Current Pre-exposure Prophylaxis Research Articles

PrEP15-19 Choices: an implementation study protocol of HIV prevention with oral and long-acting injectable cabotegravir PrEP in real-world settings among sexual and gender minority adolescents in Brazil

IntroductionLong-acting injectable (LAI) cabotegravir is a promising new method for preventing HIV. Safe and effective long-acting agents for pre-exposure prophylaxis (PrEP) for HIV infection are needed to increase preventive options...

Factors driving decisions in the use of HIV pre-exposure prophylaxis: a real-world study in the United States

Background: Uptake of pre-exposure prophylaxis (PrEP) in the United States (US) remains below target, despite reported high efficacy in prevention of HIV infection and being considered as a strategy for ending new HIV transmissions. Here, we sought to investigate drivers for PrEP use and barriers to increased uptake using real-world data. Methods: Data were drawn from the Adelphi PrEP Disease Specific Programme™, a cross-sectional survey of PrEP users and PrEP non-users at risk for HIV and their physicians in the US between August 2021 and March 2022. Physicians reported demographic data, clinical characteristics, and motivations for prescribing PrEP. PrEP users and non-users reported reasons for or against PrEP use, respectively. Bivariate analyses were performed to compare characteristics of users and non-users. Results: In total, 61 physicians reported data on 480 PrEP users and 121 non-users. Mean ± standard deviation of age of users and non-users was 35.3 ± 10.8 and 32.5 ± 10.8 years, respectively. Majority were male and men who have sex with men. Overall, 90.0% of users were taking PrEP daily and reported fear of contracting HIV (79.0%) and having at-risk behaviors as the main drivers of PrEP usage. About half of non-users (49.0%) were reported by physicians as choosing not to start PrEP due to not wanting long-term medication. PrEP stigma was a concern for both users (50.0%) and non-users (65.0%). More than half felt that remembering to take PrEP (57.0%) and the required level of monitoring (63.0%) were burdensome. Conclusions: Almost half of people at risk for HIV were not taking PrEP due to not wanting long-term daily medication and about half of current PrEP users were not completely adherent. The most common reason for suboptimal adherence was forgetting to take medication. This study highlighted drivers for PrEP uptake from physician, PrEP user, and non-user perspectives as well as the attributes needed in PrEP products to aid increased PrEP uptake.

The PrEP cascade in a sample of HIV-negative or unknown status adolescent and young adult transgender women in Peru.

Transgender women are a key population in the HIV epidemic globally, including in Peru. This cross-sectional epidemiological study characterized the pre-exposure prophylaxis (PrEP) cascade in adolescent and young adult transgender women in Peru to inform roll-out of early HIV prevention efforts. Between February-July 2022, a community-recruited sample of HIV-negative or status unknown young transgender women (n = 140) in Peru completed a socio-behavioral survey and biological testing for HIV and bacterial STIs. Logistic regression models estimated the association of sociodemographic, healthcare, and behavioral factors to PrEP indication and willingness. Median age was 22years (range = 16-24 years); 65.7% reported sex work and 28.6% homelessness. Overall, 45.7% had a PrEP indication based on past 6months HIV behavioral risk profiles. In a multivariable model, sex work (aRR = 2.27; 95% CI = 1.24-4.17) and homelessness (aRR = 1.27; 95% CI = 1.00-1.60) were associated with PrEP indication. More than one-third (38.6%) had never been HIV tested; 25.3% were tested >1 year ago. Only 34.3% heard of daily oral PrEP, 8.6% reported ever PrEP use, and 5.0% current PrEP use. Nearly half (49.3%) reported willingness to take daily oral PrEP. In a multivariable model, younger age was associated with increased willingness to use PrEP (aRR = 0.92; 95% CI = 0.87-0.98). Highest ranked PrEP preferences were a daily oral pill (35.7%), implant (32.1%), and injection by a provider (10.0%). PrEP indication and willingness were high in this sample, but HIV testing and PrEP uptake were low. Findings highlight opportunities for age-responsive and contextually-relevant interventions to increase HIV prevention among young transgender women in Peru.

Preferences for Starting Daily, On-Demand, and Long-Acting Injectable HIV Preexposure Prophylaxis Among Men Who Have Sex With Men in the United States (2021-2022): Nationwide Online Cross-Sectional Study.

