CDC Clinical Guidelines on the Use of Doxycycline Postexposure Prophylaxis for Bacterial Sexually Transmitted Infection Prevention, United States, 2024.

No vaccines and few chemoprophylaxis options exist for the prevention of bacterial sexually transmitted infections (STIs) (specifically syphilis, chlamydia, and gonorrhea). These infections have increased in the United States and disproportionately affect gay, bisexual, and other men who have sex with men (MSM) and transgender women (TGW). In three large randomized controlled trials, 200 mg of doxycycline taken within 72 hours after sex has been shown to reduce syphilis and chlamydia infections by >70% and gonococcal infections by approximately 50%. This report outlines CDC's recommendation for the use of doxycycline postexposure prophylaxis (doxy PEP), a novel, ongoing, patient-managed biomedical STI prevention strategy for a selected population. CDC recommends that MSM and TGW who have had a bacterial STI (specifically syphilis, chlamydia, or gonorrhea) diagnosed in the past 12 months should receive counseling that doxy PEP can be used as postexposure prophylaxis to prevent these infections. Following shared decision-making with their provider, CDC recommends that providers offer persons in this group a prescription for doxy PEP to be self-administered within 72 hours after having oral, vaginal, or anal sex. The recommended dose of doxy PEP is 200 mg and should not exceed a maximum dose of 200 mg every 24 hours.Doxy PEP, when offered, should be implemented in the context of a comprehensive sexual health approach, including risk reduction counseling, STI screening and treatment, recommended vaccination and linkage to HIV PrEP, HIV care, or other services as appropriate. Persons who are prescribed doxy PEP should undergo bacterial STI testing at anatomic sites of exposure at baseline and every 3-6 months thereafter. Ongoing need for doxy PEP should be assessed every 3-6 months as well. HIV screening should be performed for HIV-negative MSM and TGW according to current recommendations.

The Effect of Navigation on Linkage to a PrEP Provider Among PrEP-Eligible Men who have Sex with Men in a U.S. Demonstration Project.

Our objective is to evaluate the effect of navigation on linkage to a PrEP provider among PrEP-eligible men who have sex with men (MSM) in THRIVE, a demonstration project in seven U.S. public health jurisdictions during 2015-2020. We describe PrEP linkage and navigation use among MSM in THRIVE. We performed multivariable probit regression modeling, controlling for demographic covariates, to estimate the association between navigation and linkage to a PrEP provider among MSM and to assess for disparities in linkage to PrEP among MSM who used navigation. Among 9538 PrEP-eligible MSM, 51.3% used navigation and 53.8% were linked to PrEP. From the three sites where navigation was optional and the main form of PrEP support, MSM who used navigation were 16.69 times (95% CI 13.07-21.32) more likely to link to PrEP compared with MSM who did not use navigation. Among 4895 MSM who used navigation from all seven sites, Black MSM were 21% less likely to link to PrEP compared with White MSM (aRR 0.79; 95% CI 0.74-0.83). Navigation is a promising strategy for improving uptake of PrEP among U.S. MSM, but disparities persist. Addressing the underlying causes of inequities will be important to end the HIV epidemic.

Impact of Providing Preexposure Prophylaxis for Human Immunodeficiency Virus at Clinics for Sexually Transmitted Infections in Baltimore City: An Agent-based Model.

BACKGROUND: Preexposure prophylaxis (PrEP) greatly reduces the risk of human immunodeficiency virus (HIV) acquisition, but its optimal delivery strategy remains uncertain. Clinics for sexually transmitted infections (STIs) can provide an efficient venue for PrEP delivery. METHODS: To quantify the added value of STI clinic-based PrEP delivery, we used an agent-based simulation of HIV transmission among men who have sex with men (MSM). We simulated the impact of PrEP delivery through STI clinics compared with PrEP delivery in other community-based settings. Our primary outcome was the projected 20-year reduction in HIV incidence among MSM. RESULTS: Assuming PrEP uptake and adherence of 60% each, evaluating STI clinic attendees and delivering PrEP to eligible MSM reduced HIV incidence by 16% [95% uncertainty range, 14%-18%] over 20 years, an impact that was 1.8 (1.7-2.0) times as great as that achieved by evaluating an equal number of MSM recruited from the community. Comparing strategies where an equal number of MSM received PrEP in each strategy (ie, evaluating more individuals for PrEP in the community-based strategy, because MSM attending STI clinics are more likely to be PrEP eligible), the reduction in HIV incidence under the STI clinic-based strategy was 1.3 (1.3-1.4) times as great as that of community-based delivery. CONCLUSIONS: Delivering PrEP to MSM who attend STI clinics can improve efficiency and effectiveness. If high levels of adherence can be achieved in this population, STI clinics may be an important venue for PrEP implementation.

