Low selection of HIV PrEP refills at private pharmacies among clients who initiated PrEP at public clinics: findings from a mixed-methods study in Kenya.

BACKGROUND: In Africa, the delivery of HIV pre-exposure prophylaxis (PrEP) at public healthcare clinics is challenged by understaffing, overcrowding, and HIV-associated stigma, often resulting in low PrEP uptake and continuation among clients. Giving clients the option to refill PrEP at nearby private pharmacies, which are often more convenient and have shorter wait times, may address these challenges and improve PrEP continuation. METHODS: This mixed methods study used an explanatory sequential design. At two public clinics in Kiambu County, Kenya, clients ≥ 18 years initiating PrEP were given the option to refill PrEP at the clinic where they initiated for free or at one of three nearby private pharmacies for 300 Kenyan Shillings (~ $3 US Dollars). The providers at these pharmacies (pharmacists and pharmaceutical technologists) were trained in PrEP service delivery using a prescribing checklist and provider-assisted HIV self-testing, both with remote clinician oversight. Clients were followed up to seven months, with scheduled refill visits at one, four, and seven months. The primary outcomes were selection of pharmacy-based PrEP refills and PrEP continuation. Following pilot completion, 15 in-depth interviews (IDIs) with clients who refilled PrEP were completed. We used descriptive statistics and thematic analysis to assess study outcomes. RESULTS: From November 2020 to November 2021, 125 PrEP clients were screened and 106 enrolled. The majority (59%, 63/106) of clients were women and the median age was 31 years (IQR 26-38 years). Over 292 client-months of follow-up, 41 clients (39%) refilled PrEP; only three (3%) at a participating pharmacy. All clients who completed IDIs refilled PrEP at clinics. The reasons why clients did not refill PrEP at pharmacies included: a preference for clinic-delivered PrEP services (i.e., pre-existing relationships, access to other services), concerns about pharmacy-delivered PrEP services (i.e., mistrust, lower quality care, costs), and lack of knowledge of this refill location. CONCLUSIONS: These findings suggest that clients who initiate PrEP at public clinics in Kenya may have already overcome barriers to clinic-delivered PrEP services and prefer PrEP access there. To reach new populations that could benefit from PrEP, a stand-alone model of pharmacy-delivered PrEP services may be needed. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04558554 [registered: June 5, 2020].

User Experience of Persons Using Ingestible Sensor-Enabled Pre-Exposure Prophylaxis to Prevent HIV Infection: Cross-Sectional Survey Study.

Background: A digital health technology's success or failure depends on how it is received by users. objectives: We conducted a user experience (UX) evaluation among persons who used the Food and Drug Administration-approved Digital Health Feedback System incorporating ingestible sensors (ISs) to capture medication adherence, after they were prescribed oral pre-exposure prophylaxis (PrEP) to prevent HIV infection. We performed an association analysis with baseline participant characteristics, to see if "personas" associated with positive or negative UX emerged. Methods: UX data were collected upon exit from a prospective intervention study of adults who were HIV negative, prescribed oral PrEP, and used the Digital Health Feedback System with IS-enabled tenofovir disoproxil fumarate plus emtricitabine (IS-Truvada). Baseline demographics; urine toxicology; and self-report questionnaires evaluating sleep (Pittsburgh Sleep Quality Index), self-efficacy, habitual self-control, HIV risk perception (Perceived Risk of HIV Scale 8-item), and depressive symptoms (Patient Health Questionnaire-8) were collected. Participants with ≥28 days in the study completed a Likert-scale UX questionnaire of 27 questions grouped into 4 domain categories: overall experience, ease of use, intention of future use, and perceived utility. Means and IQRs were computed for participant total and domain subscores, and linear regressions modeled baseline participant characteristics associated with UX responses. Demographic characteristics of responders versus nonresponders were compared using the Fisher exact and Wilcoxon rank-sum tests. Results: Overall, 71 participants were enrolled (age: mean 37.6, range 18-69 years; n=64, 90% male; n=55, 77% White; n=24, 34% Hispanic; n=68, 96% housed; and n=53, 75% employed). No demographic differences were observed in the 63 participants who used the intervention for ≥28 days. Participants who completed the questionnaire were more likely to be housed (52/53, 98% vs 8/10, 80%; P=.06) and less likely to have a positive urine toxicology (18/51, 35% vs 7/10, 70%; P=.08), particularly methamphetamine (4/51, 8% vs 4/10, 40%; P=.02), than noncompleters. Based on IQR values, ≥75% of participants had a favorable UX based on the total score (median 3.78, IQR 3.17-4.20), overall experience (median 4.00, IQR 3.50-4.50), ease of use (median 3.72, IQR 3.33-4.22), and perceived utility (median 3.72, IQR 3.22-4.25), and ≥50% had favorable intention of future use (median 3.80, IQR 2.80-4.40). Following multipredictor modeling, self-efficacy was significantly associated with the total score (0.822, 95% CI 0.405-1.240; P<.001) and all subscores (all P<.05). Persons with more depressive symptoms reported better perceived utility (P=.01). Poor sleep was associated with a worse overall experience (-0.07, 95% CI -0.133 to -0.006; P=.03). Conclusions: The UX among persons using IS-enabled PrEP (IS-Truvada) to prevent HIV infection was positive. Association analysis of baseline participant characteristics linked higher self-efficacy with positive UX, more depressive symptoms with higher perceived utility, and poor sleep with negative UX.