Long-acting (LA) injectable preexposureprophylaxis (PrEP) and on-demand PrEP may improve overall PrEP uptake among men who have sex with men (MSM), but little is understood about the PrEP option preferences of MSM in practical scenarios where they may choose between various PrEP options. This study aims to examine the preferences for starting various PrEP options among a US nationwide online convenience sample of MSM from September 2021 to February 2022. Participants reporting no prior HIV diagnosis were provided brief descriptions of each PrEP option and were asked, "If [PrEP option] were available from your local doctor and you could access it for free, would you go to your doctor in the next month to start [PrEP option]?" Those who said "yes" to multiple options were asked to rank them in order of preference. MSM currently taking daily oral (DO) PrEP were asked whether they would switch to on-demand or LA PrEP options. Log binomial models were created to examine the association between willingness to start or switch to on-demand and LA PrEP with various sociodemographic and behavioral factors. In the analytic sample (N=7760), among the participants who did not use any PrEP in the past 12 months (n=5108, 66%), 54% (n=2445) reported willingness to start at least 1 PrEP option and 41% (n=1845) of participants showed interest in starting multiple PrEP options. Overall, the highest willingness was reported for on-demand PrEP (n=2235, 44%), followed by DO PrEP (n=2174, 43%) and LA PrEP (n=1482, 29%). LA PrEP was ranked first among those interested in multiple options. Characteristics associated with ranking LA PrEP as a first option to start PrEP versus DO or on-demand PrEP were region of residence (residing in the West vs Northeast), report of sexually transmitted infection diagnosis in the past year, report of illicit drug use other than marijuana in the past year, and prior awareness of LA PrEP. Among current DO PrEP users (n=2379, 31%), 58% (n=1386) were willing to switch to on-demand or LA PrEP, and LA PrEP was ranked first among participants who were open to switching to both options. Willingness to switch to LA PrEP was higher among those who used illicit drugs other than marijuana in the past year, who heard of LA PrEP prior to the survey, and those who took 15 or less doses of oral PrEP in the last 30 days. LA PrEP was the highest-ranked option among most MSM who were willing to try multiple options or switch from DO PrEP. These findings highlight that LA PrEP might fill coverage gaps among MSM who use illicit drugs, have had a recent sexually transmitted infection diagnosis, and have less than optimal DO PrEP adherence.

Perceptions, experiences and concerns with sexually transmitted infections among current and former PrEP users: a longitudinal qualitative study of gay, bisexual and queer men in Canada.

Background Pre-exposure prophylaxis (PrEP) use has been attributed to heightened rates of sexually transmitted infections (STIs), ostensibly due to increased condomless anal sex (CAS) and greater frequency of STI testing. Few qualitative studies have assessed how gay, bisexual and queer men (GBQM) who use PrEP perceive STIs and how these attitudes have evolved post-PrEP uptake. We investigated the perspectives of current and former PrEP users on STIs. Methods Annual, in-depth longitudinal interviews were conducted with 38 current and former PrEP users in Ontario (n =18) and British Columbia (n =20), Canada, as part of a mixed-methods implementation science study (2020-2022). Over 3years, 109 interviews were conducted. Data analysis included reflexive thematic coding and longitudinal recurrent cross-sectional analysis using NVivo 12. Results Four STI-related themes emerged: (1) lack of STI-related concerns due to treatment and prevention optimism, (2) stigma-related concerns, (3) perceived risk among other PrEP users due to increased CAS, and (4) inconsistent testing concerns among non-PrEP users. Over time, some STI-related anxieties decreased with increased knowledge and reduced stigma. However, concerns persisted for other participants due to perceived risky sexual behaviours among other PrEP users and non-PrEP users. Both current and former PrEP users who expressed STI-related apprehensions consistently indicated adopting risk-reduction strategies, including condom use and having fewer sexual partners throughout the study. Conclusions Findings show how varied STI perceptions and experiences among current and former PrEP users shaped sexual decision-making over time. Providers, public health experts, and policymakers should develop a more comprehensive strategy to address STI concerns among GBQM.

Future options for long-acting HIV treatment and prevention.

The aim of this review was to describe future options for long-acting HIV treatment and preexposure prophylaxis (PrEP) regimens featuring both innovations with currently approved antiretrovirals and a profile of investigational agents in the pipeline. Newer formulations and modes of delivery for existing antiretroviral drugs and a number of investigational agents are under study for long-acting HIV treatment and PrEP. Regimens with weekly oral dosing for HIV treatment, monthly oral dosing for HIV PrEP, and injectable agents with longer dosing intervals (every 3 months or longer) for treatment and PrEP are in clinical development. Newer agents with novel mechanisms of action and newer modes of administration including vaginal rings, implants, patches, and rectal douches also are under investigation. Despite the success of current antiretroviral therapy and PrEP with one-pill, once-daily regimens, there is a continuing need for new formulations, investigational agents, and novel modes of delivery to overcome barriers to implementation and ensure real-world effectiveness. Newer long-acting antiretroviral regimens for HIV treatment and PrEP using novel preparations and strategies will offer choice, enhance adherence, decrease toxicity, and improve patient and provider satisfaction.

