Population Percentage and Population Size of Men Who Have Sex With Men in the United States, 2017-2021: Meta-Analysis of 5 Population-Based Surveys.

BACKGROUND: Male-to-male sexual transmission continues to account for the greatest proportion of new HIV diagnoses in the United States. However, calculating population-specific surveillance metrics for HIV and other sexually transmitted infections requires regularly updated estimates of the number and proportion of men who have sex with men (MSM) in the United States, which are not collected by census surveys. OBJECTIVE: The purpose of this analysis was to estimate the number and percentage of MSM in the United States from population-based surveys. METHODS: We used data from 5 population-based surveys to calculate weighted estimates of the proportion of MSM in the United States and pooled these estimates using meta-analytic procedures. We estimated the proportion of MSM using sexual behavior-based questions (encompassing anal or oral sex) for 3 recall periods-past 12 months, past 5 years, and lifetime. In addition, we estimated the proportion of MSM using self-reported identity and attraction survey responses. The total number of MSM and non-MSM in the United States were calculated from estimates of the percentage of MSM who reported sex with another man in the past 12 months. RESULTS: The percentage of MSM varied by recall period: 3.3% (95% CI 1.7%-4.9%) indicated sex with another male in the past 12 months, 4.7% (95% CI 0.0%-33.8%) in the past 5 years, and 6.2% (95% CI 2.9%-9.5%) in their lifetime. There were comparable percentages of men who identified as gay or bisexual (3.4%, 95% CI 2.2%-4.6%) or who indicated that they are attracted to other men (4.9%, 95% CI 3.1%-6.7%) based on pooled estimates. Our estimate of the total number of MSM in the United States is 4,230,000 (95% CI 2,179,000-6,281,000) based on the history of recent sexual behavior (sex with another man in the past 12 months). CONCLUSIONS: We calculated the pooled percentage and number of MSM in the United States from a meta-analysis of population-based surveys collected from 2017 to 2021. These estimates update and expand upon those derived from the Centers for Disease Control and Prevention in 2012 by including estimates of the percentage of MSM based on sexual identity and sexual attraction. The percentage and number of MSM in the United States is an important indicator for calculating population-specific disease rates and eligibility for preventive interventions such as pre-exposure prophylaxis.

Randomized controlled phase IIa clinical trial of safety, pharmacokinetics and pharmacodynamics of tenofovir and tenofovir plus levonorgestrel releasing intravaginal rings used by women in Kenya.

Introduction: Globally, many young women face the overlapping burden of HIV infection and unintended pregnancy. Protection against both may benefit from safe and effective multipurpose prevention technologies. Methods: Healthy women ages 18-34 years, not pregnant, seronegative for HIV and hepatitis B surface antigen, not using hormonal contraception, and at low risk for HIV were randomized 2:2:1 to continuous use of a tenofovir/levonorgestrel (TFV/LNG), TFV, or placebo intravaginal ring (IVR). In addition to assessing genital and systemic safety, we determined TFV concentrations in plasma and cervicovaginal fluid (CVF) and LNG levels in serum using tandem liquid chromatography-mass spectrometry. We further evaluated TFV pharmacodynamics (PD) through ex vivo CVF activity against both human immunodeficiency virus (HIV)-1 and herpes simplex virus (HSV)-2, and LNG PD using cervical mucus quality markers and serum progesterone for ovulation inhibition. Results: Among 312 women screened, 27 were randomized to use one of the following IVRs: TFV/LNG (n = 11); TFV-only (n = 11); or placebo (n = 5). Most screening failures were due to vaginal infections. The median days of IVR use was 68 [interquartile range (IQR), 36-90]. Adverse events (AEs) were distributed similarly among the three arms. There were two non-product related AEs graded >2. No visible genital lesions were observed. Steady state geometric mean amount (ssGMA) of vaginal TFV was comparable in the TFV/LNG and TFV IVR groups, 43,988 ng/swab (95% CI, 31,232, 61,954) and 30337 ng/swab (95% CI, 18,152, 50,702), respectively. Plasma TFV steady state geometric mean concentration (ssGMC) was <10 ng/ml for both TFV IVRs. In vitro, CVF anti-HIV-1 activity showed increased HIV inhibition over baseline following TFV-eluting IVR use, from a median of 7.1% to 84.4% in TFV/LNG, 15.0% to 89.5% in TFV-only, and -27.1% to -20.1% in placebo participants. Similarly, anti-HSV-2 activity in CVF increased >50 fold after use of TFV-containing IVRs. LNG serum ssGMC was 241 pg/ml (95% CI 185, 314) with rapid rise after TFV/LNG IVR insertion and decline 24-hours post-removal (586 pg/ml [95% CI 473, 726] and 87 pg/ml [95% CI 64, 119], respectively). Conclusion: TFV/LNG and TFV-only IVRs were safe and well tolerated among Kenyan women. Pharmacokinetics and markers of protection against HIV-1, HSV-2, and unintended pregnancy suggest the potential for clinical efficacy of the multipurpose TFV/LNG IVR. Clinical Trial Registration: NCT03762382 [https://clinicaltrials.gov/ct2/show/NCT03762382].

