PrEP Providers Research Articles

Understanding PrEP Persistence: Provider and Patient Perspectives.

PrEP persistence, or PrEP use over time, has been shown to be short, with most PrEP users stopping within 6-12months. Furthermore, those most vulnerable to HIV often use PrEP for shorter periods. This qualitative study explores patient, provider, and contextual factors that influence PrEP persistence. In interviews with 25 PrEP users and 18 PrEP providers in San Francisco's safety net clinics, we analyze the perceived benefits and difficulties of taking PrEP, including structural barriers. We identify different steps in receipt of PrEP care (clinic visits and lab tests, pharmacy interactions, and medication adherence), and describe barriers and facilitators for providers and patients at each step. Our findings suggest that drop-in visits, streamlined testing, standing orders for labs, and 90-day PrEP prescriptions are highly desirable for many PrEP users. Also important are the proactive provision of adherence support and counseling, and referrals for housing, substance use, and mental health services.

Protocol for a multicenter, real-world study of HIV pre-exposure prophylaxis among men who have sex with men in China (CROPrEP)

BackgroundPre-exposure prophylaxis (PrEP) is a promising and effective tool to prevent human immunodeficiency virus (HIV) transmission; however, context-specific data to guide optimal implementation are currently lacking in China. This study aims to systematically collect comprehensive, empirical data to determine effective ways to implement PrEP among at-risk men who have sex with men (MSM) in China.MethodsThe CROPrEP project, a real-world study of PrEP use, will recruit 1000 high-risk HIV-negative MSM participants from four cities in China, who will be able to choose between daily or event-driven dosing regimens, according to their preference. Participants will be followed up at months 1, 3, 6, 9, and 12 for PrEP provision, clinical evaluation, laboratory testing (e.g., emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) concentrations, and HIV/sexually transmitted infections), alongside detailed, self-administered online questionnaires regarding sexual behaviors, adherence, and attitudes. Online weekly notes will be used to record pill use and sexual practice. Various measurements will be triangulated to assess adherence, including: self-reported adherence, pill count, and drug concentration. A propensity score matching model will be fitted to examine the effectiveness of PrEP use in HIV seroconversion compared with non-PrEP users selected from a local expanding cohort study of HIV-1-negative MSM at participating research centers. Analyses using a generalized estimating equation model will focus on elucidation of the cascade of PrEP implementation, effectiveness, safety, and possible effects of PrEP use on sexual behaviors. This study will provide a comprehensive assessment of real-world PrEP use among Chinese MSM, to develop guidelines and strategies for PrEP implementation in China.DiscussionThe CROPrEP project is the first study of the TDF/FTC combination as PrEP in China, which will provide primary data on PrEP implementation, including: the cascade of PrEP use, “real-world” effectiveness, adherence, and safety. The findings from this study have potential to be vital for promoting the integration of PrEP within the portfolio of HIV prevention interventions and developing guidance on PrEP implementation in China.Trial registrationChiCTR-IIN-17013762 (Chinese Clinical Trial Registry). Date of registration: 8 December 2017.

An Electronic Pre-Exposure Prophylaxis Initiation and Maintenance Home Care System for Nonurban Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.