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.

Equity of PrEP uptake by race, ethnicity, sex and region in the United States in the first decade of PrEP: a population-based analysis.

Background: PrEP was approved for HIV prevention in the US in 2012; uptake has been slow. We describe relative equity with the PrEP Equity Ratio (PER), a ratio of PrEP-to-Need Ratios (PnRs). Methods: We used commercial pharmacy data to enumerate PrEP users by race and ethnicity, sex, and US Census region from 2012 to 2021. We report annual race and ethnicity-, sex-, and region-specific rates of PrEP use and PnR, a metric of PrEP equity, to assess trends. Findings: PrEP use increased for Black, Hispanic and White Americans from 2012 to 2021. By 2021, the rate of PrEP use per population was similar in Black and White populations but slightly lower among Hispanic populations. PnR increased from 2012 to 2021 for all races and ethnicities and regions; levels of PrEP use were inconsistent across regions and highly inequitable by race, ethnicity, and sex. In all regions, PnR was highest for White and lowest for Black people. Inequity in PrEP use by race and ethnicity, as measured by the PER, grew early after availability of PrEP and persisted at a level substantially below equitable PrEP use. Interpretation: From 2012 to 2021, PrEP use increased among Americans, but PrEP equity for Black and Hispanic Americans decreased. The US South lagged all regions in equitable PrEP use. Improved equity in PrEP use will be not only just, but also impactful on the US HIV epidemic; persons most at-risk of acquiring HIV should have the highest levels of access to PrEP. Prevention programs should be guided by PrEP equity, not PrEP equality. Funding: National Institutes of Health, Gilead Sciences.

Impacts of COVID-19 on sexual behaviors, HIV prevention and care among men who have sex with men: A comparison of New York City and Metropolitan Atlanta.

The COVID-19 pandemic has disrupted HIV prevention, care, and transmission opportunities. This likely varies by geography, given differences in COVID-19 burden and mandates over time, and by age, given different likelihoods of severe COVID-19 consequences. We consider changes in sexual behavior, HIV testing, pre-exposure prophylaxis (PrEP) use and antiretroviral therapy (ART) use among men who have sex with men (MSM) over the first year of the COVID-19 epidemic, comparing the Atlanta metropolitan area and New York City (NYC). We use two continuous time-series datasets and one panel dataset, assessing changes over time within city and comparing across cities, and disaggregate major findings by age. For clinical results, ART use showed by far the smallest reductions, and testing the largest. Disruptions occurred concurrently between cities, despite the major wave of COVID-19, and government mandates, occurring later in Atlanta. Test positivity increased in NYC only. In both cities, younger MSM saw the greatest reductions in testing and PrEP use, but the smallest in sexual behavior. Reduced clinical service usage would be unconcerning if stemming solely from reductions in exposure; however, the patterns for young MSM suggest that the COVID-19 epidemic likely generated new conditions for increased HIV transmission, especially in this cohort.

HIV Preexposure Prophylaxis Provision among Adolescents: 2018 to 2021.

BACKGROUND AND OBJECTIVES: HIV preexposure prophylaxis (PrEP) is safe, effective, and was approved for adolescents in 2018. Adolescents and young adults make up 20% of HIV diagnoses in the United States. Our objective was to describe trends in adolescents prescribed PrEP during 2018 through 2021 and characteristics of these adolescents and their PrEP providers. METHODS: We identified adolescents aged 13 to 19 years with oral PrEP prescriptions during 2018 through 2021 in a national pharmacy database using a validated algorithm. We assessed trends by calculating the overall percentage change and estimated annual percentage change with 95% confidence intervals. We described characteristics of adolescents and their PrEP providers in 2021. We performed χ2 analyses to assess differences by sex and age group. RESULTS: The number of adolescents prescribed PrEP increased 76.2% from 2018 to 2021 (estimated annual percentage change: 18.0% [95% confidence interval: 16.6-19.5]), despite decreases in 2020. We observed increases among all sex and age groups, with larger increases among older adolescents aged 18 to 19 years. The majority of the 6444 adolescents prescribed PrEP in 2021 were male (82.6%) and aged 18 to 19 years (87.8%). Among 2455 physician PrEP providers, 29.6% were pediatricians, with varying specialty distributions by adolescent age group (P < .001). Among the 217 pediatricians who prescribed PrEP to adolescents aged 13 to 17 years, 67.7% were general pediatricians. CONCLUSIONS: PrEP provision for adolescents has increased, largely among older and male adolescents. The availability of PrEP provides an important opportunity for pediatric providers to take an active role in HIV prevention.

