Pre-exposure Prophylaxis Clinic Research Articles

Implementation Science of Integrating Pre-Exposure Prophylaxis in Pharmacist-Led Services in the United States.

Racial inequities in HIV in the United States (US) are pervasive. Pre-exposure prophylaxis (PrEP) is one of the most effectiveyet underutilized HIV prevention strategies, and stark inequities in PrEP uptake exist. Lack of access to PrEP clinics is a majorbarrier to access that could be overcome by integrating pharmacists into the provision of PrEP services including prescribingand dispensing. A number of reviews have shown promise in folding pharmacies into the expansion of PrEP services, but this review extends those by examining the implementation science evidence of pharmacist-led PrEP services in the US. We reviewed literature over the past five years of the implementation science of pharmacist PrEP services (2018-2023) and present seminal findings in this area. Only two studies are anchored within an implementation science framework despite all studies assessing common implementation science constructs. Overwhelming evidence supports feasibility and adoption of PrEP services in pharmacies yet gaps in workflow integration, scalability and sustainability exist. Continuing to build the implementation science evidence of pharmacy-based PrEP services is critical to standardize our measures across varying contexts and inform policy efforts that support pharmacy-based PrEP services.

Experiences and challenges of pre-exposure prophylaxis initiation and retention among high-risk populations: qualitative insights among service providers in Thailand.

Pre-exposure prophylaxis (PrEP) has been an essential element of the national combination prevention package and included in the Universal Health Coverage (UHC) of Thailand since 2019. As a part of the national monitoring and evaluation framework, this qualitative study aims to describe experiences and barriers concerning PrEP initiation and retention among service providers from both hospital and Key Population Led Health Service (KPLHS) settings under the country's UHC roll-out. Between September and October 2020, ten focus group discussions with PrEP service providers from both hospitals and KPLHS across Thailand were conducted of which there were six hospitals, one health service center, three KPLHS. All interviews were recorded and transcribed verbatim to identify providers' experiences, attitudes, and perceived barriers regarding PrEP service delivery in Thailand. Among the 35 PrEP service providers, most of them reported positive attitudes toward PrEP and believed that it is an effective tool for HIV prevention. Men who have sex with men were perceived to be the easiest group to reach while PrEP uptake remains a challenge in other key populations. Integration of a PrEP clinic with other HIV services at hospitals made most healthcare providers unable to adopt an active approach in recruiting new clients like at KPLHS settings. Challenges in delivering PrEP services included lack of public awareness, high workload, limited benefit package coverage, structural and human resources. Additional services to address different health needs should be considered to increase PrEP uptake among harder-to-reach populations. Novel approaches to PrEP service integration and close collaboration between hospitals and KPLHS would be essential in optimizing PrEP uptake and retention. Support regarding raising awareness, expanding service coverage and access, improving facilities and workforce, and providers' capacities are crucial for the success of the national PrEP programme.

Opt-Out Syphilis Screening at an Urgent Care Center in Atlanta: Evaluation of a Pilot Program.

HIV and syphilis disproportionately impact communities with low access to primary care, who often utilize urgent care centers (UCC) for sexual healthcare. UCC visits represent an opportunity for identification and treatment of syphilis and linkage to HIV testing and prevention services. We describe a universal, opt-out syphilis screening program pilot at an Atlanta UCC. A chart review was performed on patients 18 years and older who were offered opt-out syphilis screening and had a rapid plasma reagin (RPR) test collected from 9/1/21 to 12/31/21. Demographic data, syphilis stage and treatment, and HIV testing and serostatus were abstracted from the electronic health record. Patients with reactive RPRs were contacted by a study physician for syphilis staging and treatment, counseling, and referral for HIV pre-exposure prophylaxis (PrEP) or treatment. From 9/1/21 to 12/31/21, 5794 patients were triaged and 1381 underwent RPR screening (23.8%). Eighty (5.8%) had reactive RPRs, and 42 (52.5%) had active syphilis. Of those with active syphilis, 39 (92.9%) received any treatment, and 35 (83.3%) completed treatment. Patients with late syphilis were less likely to complete syphilis treatment (aOR 0.03, p = 0.009, 95% CI 0.002-0.42). Among 955 offered PrEP, 41 (4.3%) expressed interest in PrEP, and 7 (0.7%) completed PrEP clinic intake. Univariate analysis did not identify any factors associated with interest in PrEP. In a UCC setting, routine, opt-out syphilis testing resulted in increased syphilis identification and treatment. It also provided an opportunity for PrEP counseling and referral, although few patients completed PrEP clinic intake.

