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Purpose Our primary aim was to explore themes regarding attitudes toward HIV pre-exposure prophylaxis (PrEP) among young transgender women (YTW), in order to develop a theoretical model of PrEP uptake in this population disproportionally affected by HIV. Methods Qualitative study nested within a mixed-method study characterizing barriers and facilitators to health services for YTW. Participants completed an in-depth interview exploring awareness of and attitudes toward PrEP. Key themes were identified using a grounded theory approach. Results Participants (n = 25) had a mean age of 21.2 years (standard deviation 2.2, range 17–24) and were predominately multiracial (36%) and of HIV-negative or unknown status (68%). Most participants (64%) reported prior knowledge of PrEP, and 28% reported current use or intent to use PrEP. Three major content themes that emerged were variability of PrEP awareness, barriers and facilitators to PrEP uptake, and emotional benefits of PrEP. Among participants without prior PrEP knowledge, participants reported frustration that PrEP information has not been widely disseminated to YTW, particularly by health care providers. Attitudes toward PrEP were overwhelmingly positive; however, concerns were raised regarding barriers including cost, stigma, and adherence challenges. Both HIV-positive and negative participants discussed emotional and relationship benefits of PrEP, which were felt to extend beyond HIV prevention alone. Conclusions A high proportion of YTW in this study had prior knowledge of PrEP, and attitudes toward PrEP were positive among participants. Our findings suggest several domains to be further explored in PrEP implementation research, including methods of facilitating PrEP dissemination and emotional motivation for PrEP uptake. [ABSTRACT FROM AUTHOR]

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Objectives: Pre-exposure prophylaxis (PrEP) can reduce HIV transmission risk for many gay, bisexual and other men who have sex with men. However, bacterial STI (BSTI) associated with decreasing condom use among HIV PrEP users is a growing concern. Determining the characteristics of current PrEP users at highest BSTI risk fills a critical gap in the literature.Methods: Gay and bisexual men (GBM) in New York City on HIV PrEP for 6 or more months (n=65) were asked about chlamydia, gonorrhoea and syphilis diagnoses in the past 6 months. By design, half (51%) of the sample were club drug users. We examined the associations of length of time on PrEP, type of PrEP care provider, PrEP adherence, number of sexual partners, number of condomless anal sex acts and club drug use on self-reported BSTI using multivariable, binary logistic regressions, adjusting for age, race/ethnicity, education and income.Results: Twenty-six per cent of GBM on HIV PrEP reported a diagnosis of BSTI in the past 6 months. Men who reported club drug use (adjusted OR (AOR)=6.60, p<0.05) and more frequent condomless anal sex in the past 30 days (AOR=1.13, p<0.05) had higher odds of reporting a BSTI. No other variables were significantly associated with self-reported BSTI in the multivariable models.Conclusions: Club drug users could be at a unique BSTI risk, perhaps because of higher risk sexual networks. Findings should be considered preliminary, but suggest the importance of ongoing BSTI screening and risk-reduction counselling for GBM on HIV PrEP. [ABSTRACT FROM AUTHOR]

Research involving human subjects can impose risk on some 'bystanders'– people who are not themselves research subjects but whom the study may affect. We examine the consequences of research for a particular category of bystanders – research subjects' sex partners – in trials testing interventions to reduce (1) HIV transmission (HIV treatment-as-prevention trials) and (2) HIV acquisition (HIV pre-exposure prophylaxis trials). Both types of trials provide useful test cases for assessing whether bystanders to research deserve special consideration in ethics reviews, and potentially some of the benefits and protections that research subjects receive. In HIV treatment-as-prevention trials, there are two groups of people who are alike in many important respects but treated very differently by research ethics: research subjects who contribute data on the primary endpoint of the trial (because some of them have sex with the people receiving the treatment conditions of the trials) – and bystanders who are not enrolled in the trials but who could have contributed primary endpoint data in the same way as the first group. In pre-exposure trials, the sex partners of people participating in pre-exposure prophylaxis trials are bystanders, even though they are necessary for the success of the trial. Research subjects' autonomy is fiercely protected by trial enrolment processes. Bystanders, by contrast, often have no choice but to be affected by the study, because of their relationship to a research subject. In HIV prevention trials, standing by can come with important risks, including the same ones on which the success of the research hinges. It is thus important to consider the ethical obligations to protect bystanders, and the related procedural responsibilities. [ABSTRACT FROM AUTHOR]

Hepatitis A is a sexually transmitted enteric infection in men who have sex with men (MSM). HIV pre-exposure prophylaxis (PrEP) has increased opportunities for sexual health interventions in MSM. 588 (372 in 2019, 216 in 2021) MSM attended for the first time in the study periods. MSM were significantly more likely to be screened for Hepatitis A susceptibility in 2021 than 2019 (93% vs 56%, P =0.0001). Susceptibility (Hepatitis A IgG negative) to Hepatitis A did not change between in 2021 and 2019 (48% vs 47%, P =0.921). De-medicalising PrEP is important as it will increase overall uptake. However, coupling PrEP with other sexual health interventions must not be lost. [ABSTRACT FROM AUTHOR]

