PrEP Use and Adherence among Transgender Persons in Chicago, IL (SHIPP Study, 2014-2018, USA).

Few studies investigating daily oral preexposure prophylaxis (PrEP) focus on transgender persons. The Sustainable Health Center Implementation PrEP Pilot (SHIPP) Study included a large observational cohort of transgender persons with implications for PrEP in the United States. We examined data from SHIPP's observational cohort and its Medication Adherence Substudy (MAS) to understand adherence among transgender participants in Chicago, IL. We assessed adherence by the proportion of days covered (PDC) for PrEP medication prescriptions, self-reported interview data, and concentrations of intracellular tenofovir diphosphate (TFV-DP) in dried blood spot (DBS) samples. Between 2014 and 2018, there were 510 transgender participants, 349 (68.4%) transgender women and 152 (29.8%) transgender men. Forty-five of these participants were enrolled in the MAS, 31 (68.9%) transgender women and 9 (20.0%) transgender men. By the 3-month follow up, 100% of MAS participants who completed an interview reported taking 4 or more doses of PrEP in the previous week. At 6, 9, and 12 months, taking 4 or more doses in the past week was reported by 81.0%, 94.1%, and 83.3% of participants, respectively. Results from TFV-DP DBS indicated that fewer participants reached the same level of adherence (4 or more doses/week) at clinical visits compared to self-report and even fewer participants reached this level of adherence based on the calculated PDC. Among participants who remained on PrEP throughout the study, DBS adherence levels declined after the first three months. There remains a critical need to develop strategies to address barriers and interventions that support PrEP adherence among transgender people.

Achieving the "Ending the HIV Epidemic in the U.S." incidence reduction goals among at-risk populations in the South.

INTRODUCTION: Antiretroviral medication coverage remains sub-optimal in much of the United States, particularly the Sothern region, and Non-Hispanic Black or African American persons (NHB) continue to be disproportionately impacted by the HIV epidemic. The "Ending the HIV Epidemic in the U.S." (EHE) initiative seeks to reduce HIV incidence nationally by focusing resources towards the most highly impacted localities and populations. This study evaluates the impact of hypothetical improvements in ART and PrEP coverage to estimate the levels of coverage needed to achieve EHE goals in the South. METHODS: We developed a stochastic, agent-based network model of 500,000 individuals to simulate the HIV epidemic and hypothetical improvements in ART and PrEP coverage. RESULTS: New infections declined by 78.6% at 90%/40% ART/PrEP and 94.3% at 100%/50% ART/PrEP. Declines in annual incidence rates surpassed 75% by 2025 with 90%/40% ART/PrEP and 90% by 2030 with 100%/50% ART/PrEP coverage. Increased ART coverage among NHB MSM was associated with a linear decline in incidence among all MSM. Declines in incidence among Hispanic/Latino and White/Other MSM were similar regardless of which MSM race group increased their ART coverage, while the benefit to NHB MSM was greatest when their own ART coverage increased. The incidence rate among NHB women declined by over a third when either NHB heterosexual men or NHB MSM increased their ART use respectively. Increased use of PrEP was associated with a decline in incidence for the groups using PrEP. MSM experienced the largest absolute declines in incidence with increasing PrEP coverage, followed by NHB women. CONCLUSIONS: Our analysis indicates that it is possible to reach EHE goals. The largest reductions in HIV incidence can be achieved by increasing ART coverage among MSM and all race groups benefit regardless of differences in ART initiation by race. Improving ART coverage to > 90% should be prioritized with a particular emphasis on reaching NHB MSM. Such a focus will reduce the largest number of incident cases, reduce racial HIV incidence disparities among both MSM and women, and reduce racial health disparities among persons with HIV. NHB women should also be prioritized for PrEP outreach.

Epidemiologic Features of the Monkeypox Outbreak and the Public Health Response - United States, May 17-October 6, 2022.

