Pre-exposure Prophylaxis Prescription Research Articles

Healthcare practitioner experiences and willingness to prescribe pre-exposure prophylaxis in the US.

Less than 10 percent of the more than one million people vulnerable to HIV are using pre-exposure prophylaxis (PrEP). Practitioners are critical to ensuring the delivery of PrEP across care settings. In this study, we target a group of prescribers focused on providing HIV care and seeking up-to-date information about HIV. We assessed their experiences prescribing PrEP, whether these experiences differed by clinical specialty, and examined associations between willingness to prescribe PrEP as a "best first step" and different hypothetical prescribing scenarios. Between March and May 2015, we circulated a paper survey to 954 participants ((652 of whom met our inclusion criteria of being independent prescribers and 519 of those (80%) responded to the survey)) at continuing medical education advanced-level HIV courses in five locations across the US on practitioner practices and preferences of PrEP. We employed multivariable logistic regression analysis for binary and collapsed ordinal outcomes. Among this highly motivated group of practitioners, only 54% reported ever prescribing PrEP. Internal medicine practitioners were 1.6 times more likely than infectious disease practitioners to have prescribed PrEP (95% CI: 0.99-2.60, p = .0524) and age, years of training, and sex were significantly associated with prescribing experience. Based on clinical vignettes describing different hypothetical prescribing scenarios, practitioners who viewed PrEP as the first clinical step for persons who inject drugs (PWID) were twice as likely to have also considered PrEP as the first clinical option for safer conception, and vice-a-versa (95% CI: 1.4-3.2, p < .001). Practitioners considering PrEP as the first preventive option for MSM were nearly six times as likely to also consider PrEP as the first clinical step for PWID, and vice-a-versa (95% CI: 2.28-13.56, p = .0002). Our findings indicate that even among a subset of HIV-focused practitioners, PrEP prescribing is not routine. This group of practitioners could be an optimal group to engage individuals that could most benefit from PrEP.

Human Immunodeficiency Virus in the State of Texas of the United States: Past Reflections, Present Shortcomings, and Future Needs of the Public Health Response.

A strategy titled “Ending the HIV Epidemic: A Plan for America” aims to reduce human immunodeficiency virus (HIV) incidence in the United States by at least 90% by 2030, using diagnosis, treatment, and prevention strategies. Texas is a Southern state that has one of the highest numbers of new HIV diagnoses and people with HIV in the country, and where HIV disproportionately impacts minorities. We retrace the historical epidemic in its largest city, Houston, to illustrate the lessons learned and milestones accomplished, which could serve as guideposts for the future. We examine the current epidemic in Texas, including the achieved levels of HIV testing, treatment continua, and pre-exposure prophylaxis prescription, and compare and contrast these with the national estimates and Plan targets. Our findings call for urgent and accelerated expansion of efforts to end HIV in Texas.

Acceptability of pre-exposure prophylaxis for HIV prevention: facilitators, barriers and impact on sexual risk behaviors among men who have sex with men in Benin

BackgroundIn Benin, men who have sex with men (MSM) do not always use condoms during anal sex. Pre-exposure prophylaxis (PrEP) using Truvada® (tenofovir disoproxil fumarate / emtricitabine) may be a complementary HIV prevention measure for MSM. This study aimed at identifying the potential facilitators and barriers to the use of PrEP.MethodsThis was a cross-sectional study conducted in 2018 among male-born MSM aged 18 years or older who reported being HIV-negative or unaware of their HIV status. The participants were recruited by the RDS technique (respondent driven sampling) in six cities of Benin. Logistic regression analyses, adapted to RDS statistical requirements, were performed to identify the factors associated with PrEP acceptability.ResultsMean age of the 400 MSM recruited was 26.2 ± 5.0 years. PrEP was known by 50.7% of respondents. The intention to use PrEP was expressed by 90% of MSM. If PrEP effectiveness were 90% or more, 87.8% of the respondents thought they would decrease condom use. In multivariate analysis, the facilitators associated with PrEP acceptability were: not having to pay for PrEP (odds ratio (OR) = 2.39, 95% CI: 1.50–4.46) and its accessibility within MSM networks (OR = 9.82, 95% CI: 3.50–27.52). Only one barrier was significant: the concern that taking PrEP be perceived as marker of adopting HIV risky behaviors (OR = 0.11, 95% CI: 0.04–0.30).ConclusionIn Benin, not all MSM know about PrEP. But once well informed, the majority seems willing to use it if made available. The free availability of the drug and its accessibility in the MSM networks are important facilitators. The possibility of decrease in condom use should not be a barrier to the prescription of PrEP if made available.