Men who have sex with men (MSM) have an increased risk of infection by pathogens transmitted by the oro-fecal route. Here, we investigated the seroprevalence and incidence of hepatitis E virus (HEV) infection in 416 MSM included in the ANRS IPERGAY PrEP trial. Among the 62 (14.9% (95% CI: [11.6%-18.7%]) seropositive for HEV at inclusion, the only factor associated with testing seropositive for HEV was older age. Geographical origin, use of recreational drugs, number of sexual partners, status for HAV and bacterial sexually transmitted infection (STI) at inclusion were not associated. Among the 342 HEV-seronegative patients with available samples, 9 seroconverted after a median of follow-up of 2.1 years (IQR (interquartile range): [1.6; 3.0]). Overall, the HEV incidence was 1.19% per 100 person-years [95% CI: 0.54%; 2.26%]. Sexual transmission does not seem to be a major route of HEV infection in MSM, unlike HAV. [ABSTRACT FROM AUTHOR]

HIV disproportionally affects persons who inject drugs (PWID), but engagement with HIV pre-exposure prophylaxis (PrEP) is low. We describe the rationale and study design for a new study, " Co ntingency M anagement and P re-Exposure Prophylaxis (PrEP) A dherence S upport S ervices (CoMPASS)," a hybrid type 1 effectiveness-implementation trial to promote HIV risk reduction among PWID. In four community-based programs in the northeastern United States, PrEP-eligible PWID (target n = 526) are randomized to treatment as usual or Co ntingency M anagement (CM) and, as indicated, stepped up to P rEP A dherence S upport S ervices (CoMPASS) over 24 weeks. During CM sessions, participants receive timely tangible rewards for verifiable activities demonstrating 1) PrEP initiation and adherence, and 2) engagement with medications for opioid use disorder (MOUD) and other OUD-related care. Participants who do not have high levels of biomarker-confirmed PrEP adherence at week 12 will be stepped up to receive P rEP A dherence S upport S ervices (PASS) consisting of strengths-based case management over 12 weeks. Interventions are delivered by trained PrEP navigators, staff embedded within the respective sites. The primary outcome is sustained PrEP adherence by dried blood spot testing at 24 weeks. To inform future implementation, we are conducting implementation-focused process evaluations throughout the clinical trial. Results from this protocol are anticipated to yield novel findings regarding the impact and scalability of CoMPASS to promote HIV prevention among PWID in partnership with community-based organizations. http://ClinicalTrials.gov identifier: NCT04738825. • Few persons who inject drugs (PWID) are taking HIV pre-exposure prophylaxis (PrEP). • Contingency management with stepped care may promote sustained PrEP adherence. • Point-of-care testing may be useful for verifying self-reported PrEP adherence among PWID. • PWID may be reachable for HIV prevention in opioid treatment and harm reduction programs. [ABSTRACT FROM AUTHOR]

Introduction: With recent approvals of long-acting (LA) HIV pre-exposure prophylaxis (PrEP) in the form of injectable cabotegravir and the dapivirine ring, programmes need to consider how to optimize the delivery of PrEP methods, including by leveraging lessons from the past decade of oral PrEP delivery., Discussion: Framed around differentiated service delivery building blocks, the major considerations for the delivery of LA PrEP are how to reach the populations who would most benefit from PrEP, where to locate PrEP services, how to reduce the user burden of accessing and continuing with PrEP, and how to integrate PrEP with other services. Demand creation for LA PrEP and education about new LA PrEP options should be co-developed with communities and be positively framed. Client-facing clinical decision support tools provide information about HIV prevention and PrEP options in non-technical ways and can support their informed decision-making about PrEP. Training for providers is needed to increase their ability to ask about sexual and drug use behaviours in a non-judgmental and comfortable manner as part of risk assessment, discuss harm reduction strategies and counsel about available PrEP options that fit clients' circumstances and needs. PrEP adherence support should include supportive counselling and be tailored to address an individual's particular barriers and needs. Reminders through text messaging or calls can foster PrEP persistence, given the narrow the window around dosing for injectable cabotegravir. Strategies are needed to expand PrEP delivery options, including telePrEP, pharmacy-based PrEP, key population-led services and mobile venues. Integrated delivery models are needed which include sexually transmitted infection testing and treatment, contraception for cis-women not desiring to become pregnant, PrEP for pregnant women in high HIV prevalence settings, and gender-affirming hormones and support for transgender persons., Conclusions: The outcome of expanding PrEP options through LA PrEP formulations is to increase PrEP coverage, adherence, persistence and effectiveness by offering a choice of PrEP that meets the needs of persons who would benefit from PrEP. The lessons learned from the delivery of oral PrEP about demand creation, informed client decision-making, provider training, adherence support and service delivery model are relevant to the delivery of LA PrEP and integration with other services., (© 2023 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Purpose: Long-acting formulations of the potent antiretroviral prodrug tenofovir alafenamide (TAF) hold potential as biomedical HIV prevention modalities. Here, we present a rigorous comparison of three animal models, C57BL/6 J mice, beagle dogs, and merino sheep for evaluating TAF implant pharmacokinetics (PKs)., Methods: Implants delivering TAF over a wide range of controlled release rates were tested in vitro and in mice and dogs. Our existing PK model, supported by an intravenous (IV) dosing dog study, was adapted to analyze mechanistic aspects underlying implant TAF delivery., Results: TAF in vitro release in the 0.13 to 9.8 mg d -1 range with zero order kinetics were attained. Implants with equivalent fabrication parameters released TAF in mice and sheep at rates that were not statistically different, but were 3 times higher in dogs. When two implants were placed in the same subcutaneous pocket, a two-week creep to C max was observed in dogs for systemic drug and metabolite concentrations, but not in mice. Co-modeling IV and TAF implant PK data in dogs led to an apparent TAF bioavailability of 9.6 in the single implant groups (compared to the IV group), but only 1.5 when two implants were placed in the same subcutaneous pocket., Conclusions: Based on the current results, we recommend using mice and sheep, with macaques as a complementary species, for preclinical TAF implant evaluation with the caveat that our observations may be specific to the implant technology used here. Our report provides fundamental, translatable insights into multispecies TAF delivery via long-acting implants., (© 2022. The Author(s).)