On May 17, 2022, the Massachusetts Department of Health announced the first suspected case of monkeypox associated with the global outbreak in a U.S. resident. On May 23, 2022, CDC launched an emergency response (1,2). CDC's emergency response focused on surveillance, laboratory testing, medical countermeasures, and education. Medical countermeasures included rollout of a national JYNNEOS vaccination strategy, Food and Drug Administration (FDA) issuance of an emergency use authorization to allow for intradermal administration of JYNNEOS, and use of tecovirimat for patients with, or at risk for, severe monkeypox. During May 17-October 6, 2022, a total of 26,384 probable and confirmed* U.S. monkeypox cases were reported to CDC. Daily case counts peaked during mid-to-late August. Among 25,001 of 25,569 (98%) cases in adults with information on gender identity,† 23,683 (95%) occurred in cisgender men. Among 13,997 cisgender men with information on recent sexual or close intimate contact,§ 10,440 (75%) reported male-to-male sexual contact (MMSC) ≤21 days preceding symptom onset. Among 21,211 (80%) cases in persons with information on race and ethnicity,¶ 6,879 (32%), 6,628 (31%), and 6,330 (30%) occurred in non-Hispanic Black or African American (Black), Hispanic or Latino (Hispanic), and non-Hispanic White (White) persons, respectively. Among 5,017 (20%) cases in adults with information on HIV infection status, 2,876 (57%) had HIV infection. Prevention efforts, including vaccination, should be prioritized among persons at highest risk within groups most affected by the monkeypox outbreak, including gay, bisexual, and other men who have sex with men (MSM); transgender, nonbinary, and gender-diverse persons; racial and ethnic minority groups; and persons who are immunocompromised, including persons with advanced HIV infection or newly diagnosed HIV infection.

Incidence of Monkeypox Among Unvaccinated Persons Compared with Persons Receiving ≥1 JYNNEOS Vaccine Dose - 32 U.S. Jurisdictions, July 31-September 3, 2022.

Human monkeypox is caused by Monkeypox virus (MPXV), an Orthopoxvirus, previously rare in the United States (1). The first U.S. case of monkeypox during the current outbreak was identified on May 17, 2022 (2). As of September 28, 2022, a total of 25,341 monkeypox cases have been reported in the United States.* The outbreak has disproportionately affected gay, bisexual, and other men who have sex with men (MSM) (3). JYNNEOS vaccine (Modified Vaccinia Ankara vaccine, Bavarian Nordic), administered subcutaneously as a 2-dose (0.5 mL per dose) series with doses administered 4 weeks apart, was approved by the Food and Drug Administration (FDA) in 2019 to prevent smallpox and monkeypox infection (4). U.S. distribution of JYNNEOS vaccine as postexposure prophylaxis (PEP) for persons with known exposures to MPXV began in May 2022. A U.S. national vaccination strategy† for expanded PEP, announced on June 28, 2022, recommended subcutaneous vaccination of persons with known or presumed exposure to MPXV, broadening vaccination eligibility. FDA emergency use authorization (EUA) of intradermal administration of 0.1 mL of JYNNEOS on August 9, 2022, increased vaccine supply (5). As of September 28, 2022, most vaccine has been administered as PEP or expanded PEP. Because of the limited amount of time that has elapsed since administration of initial vaccine doses, as of September 28, 2022, relatively few persons in the current outbreak have completed the recommended 2-dose series.§ To examine the incidence of monkeypox among persons who were unvaccinated and those who had received ≥1 JYNNEOS vaccine dose, 5,402 reported monkeypox cases occurring among males¶ aged 18-49 years during July 31-September 3, 2022, were analyzed by vaccination status across 32 U.S. jurisdictions.** Average monkeypox incidence (cases per 100,000) among unvaccinated persons was 14.3 (95% CI = 5.0-41.0) times that among persons who received 1 dose of JYNNEOS vaccine ≥14 days earlier. Monitoring monkeypox incidence by vaccination status in timely surveillance data might provide early indications of vaccine-related protection that can be confirmed through other well-controlled vaccine effectiveness studies. This early finding suggests that a single dose of JYNNEOS vaccine provides some protection against monkeypox infection. The degree and durability of such protection is unknown, and it is recommended that people who are eligible for monkeypox vaccination receive the complete 2-dose series.

The Potential of Telecommunication Technology to Address Racial/Ethnic Disparities in HIV PrEP Awareness, Uptake, Adherence, and Persistence in Care: A Review.