Examining the potential of pharmacies to expand pre-exposure prophylaxis access along Georgia’s fixed-route public transit: A geospatial analysis

BackgroundDespite accounting for more than half of new Human Immunodeficiency Virus diagnoses in the United States, the South has fewer than 30% of all pre-exposure prophylaxis users. Pre-exposure prophylaxis access geospatial analyses have focused on drive time but analyses along public transit routes have not been evaluated. Given the proximity to pharmacists and pharmacies, involvement in pre-exposure prophylaxis services may increase access and uptake of this preventative health need. ObjectiveThe objectives were to compare the rate of pre-exposure prophylaxis uptake between Georgia counties with and without public transit, to assess the geospatial accessibility of services along public transit, and to evaluate the potential impact of expanding pre-exposure prophylaxis services to community pharmacies. MethodsPre-exposure prophylaxis uptake rates between counties with and without public transit were compared using the Mann–Whitney U test. Geospatial analysis was performed using ArcGIS Pro and Geoda. The Pearson correlation coefficient was used to determine the relationship between pre-exposure prophylaxis uptake rates and population and county characteristics. Spatial analysis was completed to uncover predictors for pre-exposure prophylaxis uptake rates. Increased access to pre-exposure prophylaxis along public transit was calculated by reporting the number of counties that would experience at least a 50% increase in pre-exposure prophylaxis access through community pharmacies. ResultsPre-exposure prophylaxis uptake is significantly higher in Georgia counties with versus without public transit (P < 0.001). Pre-exposure prophylaxis rate is positively correlated with the accessibility of community pharmacies and pre-exposure prophylaxis clinics along fixed-route public transit (R2 = 0.524). Among pre-exposure prophylaxis clinics, 44% are inaccessible by public transit alone. Community pharmacies are significantly more widely distributed and accessible along public transit routes than pre-exposure prophylaxis clinics. ConclusionTransportation remains a barrier to accessing pre-exposure prophylaxis. Georgia community pharmacies along public transit may serve as a solution to pre-exposure prophylaxis care access barriers.

Effect of screening for Neisseria gonorrhoeae and Chlamydia trachomatis on incidence of these infections in men who have sex with men and transgender women taking HIV pre-exposure prophylaxis (the Gonoscreen study): results from a randomised, multicentre, controlled trial

Guidelines recommend screening for Neisseria gonorrhoeae and Chlamydia trachomatis at three anatomical sites (urethra, anus, and pharynx) every 3 months (3 × 3) in men who have sex with men (MSM) and transgender women taking HIV pre-exposure prophylaxis (PrEP). We present the first randomised controlled trial to compare the effect of screening versus non-screening for N gonorrhoeae and C trachomatis on the incidence of these infections in MSM and transgender women taking PrEP. A multicentre, randomised, controlled trial of 3 × 3 screening for N gonorrhoeae and C trachomatis versus non-screening was done among MSM and transgender women taking PrEP in five HIV reference centers in Belgium. Participants attended the PrEP clinics quarterly for 12 months. N gonorrhoeae and C trachomatis was tested at each visit in both arms, but results were not provided to the non-screening arm, if asymptomatic. The primary outcome was incidence rate of N gonorrhoeae and C trachomatis infections in each arm, assessed in the per-protocol population. Non-inferiority of the non-screening arm was proven if the upper limit of the 95% CI of the incidence rate ratio (IRR) was lower than 1·25. This trial is registered with ClinicalTrials.gov, NCT04269434, and is completed. Between Sept 21, 2020, and June 4, 2021, 506 participants were randomly assigned to the 3 × 3 screening arm and 508 to the non-screening arm. The overall incidence rate of N gonorrhoeae and C trachomatis was 0·155 cases per 100 person-days (95% CI 0·128-0·186) in the 3 × 3 screening arm and 0·205 (95% CI 0·171-0·246) in the non-screening arm. The incidence rate was significantly higher in the non-screening arm (IRR 1·318, 95% CI 1·068-1·627). Participants in the non-screening arm had a higher incidence of C trachomatis infections and symptomatic C trachomatis infections. There were no significant differences in N gonorrhoeae infections. Participants in the non-screening arm consumed significantly fewer antimicrobial drugs. No serious adverse events were reported. We failed to show that non-screening for N gonorrhoeae and C trachomatis is non-inferior to 3 × 3 screening in MSM and transgender women taking PrEP in Belgium. However, screening was associated with higher antibiotic consumption and had no effect on the incidence of N gonorrhoeae. Further research is needed to assess the benefits and harms of N gonorrhoeae and C trachomatis screening in this population. Belgian Health Care Knowledge Centre.