Background: HIV incidence rates have increased in adolescent men who have sex with men (AMSM) and adolescent transgender women (ATGW). Thus, it is essential to promote access to HIV prevention, including pre-exposure prophylaxis (PrEP), among these groups. Moreover, using artificial intelligence and online social platforms to create demand and access to health care services are essential tools for adolescents and youth., Objective: This study aims to describe the participative process of developing a chatbot using artificial intelligence to create demand for PrEP use among AMSM and ATGW in Brazil. Furthermore, it analyzes the chatbot's acceptability, functionality, and usability and its results on the demand creation for PrEP., Methods: The chatbot Amanda Selfie integrates the demand creation strategies based on social networks (DCSSNs) of the PrEP1519 study. She was conceived as a Black transgender woman and to function as a virtual peer educator. The development process occurred in 3 phases (conception, trial, and final version) and lasted 21 months. A mixed methodology was used for the evaluations. Qualitative approaches, such as in-depth adolescent interviews, were used to analyze acceptability and usability, while quantitative methods were used to analyze the functionality and result of the demand creation for PrEP based on interactions with Amanda and information from health care services about using PrEP. To evaluate Amanda's result on the demand creation for PrEP, we analyzed sociodemographic profiles of adolescents who interacted at least once with her and developed a cascade model containing the number of people at various stages between the first interaction and initiation of PrEP (PrEP uptake). These indicators were compared with other DCSs developed in the PrEP1519 study using chi-square tests and residual analysis (P=.05)., Results: Amanda Selfie was well accepted as a peer educator, clearly and objectively communicating on topics such as gender identity, sexual experiences, HIV, and PrEP. The chatbot proved appropriate for answering questions in an agile and confidential manner, using the language used by AMSM and ATGW and with a greater sense of security and less judgment. The interactions with Amanda Selfie combined with a health professional were well evaluated and improved the appointment scheduling. The chatbot interacted with most people (757/1239, 61.1%) reached by the DCSSNs. However, when compared with the other DCSSNs, Amanda was not efficient in identifying AMSM/ATGW (359/482, 74.5% vs 130/757, 17.2% of total interactions, respectively) and in PrEP uptake (90/359, 25.1% vs 19/130, 14.6%). The following profiles were associated (P<.001) with Amanda Selfie's demand creation, when compared with other DCS: ATGW and adolescents with higher levels of schooling and White skin color., Conclusions: Using a chatbot to create PrEP demand among AMSM and ATGW was well accepted, especially for ATGW with higher levels of schooling. A complimentary dialog with a health professional increased PrEP uptake, although it remained lower than the results of the other DCSSNs., (©Paula Massa, Dulce Aurélia de Souza Ferraz, Laio Magno, Ana Paula Silva, Marília Greco, Inês Dourado, Alexandre Grangeiro. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 23.06.2023.)

Background: Long-acting injectable cabotegravir (CAB-LA) represents a new additional option for HIV prevention in people at substantial risk of HIV infection that may fill the gaps in pre-exposure prophylaxis (PrEP) uptake, adherence, and retention in users having difficulty with oral PrEP. Data from clinical trials demonstrated that CAB-LA was safe, highly effective, and well-accepted for HIV prevention. However, the occurrence of breakthrough HIV infections despite timely injections, HIV seroconversion timing and patterns, risk of selection and dissemination of resistance-associated mutations to integrase inhibitors, complexity of follow-up, logistical considerations, and its cost effectiveness compared with oral PrEP constitute significant issues for the integration of CAB-LA into clinical routine., Findings: These concerns need to be addressed before moving forward with large-scale implementation programmes. Pilot and implementation projects are required in the following areas: HIV testing algorithms, patient education, clinic procedures, protocols for switching and discontinuation, efficacy and safety in populations not included in clinical trials, and demedicalization processes. The development of models to increase the uptake of, adherence to, and persistence with and after CAB-LA injections will also be of paramount importance for success. Lessons learned from these projects will increase experience, staff expertise, and organizational and training capacities to support the roll-out of this new agent as part of HIV prevention programmes., Conclusion: CAB-LA has not yet achieved its full potential in HIV prevention, and strong commitment from all stakeholders is required to push CAB-LA as a game-changer in HIV response., (© 2022 The Authors. HIV Medicine published by John Wiley & Sons Ltd on behalf of British HIV Association.)