BackgroundPre-exposure prophylaxis (PrEP) is highly efficacious for preventing HIV but has not yet been brought to scale among at-risk persons. In several clinical trials in urban areas, technology-based interventions have shown a positive impact on PrEP adherence. In rural and small-town areas in the United States, which often do not have geographically proximal access to PrEP providers, additional support may be needed. This may be particularly true for younger persons who are more likely to face multiple barriers to accessing PrEP services. Home-based care, accomplished through a tailored mobile phone app, specimen self-collection (SSC), and interactive video consultations, could increase both PrEP initiation and persistence in care.ObjectiveThe goal of this study is to assess the initiation and persistence in PrEP care for those randomized to a home-care intervention (electronic PrEP, ePrEP) relative to those assigned to the standard of care (control) condition. We will conduct additional assessments, including quantitative and qualitative analyses, to contextualize trial results and facilitate scale-up.MethodsThis 2-arm, randomized controlled trial will enroll young men who have sex with men (YMSM) aged between 18 and 24 years from rural areas of Georgia, Mississippi, and North Carolina. The trial will seek to recruit a diverse sample, targeting 50% participation among highly impacted groups of black or Latino men who have sex with men. Intervention participants will receive a study app that incorporates a messaging platform, a scheduling and milestone-based tracking system for PrEP care progress, electronic behavioral surveys, and interactive video consultations with a clinician. Complemented by SSC kits mailed to laboratories for standard PrEP-related monitoring, the ePrEP system will allow participants to access PrEP care without leaving their homes. YMSM randomized to the control condition will receive a listing of nearest local PrEP providers to receive standard PrEP care. Both groups will complete quarterly electronic surveys. The primary outcome, assessed at 6 and 12 months after randomization, will be the difference in the proportion of intervention versus control participants that achieve protective levels of the active metabolite of oral PrEP (tenofovir diphosphate in dried blood spots).ResultsEnrollment will begin in May 2019, with study completion in 2022.ConclusionsThis trial will determine whether home PrEP care provided through an app-based platform is an efficacious means of expanding access to PrEP care for a diverse group of YMSM in rural and small-town areas of the United States.Trial RegistrationClinicalTrials.gov NCT03729570; https://clinicaltrials.gov/ct2/show/NCT03729570 (Archived by WebCite at http://www.webcitation.org/78RE2Qizf)International Registered Report Identifier (IRRID)PRR1-10.2196/13982

Trends in the awareness, acceptability, and usage of HIV pre-exposure prophylaxis among at-risk men who have sex with men in Toronto

ObjectivesPre-exposure prophylaxis (PrEP) with daily oral tenofovir/emtricitabine dramatically reduces HIV risk in men who have sex with men (MSM). However, uptake is slow worldwide.MethodsWe administered anonymous cross-sectional questionnaires to MSM presenting for anonymous HIV testing at a Toronto sexual health clinic at four successive time points during the period 2013–2016. We assessed trends in PrEP awareness, acceptability, and use over time using the Cochran-Armitage Trend Test, and identified barriers to using PrEP by constructing “PrEP cascades” using 2016 data. We assumed that to use PrEP, MSM must (a) be at risk for HIV, (b) be at objectively high risk (HIRI-MSM score ≥ 10), (c) perceive themselves to be at medium-to-high risk, (d) be aware of PrEP, (e) be willing to use PrEP, (f) have a family doctor, (g) be comfortable discussing sexual health with that doctor, and (h) have drug coverage/be willing to pay out of pocket.ResultsMSM participants were mostly white (54–59.5%), with median age 31 years (IQR = 26–38). PrEP awareness and use increased significantly over time (both p < 0.0001), reaching 91.3% and 5.0%, respectively, in the most recent wave. Willingness to use PrEP rose to 56.5%, but this increase did not reach statistical significance (p = 0.06). The full cascade, ABCDEFGH, suggested few could readily use PrEP under current conditions (11/400 = 2.8%). The largest barriers, in descending order, were low self-perceived HIV risk, unwillingness to use PrEP, and access to PrEP providers.ConclusionTo maximize its potential public health benefits, PrEP scale-up strategies must address self-perceived HIV risk and increase access to PrEP providers.

A Simple Pre-Exposure Prophylaxis (PrEP) Optimization Intervention for Health Care Providers Prescribing PrEP: Pilot Study.