(280) Innovative Team Approach to Sexual Health Counseling; Partnership of Urology, Infectious Disease and Pelvic Floor Therapy to Increase Access to Care

Abstract Introduction Despite the prevalence and availability of HIV (Pre-exposure Prophylaxis i.e., PrEP), the number of new AIDS diagnoses continues to outpace treatment and prevention. Stigma, discrimination, lack of access continue to remain significant barriers in the prevention of new HIV infections, especially amongst vulnerable groups (i.e. LGBTQ, women, and minorities). We present a novel strategy to address a comprehensive approach to sexual health medicine through the partnership of Urology, Infectious Disease, and Pelvic Floor therapy. Objective Men who have sex with men (M2M) who either currently use or have an interests in use of pre-exposure prophylaxis (PrEP) continue to face barriers with respect to access to care, stigma, and or availability of effective partnerships to address and offer culturally competent care. The objective of this study is to assess attitudes and barriers to conventional and novel PrEP offerings as well as to present an innovative team approach between Urology, Infectious Disease (ID) Medicine and Pelvic Floor Therapy to offer a comprehensive multidisciplinary approach to treatment and care. Methods We enrolled 6 candidates (M2M) into our PrEP clinic which offers the Apretude (Cabotegivir 600 mg/3mL) injections. We conducted interviews, focused groups, and provided questionnaires to detail their experiences, beliefs, attitudes, barriers, and considerations for therapy. Results First, the preliminary results and findings of our study has shown that the needs, considerations, and beliefs of M2M is more varied, nuanced, and divergent with need to characterize, understand, and offer more specific culturally competent care in Sexual Health Medicine with respect to PrEP. Second, M2M designation does not exclude men from having sex with the opposite gender. These man preferred injectable PrEP option. Third, the partnership of Urology, Infectious Disease and Pelvic Floor Therapy reduced barriers, increased access to care, and decreased stigma as M2M felt more comfortable in the Urological setting. Conclusions M2M patients stated hesitancy, increased stigma and “shame” in going to ID for sexual health. Additionally, for M2M who have sexual partners of the opposite sex this would further increase stigma. Urology practices are accustomed to having discussions surrounding men’s sexual health with reduced stigma. The combination of Infectious Disease has presented an innovative partnership to discuss, prevent, and treat sexuallly transmited infections amongst M2M. Disclosure No.

Prospective screening for monkeypox infection among users of HIV pre-exposure prophylaxis in Denmark.

During the 2022 outbreak of mpox (previously called monkeypox), which primarily affected Gay, Bisexual, and other Men who have Sex with Men (GBMSM), testing was mainly limited to individuals with symptoms of infection. Although sporadic cases of mpox continue to be diagnosed in Denmark, the feasibility of screening asymptomatic high-risk populations, such as those using HIV pre-exposure prophylaxis (PrEP), is still unknown. During the autumn of 2022, a rectal swab test for mpox PCR was included in the routine sexually transmitted infections (STI) screening for PrEP users. The screening included 224 asymptomatic men with a median age of 36.5years. One patient (0.4%) tested positive for mpox. Ten (4.5%) and nine (4.0%) had chlamydia and gonorrhea, respectively. Our study demonstrates that screening for mpox is feasible in two Danish PrEP clinics.