The assessment of mood disorders and addiction linked to the practice of chemsex is of interest given the psychoactive substances used. The aim of this study was to assess risky sexual and addictive behavior to chemsex and related anxiety/depression symptoms in individuals receiving HIV pre-exposure prophylaxis (PrEP). In this cross-sectional study, all adults presenting for PrEP renewal at French sexual health centers were enrolled from January 2018 to March 2019. Participants completed a questionnaire on chemsex (i.e., the use of psychoactive substances before/during sex), including adapted Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) to chemsex addiction (questions of ASSIST were modified to focus on chemsex). Anxiety/depression was assessed with the Hospital Anxiety and Depression Scale. In the last 3 months before enrollment, 39.8% (94/236) of participants reported chemsex. The main psychoactive substances consumed during chemsex were cathinones (74.6%), gamma-hydroxybutyrate (66.3%), and other psychostimulants (60%). The median score of the chemsex-focused ASSIST was 8 [IQR 25-75 : 3-15]; 72.2% of participants had a score justifying at least a brief intervention (>4). In multivariate analyses, anxiety and cathinones consumption were associated with an ASSIST score >4: OR 13.65 ( 95% CI 1.68-662.7), P = 0.0062, and OR 8.468 ( 95% CI 2.066-43.059), P = 0.0014, respectively. The level of addiction to the practice of chemsex can be difficult to estimate for the user, and the ASSIST makes it possible to evaluate this addiction and to direct the subjects toward specialized consultations of addictology, sexual health, or PrEP renewals. The implementation of the modified ASSIST in these consultations can allow early systematic screening and counseling., (© 2022 Société Française de Pharmacologie et de Thérapeutique. Published by John Wiley & Sons Ltd.)

Background: HIV remains a persistent health problem in the United States, especially among women. Approved in 2012, HIV pre-exposure prophylaxis (PrEP) is a daily pill or bimonthly injection that can be taken by individuals at increased risk of contracting HIV to reduce their risk of new infection. Women who are at risk of HIV face numerous barriers to HIV services and information, underscoring the critical need for strategies to increase awareness of evidence-based HIV prevention methods, such as HIV PrEP, among women., Objective: We aimed to identify historical trends in the use of Twitter hashtags specific to women and HIV PrEP and explore content about women and PrEP shared through Twitter., Methods: This was a qualitative descriptive study using a purposive sample of tweets containing hashtags related to women and HIV PrEP from 2009 to 2022. Tweets were collected via Twitter's API. Each Twitter user profile, tweet, and related links were coded using content analysis, guided by the framework of the Health Belief Model (HBM) to generate results. We used a factor analysis to identify salient clusters of tweets., Results: A total of 1256 tweets from 396 unique users were relevant to our study focus of content about PrEP specifically for women (1256/2908, 43.2% of eligible tweets). We found that this sample of tweets was posted mostly by organizations. The 2 largest groups of individual users were activists and advocates (61/396, 15.4%) and personal users (54/396, 13.6%). Among individual users, most were female (100/166, 60%) and American (256/396, 64.6%). The earliest relevant tweet in our sample was posted in mid-2014 and the number of tweets significantly decreased after 2018. We found that 61% (496/820) of relevant tweets contained links to informational websites intended to provide guidance and resources or promote access to PrEP. Most tweets specifically targeted people of color, including through the use of imagery and symbolism. In addition to inclusive imagery, our factor analysis indicated that more than a third of tweets were intended to share information and promote PrEP to people of color. Less than half of tweets contained any HBM concepts, and only a few contained cues to action. Lastly, while our sample included only tweets relevant to women, we found that the tweets directed to lesbian, gay, bisexual, transgender, queer (LGBTQ) audiences received the highest levels of audience engagement., Conclusions: These findings point to several areas for improvement in future social media campaigns directed at women about PrEP. First, future posts would benefit from including more theoretical constructs, such as self-efficacy and cues to action. Second, organizations posting on Twitter should continue to broaden their audience and followers to reach more people. Lastly, tweets should leverage the momentum and strategies used by the LGBTQ community to reach broader audiences and destigmatize PrEP use across all communities., (©Shimrit Keddem, Aneeza Agha, Sabrina Morawej, Amy Buck, Peter Cronholm, Sarita Sonalkar, Matthew Kearney. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 11.05.2023.)

Despite efficacy in HIV prevention, Pre-exposure Prophylaxis (PrEP) is underutilized in the US, especially among populations at highest risk. PrEP-related stigma may play a role. We developed measures of PrEP-related stigma dimensions and PrEP adherence. We administered them to current PrEP users. We hypothesized that PrEP-related stigma would negatively impact PrEP adherence. Questionnaire measures were developed using data from previous qualitative work and existing validated HIV-related stigma measures. The resultant survey was administered to current PrEP users from two Birmingham, Alabama PrEP clinics. Plasma tenofovir disoproxil fumarate levels were collected to measure PrEP adherence. Exploratory factor analyses were performed to determine the factor structure of each PrEP-related stigma dimension (internalized, perceived, experienced, anticipated, disclosure concerns). Separate binary logistic (or linear) regressions were performed to assess associations between PrEP-related stigma dimensions and adherence (treatment adherence self-efficacy, self-reported adherence, and plasma tenofovir levels), adjusting for education, race, and time on PrEP. In 2018, 100 participants completed the survey, with 91 identifying as male and 66 as white. Only internalized stigma was associated with lower self-reported PrEP adherence. Exploratory mediation analyses suggested that the association between all stigma dimensions and self-reported PrEP adherence is mediated by PrEP adherence self-efficacy. No associations were found between any PrEP-related stigma measures and plasma tenofovir levels. Internalized PrEP stigma may reduce PrEP adherence, possibly by reducing PrEP adherence self-efficacy among experienced PrEP users. Further investigation of how stigma dimensions affect PrEP adherence in populations at risk for HIV may shed light on drivers of PrEP underutilization., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