Health Profession Students' Awareness, Knowledge, and Confidence Regarding Preexposure Prophylaxis: Results of a National, Multidisciplinary Survey.

Preexposure prophylaxis (PrEP) is a highly effective, pharmacologic method of HIV prevention. Despite its safety and efficacy, PrEP prescription remains low in those patients who are at highest risk for HIV infection. One possible reason for this may be the lack of inclusion of PrEP and HIV prevention discussions within the curricula of health professions education. An online survey was administered to a cross-sectional sample of future prescribers (osteopathic/allopathic medical and physician assistant students), future nurses, and future pharmacists (n = 2085) in the United States between January and July 2019 to assess and compare awareness of PrEP, PrEP education, PrEP knowledge, and confidence in 2 areas related to PrEP. We show that, overall, awareness of PrEP is high among future health care providers (81.6%), with the future pharmacists reporting the greatest awareness (92.2%; P < 0.001) and more commonly reporting PrEP education (71.0%). Students had mixed knowledge of PrEP, with future pharmacists reporting the highest knowledge of PrEP. Approximately 30% of students in all disciplines reported having low confidence counseling a patient about PrEP and low confidence educating a colleague about PrEP. Knowledge of PrEP was a significant predictor of confidence counseling a patient about PrEP (P < 0.001) and educating a colleague about PrEP (P < 0.001). This study identifies opportunities to improve and incorporate evidence-based strategies for educating future health care providers about PrEP for HIV prevention within health professions curricula.

Initiation of HIV pre-exposure prophylaxis in adolescents and young adults: Barriers and opportunities

Adolescents and young adults (AYA) ages 13 to 24 years comprise a quarter of the new HIV diagnoses in the United States. Lack of access to HIV-preventive biomedical tools such as pre-exposure prophylaxis (PrEP) reduces opportunities to prevent HIV infection in this population. Initiating PrEP in AYA significantly reduces the negative health outcomes of HIV, but many providers are still reluctant to initiate PrEP in their AYA patients based on perceived threats and barriers. This review aims to highlight the barriers and opportunities for initiating PrEP services in AYA and provides recommendations for PrEP services in this population. Ten scholarly articles rated levels IIA through IIIB were identified using the Johns Hopkins Evidence-Based Practice ratings. These included quasi-experimental and nonexperimental publications. Both quantitative and qualitative data contributed to identifying perceived barriers, opportunities, and recommendations for increased PrEP access and prescription in AYA. Pre-exposure prophylaxis is a vital component of a robust HIV prevention program. Themes that emerged hindering optimal PrEP utilization in AYA included provider-related barriers (e.g., knowledge deficit, lack of familiarity with PrEP guidelines, and protocols), patient-related barriers (e.g., lack of awareness, confidentiality issue, and HIV stigma), and structure-related barriers (e.g., lack of AYA-friendly clinics and insurance coverage). Providers in any setting should be able identify at-risk AYA and prescribe PrEP accordingly. Nurse practitioners should make PrEP accessible to AYA by addressing the barriers to PrEP utilization, prescribing, and continuity of care. Nurse practitioner curriculum, training, and continuing education should include PrEP for AYA.

Attitudes and Knowledge About Human Immunodeficiency Virus Pre-Exposure Prophylaxis Among Brazilian Infectious Disease Physicians.