Advances in HIV management and challenges in Japan: Current situation of pre-exposure prophylaxis in Tokyo, Japan

Since the world's first case series of human immunodeficiency virus (HIV) infection were reported, more than 40 decades have passed. The advancement of HIV treatment and prevention has progressed drastically. Especially, the efficacy of pre-exposure prophylaxis (PrEP) for HIV prevention has been proven by a number of trials and the number of new HIV cases has declined over the years due to the large-scale and rapid implementation of PrEP and universal HIV treatment in multiple countries. However, in Japan, PrEP is not approved or officially supported as of June 2024. Despite of the absence of top-down movement, men who have sex with men (MSM)-friendly private clinics initiated prescriptions of generic medicines for oral PrEP with necessary tests in Tokyo, which greatly contributed to improve access to PrEP. It is of note that current situation of bottom-up PrEP implementation using generic medicines in Tokyo is obviously cost-saving, which is needless to evaluate. However, expense of PrEP is fully out-of-pocket, which will hinder those with low or no income from accessing PrEP services despite the low prices of generic medicines. Furthermore, current PrEP implementation based on user-friendly clinics is functioning only in Tokyo. The role of public health authorities is important to solve these financial and geographical disparities in accessing PrEP services, without impairing existing virtues of accessibility and cost-saving in the current system.

Preferences for pre-exposure prophylaxis delivery via online pharmacy among potential users in Kenya: a discrete choice experiment.

Oral pre-exposure prophylaxis (PrEP) is highly effective, but coverage remains low in high HIV prevalence settings. Initiating and continuing PrEP remotely via online pharmacies is a promising strategy to expand PrEP uptake, but little is known about potential users' preferences. We conducted a discrete choice experiment (DCE) to assess preferences for online pharmacy PrEP services. We partnered with MYDAWA, an online pharmacy in Nairobi, Kenya. Eligibility criteria were: ≥18 years, not known HIV positive, interested in PrEP. The DCE contained four attributes: PrEP eligibility assessment (online self-assessed, guided), HIV test type (provider administered, oral HIV self-test [HIVST], blood-based HIVST), clinical consultation (remote, in-person) and user support options (text messages, phone/video call, email). Additionally, participants indicated whether they were willing to uptake their selected service. The survey was advertised on MYDAWA's website; interested participants met staff in-person at a convenient location to complete the survey from 1 June to 20 November 2022. We used conditional logit modelling with an interaction by current PrEP use to estimate overall preferences and latent class analysis (LCA) to assess preference heterogeneity. Overall, 772 participants completed the DCE; the mean age was 25 years and 54% were female. Most participants indicated a willingness to acquire online PrEP services, with particularly high demand among PrEP-naive individuals. Overall, participants preferred remote clinical consultation, HIV self-testing, online self-assessment and phone call user support. The LCA identified three subgroups: the "prefer online PrEP with remote components" group (60.3% of the sample) whose preferences aligned with the main analysis, the "prefer online PrEP with in-person components" group (20.7%), who preferred in-person consultation, provider-administered HIV testing, and guided assessment, and the "prefer remote PrEP (18.9%)" group who preferred online PrEP services only if they were remote. Online pharmacy PrEP is highly acceptable and may expand PrEP coverage to those interested in PrEP but not accessing services. Most participants valued privacy and autonomy, preferring HIVST and remote provider interactions. However, when needing support for questions regarding PrEP, participants preferred phone/SMS contact with a provider. One-fifth of participants preferred online PrEP with in-person components, suggesting that providing multiple options can increase uptake.

HIV Pre-Exposure Prophylaxis (PrEP) Users' Experiences of PrEP Access, Sexual Behaviour, and Well-Being During the COVID-19 Pandemic: A Welsh Qualitative Study.