HIV pre-exposure prophylaxis (PrEP) has been introduced as another biomedical tool in HIV prevention. Whereas other such tools—including post-exposure prophylaxis (PEP) and interruption of perinatal transmission—have been embraced by those impacted by HIV, PrEP has been met with more conflict, especially within the gay community and HIV organizations. The “PrEP whore” has come to designate the social value and personal practices of those taking PrEP. This study examines the “PrEP whore” discourse by using queer theory and quare theory. Within these theoretical vantage points, the study explicates four discursive areas: slut shaming, dirty/clean binaries, mourning the loss of condoms, and reclaiming the inner whore. The study illuminates possible discursive strategies that lie outside of the domains of public health and within the individual and community. [ABSTRACT FROM PUBLISHER]

The pharmacokinetics (PK) of tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP), the active anabolites of tenofovir disoproxil fumarate (TDF), and emtricitabine (FTC) in blood, genital, and rectal compartments was determined in HIV-positive and seronegative adults who undertook a 60-day intensive PK study of daily TDF/FTC (plus efavirenz in HIV positives). Lymphocyte cell sorting, genital, and rectal sampling occurred once per subject, at staggered visits. Among 19 HIV-positive (3 female) and 21 seronegative (10 female) adults, TFV-DP in peripheral blood mononuclear cells (PBMC) accumulated 8.6-fold [95% confidence interval (CI): 7.2-10] from first-dose to steady-state concentration (Css) versus 1.7-fold (95% CI: 1.5-1.9) for FTC-TP. Css was reached in ∼11 and 3 days, respectively. Css values were similar between HIV-negative and HIV-positive individuals. Css TFV-DP in rectal mononuclear cells (1,450 fmol/106 cells, 898-2,340) was achieved in 5 days and was >10 times higher than PBMC (95 fmol/106 cells, 85-106), seminal cells (22 fmol/106 cells, 6-79), and cervical cells (111 fmol/106 cells, 64-194). FTC-TP Css was highest in PBMC (5.7 pmol/106 cells, 5.2-6.1) and cervical cells (7 pmol/106 cells, 2-19) versus rectal (0.8 pmol/106 cells, 0.6-1.1) and seminal cells (0.3 pmol/106 cells, 0.2-0.5). Genital drug concentrations on days 1-7 overlapped with estimated Css, but accumulation characteristics were based on limited data. TFV-DP and FTC-TP in cell sorted samples were highest and achieved most rapidly in CD14+ compared with CD4+, CD8+, and CD19+ cells. Together, these findings demonstrate cell-type and tissue-dependent cellular pharmacology, preferential accumulation of TFV-DP in rectal mononuclear cells, and rapid distribution into rectal and genital compartments. [ABSTRACT FROM AUTHOR]

Background: The impact of starting HIV pre-exposure prophylaxis (PrEP) on diagnoses of sexually transmitted infections (STI) remains unclear. We used data from German HIV/STI Checkpoints collected from 01/2019 to 08/2021 to determine the impact of PrEP use on syphilis, gonorrhoea and chlamydia diagnoses., Methods: We used self-reported data on demographics, sexual behaviour, testing and PrEP use, as well as lab-confirmed diagnoses from visits to HIV/STI Checkpoints in Germany. PrEP use was categorized as (1) never used; (2) intention to use; (3) former use; (4) current on-demand use; (5) daily use. In multivariate regression analyses (MRA) with gonorrhoea, chlamydia, and syphilis diagnoses as outcomes, we controlled for age, number of sexual partners, number of condomless anal intercourse (CAI) partners in the last six months, and testing recency., Results: For the analysis, we included 9,219 visits for gonorrhoea and chlamydia testing and 11,199 visits for syphilis testing conducted at checkpoints from 01/2019 to 08/2021. MRA identified age (aOR 0.98; 95%CI 0.97-0.99), number of sexual partners in the past six months (aOR 4.90; 95%CI 2.53-9.52 for 11 + partners), and use of chemsex substances (aOR 1.62; 95%CI 1.32-2.00) as risk factors for gonorrhoea, while age (aOR 0.99; 95%CI 0.98-1.00), number of CAI partners (aOR 3.19; 95%CI 2.32-4.41 for 5 + partners), partner sorting (aOR 1.30; 95%CI 1.09-1.54), and use of chemsex substances (aOR 1.29; 95%CI 1.05-1.59) were risk factors for chlamydia infections. For syphilis, the number of CAI partners (aOR 3.19; 95%CI 1.60-6.34 for 5 + partners) was found to be the only significant risk factor. There was a strong association between PrEP use and the number of sexual partners (≤ 5 vs.>5: aOR 3.58; 95%CI 2.15-5.97 for daily PrEP use), the number of CAI partners in the past six months (≤ 1 vs.>1: aOR 3.70; 95%CI 2.15-6.37 for daily PrEP use), and the number of STI tests performed (suggesting higher testing frequency). Both outcomes were also related to partner sorting, chemsex, and selling sex., Conclusions: Checkpoint visits reporting current PrEP use or intention to start PrEP correlated with eligibility criteria for PrEP, i.e. high partner numbers, inconsistent condom use during anal intercourse, and use of chemsex drugs. Use of HIV-specific prevention methods such as HIV serosorting, PrEP sorting, and viral load sorting was reported more frequently. (Daily) PrEP use was an independent risk factor for a chlamydia diagnosis only., (© 2023. The Author(s).)