The objective was to describe levels and predictors of knowledge, attitudes, and willingness to prescribe pre-exposure prophylaxis (PrEP) among Brazilian Infectious Disease (ID) Physicians. The design was a cross-sectional study. We collected information on demographics and attitudes/knowledge about PrEP using an anonymous electronic survey. Willingness to prescribe PrEP, fear of adherence issues, and concerns about risk compensation were addressed in three case vignettes that varied by a single characteristic (i.e., by gender identity, drug use, and socioeconomic status) randomly assigned to physicians. Three hundred seventy ID physicians responded to the survey. Although most identified as informed/well informed about PrEP (75%) and believed PrEP availability to be necessary (38%), concerns with adherence (49%), side effects (38%), risk compensation (28%), and increase in sexually transmitted infection incidence (38%) were raised. We found no statistically significant differences in willingness to prescribe PrEP and concerns around risk compensation across the three case vignettes. ID physicians who declared having a religion reported more concerns about risk compensation compared to those self-identified as atheists (72% vs. 46%, p < .001). Most Brazilian ID physicians reported a positive attitude toward PrEP. Patients' gender identity, drug use, and socioeconomic status were not associated with willingness to prescribe PrEP. However, ID physicians who declared having a religion were more frequently concerned about risk compensation among PrEP users, suggesting that personal beliefs can influence PrEP implementation.

Trends in HIV Preexposure Prophylaxis Prescribing in the United States, 2012-2018

The US Preventive Services Task Force recommends use of preexposure prophylaxis (PrEP) for individuals at risk of acquiring HIV 1 The Centers for Disease Control and Prevention estimated that 1 1 million US individuals might benefit from PrEP,2 but only 7% of those used it in 2016 3 Clinicians have been slow to prescribe PrEP, citing concerns regarding its effectiveness outside a clinical trial setting, unintended consequences, and ambiguity surrounding which type of clinician is best suited to prescribe PrEP 4 Using a commercial insurance database, this study examined trends in the number of persons prescribed PrEP, prescriptions for PrEP, and specialty of prescribing clinicians

Attitudes about community pharmacy access to HIV prevention medications in California

ObjectiveIncreasing access to human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) and postexposure prophylaxis (PEP) is a high priority for the Ending the HIV Epidemic Initiative. Expanding access to PrEP and PEP through a variety of health care settings, including community pharmacies, may increase access in communities most in need. California is the first state to allow community pharmacists to furnish PrEP and PEP directly to consumers. Our objective was to assess attitudes among key stakeholders about a California policy to allow community pharmacists to furnish HIV PrEP and PEP. MethodsWe conducted a qualitative case study with key pharmacy stakeholders. Semistructured phone interviews were audio-recorded and transcribed verbatim. We generated analytical memos for each interview and working with these analytical memos, we conducted a constant comparison across cases to identify commonalities and differences. ResultsWe launched the study in October 2018 and interviewed pharmacists (n = 7) working in a variety of settings, including retail-, clinic-, and community-based pharmacies. We also interviewed medical providers (n = 2) working in high-volume PrEP clinics and sought input from representatives of large retail chain pharmacies (n = 2). Overall, pharmacists and medical provider informants shared similar opinions about the central benefits as well as the key challenges related to pharmacist-delivered PrEP and PEP services. Benefits included: community pharmacists are widely accessible, PrEP and PEP protocols are similar to other preventative medications, policy may lead to efficiencies in the health care workforce, and community pharmacists are authorities on medication adherence. Challenges included: implementation issues may limit pharmacist involvement, and missed opportunities to diagnose and treat other health conditions. ConclusionThis study characterizes the types of benefits and challenges that can be expected when PrEP and PEP prescribing privileges are extended to community pharmacists. This information may be useful to policymakers and other stakeholders considering legislation to permit direct prescription of PrEP and PEP by pharmacists.

PrEP (Pre-Exposure Prophylaxis) Education for Clinicians: Caring for an MSM Patient.