HIV Pre-Exposure Prophylaxis (PrEP) has been available in Wales since 2017. The coronavirus disease (COVID-19) pandemic impacted UK sexual health services, leading to a reduction in service provision. There is a lack of research on the experiences of PrEP users during this time. We aimed to explore the experiences of PrEP users in Wales following the introduction of COVID-19 pandemic measures. We conducted a secondary data analysis of two prior interview studies (DO-PrEP and UPrEP). Data collection was undertaken between May 2020 and February 2021 using remote interviewing. Semi-structured interviews were conducted. Participants were ≥18 years of age, residents of Wales, current or previous PrEP users, and men who have sex with men (MSM). Reflexive thematic analysis was conducted. A total of 32 interviews were included in the analysis. Themes include the following: (1) PrEP use during COVID-19, (2) sexual behaviour and relationship changes following COVID-19 restrictions, (3) NHS service provision during the COVID-19 pandemic, and (4) wider contextual effects of the pandemic. Participants reported a change in PrEP use (pausing or switching to event-based PrEP). Participants reported reduced access to clinics and appointments. Support for changing to event-based PrEP was varied. Social isolation resulted in varied responses to lockdown rules, especially in later lockdowns. This study provides patient perspectives on the challenges the COVID-19 pandemic posed to PrEP use and access. It offers insights into the broader support needs around PrEP use when an individual's circumstances change. Flexible models of PrEP provision, which can be adapted to the patient's needs, will be essential as PrEP delivery extends into the wider community. Both the DO-PrEP and UPrEP studies received input from various stakeholders in the design of the topic guides for the study; these included public lay members, PrEP users, PrEP providers, and individuals involved with HIV advocacy and policy.

Applying CFIR to assess multi-level barriers to PrEP delivery in rural South Africa: Processes, gaps and opportunities for service delivery of current and future PrEP modalities

Despite established efficacy for oral pre-exposure prophylaxis (PrEP) in reducing HIV incidence, multi-level barriers within the health system, clinics, and the processes that shape practice have hindered service delivery and subsequent population-level effects. We applied the Consolidated Framework for Implementation Research (CFIR) to assess the context of PrEP delivery for adolescent girls and young women (AGYW) in rural South Africa and identify the factors supporting and impeding PrEP implementation to develop strategies to improve PrEP delivery. Between 2021 and 2022, we conducted in-depth interviews with five young women with PrEP use experience and 11 healthcare providers as well as four key informant stakeholder interviews. Tailored interviews organized around the CFIR domains provided multiple perspectives on the inter-connected processes, gaps, and opportunities between health systems, clinics, communities, and PrEP services. Shifts in PrEP policies, funding pressures, and inconsistent communications from the National Department of Health spurred fragmented planning, engagement, execution, and monitoring of PrEP delivery processes within clinics already struggling to address multiple population health needs. Resulting challenges included: conflicting priorities within clinics and across NGO partners, unclear goals and targets, staffing and space constraints, and insufficient community engagement. Individual clinics’ implementation climate and readiness to deliver PrEP varied in terms of operational plans and delivery models. Interviewees reported complexity of initiation procedures and support for PrEP maintenance, with opportunities to improve systems communications and processes to facilitate integrated services and more user-friendly experiences. Applying CFIR identified opportunities to strengthen PrEP delivery across levels within this complex service delivery setting.

What can PrEP do for female sex workers? Unpacking the “effectosphere” of biomedical HIV prevention in Dar es Salaam

Pre-exposure prophylaxis (PrEP) is a drug with the power to prevent HIV transmission. This study delved into the broader implications of PrEP use among female sex workers in Dar es Salaam, Tanzania, a group disproportionately affected by HIV and socio-structural challenges. Through 46 in-depth interviews with 40 women who were either former or current PrEP users or intended to start PrEP between January 2021 and February 2022, we sought to explore the nuanced effects of PrEP. Inspired by Whyte et al. and “Social Life of Medicines”, we asked what PrEP could do in the lives of female sex workers and analyzed the data using reflexive thematic analysis and an interpretative phenomenological approach. We found that PrEP had multiple and diverse effects in many domains of women's lives and refer to these collectively as the “effectosphere” of PrEP. The study identifies four key themes that jointly describe this effectosphere: (1) PrEP could promote human flourishing and empowerment by facilitating a feeling of freedom and confidence which could promote health, social relations, and economic and work opportunities, (2) PrEP could inflict harm (and fears of such harms), partially reflecting medical mistrust rooted in an understanding that sex workers were undesired in society, (3) PrEP could expose sensitive information about its users that could lead to stigma, arguments and needs for elaborate explanations, and (4) PrEP could medicalize daily life, evidenced through daily pill taking, clinical appointments, side-effects, becoming reliant on the medication, and the challenges of integrating PrEP use with other life priorities. We argue that investigating the full effectosphere of any medicine in particular geographic and sociocultural contexts can lead to a better understanding of its use and non-use, highlighting that engaging with medication extends beyond just “taking a pill.”