HIV Prevention Services for Hispanic/Latino Persons in THRIVE, 2015-2020.

INTRODUCTION: Hispanic/Latino men who have sex with men (MSM) and transgender women (TGW) are disproportionately affected by HIV in the U.S. This study evaluated HIV prevention services and outcomes among Hispanic/Latino MSM and TGW in the Targeted Highly Effective Interventions to Reduce the HIV Epidemic (THRIVE) demonstration project and consider lessons learned. METHODS: The authors described the THRIVE demonstration project services provided to Hispanic/Latino MSM and TGW in 7 U.S. jurisdictions from 2015 to 2020. HIV prevention service outcomes were compared between 1 site with (2,147 total participants) and 6 sites without (1,129 total participants) Hispanic/Latino-oriented pre-exposure prophylaxis clinical services, and Poisson regression was used to estimate the adjusted RR between sites and pre-exposure prophylaxis outcomes. Analyses were conducted from 2021 to 2022. RESULTS: The THRIVE demonstration project served 2,898 and 378 Hispanic/Latino MSM and TGW, respectively, with 2,519 MSM (87%) and 320 TGW (85%) receiving ≥1 HIV screening test. Among 2,002 MSM and 178 TGW eligible for pre-exposure prophylaxis, 1,011 (50%) MSM and 98 (55%) TGW received pre-exposure prophylaxis prescriptions, respectively. MSM and TGW were each 2.0 times more likely to be linked to pre-exposure prophylaxis (95% CI=1.4, 2.9 and 95% CI=1.2, 3.6, respectively) and 1.6 and 2.1 times more likely to be prescribed pre-exposure prophylaxis (95% CI=1.1, 2.2 and 95% CI=1.1, 4.1), respectively, at the site providing Hispanic/Latino-oriented pre-exposure prophylaxis clinical services than at other sites and adjusted for age group. CONCLUSIONS: The THRIVE demonstration project delivered comprehensive HIV prevention services to Hispanic/Latino MSM and TGW. Hispanic/Latino-oriented clinical settings may improve HIV prevention service delivery to persons in Hispanic/Latino communities.

HIV Pre-exposure Prophylaxis Services for Black and Hispanic or Latino Gay, Bisexual, and Other Men Who Have Sex With Men and Transgender Women in THRIVE, 2015-2020.

BACKGROUND AND SETTING: From 2015 to 2020, the THRIVE project supported 7 US health departments to improve HIV prevention services for Black or African American (Black) and Hispanic or Latino gay, bisexual, and other men who have sex with men (GBM) and transgender women (TGW). METHODS: We described services provided in the THRIVE PrEP continuum. Using Poisson regression models, we estimated associations between race or ethnicity and age and PrEP screening, linkage, and prescription. We examined associations between colocation of services and PrEP linkage and prescription for 2 sites. RESULTS: THRIVE served 12,972 GBM without HIV; 37% of PrEP-eligible GBM were prescribed PrEP. THRIVE served 1185 TGW without HIV; 45% of PrEP-eligible TGW were prescribed PrEP. Black and Hispanic or Latino GBM were 29% (RR = 0.71, 95% CI: 0.66-0.77) and 19% (RR = 0.81, 95% CI: 0.75-0.87) less likely, respectively, to be prescribed PrEP than White GBM. GBM aged 18-24 years and 55 years or older were 19% (RR = 0.81, 95% CI: 0.75-0.87) and 22% (RR = 0.78, 95% CI: 0.67-0.9) less likely, respectively, to be prescribed PrEP compared with those aged 35-44 years. Colocated services were associated with a 54% (RR = 1.54, 95% CI: 1.44-1.64) and a 31% (RR = 1.31, 95% CI: 1.19-1.43) greater likelihood of PrEP linkage and prescription, respectively, compared with services at different locations. CONCLUSIONS: THRIVE provided PrEP to higher proportions of PrEP-eligible persons than current national estimates; however, PrEP use disparities persist. Colocation of services may be a useful component of jurisdictional strategies to increase PrEP coverage.

Restricting Access: A Secondary Analysis of Scope of Practice Laws and Pre-exposure Prophylaxis Prescribing in the United States, 2017.