Impact of simplified HCV diagnostic strategies on the HCV epidemic among men who have sex with men in the era of HIV oral pre-exposure prophylaxis in Taiwan: a modelling study.

INTRODUCTION: Simplified hepatitis C virus (HCV) diagnostic strategies have the potential to improve HCV diagnoses and treatment. We aimed to investigate the impact of simplified HCV diagnostic strategies on HCV incidence and its effect on HCV diagnosis and treatment among men who have sex with men (MSM) regardless of HIV status and use of HIV pre-exposure prophylaxis (PrEP) in Taiwan. METHODS: A compartmental deterministic model was developed to describe the natural history of HCV disease progression, the HCV care cascade and the HIV status and PrEP using among MSM. The model was calibrated to available data for HCV and HIV epidemiology and population demographics in Taiwan. We simulated the epidemic from 2004 and projected the impact of simplified testing strategies on the HCV epidemic among MSM over 2022-2030. RESULTS: Under the current testing approach in Taiwan, total HCV incidence would increase to 12.6 per 1000 person-years among MSM by 2030. Single-visit point-of-care RNA testing had the largest impact on reducing the number of new HCV infections over 2022-2030, with a 31.1% reduction (interquartile range: 24.9%-32.8%). By 2030, single-visit point-of-care HCV testing improved HCV diagnosis to 90.9%, HCV treatment to 87.7% and HCV cure to 81.5% among MSM living with HCV. Compared to status quo, prioritized simplified HCV testing for PrEP users and MSM living with diagnosed HIV had considerable impact on the broader HCV epidemic among MSM. A sensitivity analysis suggests that reinfection risk would have a large impact on the effectiveness of each point-of-care testing scenario. CONCLUSIONS: Simplified HCV diagnostic strategies could control the ongoing HCV epidemic and improve HCV testing and treatment among Taiwanese MSM. Single-visit point-of-care RNA testing would result in large reductions in HCV incidence and prevalence among MSM. Efficient risk-reduction strategies will need to be implemented alongside point-of-care testing to achieve HCV elimination among MSM in Taiwan.

Exploring adolescent girls and young women's PrEP-user profiles: qualitative insights into differentiated PrEP delivery platform selection and engagement in Cape Town, South Africa.