IntroductionGaps exist in educational materials addressing LGBTQ patient care and LGBTQ health. One such area is prescribing HIV pre-exposure prophylaxis (PrEP) for men who have sex with men (MSM). PrEP awareness, familiarity, and comfort in prescribing are very important in the rollout and success of PrEP as a preventative measure. Our needs assessments showed a lack of familiarity and comfort among clinicians/medical students in prescribing PrEP. Furthermore, studies have shown that since its launch as an effective prevention method of HIV transmission, PrEP has not been widely prescribed to at-risk populations. Educating clinicians about PrEP may increase its use among high-risk MSM populations and reduce the incidence of HIV infections.MethodsFor medical students, we developed a didactic presentation and video recording discussing (1) a brief history of HIV prevention, (2) indications for PrEP prescription, (3) medical testing for PrEP onboarding, (4) common PrEP side effects, and (5) appropriate follow-up and testing for PrEP maintenance and discontinuation. We also developed a videotaped clinical encounter demonstrating communication skills used in PrEP counseling. Pre- and postworkshop surveys assessed participants’ PrEP attitudes and knowledge.ResultsAll 43 survey respondents were second- through fourth-year medical students. Pre- and postpresentation evaluation of questions assessing comfort demonstrated a statistically significant improvement in level of comfort with understanding when to prescribe PrEP and in level of knowledge in prescribing PrEP.DiscussionWorkshop participants acknowledged their training gaps in PrEP prescribing and acquired knowledge and comfort with prescribing PrEP for at-risk populations.

Physician Assistant's Knowledge and Confidence Regarding Prescribing Preexposure Prophylaxis for HIV Prevention

Physician assistants (PAs) have an important role to play in increasing preexposure prophylaxis (PrEP) prescriptions. We surveyed PAs regarding knowledge of Centers for Disease Control and Prevention guidelines for PrEP and confidence regarding PrEP. Physician assistants in primary care reported more accurate knowledge and higher confidence. However, knowledge and confidence gaps were present among all PAs, regardless of specialty.

Physician Survey Results: Clinical Practice Training Is Needed to Improve Ob/Gyn PrEP Adoption [02A

INTRODUCTION: Human immunodeficiency (HIV) disease prevention with pre-exposure prophylaxis (PrEP) is marred by disparities, especially among women and other high risk groups. PrEP prescribing adoption by primary care physicians including obstetrics and gynecology (Ob/Gyn) providers is crucial to improve HIV prevention. METHODS: We modified a previously validated PrEP provider survey and administered it online through REDCap to faculty and categorical residents in the Departments of Ob/Gyn and General Internal Medicine (GIM) of a large urban hospital. T-tests and chi-square tests were performed with an alpha significance value of 0.05. RESULTS: 61 provider-surveys were completed (24 Ob/Gyn, 37 GIM). No statistically significant differences were observed by age or race, however there were a higher proportion of female-identified providers in Ob/Gyn (87.5%) compared to GIM (54.1%) (P=.01). The Ob/Gyn surveys demonstrated significant differences in the clinical processes for PrEP management. Surveys demonstrated perceived deficiencies in provider training/education (P=.006), clinical practice guidelines (P=.001), availability of resource access (such as PrEP guidelines/protocols) (P=.003), peers/colleagues who are knowledgeable about or supportive of PrEP provision within their practice (P=.008), and lab monitoring requirements (P=.019). GIM respondents were more likely to believe they knew enough about PrEP to feel comfortable prescribing it (P=.005), thought it was feasible to prescribe in GIM and OB/Gyn settings compared to HIV prevention/care clinics (P=.019) and to say they would be likely to prescribe PrEP in the next 6 months (P=.01). CONCLUSION: Overall, results indicate that improved clinical practice training and processes are necessary to increase PrEP adoption in OB/Gyn clinical settings.

Patient perception of community pharmacists prescribing pre-exposure prophylaxis for HIV prevention