User costs constitute a barrier to the uptake of HIV pre-exposure prophylaxis (PrEP), but their magnitude appears rarely assessed. In this prospective observational study, we assessed self-reported out-of-pocket expenses (OOPE) and time spent on clinic visits during a PrEP demonstration project in Eswatini. At six public primary care clinics, 240 PrEP users and other clinic attendees were interviewed after a clinic visit. Among the 79.2% of clinic attendees reporting any medical OOPE (e.g., expenses for consultations or drugs) and/or non-medical OOPE (e.g., expenses for transport, food, or phone use), the median total OOPE was $1.36 (IQR 0.91-1.96). Non-medical OOPE occurred mostly due to transport expenses. The median travel time for a clinic visit was 1.0 h (IQR 0.67-2.0). The median time spent in the clinic was 2.0 h (IQR 1.15-3.0). The median opportunity cost of a clinic visit was $7.54 (IQR 5.42-11) when valuing time spent on a clinic visit with Eswatini's per-capita gross domestic product. Our findings can guide measures to reduce the user costs of PrEP in Eswatini and other contexts in which oral PrEP is provided through health care facilities., (© 2022. The Author(s).)

Although roll-out of HIV pre-exposure prophylaxis (PrEP) has been reported to have changed contexts of HIV risk in areas where it was well-implemented. The rate of its uptake and retention amongst young females has not been described in Gauteng Province. This paper aimed at assessing PrEP uptake and retention among young females in Gauteng Province. Total of young females who tested HIV across five clinics from 01/January/2017 to 31/December/2020 was 19,671 with 17,937 tested HIV negative. Of the HIV tested negative, PrEP was initiated to 1307 (7%). The analysis revealed that 27% of young females returned for their first follow up visit after PrEP initiation, while third month declined to 14%, fourth month to 11%, and fifth month to 3%, sixth month to 2% and seventh month at 1% and from the eighth month, the rate of follow up was 0%. Uptake and retention of PrEP was low among young females as measured against the total tested HIV negative., (© 2022. Springer Science+Business Media, LLC, part of Springer Nature.)

Objective: We aimed to evaluate the usability and acceptability of a co-designed mobile health (mHealth) application (PrEP-EmERGE) within a digital health pathway to support HIV pre-exposure prophylaxis (PrEP)., Methods: This was a cross-sectional study to evaluate the usability and acceptability of the PrEP-EmERGE app. Data were collected via an online survey sent to all PrEP EmERGE users in September 2021. Usability was assessed with a validated usability tool, the System Usability Scale (SUS). Acceptability was assessed using modified patient-reported experience measures (PREMs). Quantitative data were analysed using descriptive and/or inferential statistics and qualitative data (free text responses) using thematic analysis., Results: In total, 81/133 (61%) active PrEP EmERGE users completed the online survey, which was available directly from their PrEP EmERGE app: 78/81 (96%) identified as cis-male, 74/81 (91%) reported their ethnicity as 'white', 69/81 (85%) reported daily PrEP use, 7/81 (9%) reported using an event-based dosing schedule, and 5/81 (6%) were switching between dosing schedules. Overall, the median SUS score was 78/100 (interquartile range: 70-92). There were no differences in median SUS scores by PrEP dosing schedules (p = 0.78) or months of experience of using the app (p = 0.31). Overall, 73/81 (90%) would recommend the PrEP EmERGE app to a friend and 78/81 (96%) rated their satisfaction of the app as excellent, good or satisfactory. The free text responses generated three key themes: accessibility (for results and information); autonomy [taking responsibility for their (sexual) health] and functionality (including technical recommendations for app development and the digital health pathway)., Conclusions: Innovative, co-designed digital health pathways, such as PrEP EmERGE can help sexual health services to manage increasing numbers of people accessing PrEP - ensuring that they retain access for those who need to be seen face-to-face. We report high levels of acceptability and usability during the first 4 months of this novel pathway., (© 2022 The Authors. HIV Medicine published by John Wiley & Sons Ltd on behalf of British HIV Association.)

Purpose: HIV rates are increasing in rural areas, and adolescents are disproportionately affected. HIV pre-exposure prophylaxis (PrEP) is a daily pill that is effective at preventing HIV; however, PrEP uptake among adolescents is low. PrEP is dependent on primary care providers (PCPs) prescribing it, but research has overwhelmingly sampled urban PCPs. This study compared the PrEP awareness, practices, and comfort between rural and urban family medicine physicians., Methods: A total of 256 family medicine physicians in the United States were recruited from a Qualtrics panel to complete an online cross-sectional survey between July 15 and August 9, 2022. Participants completed items assessing their demographic characteristics and PrEP awareness, practices, and comfort. A chi-square test of independence and multiple logistic regression were used to determine rural/urban differences., Findings: Rural family medicine physicians were less comfortable than urban family medicine physicians in providing sexual risk reduction counseling to adolescents, telling an adolescent patient their HIV test result was HIV positive, and implementing all of the PrEP clinical activities for adolescents., Conclusions: Education, skill-building, and collaborative partnership interventions could improve the comfort levels of rural family medicine physicians in implementing the PrEP guidelines for their adolescent patients. Future research is needed to understand the factors that explain the differences in PrEP-related attitudes and practices between urban and rural family medicine physicians. Results from such studies could inform provider-based interventions that ultimately increase PrEP use and decrease HIV rates among rural adolescents., (© 2022 National Rural Health Association.)