INTRODUCTION: Adolescent girls and young women (AGYW), a priority population for HIV prevention in Africa, show high interest but difficulty in sustained effective use of pre-exposure prophylaxis (PrEP). With ongoing PrEP scale-up focused on increasing access, it is important to understand what influences AGYW's choice of PrEP delivery platforms. METHODS: The POWER implementation study in Cape Town provided PrEP between 2017 and 2020 to AGYW (16-25 years) from four differentiated delivery platforms: mobile clinic, government facility, courier delivery or community-based youth club. Healthcare providers at government and mobile clinics provided PrEP (initiation and refills) as part of comprehensive, integrated sexual and reproductive health services. Courier and youth club platforms provided light-touch PrEP refill services incorporating rapid HIV self-testing. We conducted in-depth interviews with a purposive sample of AGYW who had ≥3 months of PrEP-use and accessed ≥2 PrEP delivery platforms. The thematic analysis explored AGYW's preferences, decision-making and habits related to PrEP access to inform market segmentation. RESULTS: We interviewed 26 AGYW (median age 20) PrEP-users between November 2020 and March 2021. AGYW PrEP-users reported accessing different services with, 24 accessing mobile clinics, 17 courier delivery, 9 government health facilities and 6 youth clubs for their PrEP refills. Qualitative findings highlighted four potential behavioural profiles. The "Social PrEP-user" preferred PrEP delivery in peer spaces, such as youth clubs or adolescent-friendly mobile clinics, seeking affirmation and social support for continued PrEP use. The "Convenient PrEP-user" favoured PrEP delivery at easily accessible locations, providing quick (courier) or integrated contraception-PrEP refill visits (mobile and government clinic). The "Independent PrEP-user" preferred PrEP delivery that offered control over delivery times that fit into their schedule, such as the courier service. The "Discreet PrEP-user" highly valued privacy regarding their PrEP use (courier delivery) and avoided delivery options where unintentional disclosure was evident (youth club). Comfort with HIV self-testing had minimal influence on PrEP delivery choice. CONCLUSIONS: Market segmentation of AGYW characterizes different types of PrEP-users and has the potential to enhance tailored messaging and campaigns to reach specific segments, with the aim of improving sustained PrEP use and HIV prevention benefits.

Experiences of oral pre-exposure prophylaxis use among heterosexual men accessing sexual and reproductive health services in South Africa: a qualitative study.

INTRODUCTION: South African men face a substantial burden of HIV and are less likely to test for HIV and initiate antiretroviral therapy if tested positive and more likely to die from AIDS-related causes than women. In addition to condoms and circumcision, guidelines provide for the use of daily oral pre-exposure prophylaxis (PrEP) as an HIV prevention intervention for any men who recognize their need and request PrEP. However, heterosexual men have not been a focus of PrEP programmes, and since its introduction, there is limited literature on PrEP use among men in South Africa. This study explores the experiences, motivators and barriers to oral PrEP use among heterosexual men accessing primary healthcare services in South Africa. METHODS: This study forms part of a mixed-methods implementation science study aimed at generating evidence for oral PrEP introduction and conducted in primary healthcare clinics in South Africa since 2018. Men aged ≥15 years who initiated oral PrEP and enrolled in a parent cohort study were purposefully invited to participate in an in-depth interview (IDI). Between March 2020 and May 2022, 30 men participated in IDIs exploring their motivators for PrEP use, and experiences with accessing health services. Interviews were audio recorded, transcribed and analysed thematically. RESULTS: The final analysis included 28 heterosexual men (18-56 years old). Motivations to initiate PrEP included fear of acquiring HIV, self-perceived vulnerability to HIV and mistrust in relationships; health systems factors which motivated PrEP use included the influence of healthcare providers, educational materials and mobile services. Perceived reduction in HIV vulnerability and changing proximity to partners were reasons for PrEP discontinuation. Side effects, daily-pill burden and stigma were noted as challenges to PrEP use. Health system barriers to PrEP use included limited PrEP availability, school and work demands, and inconsistent mobile clinic schedules. CONCLUSIONS: Our study reports on the experiences of heterosexual men accessing oral PrEP in real-world settings and contributes to the limited literature among this population. We highlight multiple levels which could be strengthened to improve men's PrEP use, including individual support, education among partners and communities, and addressing health system barriers to access.