ObjectiveThe primary objective of this study was to determine patients’ perceptions of pharmacists prescribing pre-exposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) prevention. DesignAn anonymous, 26-item, cross-sectional survey was administered to individuals and data collection occurred during a 12-week period from January to March 2019. Setting and participantsIndividuals were recruited to complete the survey in person at 5 locations of a large grocery-chain pharmacy in Washington, D.C. and Maryland. Inclusion criteria included individuals who were at least 18 years old and able to read and write English. Exclusion criteria included persons living with HIV or acquired immunodeficiency syndrome. Outcome measuresIn order to measure perception, participants were asked on the survey to select their level of agreement using a Likert scale from 1 to 5 (1 = strongly disagree, 5 = strongly agree). Researchers analyzed overall perception in addition to differences in perception based on various demographic characteristics. ResultsIn total, 117 surveys were collected and analyzed. Most participants were comfortable with pharmacists prescribing PrEP. Notable statistically significant findings included participants who interacted with pharmacists through medication therapy review (4.4, 3.1 [P < 0.05]) and vaccinations (4.3, 3.1 [P < 0.05]) were more likely to agree with pharmacists prescribing PrEP than participants who had no previous interactions with pharmacists. Participants who had previously used PrEP were more likely to agree with pharmacists prescribing PrEP than those who had not used PrEP before. ConclusionThis study provided a glimpse into patients’ perceptions of pharmacists prescribing PrEP. Patients were generally favorable of pharmacists prescribing PrEP; however, there are still barriers to overcome before prescribing PrEP for HIV prevention can feasibly occur in the community setting.

Pre-exposure prophylaxis for preventing acquisition of HIV: A cross-sectional study of patients, prescribers, uptake, and spending in the United States, 2015-2016.

BackgroundIn 2015, there were approximately 40,000 new HIV diagnoses in the United States. Pre-exposure prophylaxis (PrEP) is an effective strategy that reduces the risk of HIV acquisition; however, uptake among those who can benefit from it has lagged. In this study, we 1) compared the characteristics of patients who were prescribed PrEP with individuals newly diagnosed with HIV infection, 2) identified the specialties of practitioners prescribing PrEP, 3) identified metropolitan statistical areas (MSAs) within the US where there is relatively low uptake of PrEP, and 4) reported median amounts paid by patients and third-party payors for PrEP.Methods and findingsWe analyzed prescription drug claims for individuals prescribed PrEP in the Integrated Dataverse (IDV) from Symphony Health for the period of September 2015 to August 2016 to describe PrEP patients, prescribers, relative uptake, and payment methods in the US. Data were available for 75,839 individuals prescribed PrEP, and findings were extrapolated to approximately 101,000 individuals, which is less than 10% of the 1.1 million adults for whom PrEP was indicated. Compared to individuals with newly diagnosed HIV infection, PrEP patients were more likely to be non-Hispanic white (45% versus 26.2%), older (25% versus 19% at ages 35–44), male (94% versus 81%), and not reside in the South (30% versus 52% reside in the South).Using a ratio of the number of PrEP patients within an MSA to the number of newly diagnosed individuals with HIV infection, we found MSAs with relatively low uptake of PrEP were concentrated in the South. Of the approximately 24,000 providers who prescribed PrEP, two-thirds reported primary care as their specialty. Compared to the types of payment methods that people living with diagnosed HIV (PLWH) used to pay for their antiretroviral treatment in 2015 to 2016 reported in the Centers for Disease Control and Prevention (CDC) HIV Surveillance Special Report, PrEP patients were more likely to have used commercial health insurance (80% versus 35%) and less likely to have used public healthcare coverage or a publicly sponsored assistance program to pay for PrEP (12% versus 45% for Medicaid). Third-party payors covered 95% of the costs of PrEP. Overall, we estimated the median annual per patient out-of-pocket spending on PrEP was approximately US$72. Limitations of this study include missing information on prescription claims of patients not included in the database, and for those included, some patients were missing information on patient diagnosis, race/ethnicity, educational attainment, and income (34%–36%).ConclusionsOur findings indicate that in 2015–2016, many individuals in the US who could benefit from being on PrEP were not receiving this HIV prevention medication, and those prescribed PrEP had a significantly different distribution of characteristics from the broader population that is at risk for acquiring HIV. PrEP patients were more likely to pay for PrEP using commercial or private insurance, whereas PLWH were more likely to pay for their antiretroviral treatment using publicly sponsored programs. Addressing the affordability of PrEP and otherwise promoting its use among those with indications for PrEP represents an important opportunity to help end the HIV epidemic.