Achieving Elimination of Perinatal HIV in the United States.

ABSTRACT: In 2012, the Centers for Disease Control and Prevention published a Framework for Elimination of Perinatal Transmission of HIV in the United States in Pediatrics, setting the goals of an incidence of <1 case of perinatal HIV per 100 000 live births, and a perinatal transmission rate of <1%. We used National HIV Surveillance System data to monitor the numbers of perinatally acquired HIV cases among US-born persons and perinatal HIV diagnosis rates per 100 000 live births to approximate incidence. Perinatal HIV transmission rates from 2010 to 2019 were calculated by using estimates of live births to women with an HIV diagnosis from the National Inpatient Sample, Healthcare Cost and Utilization Project. The annual estimated number of live births to women with diagnosed HIV decreased from 4587 in 2010 to 3525 in 2019, and the number of US-born infants with perinatally acquired HIV decreased from 74 in 2010 to 32 in 2019. Annual perinatal HIV diagnosis rates declined from 1.9 to 0.9 per 100 000 live births, and perinatal HIV transmission rates declined from 1.6% to 0.9%. Racial and ethnic disparities in HIV diagnosis rates persisted but declined substantially over the 10-year period. Both diagnosis and transmission rate elimination goals were first achieved in 2019. To maintain the elimination of perinatal HIV, and to eliminate racial disparities, the continued coordinated effort of health care and public health is required. The approach to perinatal HIV elimination is a public health model that can be replicated or expanded to areas beyond HIV.

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.

An estimate of excess deaths among people with HIV during the coronavirus disease 2019 pandemic in the United States, 2020.

We developed an ad hoc method to estimate the number of excess deaths among persons with HIV (PWH) during the coronavirus disease 2019 (COVID-19) pandemic in the United States. Using this method, we estimated approximately 1448 excess deaths from COVID-19 among PWH in 2020 in the United States. We also developed an Excel workbook for use as a tool to quickly assess excess deaths among PWH in settings with limited surveillance data.

Decreased Human Immunodeficiency Virus Diagnosis Rates Among Black and Hispanic or Latino Men Who Have Sex With Men in US Jurisdictions Supported by the THRIVE Demonstration Project, 2014-2019.