Urine tenofovir testing for real-time PrEP adherence feedback: a qualitative study involving transgender women in Uganda.

INTRODUCTION: Adherence counselling with point-of-care (POC) drug-level feedback using a novel tenofovir assay may support pre-exposure prophylaxis (PrEP) adherence; however, perceptions of urine testing and its impact on adherence are not well studied. We qualitatively examined how POC tenofovir testing was experienced by transgender women (TGW) in Uganda. METHODS: Within a cluster randomized trial of peer-delivered HIV self-testing, self-sampling for sexually transmitted infections and PrEP among HIV-negative TGW showing overall low PrEP prevention-effective adherence (NCT04328025), we conducted a nested qualitative sub-study of the urine POC assay among a random sample of 30 TGW (August 2021-February 2022). TGW interviews explored: (1) experiences with POC urine tenofovir testing and (2) perceptions of PrEP adherence counselling with drug-level feedback. We used an inductive content analytic approach for analysis. RESULTS: Median age was 21 years (interquartile range 20-24), and 70% engaged in sex work. Four content categories describe how TGW experienced POC urine tenofovir testing: (1) Urine tenofovir testing was initially met with scepticism: Testing urine to detect PrEP initially induced anxiety, with some perceptions of being intrusive and unwarranted. With counselling, however, participants found POC testing acceptable and beneficial. (2) Alignment of urine test results and adherence behaviours: Drug-level feedback aligned with what TGW knew about their adherence. Concurrence between pill taking and tenofovir detection in urine reinforced confidence in test accuracy. (3) Interpretation of urine tenofovir results: TGW familiar with the interpretation of oral-fluid HIV self-tests knew that two lines on the test device signified positivity (presence of HIV). However, two lines on the urine test strip indicated a positive result for non-adherence (absence of tenofovir), causing confusion. Research nurses explained the difference in test interpretation to participants' satisfaction. (4) White coat dosing: Some TGW deliberately chose not to attend scheduled clinic appointments to avoid detecting their PrEP non-adherence during urine testing. They restarted PrEP before returning to clinic, a behaviour called "white coat dosing." CONCLUSIONS: Incorporating POC urine testing into routine PrEP adherence counselling was acceptable and potentially beneficial for TGW but required attention to context. Additional research is needed to identify effective strategies for optimizing adherence monitoring and counselling for this population.

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.

The gender of PrEP: Transgender men negotiating legitimacy in France.

Transmasculine people (TM) constitute an invisibilized group within the transgender population. Little is known about their relationship to sexuality in transgender medicine. Their presence and needs are still unacknowledged within HIV prevention research and services. Pre-exposure prophylaxis (or PrEP) is an oral medication that prevents HIV in HIV-negative individuals at risk of infection with the virus. This paper proposes to bring TM back into the focus of PrEP research by questioning how they navigate and situate themselves in relation to existing PrEP categorization and services, and how they think about and (re)shape the meanings of PrEP. It is based on the "interpretative descriptive" method and a transfeminist theoretical framework applied to the analysis of ten semi-structured interviews with TM conducted in France between 2019 and 2023. Findings show that PrEP is gendered. We identify specific barriers to getting PrEP as well as to access healthcare and we show that a cisnormative and homonormative approach to prevention generates them. PrEP use and PrEP disclosure are embedded in structural and symbolic power relations between cisgender and transgender MSM that are reflected in the intimate sphere. TM use PrEP to prevent sexual assault and to alleviate the difficulty of condom negotiation. PrEP comes into play following major changes in TM's sexualities and is integrated post-exposure.

HIV Care Continuum and Preexposure Prophylaxis Program in Federal Bureau of Prisons, United States.