Pre-exposure Prophylaxis (PrEP) for HIV Prevention Among Men Who Have Sex with Men (MSM): A Scoping Review on PrEP Service Delivery and Programming

Pre-exposure prophylaxis (PrEP) is an evidence-based new biomedical HIV prevention intervention, which involves the pre-emptive use of daily (or event-based) antiretroviral drugs, to reduce risk of HIV acquisition if exposed. PrEP has recently been positioned as an integral prevention tool to reduce HIV acquisition risk among men who have sex with men (MSM) at country-level and within global prevention strategies. Given this global scale up of PrEP, we conducted a scoping review of extant international literature documenting service related perspectives, models and lessons learnt in PrEP programming for MSM. A systematic search of literature was conducted, and restricted to English language records in the timeframe 2008 to February 2019. Eligibility criteria centered on whether studies broadly described PrEP programming and service delivery for MSM as well as health communication. Following exclusion of ineligible records and removal of duplicates, 84 records were charted and thematically analysed according to scoping review methods. Four themes emerged from the thematic analysis of data; ‘PrEP service aspects, settings and staff’; ‘PrEP prescriber experiences, therapeutic alliance and care planning’; ‘PrEP adherence within formal service structures’; and ‘Multi-disciplinary and innovative PrEP care pathways’. The review highlights the complexities in providing optimal PrEP services for MSM by mapping and illustrating the importance of understanding the informal and formal routes to PrEP use among this HIV risk population; the barriers to uptake; the requirement for the presence of a positive therapeutic alliance between patient and prescriber in supporting patient initiation and adherence to PrEP regimes; and the need for availability in different culturally and ethnically sensitive models of PrEP service delivery according to low to high risk groups within the MSM communities.

The HIV Pre-exposure Prophylaxis (PrEP) Cascade at NYC Sexual Health Clinics: Navigation Is the Key to Uptake.

Clinics providing sexual health care pose unique opportunities to implement HIV pre-exposure prophylaxis (PrEP) programs. The PrEP program at New York City's Sexual Health Clinics provides intensive on-site navigation for linkage to PrEP care. We assessed uptake of this intervention. We categorized men who have sex with men (MSM) without HIV hierarchically as having had (1) HIV post-exposure prophylaxis (PEP) use (past year); or (2) selected sexually transmitted infections (STI) (past year); or (3) HIV-diagnosed sex/needle-sharing partners (past 6 months); or (4) expressed interest in PrEP (day of clinic visit). We constructed PrEP cascades and used multivariable regression to examine acceptance of PrEP navigation, referral to a PrEP provider, linkage (<60 days), and PrEP prescription. One thousand three hundred one of 2106 PrEP (62%) patients accepted navigation. Of those, 55% (718/1301) were black or Hispanic MSM. STI and PEP patients had lowest navigation acceptance levels (35%-46%). Of navigated patients, 56% (628/1114) accepted referrals, 46% (288/628) linked to PrEP providers, and 82% (235/288) were prescribed PrEP; overall, 11% of those offered navigation (235/2106) received prescriptions. Navigated MSM with PEP history [adjusted prevalence ratio (aPR) 1.34, 95% confidence interval (CI): 1.16 to 1.56)], previous STI (aPR 1.28, 95% CI: 1.12 to 1.45), or HIV-diagnosed partners (aPR 1.18, 95% CI: 1.01 to 1.37) were more likely than those with PrEP interest to accept referrals. Probability of linkage varied by insurance status; prescription did not vary by patient factors. Although MSM in key priority groups (eg, previous STI) showed low navigation uptake, those who accepted navigation were likely to be referred for PrEP, suggesting a need for expanded up-front engagement.

Student Education About Pre-exposure Prophylaxis (PrEP) Varies Between Regions of the United States.