Introduction: Fewer than a quarter of people considered to have factors associated with HIV acquisition are prescribed pre-exposure prophylaxis (PrEP) in the United States. Prior studies demonstrate disparities in provider comfort and knowledge regarding PrEP, suggesting a need for provider capacity building to support widespread PrEP availability. This study examined real-world PrEP clinical questions/cases from providers to a teleconsultation service to identify knowledge gaps and improve PrEP-related training materials and clinical guidelines. Methods: The National Clinician Consultation Center (NCCC) PrEPline provides educational teleconsultation services on clinical decision-making related to PrEP for U.S. health care providers. The NCCC PrEP consultation data collected between 2017 and 2020 were reviewed and systematically categorized by clinical topics, subtopics, and complexity levels (low, moderate, and high). Results: Within the study period, the PrEPline provided 1,754 teleconsultations. More than three quarters came from advanced practice nurses and physicians. The topics of questions commonly focused on medication-based HIV prevention strategies (22.7%), PrEP laboratory ordering/monitoring (17.4%), and side effects and contraindications (14.6%). The majority of teleconsultations (57.9%) involved sharing information that was directly available/addressed in the Centers for Disease Control and Prevention (CDC) 2017 PrEP Guidelines (i.e., low complexity). Discussion: The low frequency of consultations from nonphysician and non-nurse practitioner providers may suggest a need for increased training and collaborative opportunities for other types of providers. The high percentage of low-complexity inquiries may reveal a desire for capacity-building materials specifically designed for practicing providers (e.g., abridged versions of guidelines). This study may inform future research, best clinical practices, and aid in the development of training materials to increase providers' HIV prevention comfort and knowledge.

MTN-025/HOPE was an open-label trial of the dapivirine vaginal ring conducted in four African countries between 2016 and 2018. Women were first offered one ring monthly (at baseline, months 1 and 2), thereafter, transitioned to a more applicable real-world dispensation schedule, - 3 rings quarterly (at months 3, 6 and 9). Logistic regression analysis was used to assess correlates of ring acceptance at baseline and through follow-up. A total of 1456 women (median age 31 years) enrolled, 1342 (92.2%) accepted the ring at baseline and 1163 (79.9%) accepted the ring(s) at all visits. Changing ring dispensation from a monthly to a quarterly schedule had no negative effect on acceptance. Having a primary partner and him knowing about the ring being offered in HOPE, use of long-acting contraception (implants, injections, IUDs) or sterilization were associated with ring acceptance, along with prior strong intention to use the ring in the future. Efforts should consider these factors when rolling out the ring for HIV prevention., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Using baseline data from the PrEP1519 cohort, in this article we aimed to analyze: (i) the effectiveness of demand creation strategies (DCS) to enroll adolescent men who have sex with men (AMSM) and adolescent transgender women (ATGW) into an HIV combination prevention study in Brazil; (ii) the predictors of DCS for adolescents' enrollment; and (iii) the factors associated with DCS by comparing online and face-to-face strategies for enrollment. The DCS included peer recruitment (i.e., online and face-to-face) and referrals from health services and non-governmental organizations (NGOs). AMSM and ATGW who agreed to participate in the study could opt to enroll in either PrEP (PrEP arm) or to use other prevention methods (non-PrEP arm). Bivariate and multivariate analyses were conducted and logistic regression odds ratios were estimated. The DCS reached 4529 AMSM and ATGW, the majority of which were derived online (73.8%). Of this total, 935 (20.6%) enrolled to participate (76.6% in PrEP arm and 23.4% in non-PrEP arm). The effectiveness of enrolling adolescents into both arms was greater via direct referrals (235/382 and 84/382, respectively) and face-to-face peer recruitment (139/670 and 35/670, respectively) than online (328/3342). We found that a combination under DCS was required for successful enrollment in PrEP, with online strategies majorly tending to enroll adolescents of a higher socioeconomic status. Our findings reinforce the need for DCS that actively reaches out to all adolescents at the greatest risk for HIV infection, irrespective of their socioeconomic status., (© 2022. The Author(s).)