2682. Opt-Out Syphilis Screening in an Urgent Care Center Increases Recognition and Treatment of Asymptomatic Syphilis Infection and Uptake of HIV Pre-Exposure Prophylaxis

Abstract Background Atlanta, Georgia has an extremely high burden of both HIV and early syphilis. This syndemic is driven by a complex set of structural factors that result in striking healthcare inequities, further burdening communities with low access to primary care. These populations may instead utilize emergency departments and urgent care centers (UC) for medical care. UC visits represent a crucial opportunity for recognition and treatment of syphilis as well as connection to HIV prevention services. We describe a novel pilot of a universal, opt-out syphilis screening program offered to all adults in the Grady Urgent Care Center in Atlanta. Methods A retrospective chart review was performed on all patients 18 years and older who had a rapid plasma reagin (RPR) test collected from 9/1/21 to 12/31/21. Demographic data, syphilis diagnosis, syphilis treatment, and HIV testing and serostatus were abstracted from the electronic health record. Patients with reactive RPRs were contacted by a physician for diagnosis and potential syphilis treatment, sexual health counseling, and referral for HIV pre-exposure prophylaxis (PrEP) or HIV care. Results From 9/1/21 to 12/31/21, 5794 patients were triaged and 1381 underwent RPR screening (23.8%). Eighty (5.8%) had reactive RPRs, and 42 (52.5%) had active syphilis infection. Of those with active syphilis, 39 (92.9%) received treatment, and 35 (83.3%) completed treatment. Among all undergoing RPR screening, 37 (2.7%) were living with HIV. Of those who were not previously diagnosed with HIV, 1279 (93.9%) underwent concurrent HIV testing. Among all undergoing RPR screening, 41 expressed interest in PrEP, and 7 completed PrEP clinic intake. Of those with reactive RPRs, 16 expressed interest in PrEP, and 6 completed PrEP clinic intake. Syphilis Testing and Treatment Among Patients 18 Years of Age and Older Who Had an RPR Collected in the Grady Urgent Care Center, 9/1/2021-12/31/2021 HIV Testing and PrEP Among Patients 18 Years of Age and Older Who Had an RPR Collected in the Grady Urgent Care Center, 9/1/2021-12/31/2021 Conclusion Routine, opt-out syphilis testing was used to identify a substantial number of patients with active syphilis and connect a majority to treatment, underscoring the need for universal syphilis screening in this setting. It also provided an opportunity to deliver sexual health counseling and offer PrEP, although few patients completed PrEP clinic intake, suggesting that a more targeted approach to PrEP referral may be more effective. Disclosures All Authors: No reported disclosures

Same-Day Initiation of Oral Pre-Exposure Prophylaxis is High Among Adolescent Men Who Have Sex With Men and Transgender Women in Brazil

PurposeThis study analyzed the sociodemographic and behavioral characteristics of adolescent men who have sex with men (aMSM) and transgender women (aTGW) initiating oral pre-exposure prophylaxis (PrEP) in human immunodeficiency virus (HIV) prevention clinics. MethodsPrEP1519 is a prospective, multicenter, open-label PrEP demonstration cohort study of aMSM and aTGW aged 15–19 years living in three large Brazilian capital cities. For this analysis, we included adolescents who enrolled in PrEP1519 from February 2019 to August 2021. Adolescents who visited PrEP clinics were classified into four groups based on PrEP eligibility and on their decision to use PrEP: (1) ineligible for same-day PrEP initiation; (2) eligible for same-day PrEP initiation, initiated PrEP at first visit; (3) eligible for PrEP initiation, initiated PrEP after the first visit; and (4) eligible for same-day PrEP initiation but declined. The groups that were eligible for same-day PrEP initiation were compared using the Chi-square and Fisher’s exact tests. ResultsOf the 1,254 adolescents enrolled in the PrEP1519 study, 61 (4.9%) were considered ineligible for same-day PrEP initiation. Of the 1,193 eligible for same-day PrEP initiation, 1,113 (93.3%) initiated PrEP [1,054 initiated PrEP in the first visit (88.3%) and 59 in subsequent visits (4.9%)] and 80 (6.7%) did not. Despite 90% of the PrEP decliners reporting a low risk of HIV infection, most reported condomless anal sex in the past six months (70%). DiscussionSame-day PrEP initiation among aMSM and aTGW was high, highlighting that this strategy was important to promote PrEP initiation among adolescents with increased vulnerability to HIV in Brazil.

Treponema pallidum PCR screening at mucosal sites of asymptomatic men who have sex with men taking HIV pre-exposure prophylaxis.