ABSTRACT: To assess advanced practitioners' scope of practice laws (i.e., legal authority providers can prescribe regulated medications) as potential barriers to HIV pre-exposure prophylaxis (PrEP), we conducted an analysis using IQVIA Real World Data in association with scope of practice law classifications supplied by the American Association of Nurse Practitioners and scopeofpracticepolicy.org. Nurse practitioners in states that allowed independent scope of practice were 1.4 times more likely to have prescribed PrEP compared with nurse practitioners in states where their prescribing authority is determined by a supervising medical doctor (MD). Physician assistants in states where the law or a state board defined their prescribing authority were more than twice as likely to prescribe PrEP compared with those in states where a supervising MD oversaw prescribing rights. Our findings suggest that restricting scope of prescribing practice by requiring MD oversight limits PrEP access and poses a barrier to scaling up PrEP.

Trends in the Number and Characteristics of HIV Pre-Exposure Prophylaxis Providers in the United States, 2014-2019.

BACKGROUND: The number and characteristics of pre-exposure prophylaxis (PrEP) health care providers in the United States have not been reported. METHODS: We analyzed a national pharmacy database that included >90% of all prescriptions dispensed by retail pharmacies and 60%-86% dispensed by mail-order outlets. We estimated the number of PrEP providers by year, provider type, physician specialty, and geographic location. We also measured the Gini coefficients for the distribution of PrEP patients among providers. RESULTS: The number of PrEP providers increased from 9621 in 2014 to 65,822 in 2019. In 2019, 68.1% of PrEP providers were physicians. The proportion of nurse practitioners or physician assistants increased from 18.0% in 2014 to 29.7% in 2019. Among all the US health care providers, those who prescribed PrEP increased from 0.7% in 2014 to 4.3% in 2019. Among all general practice/family medicine physicians, the percentage of who prescribed PrEP increased from 1.8% in 2014 to 13.6% in 2019 and from 14.2% to 34.2% among infectious disease physicians. The ratio of PrEP providers to 100 persons with PrEP indications was lowest in the South with 4.4. The Gini coefficient for the distribution of PrEP patients among providers was 0.75 in 2019, with 50% of the PrEP patients prescribed PrEP by 2.2% of PrEP providers. CONCLUSIONS: An increasing number of providers prescribed PrEP during 2014-2019. The South had the largest number of new HIV diagnoses and greatest need for HIV prevention but had less PrEP service capacity compared with other regions. Expanded access to PrEP services is needed in the United States.

HIV Diagnoses and the HIV Care Continuum Among Women and Girls Aged ≥13 Years-39 States and the District of Columbia, 2015-2016.

BACKGROUND: In 2017, 19% of new HIV diagnoses in the United States were in women. HIV acquisition can be prevented with pre-exposure prophylaxis, and HIV transmission with viral suppression. HIV viral suppression is achieved by linking women to care and supporting adherence to antiretroviral medications. The national HIV prevention goal for viral suppression is 80%. SETTING: United States. METHODS: We analyzed data reported by 40 US jurisdictions to the Centers for Disease Control and Prevention's National HIV Surveillance System to determine the number and rate of HIV diagnoses per 100,000 women in 2016. We also determined the percentages of women with diagnosed HIV who were linked to care within 1 and 3 months, received HIV care, were retained in HIV care, and were virally suppressed in 2015. Findings were stratified by demographic characteristics and HIV transmission category. RESULTS: In 2016, 6407 women were diagnosed with HIV. Black women had a rate of 783.7 per 100,000, Hispanic/Latino women 182.7, and white women 43.6. In 2015, 190,735 women were living with diagnosed HIV. Viral suppression increased with age, ranging from 46.5% among women aged 13-24 years to 62.3% among women aged ≥45 years. Black women had the lowest rate of viral suppression (55.5%). No age group of women achieved 80% viral suppression. CONCLUSIONS: Pre-exposure prophylaxis implementation for women at high risk for HIV infection can help to decrease new infections. Women living with HIV would benefit from interventions that support linkage to HIV care and antiretroviral medication adherence to increase viral suppression.

Optimal costs of HIV pre-exposure prophylaxis for men who have sex with men.