Examining the Effects of PrEP Use on Sexual Behaviors and Sexually Transmitted Infections Among Chinese Men who have Sex with Men: A Cross-Sectional Study

Men who have sex with men (MSM) is a high-risk population for HIV and sexually transmitted infections (STIs). Pre-exposure prophylaxis (PrEP) is effective in HIV prevention. This study aims to examine the differences in sexual behaviors, STI prevalence and HIV/STI testing across subgroups of MSM with various PrEP use. Data were collected via a cross-sectional survey in an MSM community in Xi’an, Shaanxi, from 2022.01 to 2022.09. Participants were categorized as ‘PrEP-naïve and unwilling to use’, ‘PrEP-naïve but willing to use’, and ‘current or former PrEP users’. Shannon index was used to assess sexual act diversity and multivariate logistic regression analyzed factors associated with PrEP use. Of the 1,131 MSM participants, 23.52% were PrEP-naïve and unwilling, 64.98% were PrEP-naïve but willing, and 11.49% were current or former PrEP users. The PrEP-naïve but willing group had the highest recent STI testing rates at 73.06% and showed greater sexual act diversity (Shannon index 1.61). This group also had the highest syphilis rates (7.49% vs. 6.47% and2.54%, p < 0.01). Younger age (18–30: OR = 0.39 (0.18–0.85); 31–40: OR = 0.43 (0.20–0.96)) and lower education (high school/vocational: OR = 0.15 (0.04–0.58); associate degree: OR = 0.21 (0.06–0.71)) were factors that negatively influenced PrEP use. Current or former PrEP users had the highest oropharyngeal gonorrhea (14.39% vs. 9.68% and 5.80%, p < 0.01) and overall gonorrhea rates (20.86% vs. 17.17% and 8.37%, p < 0.001). ‘PrEP-naïve but willing’ participants consistently demonstrated high-risk sexual behavior, increased STI testing, and more diverse sexual acts, whereas PrEP users had the highest STI prevalence.

Understanding Preferences for Visualized New and Future HIV Prevention Products Among Gay, Bisexual and Other Men Who Have Sex with Men in the Southern United States: A Mixed-Methods Study

ABSTRACT Men who have sex with men (MSM) are vulnerable to HIV infection. Although daily oral pre-exposure prophylaxis (PrEP) prevents HIV among MSM, its usage remains low. We conducted virtual in-depth interviews (IDIs) and focus groups (FGs) with Black, Hispanic/Latino, and White MSM consisting of current PrEP users and those aware of but not currently using PrEP. We delved into their preferences regarding six emerging PrEP products: a weekly oral pill, event-driven oral pills, anal douche/enema, anal suppository, long-acting injection, and a skin implant. Our mixed methods analysis involved inductive content analysis of transcripts for thematic identification and calculations of preferences. Among the sample (n = 98), the weekly oral pill emerged as the favored option among both PrEP Users and PrEP Aware IDI participants. Ranking exercises during FGs also corroborated this preference, with the weekly oral pill being most preferred. However, PrEP Users in FGs leaned toward the long-acting injectable. Conversely, the anal suppository and douche/enema were the least preferred products. Overall, participants were open to emerging PrEP products and valued flexibility but expressed concerns about limited protection for products designed solely for receptive sex. Public health practitioners should tailor recommendations based on individuals’ current sexual behaviors and long-term vulnerability to infection.

Pre-exposure Prophylaxis Awareness and Use Among Transgender and Nonbinary Individuals in Canada.

Transgender and nonbinary populations are disproportionately affected by HIV and face barriers to accessing HIV-related services. Pre-exposure prophylaxis (PrEP) may benefit those at risk of HIV acquisition. However, PrEP awareness and uptake, along with potential barriers and facilitators, have not been investigated among transgender and nonbinary individuals living in Canada. This study analyzed data from 1965 participants of the 2019 Trans PULSE Canada survey, a national convenience sampling survey of transgender and nonbinary individuals in Canada. Data were analyzed to estimate levels of PrEP awareness and uptake and to identify predictors of PrEP awareness among the study population. Prevalence ratios estimated from block-wise modified Poisson regression models were used to assess predictors of PrEP awareness. PrEP awareness, lifetime PrEP use, and current PrEP use were estimated to be 71.0%, 2.2%, and 0.9%, respectively, among the full sample, and 82.3%, 7.3%, and 3.8% among those with indications for PrEP use. Respondents who were aged 45 years or older, transfeminine, Indigenous, living in Atlantic Canada or Quebec, and had high school education or less were significantly less likely to be aware of PrEP. Lifetime sex work, past-year HIV/STI testing, being single or in a nonmonogamous relationship, and higher levels of emotional social support were positively associated with PrEP awareness. There is a need to improve PrEP awareness and particularly uptake among transgender and nonbinary individuals in Canada. This study revealed inequities in PrEP awareness within this population, which may serve as targets for future public health initiatives.