In 2019, the US Department of Health and Human Services launched the Ending the HIV Epidemic in the US initiative (EHE) with the goal of reducing new HIV infections by 90% by 2030. This initiative identifies 4 pillars (diagnose, treat, prevent, and respond) to address the HIV epidemic in the United States. To advance the EHE goals, the Federal Bureau of Prisons (FBOP) has implemented interventions at all points of the HIV care continuum. The FBOP has addressed the EHE pillar of prevention through implementing preexposure prophylaxis, developing a strategy to decrease the risk of new HIV infection, and providing guidance to FBOP healthcare providers. This article describes the implementation of programs to improve the HIV care continuum and end the epidemic of HIV within the FBOP including a review of methodology to implement an HIV preexposure prophylaxis program.

[Perception of risk of HIV infection and knowledge about the use of antiretrovirals in prevention]. / Percepción de riesgo de infección por HIV y conocimiento sobre uso de antirretrovirales en prevención.

INTRODUCTION: Combined prevention (CP) is considered the key strategy against the HIV epidemic. The objective of the study was to evaluate the perception of risk of HIV infection and the knowledge about the use of antiretrovirals (ARV) for prevention, among patients who attend a Sexually Transmitted Infections (STI) clinic. METHODS: A survey on personal data and perception of risk of HIV infection, knowledge about post-exposure prophylaxis (PEP) and pre-exposure prophylaxis (PrEP), was administered to patients at the time of applying doses of penicillin for the treatment of syphilis, or when taking a blood sample for STI diagnosis, between May and December, 2022. RESULTS: 100 persons were surveyed: 43 were under 25 years of age, 67 reported male sex-gender and 33 females. Thirty of 91 (33%) perceived they had had some risk of infection in their lives, 19 of them in the last year; 77/96 (80%) stated that they had no knowledge about PEP, and 82/100, about PrEP. Only 22 out of 100 responded that antiretrovirals could provide benefit in preventing HIV; 26 (60%) of the 43 patients <25 years of age, and 18 of the 57 ≥ 25 years (31.6%) responded they have had two or more sexual partners in the last year. No statistically significant differences were observed related to gender and age group. DISCUSSION: The low perception of infection risk and knowledge about the use of antiretrovirals in HIV prevention, show the existing difficulties for the implementation of combined prevention (PEP-PrEP) in this population.

Introducción: La prevención combinada (PC) se considera la estrategia clave frente a la epidemia de HIV. El objetivo del estudio fue evaluar la percepción de riesgo de infección por HIV y el conocimiento sobre uso de antirretrovirales (ARV) para prevención, entre pacientes que concurren a un consultorio de Infecciones de Transmisión Sexual (ITS). Métodos: Una encuesta sobre datos personales y percepción de riesgo de infección por HIV, conocimiento sobre profilaxis posterior a la exposición (PEP) y previa a la exposición (PrEP), fue administrada a pacientes al momento de aplicar dosis de penicilina para tratamiento de sífilis, o de extraer muestra de sangre para diagnóstico de ITS, entre mayo y diciembre, 2022. Resultados: De 100 personas encuestadas, 43 eran menores de 25 años, 67 reportaron sexo-género masculino y 33 femenino. Treinta de 91, (33%), percibían haber tenido en su vida algún riesgo de infección, 19 de ellas en el último año; 77/96 (80%) manifestaron no tener conocimiento sobre PEP, y 82/100, sobre PrEP. Solo 22% respondió que los antirretrovirales podrían brindar beneficio para prevenir el HIV; 26 (60%) de los 43 menores de 25 años, y 18 de los 57 ≥ 25 años (31.6%) respondieron haber tenido dos o más parejas sexuales el último año. No se observaron diferencias estadísticamente significativas, relacionadas con género y grupo etario. Discusión: La baja percepción de riesgo de infección y del conocimiento sobre uso de antirretrovirales para prevención de HIV, evidencian las dificultades existentes en la implementación de prevención combinada (PEPPrEP) en esta población.

Pre-exposure prophylaxis and telemedicine during coronavirus (COVID-19): a qualitative study of the experiences of health care professionals in Mexico.