Early detection and treatment of syphilis will reduce the infectious period and transmission. We aimed to determine whether screening men who have sex with men (MSM) taking HIV pre-exposure prophylaxis (PrEP) for syphilis using Treponema pallidum polymerase chain reaction (PCR) could detect syphilis before the appearance of syphilis antibodies in serology. MSM attending 3-monthly PrEP clinic visits in Melbourne, Australia, were screened with a PCR assay targeting the polA gene of T. pallidum from an anal swab and an oral rinse between November 2019 and March 2020. Participants were serologically screened for syphilis using chemiluminescence immunoassay. A total of 309 asymptomatic participants provided an anal swab and oral rinse sample for T. pallidum PCR screening. Two syphilis cases (0.6%) were detected: one man had a positive serology only; another man had T. pallidum detected by PCR from an anal swab and a positive serology. PCR positivity was 0.3% (n = 1) for anal swabs and 0% (n = 0) for oral rinse. In this study, T. pallidum PCR screening at routine PrEP clinic visits did not identify additional cases of early syphilis over serological screening performed at these visits. IMPORTANCE With the ongoing syphilis epidemic in men who have sex with men (MSM), we investigated the role of using Treponema pallidum polymerase chain reaction (PCR) testing at the oral cavity and anus in MSM taking pre-exposure prophylaxis for the early detection of syphilis. We evaluated whether the PCR tests from these mucosal sites can detect syphilis infection early, before the development of syphilis antibodies in serology. Our study found two syphilis cases among 309 MSM, and only one syphilis case had a positive anal PCR swab, although serology was positive. We conclude that additional PCR testing is likely to be expensive and would not be cost effective for individuals who regularly screen for syphilis. However, future studies with a larger sample size are required.

Pharmacist-Led Management of HIV PrEP Within the Veterans Health Administration.

Uptake and access to HIV preexposure prophylaxis (PrEP) is key to reducing incident HIV infections. Pharmacists are one of the most accessible health care professionals in the United States and are well suited to address this need. We describe a model of care at the Veterans Affairs Greater Los Angeles Healthcare System in which clinical pharmacist practitioners developed and implemented a pharmacy-led PrEP clinic colocated within an infectious disease clinic. Veterans Health Administration clinical pharmacists provide direct patient care under a scope of practice that includes ordering and interpreting laboratory tests and providing PrEP prescriptions. To improve access and patient acceptability, we also used novel telemedicine modes of care to ensure flexible appointment scheduling. This model can be used by other federal and community-based health care organizations to implement interdisciplinary pharmacist-managed PrEP clinics and expand telehealth modalities to deliver outpatient services.

Increased PrEP uptake and PrEP-RN coincide with decreased HIV diagnoses in men who have sex with men in Ottawa, Canada.

We sought to evaluate if increased uptake of HIV pre-exposure prophylaxis (PrEP) correlated to population-level changes in human immunodeficiency virus (HIV) epidemiology, in a setting with an integrated PrEP delivery system centred on a public health nurse-led PrEP clinic and referral process. This study was conducted in Ottawa, Canada, where all positive HIV test results are reported to the public health units. Risk factor information is also collected by nurses and subsequently entered into a provincial database. We extracted these data for Ottawa from 2017 to 2021 and restricted our analyses to first-time diagnoses. We identified 154 persons with a new HIV diagnosis. Over this period, the number of new diagnoses among men who have sex with men, the group most targeted for PrEP, decreased by 50%-60%. We did not identify changes in the number of new diagnoses based on race, intravenous drug use or among women. Increasing PrEP uptake in Ottawa in 2017 to 2021 coincided with a significant decrease in new HIV diagnoses among men who have sex with men. PrEP uptake in Ottawa, particularly by those most at risk, is likely supported by an integrated approach via PrEP-RN, a nurse-led public health program where individuals diagnosed with syphilis or rectal gonorrhea or chlamydia receive an automatic offer of PrEP. While these findings cannot causally link PrEP-RN or PrEP with this reduction in new HIV diagnoses, these changes in HIV epidemiology in Ottawa occurred exclusively among the group targeted for PrEP. These data highlight the efficacy and importance of PrEP.

Important steps for PrEP uptake among adolescent men who have sex with men and transgender women in Brazil.