Navigating patterns of oral PrEP use: A qualitative longitudinal study of gay, bisexual, and queer men's dynamic practices of pausing, on-demand, and stopping PrEP in Canada

The Canadian HIV pre-exposure prophylaxis (PrEP) guidelines recommend both daily and on-demand dosing for gay, bisexual, and queer men (GBQM), meeting additional risk criteria. However, limited research explored how GBQM implement pausing, on-demand, discontinuation, and resumption of PrEP, including the contextual factors affecting decision-making. Using a relationally situated implementation science framework, we examined how GBQM tailor PrEP use to changing social and sexual circumstances. We conducted 109 longitudinal interviews with current and former PrEP users from Ontario (n = 18) and British Columbia (n = 20), Canada, at three time points between 2020 and 2022. We identified three dynamic PrEP use trajectories: pausing, on-demand, and stopping. Pausing involved brief breaks followed by a return to daily use during heightened sexual activity. Others followed the 2-1-1 on-demand schedule, while some stopped PrEP with plans to resume if social and sexual circumstances change. During the COVID-19 pandemic, participants paused PrEP when sexual activities decreased, restarting daily use when sexual engagements resumed. Others paused due to relationship changes or sexual inactivity, resuming PrEP in anticipation of sex. On-demand PrEP was adopted to manage side effects or save costs. Some stopped PrEP for sustained periods due to monogamy, private insurance loss, side effects, or low perceived HIV risk. Participants expressed concerns regarding lack of information on these strategies, relying on online sources or peers for guidance. Most participants obtained enough PrEP knowledge to adapt use appropriately. Comprehensive education campaigns on adaptable PrEP use effectiveness and strategies to discontinue and resume PrEP for clinicians and GBQM should be implemented.

Optimal strategies to improve uptake of and adherence to HIV prevention among young people at risk for HIV acquisition in the USA (ATN 149): a randomised, controlled, factorial trial

Pre-exposure prophylaxis (PrEP), condom use, post-exposure prophylaxis (PEP), and sexual partner reduction help to prevent HIV acquisition but have low uptake among young people. We aimed to assess the efficacy of automated text messaging and monitoring, online peer support, and strengths-based telehealth coaching to improve uptake of and adherence to PrEP, condom use, and PEP among adolescents aged 12-24 years at risk of HIV acquisition in Los Angeles, CA, USA, and New Orleans, LA, USA. We conducted a four-arm randomised controlled factorial trial, assessing interventions designed to support uptake and adherence of HIV prevention options (ie, PrEP, PEP, condom use, and sexual partner reduction). We recruited young people aged 12-24 years who were at risk of HIV acquisition from 13 community-based organisations, adolescent medicine clinics, and organisations serving people who are unstably housed, people who were previously incarcerated, and other vulnerable young people, and through dating apps, peer referrals, and social venues and events in Los Angeles, CA, USA, and New Orleans, LA, USA. Young people who tested seronegative and reported being gay, bisexual, or other men who have sex with men, transgender men or women, or gender diverse (eg. non-binary or genderqueer) were eligible for inclusion. Participants were randomly assigned to one of four intervention groups in a factorial design: automated text messaging and monitoring (AMMI) only, AMMI plus peer support via private social media, AMMI plus strengths-based telehealth coaching by near-peer paraprofessionals, or AMMI plus peer support and coaching. Assignment was further stratified by race or ethnicity and sexual orientation within each interviewer's group of participants. Participants were masked to intervention assignment until after baseline interviews when offered their randomly assigned intervention, and interviewers were masked throughout the study. Interventions were available throughout the 24-month follow-up period, and participants completed baseline and follow-up assessments, including rapid diagnostic tests for sexually transmitted infections, HIV, and substance use, at 4-month intervals over 24 months. The primary outcomes were uptake and adherence to HIV prevention options over 24 months, measured by self-reported PrEP use and adherence, consistent condom use with all partners, PEP prescription and adherence, and number of sexual partners in participants with at least one follow-up. We used Bayesian generalised linear modelling to assess changes in outcomes over time comparing the four study groups. This study is registered with ClinicalTrials.gov (NCT03134833) and is completed. We screened 2314 adolescents beginning May 1, 2017, to enrol 1037 participants (45%) aged 16-24 years between May 6, 2017, and Aug 30, 2019, of whom 895 (86%) had follow-up assessments and were included in the analytical sample (313 assigned to AMMI only, 205 assigned to AMMI plus peer support, 196 assigned to AMMI plus coaching, and 181 assigned to AMMI plus peer support and coaching). Follow-up was completed on Nov 8, 2021. Participants were diverse in race and ethnicity (362 [40%] Black or African American, 257 [29%] Latinx or Hispanic, 184 [21%] White, and 53 [6%] Asian or Pacific Islander) and other sociodemographic factors. At baseline, 591 (66%) participants reported anal sex without a condom in the past 12 months. PrEP use matched that in young people nationally, with 101 (11%) participants reporting current PrEP use at baseline, increasing at 4 months to 132 (15%) and continuing to increase in the AMMI plus peer support and coaching group (odds ratio 2·31, 95% CI 1·28-4·14 vs AMMI control). There was no evidence for intervention effect on condom use, PEP use (ie, prescription or adherence), PrEP adherence, or sexual partner numbers. No unanticipated or study-related adverse events occurred. Results are consistent with hypothesised synergistic intervention effects of evidence-based functions of informational, motivational, and reminder messaging; peer support for HIV prevention; and strengths-based, goal-focused, and problem-solving telehealth coaching delivered by near-peer paraprofessionals. These core functions could be flexibly scaled via combinations of technology platforms and front-line or telehealth HIV prevention workers. Adolescent Medicine Trials Network for HIV/AIDS Interventions, US National Institutes of Health.