Daily, oral pre-exposure prophylaxis (PrEP) is an effective and safe prevention strategy for people at risk for HIV. However, prescription of PrEP has been limited for patients at the highest risk. Disparities in PrEP prescription are pronounced among racial and gender minority patients. A significant body of literature indicates that practicing healthcare providers have little awareness and knowledge of PrEP. Very little work has investigated the education about PrEP among health professionals in training. The objective of this study was to compare health professions students' awareness of PrEP and education about PrEP between regions of the US, and to determine if correlations between regional HIV incidence and PrEP use were present. Survey study. A cross-sectional sample of health professions students (N = 1859) representing future prescribers (MD, DO, PA), pharmacists, and nurses in the US. Overall, 83.4% of students were aware of PrEP, but only 62.2% of fourth-year students indicated they had been taught about PrEP at any time during their training. Education about PrEP was most comprehensive in the Northeastern US, the area with the highest PrEP to need ratio (4.7). In all regions, transgender patients and heterosexual men and women were least likely to be presented in education as PrEP candidates, and men who have sex with men were the most frequently presented. There are marked differences in education regarding PrEP both between academic programs and regions of the USA.

A Theoretically Based Mobile App to Increase Pre-Exposure Prophylaxis Uptake Among Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.

BackgroundHealthMindr is a mobile phone HIV prevention app for men who have sex with men (MSM). In a previous pilot study, HealthMindr was found to be acceptable among users and to demonstrate preliminary effectiveness for increasing pre-exposure prophylaxis (PrEP) uptake among MSM. PrEP is a highly effective HIV prevention intervention; however, uptake remains low.ObjectiveThe aim of this study will be to assess the efficacy of a mobile app for increasing PrEP uptake among MSM in the southern United States.MethodsIn this randomized controlled trial, we will assess the efficacy of HealthMindr for increasing PrEP uptake among MSM in the following three southern US cities: Atlanta, Georgia; Jackson, Mississippi; and Washington, DC. In total, 657 men will be recruited and randomized to intervention and control arms in a 2:1 ratio. Participants in the intervention arm will receive access to the full HealthMindr app, with information and resources about PrEP (eg, frequently asked questions, risk assessment tool, and PrEP provider locator), other HIV prevention information, ability to order free HIV/sexually transmitted infection test kits, and additional resources related to substance use and mental health. Participants in the control arm will use the HealthMindr app but will only have access to the study timeline and a message center to communicate with study staff. Participants will complete quarterly surveys to assess self-reported PrEP uptake over 12 months of follow-up. Self-reported PrEP uptake will be verified by dried blood spot testing and/or uploading a photograph of a PrEP prescription.ResultsParticipant recruitment began in January 2020.ConclusionsThis trial will determine whether the HealthMindr app can increase PrEP uptake among MSM in the southern United States.Trial RegistrationClinicalTrials.gov NCT03763942; https://clinicaltrials.gov/ct2/show/NCT03763942International Registered Report Identifier (IRRID)PRR1-10.2196/16231

A Mobile Intervention to Improve Uptake of Pre-Exposure Prophylaxis for Southern Black Men Who Have Sex With Men: Protocol for Intervention Development and Pilot Randomized Controlled Trial.