INTRODUCTION: Men who have sex with men (MSM) are disproportionately affected by HIV due to their increased risk of infection. Oral pre-exposure prophylaxis (PrEP) is a highly effictive HIV-prevention strategy for MSM. Despite evidence of its effectiveness, PrEP uptake in the United States has been slow, in part due to its cost. As jurisdictions and health organizations begin to think about PrEP scale-up, the high cost to society needs to be understood. METHODS: We modified a previously-described decision-analysis model to estimate the cost per quality-adjusted life-year (QALY) gained, over a 1-year duration of PrEP intervention and lifetime time horizon. Using updated parameter estimates, we calculated: 1) the cost per QALY gained, stratified over 4 strata of PrEP cost (a function of both drug cost and provider costs); and 2) PrEP drug cost per year required to fall at or under 4 cost per QALY gained thresholds. RESULTS: When PrEP drug costs were reduced by 60% (with no sexual disinhibition) to 80% (assuming 25% sexual disinhibition), PrEP was cost-effective (at <$100,000 per QALY averted) in all scenarios of base-case or better adherence, as long as the background HIV prevalence was greater than 10%. For PrEP to be cost saving at base-case adherence/efficacy levels and at a background prevalence of 20%, drug cost would need to be reduced to $8,021 per year with no disinhibition, and to $2,548 with disinhibition. CONCLUSION: Results from our analysis suggest that PrEP drug costs need to be reduced in order to be cost-effective across a range of background HIV prevalence. Moreover, our results provide guidance on the pricing of generic emtricitabine/tenofovir disoproxil fumarate, in order to provide those at high risk for HIV an affordable prevention option without financial burden on individuals or jurisdictions scaling-up coverage.

Differences in access to healthcare and utilisation of HIV and sexually transmissible infection services between men who have sex with men and men who have sex only with women: results of the 2006-10 National Survey of Family Growth in the United States.

UNLABELLED: Background Men who have sex with men (MSM) experience disparities in access to healthcare and have specific healthcare needs. METHODS: We analysed data from the 2006-10 National Survey of Family Growth (NSFG) to examine differences in access to healthcare and HIV and sexually transmissible infection (STI) related health services by MSM and non-MSM among men in the United States aged 15-44 years who have ever had sex. MSM and sexually active MSM were identified in the NSFG as men who had ever had oral or anal sex with another man, or who had sex in the past 12 months with another man, respectively. Access was measured by the type of health insurance, having a usual place for receiving healthcare and type of usual place. RESULTS: Of men aged 15-44 years who have ever had sex, there were no significant differences between MSM and non-MSM in the three access measures. MSM were more likely than non-MSM to receive HIV counselling (22.5% v. 8.3%) and STI testing (26.2% v. 15.6%) in the past 12 months, or to ever have had HIV testing (67.8% v. 44.6%). STI testing in the past 12 months was reported by 38.7% of sexually active MSM. CONCLUSION: Our findings show no significant differences in access to healthcare between MSM and non-MSM. MSM were more likely to receive HIV- and STI-related preventive services than non-MSM. However, the low STI testing rate among MSM highlights the need for interventions to increase STI testing, and HIV and STI counselling for MSM.

Utilization of health services in physician offices and outpatient clinics by adolescents and young women in the United States: implications for improving access to reproductive health services.

PURPOSE: We examined utilization patterns of adolescents and young women as they seek general and reproductive health services in physician offices and hospital outpatient clinics. METHODS: We analyzed physician office visits in the 2003-2006 National Ambulatory Medical Care Surveys, and hospital outpatient clinic visits in the National Hospital Ambulatory Medical Care Surveys, to examine utilization patterns of females aged 9-26 years by 2-year age intervals and other characteristics such as physician specialty or clinic type. RESULTS: The number of visits to primary care physician offices increased with age, from 4.9 million for ages 9-10 years to 9.0 million for ages 25-26 years. The proportion of visits made to obstetrician-gynecologists and family practitioners increased with age, and by ages 15-16 years fewer than half of all visits to primary care providers were made to pediatricians. The proportion of visits to family practitioners increased from 25% at ages 9-10 years to 30% at ages 25-26 years. By ages 17-18 years, a larger proportion of visits were made to obstetrician-gynecologists (33% of 7.0 million visits) and to family practitioners (34%) than to pediatricians (23%). The proportion of visits for reproductive health services peaked at 53% of 7.5 million physician visits at ages 20-21 years. Similar utilization patterns were observed for the 11.0 million hospital outpatient visits to primary care providers. CONCLUSIONS: Because adolescents and young women most commonly utilize healthcare services provided by obstetrician-gynecologists and family practitioners, these specialties should be priority targets for interventions to improve the quality and availability of reproductive health services.