BACKGROUND: Black and Hispanic/Latino men who have sex with men (MSM) are disproportionately affected by human immunodeficiency virus (HIV). In the Targeted Highly Effective Interventions to Reverse the HIV Epidemic (THRIVE) demonstration project, 7 community collaboratives were developed to provide comprehensive HIV prevention services for these populations. METHODS: We analyzed National HIV Surveillance System data to determine the number of HIV diagnoses for each year from 2014 to 2019 among Black, Hispanic/Latino, and White MSM in 7 THRIVE-eligible Metropolitan Statistical Areas (MSAs) that were awarded funding and 12 THRIVE-eligible MSAs that were not awarded funding. We used generalized linear Poisson regression models to estimate adjusted estimated annual percentage changes (EAPCs) with 95% confidence intervals for HIV diagnosis rates controlling for HIV prevalence, viral suppression, HIV testing rates, preexposure prophylaxis (PrEP) prescription rates, poverty, education, and insurance status. RESULTS: We found larger estimated decreases in HIV diagnosis rates in THRIVE jurisdictions compared with non-THRIVE jurisdictions. The adjusted EAPC among Black MSM was -8.2 (-11.7 to -4.6) in THRIVE MSAs compared with -4.2 (-7.8 to -0.4) in non-THRIVE MSAs. The adjusted EAPC among Hispanic/Latino MSM was -8.6 (-12.2 to -4.8) in THRIVE MSAs compared with -2.6 (-5.1 to -0.1)in non-THRIVE MSAs. The adjusted EAPC among White MSM was -7.6 (-12.0 to -3.1) in THRIVE MSAs compared with 5.9 (1.8-10.1) in non-THRIVE MSAs. CONCLUSIONS: The THRIVE community collaborative model was associated with a decrease in HIV diagnoses among Black and Hispanic/Latino MSM. To achieve the goals of the US Ending the HIV Epidemic initiative, effective interventions aimed to increase PrEP use need to be focused on Black and Hispanic/Latino MSM.

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.

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.

HIV Services and Outcomes During the COVID-19 Pandemic - United States, 2019-2021.

Increasing HIV testing, preexposure prophylaxis (PrEP), and antiretroviral therapy (ART) are pillars of the federal Ending the HIV Epidemic in the U.S. (EHE) initiative, with a goal of decreasing new HIV infections by 90% by 2030.* In response to the COVID-19 pandemic, a national emergency was declared in the United States on March 13, 2020, resulting in the closure of nonessential businesses and most nonemergency health care venues; stay-at-home orders also limited movement within communities (1). As unemployment increased during the pandemic (2), many persons lost employer-sponsored health insurance (3). HIV testing and PrEP prescriptions declined early in the COVID-19 pandemic (4-6); however, the full impact of the pandemic on use of HIV prevention and care services and HIV outcomes is not known. To assess changes in these measures during 2019-2021, quarterly data from two large U.S. commercial laboratories, the IQVIA Real World Data - Longitudinal Prescription Database (IQVIA),† and the National HIV Surveillance System (NHSS)§ were analyzed. During quarter 1 (Q1)¶ 2020, a total of 2,471,614 HIV tests were performed, 190,955 persons were prescribed PrEP, and 8,438 persons received a diagnosis of HIV infection. Decreases were observed during quarter 2 (Q2), with 1,682,578 HIV tests performed (32% decrease), 179,280 persons prescribed PrEP (6% decrease), and 6,228 persons receiving an HIV diagnosis (26% decrease). Partial rebounds were observed during quarter 3 (Q3), with 2,325,554 HIV tests performed, 184,320 persons prescribed PrEP, and 7,905 persons receiving an HIV diagnosis. The proportion of persons linked to HIV care, the number who were prescribed ART, and proportion with a suppressed viral load test (<200 copies of HIV RNA per mL) among those tested were stable during the study period. During public health emergencies, delivery of HIV services outside of traditional clinical settings or that use nonclinical delivery models are needed to facilitate access to HIV testing, ART, and PrEP, as well as to support adherence to ART and PrEP medications.

Impact of the coronavirus disease 2019 pandemic on prescriptions for antiretroviral drugs for HIV treatment in the United States, 2019-2021.