HIV Pre-exposure prophylaxis (PrEP) is an effective prevention tool, but there are still few studies about PrEP uptake among adolescents. We aimed to analyze the PrEP uptake process and factors associated with daily oral PrEP initiation among adolescent men who have sex with men (aMSM) and transgender women (aTGW) in Brazil. Baseline data from the first demonstration PrEP cohort study among aMSM and aTGW 15-19 years old (yo) ongoing in three large Brazilian cities (PrEP1519). After completing informed consent procedures, participants were enrolled in the cohort from February/2019 to February/2021. A socio-behavioral questionnaire was applied. Factors associated with PrEP initiation were assessed using a logistic regression model with adjusted prevalence ratios (aPR) and 95% confidence intervals (95%CI). Among recruited participants, 174 (19,2%) were aged 15-17 yo and 734 (80,8%) 18-19 yo. The rate of PrEP initiation was 78.2% and 77.4% for 15-17 yo and 18-19 yo, respectively. Factors associated with PrEP initiation were: black or mixed race (aPR 2.31; 95%CI: 1.10-4.84) among the younger adolescents 15-17 yo; experienced violence and/or discrimination due to their sexual orientation or gender identity (aPR 1.21; 95%CI: 1.01-1.46); transactional sex (aPR 1.32; 95%CI: 1.04-1.68); and having had between 2 to 5 sexual partners in the previous three months (aPR 1.39; 95%CI: 1.15-1.68) among those 18-19 yo. Unprotected receptive anal intercourse in the previous six months was associated with PrEP initiation in both age groups (aPR 1.98; 95%CI: 1.02-3.85 and aPR 1.45; 95%CI: 1.19-1.76 among 15-17 yo and 18-19 yo, respectively). The biggest challenge to promoting PrEP use for aMSM and aTGW was in the first steps of the PrEP uptake process. Once they were linked to the PrEP clinic, initiation rates were high.

Exploring preferences and decision-making about long-acting injectable HIV pre-exposure prophylaxis (PrEP) among young sexual minority men 17–24 years old

Intramuscular cabotegravir for long-acting injectable HIV pre-exposure prophylaxis (i.e., LAI-PrEP) was approved by the U.S. FDA in 2021. We sought to explore LAI-PrEP decision-making among a nationwide sample of young sexual minority men (YSMM) 17–24 years old. In 2020, HIV-negative/unknown YSMM (n = 41) who met CDC criteria for PrEP were recruited online to participate in synchronous online focus groups eliciting preferences and opinions about LAI-PrEP, as well as the impact of a potential self-administered option. Data were analyzed using inductive and deductive thematic analysis with constant comparison. Preferences and decision-making about LAI-PrEP varied widely among YSMM, with participants frequently comparing LAI-PrEP to oral PrEP regimens. We identified five key themes related to LAI-PrEP decision-making including concerns about adherence to PrEP dosing and clinic appointments, awareness and knowledge of PrEP safety and efficacy data, comfort with needles, minimizing PrEP stigma, and considerations of self-administration. YSMM acknowledged more PrEP options as beneficial to supporting uptake and persistence.

Development of a Mobile App to Increase the Uptake of HIV Pre-exposure Prophylaxis Among Latino Sexual Minority Men: Qualitative Needs Assessment.

HIV disproportionally impacts Latino sexual minority men (SMM). Uptake of pre-exposure prophylaxis (PrEP), an effective biomedical intervention to prevent HIV, is low in this group compared with White SMM. Mobile health technology represents an innovative strategy to increase PrEP uptake among Latino SMM. We aimed to describe the qualitative process leading to the development of SaludFindr, a comprehensive HIV prevention mobile app aiming to increase PrEP uptake, HIV testing, and condom use by Latino SMM. We conducted 13 in-depth interviews with Latino SMM living in the Atlanta area to explore their main barriers and facilitators to PrEP uptake and to analyze their opinions of potential SaludFindr app functionalities. To explore potential app functions, we used HealthMindr, an existing HIV prevention app, as a template and added new proposed features intended to address the specific community needs. We identified general PrEP uptake barriers that, although common among non-Latino groups, had added complexities such as the influence of religion and family on stigma. Low perceived PrEP eligibility, intersectional stigma, lack of insurance, cost concerns, and misconceptions about PrEP side effects were described as general barriers. We also identified Latino-specific barriers that predominantly hinder access to existing services, including a scarcity of PrEP clinics that are prepared to provide culturally concordant services, limited availability of Spanish language information related to PrEP access, distrust of peers as credible sources of information, perceived ineligibility for low-cost services owing to undocumented status, fear of immigration authorities, and competing work obligations that prevent PrEP clinic attendance. Health care providers represented a trusted source of information, and 3 provider characteristics were identified as PrEP facilitators: familiarity with prescribing PrEP; being Latino; and being part of lesbian, gay, bisexual, transgender, queer, intersex, and asexual (LGBTQIA+) group or ally. The proposed app was very well accepted, with a particularly high interest in features that facilitate PrEP access, including a tailored list of clinics that meet the community needs and a private platform to seek PrEP information. Spanish language availability and free or low-cost PrEP care represented the 2 main clinic criteria that would facilitate PrEP uptake. Latino representation in clinic staff and providers; clinic perception as a safe space for undocumented patients; and LGBTQIA+ representation was listed as additional criteria. Only 8 of 47 clinics listed on the Centers for Diseases Control and Prevention PrEP locator website for the Atlanta area fulfilled at least 2 main criteria. This study provides further evidence of the substantial PrEP uptake barriers that Latino SMM face; exposes the urgent need to increase the number of accessible PrEP-providing clinics for Latino SMM; and proposes an innovative, community-driven, and mobile technology-based tool as a future intervention to overcome some of these barriers.