BackgroundPre-exposure prophylaxis (PrEP) has been shown to be highly effective for the prevention of HIV in clinical trials and demonstration projects, but PrEP uptake and adherence outside of these settings in the United States has been limited. Lack of knowledge and willingness of health care providers (HCPs) to prescribe PrEP is an important barrier to implementation.ObjectiveThe objective of this study was to describe and examine the feasibility and acceptability of a PrEP Optimization Intervention (PrEP-OI) targeted at HCPs. The ultimate purpose of this intervention was to increase PrEP uptake, adherence, and persistence among those at risk for HIV acquisition.MethodsThis intervention included the following: (1) a Web-based panel management tool called PrEP-Rx, which provides comprehensive HIV risk assessment, automates reminders for follow-up, and reports patients’ history of PrEP use; and (2) centralized PrEP coordination by a clinical support staff member (ie, the PrEP coordinator) who can identify individuals at risk for HIV, provide medical insurance navigation, and support multiple HCPs. Feasibility was evaluated based on HCPs’ ability to log in to PrEP-Rx and use it as needed. Acceptability was assessed via individual formative qualitative interviews with HCPs after 1 month of the intervention.ResultsThe intervention was feasible and acceptable among HCPs (N=6). HCPs identified system-level barriers to PrEP provision, many of which can be addressed by this intervention. HCPs noted that the intervention improved their PrEP knowledge; increased ease of PrEP prescription; and was likely to improve patient engagement and retention in care, enhance communication with patients, and improve patient monitoring and follow-up.ConclusionsGiven the critical role HCPs serve in disseminating PrEP, we created an easy-to-use PrEP optimization intervention deemed feasible and acceptable to providers. Further research on this tool and its ability to impact the PrEP continuum of care is needed.

P071 PRE PREP PREP

IntroductionSexual health of MSM has worsened over the last decade and with NHS PREP provision on the horizon we needed to assess the current sexual health of MSM attending our small integrated sexual health clinic to ascertain who may be eligible for PREP.MethodsRetrospective case notes review of all MSM attending as a new or rebook attendance in 2015.Results140 attendances of MSM in 2015 were analysed. 136/140 (97%) had a HIV test. 36/140 (26%) were diagnosed with an STI of which 10 were rectal STIs. 62/140 (44%) had a previous STI. Documented recent unprotected anal sex occurred in 80/140 (57%), 3 patients were in a sero-discordant relationship- all had partners with an undetectable viral load. Recreational drugs were used by 9/140 (6%) of which 4 patients were engaged in chem-sex.80/140 (57%) patients would fulfil the baseline criteria for PREP.DiscussionMSM in our clinic have a high rate of STIs and more than half have had recent unprotected anal sex. There is a low rate of recreational drug use. Over half would be eligible for PREP if they continued in engage in unprotected sex. Repeated attendances through 2015 will be analysed to assess behaviour change.

ETHICAL AND SCIENTIFIC CONSIDERATIONS FOR THE DESIGN AND IMPLEMENTATION OF THE PREP DEMONSTRATION PROJECT IN NIGERIA

BackgroundThis abstract highlights the ethical and scientific considerations that informed the development and review of the Nigeria PrEP demonstration study protocol.MethodsA desk review was conducted on all the meeting reports...

P212 Which patients may be eligible for pre-exposure prophylaxis (PrEP) for HIV?: Abstract P212 Table 1

Background/introduction HIV diagnoses remain high among men who have sex with men (MSM). Recent studies show promising results with reducing MSM HIV transmission. The PROUD and IPERGAY studies, using daily or ‘on demand’ Truvada as PrEP respectively, showed an 86% HIV transmission reduction. Clinical guidance and funding arrangements for PrEP are in development. We assessed PrEP eligibility amongst MSM attending our sexual health service. Aim(s)/objectives To ascertain the proportion of MSM attending our service eligible for PrEP on clinical grounds and estimate the service and cost implications of introducing PrEP. Methods 97 MSM attending from December 2014 to July 2015 were reviewed, including patients who had attended for post-exposure prophylaxis and STI screening. Patients were assessed against the PROUD study inclusion criteria to identify those who would benefit from PrEP. Results No patients met any of the PROUD exclusion criteria. In a further 21% of notes, the exact number of episodes of UPAI, if any, was unclear although all other criteria were met. This suggests a range of 14–35% eligible for PrEP. We assumed all patients would continue having UPAI, were willing to comply with additional visits and were able to provide consent. The annual cost of Truvada is £356 per year. Further service cost analyses will be described. Discussion/conclusion At least 14–35% of MSM attending our service may benefit from PrEP provision. Additional costs include STI screening, monitoring and care pathways will need to be introduced. However, the overall impact of PrEP may be to reduce new HIV diagnoses and the resultant care costs.