Background Telemedicine, which involves utilising technologies for remote health care delivery, proved useful to continue offering certain health services during the coronavirus disease 2019 (COVID-19) lockdown. However, the extent of its effectiveness in delivering pre-exposure prophylaxis services for HIV prevention remains underexplored from the viewpoint of health care providers. Therefore, this study aimed to assess the experiences of health care professionals in Mexico who utilised telemedicine for delivering pre-exposure prophylaxis services during the COVID-19 contingency. Methods A qualitative study was performed: 15 virtual interviews with health care professionals were conducted, transcribed and coded in ATLAS.ti. Results The results indicate that telemedicine effectively mitigated COVID-19 exposure, facilitated users' access to pre-exposure prophylaxis counselling, minimised waiting times and enhanced health care professionals' perceived control during sessions. While implementing remote services, certain organisational challenges, which were somewhat latent before the pandemic, became more apparent: colleagues recognised the necessity for more formal communication channels to disseminate information effectively. Additionally, there was a recognised need for electronic patient files to streamline data-sharing processes. An optimal approach would involve a blend of face-to-face and virtual services, contingent upon the availability of essential infrastructure, well-defined implementation protocols and comprehensive training programs. Conclusions Telemedicine streamlined certain processes, garnered positive acceptance from healthcare professionals and holds promise as a valuable post-pandemic tool for improving retention among pre-exposure prophylaxis users.

Willingness and preferences for long-acting injectable PrEP among US men who have sex with men: a discrete choice experiment.

INTRODUCTION: Cabotegravir long-acting injectable HIV pre-exposure prophylaxis (LA-PrEP) was shown to be safe and effective in multiple clinical trials. Increasing uptake and persistence among populations with elevated risk for HIV acquisition, especially among men who have sex with men (MSM), is critical to HIV prevention. OBJECTIVE: This analysis aims to understand potential users' preferences for LA-PrEP, with audience segmentation. DESIGN: Willingness to use and preferences for LA-PrEP were measured in HIV-negative, sexually active MSM in the 2020 American Men's Internet Survey. Respondents answered a discrete choice experiment with paired profiles of hypothetical LA-PrEP characteristics with an opt-out option (no LA-PrEP). Conditional and mixed logit models were run; the final model was a dummy-coded mixed logit that interacted with the opt-out. SETTING: US national online sample. RESULTS: Among 2506 MSM respondents, most (75%) indicated a willingness to use LA-PrEP versus daily oral PrEP versus no PrEP. Respondents were averse to side effects and increasing costs and preferred increasing levels of protection. Respondents preferred a 2-hour time to obtain LA-PrEP vs 1 hour, with a strong aversion to 3 hours. Overall, there was an aversion to opting out of LA-PrEP, with variations: those with only one partner, no/other insurance or who were Black, Indigenous or People of Colour were significantly less likely to prefer LA-PrEP, while those who were Hispanic/Latino, college educated and <40 years significantly preferred LA-PrEP. CONCLUSIONS: A large proportion of MSM expressed a preference for LA-PrEP over daily oral pills. Most respondents chose LA-PrEP regardless of cost, clinic time, side effects or protection level; however, preferences varied by sociodemographics. These varied groups likely require tailored intervention strategies to achieve maximum LA-PrEP uptake and persistence.

Perspectives on Injectable HIV Pre-Exposure Prophylaxis: A Qualitative Study of Health Care Providers in the United States.

The introduction of injectable HIV pre-exposure prophylaxis (PrEP) has the potential to significantly change the biomedical HIV prevention landscape. However, effective implementation will require health care providers to adopt, prescribe, and administer injectable PrEP within clinical settings. This study qualitatively examined challenges and benefit of injectable PrEP implementation from the perspective of health care providers. From April to August 2022, we conducted 19 in-depth interviews with current PrEP-prescribing health care providers in New York State, including 3 physician assistants, 5 physicians, and 11 nurse practitioners. Interviews were audio-recorded, transcribed verbatim, and thematically analyzed to report semantic-level themes regarding injectable PrEP implementation. More than half of participants (61%) were aware of injectable PrEP; only 21% had experience prescribing it. Qualitative findings highlighted five themes. Three themes represented implementation challenges, including speculative concerns about side effects, appointment compliance, and practical and logistical considerations. The remaining two themes described benefits of injectable PrEP relative to oral PrEP, which included greater convenience and enhanced privacy. Findings from this qualitative study make significant applied contributions to the sparse knowledge on health care provider perspectives of injectable PrEP post-US Food and Drug Administration approval and their concerns and considerations regarding implementation in real-world clinical settings.