Estimating the costs and perceived benefits of oral pre-exposure prophylaxis (PrEP) delivery in ten counties of Kenya: a costing and a contingent valuation study.

Kenya included oral PrEP in the national guidelines as part of combination HIV prevention, and subsequently began providing PrEP to individuals who are at elevated risk of HIV infection in 2017. However, as scale-up continued, there was a recognized gap in knowledge on the cost of delivering oral PrEP. This gap limited the ability of the Government of Kenya to budget for its PrEP scale-up and to evaluate PrEP relative to other HIV prevention strategies. The following study calculated the actual costs of oral PrEP scale-up as it was being delivered in ten counties in Kenya. This costing also allowed for a comparison of various models of service delivery in different geographic regions from the perspective of service providers in Kenya. In addition, the analysis was also conducted to understand factors that indicate why some individuals place a greater value on PrEP than others, using a contingent valuation technique. Data collection was completed between November 2017 and September 2018. Costing data was collected from 44 Kenyan health facilities, consisting of 23 public facilities, 5 private facilities and 16 drop-in centers (DICEs) through a cross-sectional survey in ten counties. Financial and programmatic data were collected from financial and asset records and through interviewer administered questionnaires. The costs associated with PrEP provision were calculated using an ingredients-based costing approach which involved identification and costing of all the economic inputs (both direct and indirect) used in PrEP service delivery. In addition, a contingent valuation study was conducted at the same 44 facilities to understand factors that reveal why some individuals place a greater value on PrEP than others. Interviews were conducted with 2,258 individuals (1,940 current PrEP clients and 318 non-PrEP clients). A contingent valuation method using a "payment card approach" was used to determine the maximum willingness to pay (WTP) of respondents regarding obtaining access to oral PrEP services. The weighted cost of providing PrEP was $253 per person year, ranging from $217 at health centers to $283 at dispensaries. Drop-in centers (DICEs), which served about two-thirds of the client volume at surveyed facilities, had a unit cost of $276. The unit cost was highest for facilities targeting MSM ($355), while it was lowest for those targeting FSW ($248). The unit cost for facilities targeting AGYW was $323 per person year. The largest percentage of costs were attributable to personnel (58.5%), followed by the cost of drugs, which represented 25% of all costs. The median WTP for PrEP was $2 per month (mean was $4.07 per month). This covers only one-third of the monthly cost of the medication (approximately $6 per month) and less than 10% of the full cost of delivering PrEP ($21 per month). A sizable proportion of current clients (27%) were unwilling to pay anything for PrEP. Certain populations put a higher value on PrEP services, including: FSW and MSM, Muslims, individuals with higher education, persons between the ages of 20 and 35, and households with a higher income and expenditures. This is the most recent and comprehensive study on the cost of PrEP delivery in Kenya. These results will be used in determining resource requirements and for resource mobilization to facilitate sustainable PrEP scale-up in Kenya and beyond. This contingent valuation study does have important implications for Kenya's PrEP program. First, it indicates that some populations are more motivated to adopt oral PrEP, as indicated by their higher WTP for the service. MSM and FSW, for example, placed a higher value on PrEP than AGYW. Higher educated individuals, in turn, put a much higher value on PrEP than those with less education (which may also reflect the higher "ability to pay" among those with more education). This suggests that any attempt to increase demand or improve PrEP continuation should consider these differences in client populations. Cost recovery from existing PrEP clients would have potentially negative consequences for uptake and continuation.