OBJECTIVE: To assess disruption in healthcare services for HIV treatment by national emergency in response to the coronavirus disease 2019 (COVID-19) pandemic in the United States. DESIGN: Time-series analysis. METHODS: We analyzed the IQVIA Real World Data-Longitudinal Prescriptions Database and calculated time trends in the weekly number of persons with active antiretroviral prescriptions for HIV treatment, and of persons who obtained antiretroviral prescriptions during January 2017-March 2021. We used interrupted time-series models to estimate the impact of the COVID-19 pandemic on antiretroviral therapy (ART) use between March 2020 and March 2021. RESULTS: We found that the weekly number of persons with active antiretroviral prescriptions decreased by an average 2.5% (95% confidence interval [CI]: -3.8% to -1.1%), compared to predicted use, during March 2020 through March 2021. The weekly number of persons who obtained antiretroviral prescriptions decreased 4.5% (95% CI: -6.0% to -3.0%), compared to the predicted number. Men, persons aged ≤34 years, privately insured persons, and persons in medication assistance programs had greater decreases than other groups. CONCLUSIONS: We demonstrated a decrease in the number of persons with active antiretroviral prescriptions during the first year of the COVID-19 pandemic and the number did not return to levels expected in the absence of the pandemic. Disruptions in HIV care and decreased ART may lead to lower levels of viral suppression and immunologic control, and increased HIV transmission in the community.

Genital microbiota of women using a 90 day tenofovir or tenofovir and levonorgestrel intravaginal ring in a placebo controlled randomized safety trial in Kenya.

In a phase-IIa trial, we investigated the influence of 90 days continuous-delivery tenofovir (TFV) intravaginal rings (IVRs) with/without levonorgestrel (LNG) on the genital microbiota of Kenyan women. Eligible women (n = 27; 18-34 years; negative for HIV, sexually transmitted infections, and Amsel-bacterial vaginosis) were randomized 2:2:1 to use of IVRs containing TFV, TFV/LNG, or placebo. Using vaginal wall and IVR swabs at IVR insertion and removal, the genital microbial composition was determined using 16S rRNA gene sequencing. The presence of Candida spp. was determined using qPCR. The vaginal total bacterial burden appeared to decrease with TFV and TFV/LNG IVR use (log100.57 and log100.27 decrease respectively; p > 0.05). The TFV/LNG IVR was more 'stabilizing': 50% of the participants' microbiota community state types remained unchanged and 50% shifted towards higher Lactobacillus abundance. Specifically, TFV/LNG IVR use was accompanied by increased abundances of Lactobacillus gasseri/hominis/johnsonii/taiwanensis (16.3-fold) and L. fermentum/reuteri/vaginalis (7.0-fold; all p < 0.01). A significant shift in the overall microbial α-diversity or ß-diversity was not observed for either IVR, and IVR use did not influence Candida spp. prevalence. TFV/LNG and TFV IVRs did not adversely affect the genital microbiota and are safe to use. Our findings support further studies assessing their efficacy in preventing HIV/HSV-2 and unintended pregnancies.

Impact of Coronavirus Disease 2019 (COVID-19) on Human Immunodeficiency Virus (HIV) Pre-exposure Prophylaxis Prescriptions in the United States-A Time-Series Analysis.

BACKGROUND: Uptake of HIV pre-exposure prophylaxis (PrEP) has been increasing in the United States since its FDA approval in 2012; however, the COVID-19 pandemic may have affected this trend. Our objective was to assess the impact of COVID-19 on PrEP prescriptions in the United States. METHODS: We analyzed data from a national pharmacy database from January 2017 through March 2021 to fit an interrupted time-series model that predicted PrEP prescriptions and new PrEP users had the pandemic not occurred. Observed PrEP prescriptions and new users were compared with those predicted by the model. Main outcomes were weekly numbers of PrEP prescriptions and new PrEP users based on a previously developed algorithm. The impact of the COVID-19 pandemic was quantified by computing rate ratios and percentage decreases between the observed and predicted counts during 15/3/2020-31/3/2021. RESULTS: In the absence of the pandemic, our model predicted that there would have been 1 058 162 PrEP prescriptions during 15/3/2020-31/3/2021. We observed 825 239 PrEP prescriptions, a 22.0% reduction (95% CI: 19.1-24.8%) after the emergency declaration. The model predicted 167 720 new PrEP users during the same period; we observed 125 793 new PrEP users, a 25.0% reduction (95% CI: 20.9-28.9%). The COVID-19 impact was greater among younger persons and those with commercial insurance. The impact of the pandemic varied markedly across states. CONCLUSIONS: The COVID-19 pandemic disrupted an increasing trend in PrEP prescriptions in the United States, highlighting the need for innovative interventions to maintain access to HIV-prevention services during similar emergencies.