BackgroundThe uptake of pre-exposure prophylaxis (PrEP) has been slow for young black men who have sex with men (BMSM) living in the southern United States. This is a significant issue because 8 of the 10 states with the highest rates of new HIV infections are in the South. Jackson, Mississippi (MS), the site of this project, has the second highest AIDS diagnosis rate in the nation and the highest rate of HIV infection for young, urban BMSM. This study will develop and test an engaging, interactive, and cost-effective mobile messaging intervention to improve engagement in PrEP care for BMSM aged 18 to 35 years living in Jackson, MS.ObjectiveThe goals of this mixed methods study are to (1) conduct qualitative interviews with young BMSM in Jackson, MS, to understand individual, community, and structural barriers affecting engagement in PrEP-related care, (2) assemble a PrEP mobile messaging intervention that includes text messages with publicly available internet content (websites and YouTube videos) that provide factual information, motivational materials, and behavioral skills related to PrEP and HIV prevention, and (3) evaluate the preliminary efficacy of the intervention in a randomized controlled study with PrEP-eligible BMSM receiving care in STI/HIV testing clinics in Jackson, MS.MethodsThis research protocol will be conducted in 2 phases. A development phase will involve in-depth interviews (n=30) with PrEP-eligible BMSM who receive care in STI/HIV testing clinics in MS. These interviews will allow researchers to select the texted material that will be sent out during the intervention. The second phase will consist of an unblinded, small, randomized controlled trial among 66 new participants to examine the preliminary efficacy of the intervention compared with enhanced standard of care (ESC) on attendance at a PrEP services appointment (the first step in initiating PrEP care) and receipt of a PrEP prescription, based on self-report and electronic medical records. The free, publicly available material will be sent to PrEP-eligible BMSM in 8 to 16 interactive text messages over 4 weeks. Study assessments will occur at enrollment and at 4- and 16-weeks postenrollment and can be completed online or in person. All participants will be recruited from a local clinic.ResultsInstitutional review board approval was received on January 16, 2017, and research activities, subsequently, began in February 2018. Recruitment for the study concluded in November 2019. In total, 65 participants were randomized with 33 being assigned to the intervention and 32 to ESC. Collection of follow-up data is ongoing.ConclusionsThis PrEP mobile messaging intervention aims to increase uptake of PrEP by BMSM in the southern United States. This intervention uses interactive, tailored text messaging and appealing free Web content (publicly accessible educational websites and YouTube videos) to promote linkage to PrEP care and increase HIV preventative behaviors. A cost-effective PrEP mobile messaging intervention has great potential to improve information about PrEP, improve motivation to use PrEP, and decrease stigma and structural barriers that often prevent engagement in PrEP-related medical care.Trial RegistrationClinicalTrials.gov NCT03308097; https://clinicaltrials.gov/ct2/show/NCT03308097International Registered Report Identifier (IRRID)DERR1-10.2196/15781

Integrating Preexposure Prophylaxis (PrEP) Into a Network of Community Health Centers

Although preexposure prophylaxis (PrEP) is more than 92% effective in preventing human immunodeficiency virus, primary care providers underprescribe it. This quality improvement project was designed to increase the provision of PrEP to people at high risk for human immunodeficiency virus via evidence-based training given to primary care providers. This training occurred within a network of 19 federally qualified health centers in Sacramento, California. After implementation, there was a 67% increase in prescriptions for PrEP. Furthermore, all providers displayed an increase in acquired knowledge of PrEP (P < .001). Via focus group, providers identified facilitators, barriers, and innovative ideas for the standardization of PrEP in primary care.

Persistence With Human Immunodeficiency Virus Pre-exposure Prophylaxis in the United States, 2012-2017.

Daily oral pre-exposure prophylaxis (PrEP) is highly effective in preventing human immunodeficiency virus (HIV) infection if used adherently throughout periods of HIV risk. We estimated PrEP persistence among cohorts of persons with commercial or Medicaid insurance. We analyzed data from the IBM MarketScan Research Database to identify persons aged 18-64 years who initiated PrEP between 2012 and 2017. We assessed PrEP persistence by calculating the time period that each person continued filling PrEP prescriptions until there was a gap in prescription fills > 30 days. We used Kaplan-Meier time-to-event methods to estimate the proportion of PrEP users who persisted with PrEP at 3, 6, and 12 months after initiation, and constructed Cox proportional hazards models to determine patient characteristics associated with nonpersistence. We studied 11 807 commercially insured and 647 Medicaid insured persons with PrEP prescriptions. Commercially insured patients persisted for a median time of 13.7 months (95% confidence interval [CI], 13.3-14.1), compared to 6.8 months (95% CI, 6.1-7.6) among Medicaid patients. Additionally, female sex, younger age, residence in rural location, and black race were associated with shorter persistence. After adjusting for covariates, we found that female sex (hazard ratio [HR], 1.81 [95% CI, 1.56-2.11]) and younger age (18-24 years: HR, 2.38 [95% CI, 2.11-2.69]) predicted nonpersistence. More than half of commercially insured persons who initiated PrEP persisted with it for 12 months, compared to a third of those with Medicaid. A better understanding of reasons for nonpersistence is important to support persistent PrEP use and to develop interventions designed for the diverse needs of at-risk populations.