Provider perspectives on service delivery modifications to maintain access to HIV pre‐exposure prophylaxis during the COVID‐19 pandemic: qualitative results from a PrEP implementation project in Kenya

HIV pre-exposure prophylaxis (PrEP) is an essential prevention strategy being scaled up for priority populations in Kenya, including for HIV serodiscordant couples. The COVID-19 pandemic posed challenges to PrEP rollout. We conducted a qualitative study of PrEP providers to understand how clinics adjusted PrEP delivery during the COVID-19 pandemic. Since 2017, the Partners Scale-Up Project has integrated PrEP into 25 HIV clinics in Central and Western Kenya. We conducted qualitative interviews with 40 purposively sampled clinic personnel. We interviewed personnel once during the first pandemic wave (May-Aug 2020) and again after some decline in COVID-19 rates (Nov-Jan 2021). We analysed data using inductive memo-writing and summarized data by themes along the PrEP delivery cascade, guided by the Framework for Reporting Adaptation and Modifications (FRAME). We interviewed 27 clinical officers, five nurses, four health records and information officers, and four counsellors from Central (n=20) and Western (n=20) Kenya. About half (n=19) were female, with a median age of 32 (IQR: 29-34) and 2.3 years of experience delivering PrEP (IQR: 2-3). All participants reported clinic changes in PrEP demand creation and service delivery during the pandemic. Modifications occurred during PrEP implementation and sustainment phases, were partly reactive to the pandemic and also facilitated by interim Ministry of Health guidance on PrEP delivery during COVID, and were made by PrEP delivery teams, clients and clinic managers. Commonly reported modifications included dispensing multiple-month PrEP refills, intensifying phone-based client engagement and collaborating with other HIV clinics to ensure that clients with prolonged stays in other regions could continue to access PrEP. Some clinics also adopted practices to streamline visits, such as within clinical-room PrEP dispensing, pre-packing PrEP and task-shifting. Most providers liked these changes and hoped they would continue after the pandemic subsides. COVID-19 served as a catalyst for PrEP delivery innovations in Kenya. HIV clinics successfully and rapidly adapted their PrEP demand creation, refill and retention strategies to promote PrEP uptake and effective use. These modified implementation strategies highlight opportunities to streamline the delivery of PrEP, as well as other HIV and chronic care services, and strengthen engagement with populations post-pandemic.

Readiness to Provide Oral and Injectable PrEP for Sexual and Gender Minority Youth Among Healthcare Providers and Clinics in the U.S. Northeast

PurposeTo examine readiness to provide oral and injectable pre-exposure prophylaxis (PrEP) for sexual and gender minority youth (SGMY) and to explore decision-making for HIV prevention strategies (e.g., condom use, daily and event-driven oral PrEP, and injectable PrEP) among healthcare providers. MethodsBetween February and April 2022, we recruited 31 prescribing providers (M.Ds, D.Os, P.As, and N.Ps) practicing in primary care and specialized clinics in the U.S. Northeast for focus groups or individual interviews. Focus groups and interview transcripts were analyzed using thematic analysis. ResultsMost providers specialized in Pediatrics (42%) or Adolescent Medicine (23%) and 58% had previously prescribed PrEP. Main barriers to PrEP readiness were low PrEP knowledge, limited time for visits, and competing clinical priorities. Organizational factors such as routine HIV/STI testing, PrEP-specific electronic health records templates, and specialized staff (e.g., PrEP navigators) promoted PrEP readiness. Providers held positive attitudes toward injectable PrEP to promote adherence among SGMY, yet barriers to implementation of this modality were identified (e.g., patient anxiety about needles, additional staffing needs). Providers described event-driven oral PrEP as an option for SGMY with episodic HIV risk. Assurances of conditional confidentiality, including preventing disclosure of sensitive information through insurance forms, and shared decision-making facilitated conversations about HIV prevention with SGMY. DiscussionFuture PrEP implementation efforts for SGMY should consider combined efforts targeting provider knowledge about PrEP modalities (e.g., decision aids) and clinic organizational factors (e.g., routine HIV/STI testing, resources to assist providers and patients in navigating the multiple steps between prescription and adherence to PrEP).