Barriers to Accessing and Engaging in HIV Preventive Care and Pre-Exposure Prophylaxis Experienced by Transgender Women in Florida.

BACKGROUND: PrEP, a biomedical HIV prevention option, continues to be underutilized among transgender women who could benefit from sustained use, especially women of color and those who identify as Latina and/or reside in the southeastern US. OBJECTIVE: We explored the barriers and facilitators experienced by transgender women who live in Florida regarding accessing, using, and/or staying on PrEP. METHODS: In-depth interviews and focus groups were conducted in either Spanish or English with adult transgender women living in Florida (N = 22). The interviews were audio-recorded, transcribed, and coded in ATLAS.ti using thematic analyses. RESULTS: The mean age of the participants was 42.2 years. Among the participants, 73% were Hispanic/Latina, 59% were foreign-born, and approximately one-third were living with HIV (but had past experience with PrEP). Transgender women cited the following barriers to accessing or considering PrEP: (1) costs and benefits of PrEP use; (2) under-representation in clinical trials resulting in unknown or misinformation regarding PrEP side effects; (3) chronic poverty; and (4) trauma and discrimination. Other stressors, such as behavioral healthcare needs, were identified. CONCLUSIONS: Our analysis revealed interlocking systems of oppression like transphobia, discrimination, and misgendering, which were common barriers experienced by our participants. These synergistically epidemic (i.e., syndemic) barriers contributed to their feelings of being systematically excluded in social spaces, research, public health planning and policies, laws, and social programs related to PrEP. These structural barriers are impediments to HIV preventive care but also act as a source of stress that contributes to mental health problems, financial vulnerability, substance abuse, and other deleterious health outcomes.

A Behavioral Economic Examination of Sexual Behaviors in the Era of Pre-exposure Prophylaxis via Explanatory Sequential Mixed Methods.

Pre-exposure prophylaxis (PrEP) use may be associated with condom use decisions. The current investigation examined sexual decision-making in the context of PrEP among young adult men who have sex with men (MSM) between 18 and 30 years old, using an explanatory sequential mixed methods design. For the quantitative aim, 99 MSM currently taking PrEP (i.e., PrEP-experienced) and 140 MSM not currently taking PrEP (i.e., PrEP-naive) completed an online survey, including the Sexual Delay Discounting Task (SDDT), which captures likelihood of condom use. For the qualitative aim, 15 people from each group were interviewed about their (1) conceptualizations of risky sex and (2) ways they manage their sexual risk. Participants were, on average, 25.69 years old (SD = 3.07) and 64% White. Results from the quantitative aim revealed, controlling for covariates, PrEP-experienced participants exhibited significantly lower likelihood of (1) using an immediately available condom and (2) waiting for a delayed condom (i.e., sexual delay discounting) compared to PrEP-naive participants. Qualitative themes explaining what young adult MSM consider to be risky sex included: (1) any sex as risky sex, (2) risky sex as "sex without a conversation," and (3) risky sex as sex with risk for physical harm. Themes on ways young adult MSM manage sexual risk were classified as proactive, reactive, and passive. Results suggest that PrEP use is related to condom use decisions. Taken together, quantitative differences in sexual delay discounting, but qualitatively similar conceptualizations and management of risky sex, suggest that the SDDT may be a useful tool in sex research to capture processes (i.e., delay discounting) underlying sexual decision-making that may be missed by traditional self-reports. Implications of results, including potentially providing (good quality) condoms with every PrEP prescription, and future research topics are discussed.