Objectives: The principal outcome was to describe clinical characteristics of a transgender male-to-female (TGW) cohort followed for pre-exposure HIV prophylaxis (PrEP).Introduction: Few efforts and preventive interventions have targeted transgender population, despite them being at great risk of HIV infection.Methods: This was a retrospective transgender male-to-female (TGW) cohort followed for PrEP at Bichat Hospital Sexual Health Clinic between February 2016 and January 2019.The principal outcome was to describe clinical characteristics of this TGW population: modalities of PrEP uptake, treatment adherence and tolerance, sanitary system retention, hormonal therapy and STIs.Data about age, ethnicity, language, sex work and sanitary healthcare insurance coverage were also collected.Results: Forty-nine TGW were included, with a median age of 33 years; 43/49 (87.7%) were from South America and 43/49 (87.7%) were sex workers. Forty-four 44/49 TGW (89.7%) had no regular healthcare insurance coverage. Nineteen out of 49 (38.7%) had a history of STI in the last 12 months. Hormone intake was reported in 16/49 (32.60%). PrEP with oral TDF/FTC was prescribed on a daily basis for 45/49 TG (91.8%). Two TGW discontinued PrEP for gastrointestinal intolerance. No case of renal toxicity or HIV seroconversion has been reported. Retention rate was high (71.4%), but average follow-up was 9 months.Conclusions: Our data showed a very vulnerable population, with a high proportion of migrants, sex workers and with a low healthcare insurance coverage. Retention rate was high (71.4%). Further multi-component interventions are needed to improve global sex health approach, PreP follow-up and sanitary system retention among TGW population. [ABSTRACT FROM AUTHOR]

Nonadherence, particularly among men who have sex with men (MSM) with substance use disorders, increases the risk of HIV acquisition. Measuring adherence to HIV pre-exposure chemoprophylaxis (PrEP), and responding to suboptimal adherence or changes in adherence behavior remains a challenging public health problem. Despite the importance of accurate adherence measurement, there is no gold standard for detecting medication ingestion events in HIV research. Current adherence measures indirectly infer ingestion events or measure medication concentrations over time, yet such approaches fail to provide direct confirmation of ingestions and contextual information surrounding adherence and nonadherence. A digital pill system (DPS) - a novel tool that leverages ingestible radiofrequency sensors to measure actual ingestion events - may advance adherence measurement in HIV research. We examined and compared the willingness of MSM across racial and ethnic identities to operate a DPS in the context of PrEP adherence measurement and suggest potential future applications of this technology.

Background: Topical on-demand forms for HIV pre-exposure prophylaxis (PrEP) may be a desirable alternative for people that prefer not to use daily PrEP. CONRAD has developed inserts containing tenofovir alafenamide (TAF) and elvitegravir (EVG) for on-demand vaginal or rectal pericoital use. We assessed the pharmacokinetics (PK) and pre-exposure efficacy of rectally applied TAF/EVG inserts in macaques., Methods: PK was assessed in 12 pigtailed macaques. Tenofovir (TFV) and EVG levels were assayed in rectal biopsies and secretions, and tenofovir-diphosphate (TFV-DP) levels in biopsies and peripheral blood mononuclear cells (PBMC). Drug biodistribution was evaluated in 10 animals at necropsy 4 h post-dosing. For efficacy assessments, one or two TAF/EVG inserts were administered to macaques (n = 6) 4 h before repeated rectal SHIV162p3 challenges., Findings: One TAF/EVG insert resulted in rapid and high EVG and TFV-DP in rectal tissue 4 h after application. Adding a second insert led to a 10-fold increase in EVG and TFV-DP in rectal tissue. Efficacy of one and two TAF/EVG inserts were 72.6% (CI 24.5%-92.6%) and 93.1% (CI 73.3%-99.2%), respectively., Interpretation: Although high TFV-DP and EVG levels were observed with one rectal TAF/EVG insert, it only conferred partial protection from rectal SHIV challenges. Adding a second insert led to an increase in TFV and EVG in rectal tissues resulting in higher (>90%) efficacy. These results highlight the high efficacy of TAF/EVG inserts as topical on-demand rectal PrEP, as well as the need for appropriate drug coverage in the deep rectum and colon to achieve high protection., Funding: The work related to animal studies was funded by CDC intramural funds and an interagency agreement between CDC and USAID (USAID/CDC IAA AID-GH-T-15-00002). The work related to the insert formulation was funded by U.S. PEPFAR through USAID under a Cooperative Agreement (AID-OAA-A-14-00010) with CONRAD/Eastern Virginia Medical School. The findings and conclusions of this manuscript are those of the authors and do not necessarily represent the official views of the Centers for Disease Control and Prevention (CDC), USAID, President's Emergency Plan for AIDS Relief (PEPFAR), Eastern Virginia Medical School (EVMS), or the US government., Competing Interests: Declaration of interests J.G.G-L and W.H. are named in the US. Government (USG) patents on “Inhibition of HIV infection through chemoprophylaxis” and “HIV post-exposure prophylaxis” and a patent application on “HIV pre-exposure prophylaxis”. W. H. and J. G. G.-L. report royalties or licenses from Mylan, Laurus Generics, TAD Pharma, and CIPLA Limited. M.M.P., V.A., G.F.D., and M.R.C. are named in patent applications on “Pharmaceutical compositions and methods of making on-demand solid dosage formulations,” inventions that were developed under US Agency for International Development (USAID)-funded cooperative agreement. N.M., T.S., J. M., A.H., C.D., M.M., Y.P., and J.M.S., declare no competing interest. The findings and conclusions of this manuscript are those of the authors and do not necessarily represent the official views of the Centers for Disease Control and Prevention (CDC), USAID, President's Emergency Plan for AIDS Relief (PEPFAR), Eastern Virginia Medical School (EVMS), or the USG., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)