Social disparities on PrEP use and awareness among sexual and gender minorities using smartphones in India.

Pre-exposure prophylaxis (PrEP) is a safe and effective HIV prevention strategy. However, in countries such as India where PrEP is driven by the private healthcare system and there is no centralized reporting, it is unknown which populations benefit from PrEP and which populations are being left behind. We examined and characterized PrEP use and awareness among the sexual and gender minorities using smartphones in India and found measures of association of PrEP use. This is a cross-sectional study design. We used Grindr-a widely used geosocial mobile application-to conduct a national cross-sectional survey in India, including respondents who were 18 years or older and reported sex with men (those who identified as cis-gender females were excluded). We examined overall PrEP awareness and PrEP use, then calculated adjusted prevalence odds ratio and 95% confidence intervals to understand PrEP use correlation with socio-behavioral factors. Out of the total of 3116 eligible participants, 30.3% (N = 947) were aware of PrEP and 3.1% (N = 97) reported current PrEP use. Our multivariate regression model found that there was a statistically significant association of PrEP use with higher income, being employed, preferred language as English for survey, relationship status as single, and use of party drugs. At the same time, there was a statistically significant association of PrEP awareness with age group, having higher education as a graduate or above, higher income, use of party drugs, and multiple sexual partners. We found overall low awareness and low PrEP use in our cross-sectional sample. PrEP use and awareness were higher among those who belonged to higher-income groups. Including PrEP in existing programmatic interventions by government and NGOs may contribute to PrEP scale-up, which is urgent to stop the HIV epidemic in India.

HIV preexposure prophylaxis and postexposure prophylaxis in women: a comprehensive guide for healthcare providers.

Great disparities and inequities in the delivery and acceptance of human immunodeficiency virus (HIV) prevention exist globally among women. Various barriers, such as societal stigma, low perceived risk, relationship dynamics, and lack of education on routes of HIV transmission can cause low utilization in HIV preexposure prophylaxis (PrEP) adoption and use. In addition, socioeconomic and structural factors, such as financial burden, lack of provider knowledge and willingness to prescribe, absence of insurance coverage, and limited access to healthcare services are additional barriers to PrEP use among cisgender women. The goal of this review is to highlight current and prospective PrEP options, attitudes, and views of PrEP use among cisgender women and healthcare providers, and the role of PrEP in special populations of cisgender women.

Physiologically Based Pharmacokinetic Modelling of Cabotegravir Microarray Patches in Rats and Humans.

Microarray patches (MAPs) are currently under investigation as a self-administered, pain-free alternative used to achieve long-acting (LA) drug delivery. Cabotegravir is a potent antiretroviral that has demonstrated superior results over current pre-exposure prophylaxis (PrEP) regimens. This study aimed to apply physiologically based pharmacokinetic (PBPK) modelling to describe the pharmacokinetics of the dissolving bilayer MAP platform and predict the optimal dosing strategies for a once-weekly cabotegravir MAP. A mathematical description of a MAP was implemented into a PBPK model, and empirical models were utilised for parameter estimation. The intradermal PBPK model was verified against previously published in vivo rat data for intramuscular (IM) and MAP administration, and in vivo human data for the IM administration of LA cabotegravir. The verified model was utilised for the prediction of 300 mg, 150 mg and 75 mg once-weekly MAP administration in humans. Cabotegravir plasma concentrations >4 × protein-adjusted 90% inhibitory concentration (PA-IC90) (0.664 µg/mL) and >8 × PA-IC90 (1.33 µg/mL) were set as targets. The 75 mg, 150 mg and 300 mg once-weekly cabotegravir MAP regimens were predicted to sustain plasma concentrations >4 × PA-IC90, while the 300 mg and 150 mg regimens achieved plasma concentrations >8 × PA-IC90. These data demonstrate the potential for a once-weekly cabotegravir MAP using practical patch sizes for humans and inform the further development of cabotegravir MAPs for HIV PrEP.