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.

Impact of viral suppression among persons with HIV upon estimated HIV incidence between 2010 and 2015 in the United States.

BACKGROUND: The suppression of viremia among persons with HIV (PWH) using antiretroviral therapy has been hypothesized to reduce HIV incidence at the population level. We investigated the impact of state level viral suppression among PWH in the United States on estimated HIV incidence between 2010 and 2015. METHODS: Viral suppression data and HIV incidence estimates from the National HIV Surveillance System were available from 29 states and the District of Columbia. We assumed a one year delay for viral suppression to impact incidence. Poisson regression models were used to calculate the estimated annual percent change (EAPC) in incidence rate. We employed a multivariable mixed-effects Poisson regression model to assess the effects of state level race/ethnicity, socioeconomic status, percent men who have sex with men (MSM) and hepatitis C virus prevalence as a proxy for injection drug use on HIV incidence. FINDINGS: Fitted HIV incidence for 30 jurisdictions declined from 11.5 in 2010 to 10.0 per 100,000 population by 2015 corresponding with an EAPC of -2.67 (95% confidence interval [95%CI] -2.95, -2.38). Southern states experienced the highest estimated incidence by far throughout this period but upon adjustment for viral suppression and demographics there was a 36% lower incidence rate than Northeast states (adjusted rate ratio [aRR] 0.64; 95%CI 0.42, 0.99). For every 10 percentage point (pp) increase in viral suppression there was an adjusted 4% decline in HIV incidence rate in the subsequent year (aRR 0.96; 95%CI 0.93, 0.99). While controlling for viral suppression, HIV incidence rate increased by 42% (aRR 1.42 95%CI 1.31, 1.54) for every 5 pp increase in percent Black race and by 27% (aRR 1.27 95%CI 1.10, 1.48) for every 1 pp increase in percent MSM in states. INTERPRETATION: A decline in estimated HIV incidence from 2010 to 2015 was associated with increasing viral suppression in the United States. Race and sexual orientation were important HIV acquisition risk factors.

Access to HIV Viral Load Testing and Antiretroviral Therapy Switch Practices: A Multicountry Prospective Cohort Study in Sub-Saharan Africa.

Poor access to HIV viral load (VL) testing prevents the timely monitoring of HIV treatment adherence and efficacy. Factors enabling clinical benefits of VL testing when added to local standards of care, can inform the development of more cost-effective routine VL scale-up plans. We compared antiretroviral therapy (ART) switch practices in 13 clinics across 6 countries, with full (N = 8), phasing-in (N = 3) or no onsite access (N = 2) to VL. The analysis used data from the Pan-African Studies to Evaluate Resistance (PASER), observing virological and drug resistance outcomes among adults receiving first- or second-line ART between 2008 and 2015. Study plasma viral load (sVL) determined at baseline, every 12 months thereafter and at the time of switch served for retrospectively validating switch decisions, categorized into "necessary," "unnecessary," and "missed." Virological failure was defined as two consecutive sVL ≥1,000 HIV-RNA copies/mL. One thousand nine hundred ninety-five of the 2,420 (82.4%) study participants had continuous virological suppression during the median 30 months of follow-up. Among the 266 virological failures (11.0%), the proportion of necessary switches were similar in clinics with full (37%), phasing-in (25%), or no access (39%) to local VL testing. Documented utilization of local VL results for the switch decision was associated with higher percentage of necessary switch (87.6% vs. 67.9%). Shorter time to necessary switch was associated with higher rates of long-term virological suppression, regardless of access to local viral load. Availability of HIV VL testing capacity does not systematically result in adequate switch practices or better virological outcomes. Systems supporting sufficient test demand execution, and actual utilization of results for patient management need strengthening.

Community Members' Pre-exposure Prophylaxis Awareness, Attitudes, and Trusted Sources for PrEP Information and Provision, Context Matters Survey, 2015-2016.