Pre-exposure prophylaxis (PrEP) is highly effective in preventing new HIV infection, but uptake remains challenging among Black and Hispanic/Latino persons. The purpose of this review was to understand how studies have used electronic telecommunication technology to increase awareness, uptake, adherence, and persistence in PrEP care among Black and Hispanic/Latino persons and how it can reduce social and structural barriers that contribute to disparities in HIV infection. Of the 1114 articles identified, 10 studies were eligible. Forty percent (40%) of studies focused on Black or Hispanic/Latino persons and 80% addressed social and structural barriers related to PrEP use such as navigation or access to PrEP. Mobile health designs were more commonly used (50%) compared to telehealth (30%) and e-health (20%) designs. There is a need to increase the development of telecommunications interventions that address the needs of Black and Hispanic/Latino persons often challenged with uptake and adherent use of PrEP.

Health Care Providers' Views on Clinic Infrastructure and Practice Models That May Facilitate HIV Preexposure Prophylaxis (PrEP) Prescribing: A Qualitative Meta-Synthesis.

HIV (human immunodeficiency virus) preexposure prophylaxis (PrEP) is an effective biomedical HIV prevention tool. Increasing PrEP use among populations disproportionately affected by HIV is one of the key efforts in the United States' Ending the HIV Epidemic (EHE) initiative and the HIV National Strategic Plan for the United States. Given that PrEP is available only through prescription, it is important to explore structural, organizational, or environmental factors that could facilitate or impede health care provider's PrEP prescribing behavior. The purpose of this systematic review (PROSPERO [CRD: 42019138889]) is to identify qualitative studies that addressed this topic and conduct meta-synthesis using the thematic synthesis method to identify major themes on the characteristics of clinic infrastructure or clinic models that providers consider as facilitators of PrEP prescribing in the United States. Eighteen citations representing 15 studies were included in this review. Five overarching themes were identified: (1) routinized HIV risk assessment; (2) interdisciplinary/coordinated PrEP teams or services; (3) clinic capacity to provide essential PrEP-related services; (4) low out-of-pocket patient costs; and (5) access to the priority populations. Some of these themes are consistent with the recommendations of CDC's PrEP clinical guidelines and the EHE initiative. More recent studies that include perspectives of diverse providers, timely analysis of these studies, and implementation research to assess strategies to address the current practice gaps are needed to further promote PrEP prescribing among providers in the United States.

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

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Use of Drug-level Testing and Single-genome Sequencing to Unravel a Case of Human Immunodeficiency Virus Seroconversion on Pre-exposure Prophylaxis.

Cases of seroconversion on pre-exposure prophylaxis (PrEP) should be carefully investigated, given their public health implications and rarity. We report a case of transmitted drug resistance causing seroconversion on PrEP in spite of high adherence, confirmed with dried blood spot and segmental hair drug-level testing and single-genome sequencing.

Preexposure Prophylaxis for Prevention of HIV Acquisition Among Adolescents: Clinical Considerations, 2020.

Preexposure prophylaxis (PrEP) with antiretroviral medication has been proven effective in reducing the risk for acquiring human immunodeficiency virus (HIV). The fixed-dose combination tablet of tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) was approved by the U.S. Food and Drug Administration (FDA) for use as PrEP for adults in 2012. Since then, recognition has been increasing that adolescents at risk for acquiring HIV can benefit from PrEP. In 2018, FDA approved revised labeling for TDF/FTC that expanded the indication for PrEP to include adolescents weighing at least 77 lb (35 kg) who are at risk for acquiring HIV. In 2019, FDA approved the combination product tenofovir alafenamide (TAF)/FTC as PrEP for adolescents and adults weighing at least 77 lb (35 kg), excluding those at risk for acquiring HIV through receptive vaginal sex. This exclusion is due to the lack of clinical data regarding the efficacy of TAF/FTC in cisgender women.Clinical providers who evaluate adolescents for PrEP use must consider certain topics that are unique to the adolescent population. Important considerations related to adolescents include PrEP safety data, legal issues about consent for clinical care and confidentiality, the therapeutic partnership with adolescents and their parents or guardians, the approach to the adolescent patient's clinical visit, and medication initiation, adherence, and persistence during adolescence. Overall, data support the safety of PrEP for adolescents. PrEP providers should be familiar with the statutes and regulations about the provision of health care to minors in their states. Providers should partner with the adolescent patient for PrEP decisions, recognizing the adolescent's autonomy to the extent allowable by law and including parents in the conversation about PrEP when it is safe and reasonable to do so. A comprehensive approach to adolescent health is recommended, including considering PrEP as one possible component of providing medical care to adolescents who inject drugs or engage in sexual behaviors that place them at risk for acquiring HIV. PrEP adherence declined over time in the studies evaluating PrEP among adolescents, a trend that also has been observed among adult patients. Clinicians should implement strategies to address medication adherence as a routine part of prescribing PrEP; more frequent clinical follow-up is one possible approach.PrEP is an effective HIV prevention tool for protecting adolescents at risk for HIV acquisition. For providers, unique considerations that are part of providing PrEP to adolescents include the possible need for more frequent, supportive interactions to promote medication adherence. Recommendations for PrEP medical management and additional resources for providers are available in the U.S. Public Health Service clinical practice guideline Preexposure Prophylaxis for the Prevention of HIV Infection in the United States - 2017 Update and the clinical providers' supplement Preexposure Prophylaxis for the Prevention of HIV Infection in the United States - 2017 Update: Clinical Providers' Supplement (https://www.cdc.gov/hiv/clinicians/prevention/prep.html).