"There hasn't been a push to identify patients in the emergency department"-Staff perspectives on automated identification of candidates for pre-exposure prophylaxis (PrEP): A qualitative study.

Automated algorithms for identifying potential pre-exposure prophylaxis (PrEP) candidates are effective among men, yet often fail to detect cisgender women (hereafter referred to as "women") who would most benefit from PrEP. The emergency department (ED) is an opportune setting for implementing automated identification of PrEP candidates, but there are logistical and practical challenges at the individual, provider, and system level. In this study, we aimed to understand existing processes for identifying PrEP candidates and to explore determinants for incorporating automated identification of PrEP candidates within the ED, with specific considerations for ciswomen, through a focus group and individual interviews with ED staff. From May to July 2021, we conducted semi-structured qualitative interviews with 4 physicians and a focus group with 4 patient advocates working in a high-volume ED in Chicago. Transcripts were coded using Dedoose software and analyzed for common themes. In our exploratory study, we found three major themes: 1) Limited PrEP knowledge among ED staff, particularly regarding its use in women; 2) The ED does not have a standardized process for assessing HIV risk; and 3) Perspectives on and barriers/facilitators to utilizing an automated algorithm for identifying ideal PrEP candidates. Overall, ED staff had minimal understanding of the need for PrEP among women. However, participants recognized the utility of an electronic medical record (EMR)-based automated algorithm to identify PrEP candidates in the ED. Facilitators to an automated algorithm included organizational support/staff buy-in, patient trust, and dedicated support staff for follow-up/referral to PrEP care. Barriers reported by participants included time constraints, hesitancy among providers to prescribe PrEP due to follow-up concerns, and potential biases or oversight resulting from missing or inaccurate information within the EMR. Further research is needed to determine the feasibility and acceptability of an EMR-based predictive HIV risk algorithm within the ED setting.

Assessing the acceptability of, adherence to and preference for a dual prevention pill (DPP) for HIV and pregnancy prevention compared to oral pre-exposure prophylaxis (PrEP) and oral contraception taken separately: protocols for two randomised, controlled, cross-over studies in South Africa and Zimbabwe.

INTRODUCTION: Oral pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention method; however, uptake and persistence have been low among southern African women. A dual prevention pill (DPP) that combines PrEP with oral contraception (OC) may increase PrEP use and better meet women's sexual and reproductive health needs. We will gauge the DPP's acceptability in two cross-over clinical trials. METHODS AND ANALYSIS: PC952 (Zimbabwe) and PC953 (South Africa) will compare acceptability, adherence and preference for an over-encapsulated DPP versus PrEP and OCs taken separately. HIV-negative, non-pregnant cisgender females in Johannesburg, South Africa (n=96, 16-40 years) and Harare, Zimbabwe (n=30, 16-24 years) will be randomised 1:1 to the order of regimens-DPP or two separate tablets-each used for three 28-day cycles, followed by a 6-month choice period in South Africa. Monthly clinic visits include HIV and pregnancy testing; safety assessments and risk reduction and adherence counselling. We will assess adherence (monthly) based on tenofovir diphosphate drug levels in dried blood spots and by self-report. We will evaluate acceptability (monthly) and preference (end of cross-over) via computer-assisted self-interviewing and in-depth interviews with a subset of participants. Data collection started in September 2022 and ended in January 2024. ETHICS AND DISSEMINATION: PC952 was approved by the Ministry of Health and Child Care, Medical Research Council, Research Council and Medicines Control Authority of Zimbabwe; the Chitungwiza City Health Ethics Committee; and the Joint Research Ethics Committee for the University of Zimbabwe Faculty of Medicine and Health Sciences and Parirenyatwa Group of Hospitals. PC953 was approved by the South African Health Products Regulatory Authority and the University of the Witwatersrand's Human Research Ethics Committee. The Population Council IRB approved both studies. We will disseminate results in open-access journals, clinical trials registries, and at local and international meetings and conferences. TRIAL REGISTRATION NUMBERS: NCT04778514, NCT04778527.