Men and women of color have had low pre-exposure prophylaxis (PrEP) uptake. How one's preferred source of health information shapes attitudes toward PrEP is unclear. We conducted cross-sectional surveys to assess changes in PrEP awareness, knowledge, and attitudes, trusted sources for PrEP information, and associations between trusted source of information and PrEP knowledge and attitudes. Participants were recruited from six areas served by community health centers in Chicago, IL (two health centers); Jackson, MS; Newark, NJ; Philadelphia, PA; and Washington, D.C. during June-September 2015 (n = 160) and June-September 2016 (n = 200). Participants were Black (74%), heterosexual (81%), and largely unaware of PrEP (72%). Participants who trusted health experts and community organizations for PrEP information had lower percentages of agreeing with statements indicative of negative PrEP attitudes. Interventions that increase PrEP awareness as well as knowledge and favorable attitudes might help increase PrEP use in communities with high HIV prevalence.

Out-of-pocket costs and HIV pre-exposure prophylaxis persistence in a US multicity demonstration project.

OBJECTIVE: To evaluate whether out-of-pocket (OOP) costs reduced HIV pre-exposure prophylaxis (PrEP) persistence. DATA SOURCE: Participants from five urban community health centers (CHCs) in four US cities enrolled in a PrEP demonstration project from September 2014 to August 2017. STUDY DESIGN: Patients initiating PrEP were followed quarterly until they withdrew from PrEP care or the study ended. Self-reported OOP medication and clinic visit costs were assessed by semiannual questionnaires. Persistence was defined as the time from study enrollment to the last visit after which two subsequent 3-month visits were missed. Multivariable Cox proportional hazard regression was used to assess the effect of demographics, insurance, and OOP costs on PrEP persistence. PRINCIPAL FINDINGS: Among 918 participants with OOP cost data, the average quarterly OOP cost was $34 (median: $5, IQR: $0-$25). Participants who were men, White, employed, completed college, and had commercial insurance had higher OOP costs. Higher OOP costs were not associated with lower PrEP persistence by Cox proportional hazards regression (adjusted hazard ratio = 1.00 per $50 increase, 95% CI = 0.97, 1.02). CONCLUSION: Among patients receiving care from these urban CHCs, OOP costs were low and did not undermine PrEP persistence.

Brief Report: HIV Shedding in the Female Genital Tract of Women on ART and Progestin Contraception: Extended Follow-up Results of a Randomized Clinical Trial.

BACKGROUND: Progestin contraception has been linked to higher risk of female to male sexual HIV transmission. SETTING: A clinical trial among HIV-infected women in Lilongwe, Malawi, randomized to initiation of depomedroxyprogesterone acetate injectable or levonorgestrel implant, and followed for up to 33 months, with the outcome of HIV shedding in the genital tract. METHODS: We compared the frequency and magnitude of HIV genital shedding before and after initiation of contraception and between study arms among women receiving antiretroviral therapy (ART). Genital HIV RNA was measured in TearFlo Strips using the Abbott RealTime HIV-1 assay. RESULTS: Among 68 HIV-infected Malawian women on ART, randomization to depot medroxyprogesterone acetate compared with the levonorgestrel implant was not associated with genital shedding and neither progestin contraceptive was associated with increased HIV genital shedding, for up to 33 months after contraceptive initiation. Having detectable plasma HIV [adjusted risk ratio (RR) 10.5; 95% confidence interval (CI): 3.18 to 34.7] and detectable genital shedding before contraceptive initiation (adjusted RR 3.53; 95% CI: 1.31 to 9.47) were associated with a higher risk of detectable genital shedding after contraceptive initiation. Higher plasma efavirenz concentrations were associated with a lower risk of detectable genital shedding (adjusted RR 0.85; 95% CI: 0.73 to 0.99, per increase of 1000 ng/mL). CONCLUSION: Among HIV-infected women receiving ART, our results provide evidence that progestin contraception does not impact women's risk of transmission of HIV to partners. Our finding that detectable genital shedding before contraceptive initiation independently predicts shedding suggests that there may be other individual-level biological or behavioral factors that increase the risk for shedding.