Pre-exposure Prophylaxis (PrEP) Awareness and Prescribing Behaviors Among Primary Care Providers: DocStyles Survey, 2016-2020, United States.

Few studies have assessed providers' intent of prescribing PrEP in the future. We analyzed cross-sectional web-based surveys to estimate trends from 2016 to 2020 in PrEP awareness and prescribing behaviors in the United States among primary care providers. Multivariable logistic regression was used to estimate prevalence of PrEP awareness, prescribing behaviors, and likelihood of prescribing PrEP in the next 12 months. The adjusted prevalence for PrEP awareness was significantly higher in 2019 (93.7%, 95% CI 91.9%, 95.2%) compared to 2018 (88.1%, 95% CI 85.5%, 90.3%). The adjusted prevalence for prescribing PrEP was significantly higher in 2019 (16.4%, 95% CI 13.6%, 19.6%) and 2020 (15.6%, 95% CI 13.0%, 18.7%) compared to 2018 (12.2%, 95% CI 10.0%, 14.7%). Practicing in the West and regularly screening for HIV were associated with higher PrEP awareness and provision. Studies should examine factors associated with PrEP provision for groups with increased risk for HIV.

Assessment of PrEP Awareness, PrEP Discussion with a Provider, and PrEP Use by Transmission Risk Group with an Emphasis on the Southern United States.

The number of new HIV diagnoses is highest in the South. Many persons who might benefit from pre-exposure prophylaxis (PrEP) are not engaged in the HIV PrEP continuum of care. We analyzed National HIV Behavioral Surveillance data to assess engagement in the PrEP continuum of care among persons with increased HIV risk. We compared PrEP awareness, discussion with a clinical provider, and use among persons living in the South to those living elsewhere in the United States. PrEP awareness was lowest among heterosexual persons (7%), highest among men who have sex with men (85%), and 26% among persons who inject drugs. PrEP use was low among each population (≤ 35% for all cycles). There was limited evidence of differences in PrEP use between persons in southern and non-southern U.S. Efforts are needed to increase use of PrEP among each of the groups with increased HIV risk.

RESUMEN: El número de nuevos diagnósticos de virus de la inmunodeficiencia humana (VIH) es más alto en el sur. Muchas personas que podrían beneficiarse de la profilaxis preexposición (PrEP) no participan en la VIH-PrEP continuidad de la atención. Analizamos datos del Sistema Nacional de Vigilancia del Comportamiento Relacionado con el VIH (conocido en inglés como National HIV Behavioral Surveillance System) para evaluar la participación en la PrEP continuidad de la atención en personas con mayor riesgo de contraer el VIH. Comparamos concientización de PrEP, discusión con un proveedor clínico, y uso entre personas que viven en el sur con las personas que viven en otras partes de los Estados Unidos. Concientización de PrEP fue más baja entre personas heterosexuales (7%), más alta entre hombres que tienen relaciones sexuales con hombres (91%), y 26% entre personas que se inyectan drogas. Utilización de PrEP fue baja para todas las poblaciones (≤35% para todos los ciclos). La evidencia de diferencias en el uso de PrEP entre personas que viven en el sur con personas que no viven en el sur de los Estados Unidos fue limitada. Se necesitan esfuerzos para aumentar el uso de PrEP entre estos grupos con más riesgo de contraer el VIH.