Costs of Providing Preexposure Prophylaxis for HIV Prevention at Community Health Centers in the United States.

Preexposure prophylaxis (PrEP) is recommended for people at risk of acquiring HIV. We assessed billable costs associated with PrEP delivery at community health centers. The Sustainable Health Center Implementation PrEP Pilot (SHIPP) study is an observational cohort of people receiving daily oral PrEP at participating federally qualified health centers and other community health centers. We assessed health care utilization and billable costs of providing PrEP at 2 health centers, 1 in Chicago, Illinois, and 1 in Washington, DC, from 2014 to 2018. The health centers followed the clinical practice guidelines for PrEP provision, including regular visits with health care providers and ongoing laboratory monitoring. Using clinic billing records and Current Procedural Terminology (CPT) coding, we retrospectively extracted data on the frequency and costs (in 2017 US dollars) of PrEP clinic visits and laboratory screening, for each patient, for 12 months since first PrEP prescription. The average annual number of PrEP clinic visits and associated laboratory screens per patient was 5.1 visits and 25.2 screens in Chicago (n = 482 patients) and 5.4 visits and 24.8 screens in Washington, DC (n = 56 patients). The average annual PrEP billable cost per patient was $583 for clinic visits and $1070 for laboratory screens in Chicago and $923 for clinic visits and $1018 for laboratory screens in Washington, DC. The average annual total cost per patient was $1653 (95% CI, $1639-$1668) in Chicago and $1941 (95% CI, $1811-$2071) in Washington, DC. Our analysis, which provides PrEP billable cost estimates based on empirical data, may help inform health care providers who are considering implementing this HIV prevention strategy.

The early-stage comprehensive costs of routine PrEP implementation and scale-up in Zambia.

Pre-exposure prophylaxis (PrEP) is an effective HIV prevention option, but cost-effectiveness is sensitive to implementation and program costs. Studies indicate that, in addition to direct delivery cost, PrEP provision requires substantial demand creation and client support to encourage PrEP initiation and persistence. We estimated the cost of providing PrEP in Zambia through different PrEP delivery models. Taking a guidelines-based approach for visits, labs and drugs, we estimated the annual cost of providing PrEP per client for five delivery models: one focused on key populations (men-who-have-sex-with-men (MSM) and female sex workers (FSW), one on adolescent girls and young women (AGYW), and three integrated programs (operated within HIV counselling and testing services at primary healthcare centres). Program start-up and support costs were based on program expenditure data and number of PrEP sites and clients in 2018. PrEP clinic visit costs were based on micro-costing at two PrEP delivery sites (2018 USD). Costs are presented in 2018 prices and inflated to 2021 prices. The annual cost/PrEP client varied by service delivery model, from $394 (AGYW) to $655 (integrated model). Cost differences were driven largely by client volume, which impacted the relative costs of program support and technical assistance assigned to each PrEP client. Direct service delivery costs ranged narrowly from $205-212/PrEP-client and were a key component in the cost of PrEP, representing 35-65% of total costs. The results show that, even when integrated into full service delivery models, accessing vulnerable, marginalised populations at substantial risk of HIV infection is likely to cost more than previously estimated due to the programmatic costs involved in community sensitization and client support. Improved data on individual client resource usage and outcomes is required to get a better understanding of the true resource utilization, expected outcomes and annual costs of different PrEP service delivery programs in Zambia.

The Relationship Between HIV Pre-exposure Prophylaxis Stigma and Treatment Adherence Among Current HIV Pre-exposure Prophylaxis Users in the Southeastern U.S.

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.