation as fuelling the larger research economy without providing research jobs to community members. Questions remain regarding optimal strategies for authentic research partnership beyond community advisory boards or focus groups. Transgender and non-binary researchers are under-represented and may be tokenized. Many demonstration projects provide much-needed services that disappear when the research funding is over, and community-based dissemination efforts are often perceived as "too little, too late" to effect change. CONCLUSIONS: Based on this review and input from study participants across the United States, we detail six recommendations for ethical HIV research with transgender and non-binary communities, including (1) equitable budgeting with community-based programme partners; (2) representation in the development of both research agenda and methods; (3) integration of research activities into the ongoing work of any clinical or service site, so that individuals' needs as "clients" can continue to be prioritized over their role as "participants;" (4) mindfully considered compensation that values the contributions of community members, but avoids undue influence; (5) transparent, community-focused and timely communication at every stage of the study, including research purpose, data usage, preliminary findings and full-scale results; and (6) planning for sustainability of any programme or services beyond the life of the research project.

Recognizing and disrupting stigma in implementation of HIV prevention and care: a call to research and action.

INTRODUCTION: There is robust evidence that stigma negatively impacts both people living with HIV and those who might benefit from HIV prevention interventions. Within healthcare settings, research on HIV stigma has focused on intra-personal processes (i.e. knowledge or internalization of community-level stigma that might limit clients' engagement in care) or inter-personal processes (i.e. stigmatized interactions with service providers). Intersectional approaches to stigma call us to examine the ways that intersecting systems of power and oppression produce stigma not only at the individual and interpersonal levels, but also within healthcare service delivery systems. This commentary argues for the importance of analysing and disrupting the way in which stigma may be (intentionally or unintentionally) enacted and sustained within HIV service implementation, that is the policies, protocols and strategies used to deliver HIV prevention and care. We contend that as HIV researchers and practitioners, we have failed to fully specify or examine the mechanisms through which HIV service implementation itself may reinforce stigma and perpetuate inequity. DISCUSSION: We apply Link and Phelan's five stigma components (labelling, stereotyping, separation, status loss and discrimination) as a framework for analysing the way in which stigma manifests in existing service implementation and for evaluating new HIV implementation strategies. We present three examples of common HIV service implementation strategies and consider their potential to activate stigma components, with particular attention to how our understanding of these dynamics can be enhanced and expanded by the application of intersectional perspectives. We then provide a set of sample questions that can be used to develop and test novel implementation strategies designed to mitigate against HIV-specific and intersectional stigma. CONCLUSIONS: This commentary is a theory-informed call to action for the assessment of existing HIV service implementation, for the development of new stigma-reducing implementation strategies and for the explicit inclusion of stigma reduction as a core outcome in implementation research and evaluation. We argue that these strategies have the potential to make critical contributions to our ability to address many system-level form stigmas that undermine health and wellbeing for people living with HIV and those in need of HIV prevention services.

Parallel reductions in anxiety and HIV-related worry among pre-exposure prophylaxis (PrEP) users over time.

OBJECTIVE: The threat of HIV has been proposed as a major contributing factor to the disproportionately higher rates of anxiety among gay and bisexual men compared to their heterosexual counterparts. The current study examined 12-month trajectories of anxiety symptoms and concomitant HIV-related worry among a cohort of preexposure prophylaxis (PrEP) users, compared to a comparison cohort who were not taking PrEP. METHOD: SPARK was a community-based PrEP demonstration project conducted between February 2014 and May 2017. Self-report anxiety and worry data were collected from PrEP patients (n = 300) quarterly, and from non-PrEP patients (n = 131) at baseline, 3, and 12 months. We ran a series of unconditional latent growth curve models (LGCMs) to examine changes in anxiety and HIV worry over the 12-month study period, followed by parallel process LGCMs to examine the association between both intercepts and growth factors, adjusting for demographic factors. RESULTS: In a parallel process model, both an association between baseline levels of HIV worry and anxiety decreases in both variables over time among PrEP users but not among non-PrEP users. Additionally, a multigroup analysis was conducted, restricting both groups to 3 time points, and forcing a comparison of slopes between the 2 groups. This analysis revealed that there was no difference in the anxiety slopes between the 2 cohorts. However, the HIV worry slope remained significantly different among the PrEP cohort compared to the non-PrEP cohort. CONCLUSIONS: These data provide some of the first quantitative evidence for the potential of PrEP to reduce both HIV worry and anxiety symptoms. Emphasizing positive mental health "side effects" of PrEP may be a strategy for engaging priority populations in biomedical HIV prevention. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Reasons for PrEP Discontinuation After Navigation at Sexual Health Clinics: Interactions Among Systemic Barriers, Behavioral Relevance, and Medication Concerns.

BACKGROUND: Pre-exposure prophylaxis (PrEP) for HIV prevention requires engagement throughout the PrEP care continuum. Using data from a PrEP navigation program, we examine reasons for PrEP discontinuation. SETTING: Participants were recruited from New York City Health Department Sexual Health Clinics with PrEP navigation programs. METHODS: Participants completed a survey and up to 3 interviews about PrEP navigation and use. This analysis includes 94 PrEP initiators that were PrEP-naive before their clinic visit, started PrEP during the study, and completed at least 2 interviews. Interview transcripts were reviewed to assess reasons for PrEP discontinuation. RESULTS: Approximately half of PrEP initiators discontinued PrEP during the study period (n = 44; 47%). Most participants (71%) noted systemic issues (insurance or financial problems, clinic or pharmacy logistics, and scheduling barriers) as reasons for discontinuation. One-third cited medication concerns (side effects, potential long-term side effects, and medication beliefs; 32%) and behavioral factors (low relevance of PrEP because of sexual behavior change; 34%) as contributing reasons. Over half (53.5%) highlighted systemic issues alone, while an additional 19% attributed discontinuation to systemic issues in combination with other factors. Of those who discontinued, approximately one-third (30%) restarted PrEP during the follow-up period, citing resolution of systemic issues or behavior change that increased PrEP relevance. CONCLUSIONS: PrEP continuation is dependent on interacting factors and often presents complex hurdles for patients to navigate. To promote sustained engagement in PrEP care, financial, clinic, and pharmacy barriers must be addressed and counseling and navigation should acknowledge factors beyond sexual risk that influence PrEP use.

Clinic-Level Strategies for Mitigating Structural and Interpersonal HIV Pre-Exposure Prophylaxis Stigma.

Uptake of and persistence on pre-exposure prophylaxis (PrEP) in the United States have been limited. The potential of new PrEP modalities to increase access will be hindered if underlying structural and interpersonal barriers-including, insurance coverage, initiation and maintenance clinical protocols, provider bias, stigma, and lack of trust in health care-are not adequately addressed. We conducted in-person and telephone-based recorded interviews with 32 US-based clinical and nonclinical PrEP providers spanning the PrEP implementation continuum (clinicians, counselors, and support staff). Providers were recruited at biomedical HIV prevention conferences and networks to explore barriers to and strategies for PrEP implementation. Providers provided care to clients spanning adolescents to adulthood and a variety of genders across all geographic regions of the United States. To directly mitigate stigma, providers called for clinic-level interventions to normalize and universalize PrEP education and services, counseling and other services that center patients' lived experiences and circumstance, staffing and community engagement models that value patients, and implementation of specific programs and processes that facilitate access to services. To address disparities in access, PrEP implementation should acknowledge the interconnectedness of stigma and structural barriers to care.