Evidence of an Association of Increases in Pre-exposure Prophylaxis Coverage With Decreases in Human Immunodeficiency Virus Diagnosis Rates in the United States, 2012-2016.

BACKGROUND: Annual human immunodeficiency virus (HIV) diagnoses in the United States (US) have plateaued since 2013. We assessed whether there is an association between uptake of pre-exposure prophylaxis (PrEP) and decreases in HIV diagnoses. METHODS: We used 2012-2016 data from the US National HIV Surveillance System to estimate viral suppression (VS) and annual percentage change in diagnosis rate (EAPC) in 33 jurisdictions, and data from a national pharmacy database to estimate PrEP uptake. We used Poisson regression with random effects for state and year to estimate the association between PrEP coverage and EAPC: within jurisdictional quintiles grouped by changes in PrEP coverage, regressing EAPC on time; and among all jurisdictions, regressing EAPC on both time and jurisdictional changes in PrEP coverage with and without accounting for changes in VS. RESULTS: From 2012 to 2016, across the 10 states with the greatest increases in PrEP coverage, the EAPC decreased 4.0% (95% confidence interval [CI], -5.2% to -2.9%). On average, across the states and District of Columbia, EAPC for a given year decreased by 1.1% (95% CI, -1.77% to -.49%) for an increase in PrEP coverage of 1 per 100 persons with indications. When controlling for VS, the state-specific EAPC for a given year decreased by 1.3% (95% CI, -2.12% to -.57%) for an increase in PrEP coverage of 1 per 100 persons with indications. CONCLUSIONS: We found statistically significant associations between jurisdictional increases in PrEP coverage and decreases in EAPC independent of changes in VS, which supports bringing PrEP use to scale in the US to accelerate reductions in HIV infections.

Missed Opportunities to Prescribe Preexposure Prophylaxis in South Carolina, 2013-2016.

Background: Expanding use of preexposure prophylaxis (PrEP) in ways that address current racial/ethnic disparities is an important human immunodeficiency virus (HIV) prevention goal. We investigated missed opportunities to provide PrEP during healthcare visits that occur prior to HIV infection. Methods: This retrospective cohort study linked South Carolina HIV case surveillance data to 3 statewide healthcare databases. Characteristics of patients, healthcare visits and providers, sexually transmitted diseases (STDs), and other diagnoses were assessed for medical encounters occurring before an initial HIV diagnosis. Adjusted odds ratios were used to identify correlates of missed opportunities for PrEP provision. Results: Of 885 persons newly diagnosed during the study period, 586 (66%) had 4029 visits to a healthcare facility prior to their HIV diagnosis (mean of 6.9 visits) with missed opportunities for provision of PrEP. Emergency medicine-trained clinicians conducted (61%) and primary care clinicians (family practice or internal medicine) conducted 10% of visits. Also, 42% of visits were by persons who were uninsured or self-paid, 36% had public insurance, and 18% had commercial insurance. In multivariable analyses, being female, black, or aged <30 years were statistically significant predictors of having prior healthcare visits. Among persons with at least 1 healthcare visit prior to their HIV diagnosis, 28.5% had a diagnosis of gonorrhea, syphilis, or chlamydia at any visit. Conclusions: Healthcare visits occurring among persons who would benefit from provision of PrEP, especially persons with diagnosed STDs, should be leveraged to increase use of PrEP and reduce the risk of HIV acquisition.

Addressing Gaps in HIV Preexposure Prophylaxis Care to Reduce Racial Disparities in HIV Incidence in the United States.

The potential for human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) to reduce the racial disparities in HIV incidence in the United States might be limited by racial gaps in PrEP care. We used a network-based mathematical model of HIV transmission for younger black and white men who have sex with men (BMSM and WMSM) in the Atlanta, Georgia, area to evaluate how race-stratified transitions through the PrEP care continuum from initiation to adherence and retention could affect HIV incidence overall and disparities in incidence between races, using current empirical estimates of BMSM continuum parameters. Relative to a no-PrEP scenario, implementing PrEP according to observed BMSM parameters was projected to yield a 23% decline in HIV incidence (hazard ratio = 0.77) among BMSM at year 10. The racial disparity in incidence in this observed scenario was 4.95 per 100 person-years at risk (PYAR), a 19% decline from the 6.08 per 100 PYAR disparity in the no-PrEP scenario. If BMSM parameters were increased to WMSM values, incidence would decline by 47% (hazard ratio = 0.53), with an associated disparity of 3.30 per 100 PYAR (a 46% decline in the disparity). PrEP could simultaneously lower HIV incidence overall and reduce racial disparities despite current gaps in PrEP care. Interventions addressing these gaps will be needed to substantially decrease disparities.

Vital Signs: Status of Human Immunodeficiency Virus Testing, Viral Suppression, and HIV Preexposure Prophylaxis - United States, 2013-2018.

BACKGROUND: Approximately 38,000 new human immunodeficiency virus (HIV) infections occur in the United States each year; these infections can be prevented. A proposed national initiative, Ending the HIV Epidemic: A Plan for America, incorporates three strategies (diagnose, treat, and prevent HIV infection) and seeks to leverage testing, treatment, and preexposure prophylaxis (PrEP) to reduce new HIV infections in the United States by at least 90% by 2030. Targets to reach this goal include that at least 95% of persons with HIV receive a diagnosis, 95% of persons with diagnosed HIV infection have a suppressed viral load, and 50% of those at increased risk for acquiring HIV are prescribed PrEP. Using surveillance, pharmacy, and other data, CDC determined the current status of these three initiative strategies. METHODS: CDC analyzed HIV surveillance data to estimate annual number of new HIV infections (2013-2017); estimate the percentage of infections that were diagnosed (2017); and determine the percentage of persons with diagnosed HIV infection with viral load suppression (2017). CDC analyzed surveillance, pharmacy, and other data to estimate PrEP coverage, reported as a percentage and calculated as the number of persons who were prescribed PrEP divided by the estimated number of persons with indications for PrEP. RESULTS: The number of new HIV infections remained stable from 2013 (38,500) to 2017 (37,500) (p = 0.448). In 2017, an estimated 85.8% of infections were diagnosed. Among 854,206 persons with diagnosed HIV infection in 42 jurisdictions with complete reporting of laboratory data, 62.7% had a suppressed viral load. Among an estimated 1.2 million persons with indications for use of PrEP, 18.1% had been prescribed PrEP in 2018. CONCLUSION: Accelerated efforts to diagnose, treat, and prevent HIV infection are needed to achieve the U.S. goal of at least 90% reduction in the number of new HIV infections by 2030.

The PrEP Care Continuum and Black Men Who Have Sex with Men: A Scoping Review of Published Data on Awareness, Uptake, Adherence, and Retention in PrEP Care.

Pre-exposure prophylaxis (PrEP) has demonstrated high efficacy to reduce HIV infections, however, racial/ethnic HIV disparities continue among black MSM. The purpose of this review was to assess available data to inform interventions to increase PrEP awareness, uptake, and adherence among black MSM. Of the 3024 studies retrieved, 36 met final inclusion criteria and were categorized into the PrEP care continuum: (1) awareness (n = 16), (2) uptake (n = 9), and (3) adherence (n = 12). Only 26 of the studies presented analytical findings by race/ethnicity. Key barrier themes included cost, HIV-related stigma, and fear of potential side effects. A key facilitator theme identified by black MSM included gaining PrEP awareness from social and sexual networks. There are significant gaps in research on black MSM and PrEP utilization, especially regarding PrEP uptake and adherence. These data are needed to inform interventions to address current inequities in PrEP services, to help improve care outcomes for black MSM.

HIV Preexposure Prophylaxis, by Race and Ethnicity - United States, 2014-2016.

Preexposure prophylaxis (PrEP) with a daily, oral pill containing antiretroviral drugs is highly effective in preventing acquisition of human immunodeficiency virus (HIV) infection (1-4). The combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) is the only medication approved by the Food and Drug Administration (FDA) for PrEP. PrEP is indicated for men and women with sexual or injection drug use behaviors that increase their risk for acquiring HIV (5). CDC analyzed 2014-2016 data from the IQVIA Real World Data - Longitudinal Prescriptions (IQVIA database) to estimate the number of persons prescribed PrEP (users) in the United States and to describe their demographic characteristics, including sex and race/ethnicity. From 2014 to 2016, the annual number of PrEP users aged ≥16 years increased by 470%, from 13,748 to 78,360. In 2016, among 32,853 (41.9%) PrEP users for whom race/ethnicity data were available, 68.7% were white, 11.2% were African American or black (black), 13.1% were Hispanic, and 4.5% were Asian. Approximately 7% of the estimated 1.1 million persons who had indications for PrEP were prescribed PrEP in 2016, including 2.1% of women with PrEP indications (6). Although black men and women accounted for approximately 40% of persons with PrEP indications (6), this study found that nearly six times as many white men and women were prescribed PrEP as were black men and women. The findings of this study highlight gaps in effective PrEP implementation efforts in the United States.

Uptake of HIV Preexposure Prophylaxis Among Commercially Insured Persons-United States, 2010-2014.

BACKGROUND: Daily, oral use of tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) for preexposure prophylaxis (PrEP) is an effective strategy to prevent acquisition of human immunodeficiency virus (HIV) infection. It is important to monitor PrEP uptake at the national level to increase our understanding of trends in its utilization, but national HIV surveillance data do not include PrEP uptake. Our objective was to develop feasible methods to estimate PrEP uptake and to estimate uptake each year among commercially insured persons during 2010-2014. METHODS: We conducted a retrospective analysis of the 2010-2014 MarketScan database, a national sample of persons with commercial health insurance in the United States. We developed an algorithm to identify persons aged ≥16 years who were prescribed TDF-FTC for PrEP each year. We generated nationally representative estimates of prevalence of persons prescribed PrEP. RESULTS: We found a significantly increasing trend in the proportion of persons prescribed TDF-FTC for PrEP during the study period, with 417 users in 2010 and 9375 in 2014 (P < .001); 97% of PrEP users were male and 98% lived in metropolitan areas in 2014. During the study period, the numbers of women prescribed PrEP were low. CONCLUSIONS: Our analytic method provides the only feasible means to monitor PrEP uptake in the United States. Although a marked increasing trend in uptake was observed for men, the number of women who used PrEP remained very low during the study period. Interventions are needed to increase PrEP use by women at substantial risk of acquiring HIV infection.

Incidence of Gonorrhea and Chlamydia Following Human Immunodeficiency Virus Preexposure Prophylaxis Among Men Who Have Sex With Men: A Modeling Study.

Background: Preexposure prophylaxis (PrEP) is highly effective for preventing human immunodeficiency virus (HIV) infection, but risk compensation (RC) in men who have sex with men (MSM) raises concerns about increased sexually transmitted infections (STIs). The Center for Disease Control and Prevention's (CDC's) PrEP guidelines recommend biannual STI screening, which may reduce incidence by treating STIs that would otherwise remain undiagnosed. We investigated these two counteracting phenomena. Methods: With a network-based mathematical model of HIV, Neisseria gonorrhoeae (NG), and Chlamydia trachomatis (CT) transmission dynamics among MSM in the United States, we simulated PrEP uptake following the prescription indications and HIV/STI screening recommendations in the CDC guidelines. Scenarios varied PrEP coverage (the proportion of MSM indicated for PrEP who received it), RC (a reduction in the per-act probability of condom use), and the STI screening interval. Results: In our reference scenario (40% coverage, 40% RC), 42% of NG and 40% of CT infections would be averted over the next decade. A doubling of RC would still result in net STI prevention relative to no PrEP. STIs declined because PrEP-related STI screening resulted in a 17% and 16% absolute increase in the treatment of asymptomatic and rectal STIs, respectively. Screening and timely treatment at quarterly vs biannual intervals would reduce STI incidence an additional 50%. Conclusions: Implementation of the CDC PrEP guidelines while scaling up PrEP coverage could result in a significant decline in STI incidence among MSM. Our study highlights the design of PrEP not only as antiretroviral medication but as combination HIV/STI prevention incorporating STI screening.

Effects of Antiretroviral Therapy to Prevent HIV Transmission to Women in Couples Attempting Conception When the Man Has HIV Infection - United States, 2017.

Existing U.S. guidelines recommend that men with human immunodeficiency virus (HIV) infection should achieve virologic suppression* with effective antiretroviral therapy (ART) before attempting conception (1). Clinical studies have demonstrated that effective ART profoundly reduces the risk for HIV transmission (2-4). This information might be useful for counseling couples planning a pregnancy in which the man has HIV infection and the woman does not (i.e., a mixed HIV-status couple, often referred to as a serodiscordant couple).