Estimating the Proportion of People Living With HIV Who May Benefit From the Reverse Algorithm for the Diagnosis of Incident Syphilis.

ABSTRACT: Among 8455 people engaged in HIV care in 4 US cities, 4925 (58%) had treponemal testing at care entry. Of the 4925 tested, 3795 (77%) had a nonreactive result and might benefit from the reverse algorithm for a future incident syphilis diagnosis. Furthermore, low-barrier treponemal testing as a first step in the reverse algorithm may increase syphilis screening and decrease time to treatment.

Treponema pallidum periplasmic and membrane proteins are recognized by circulating and skin CD4+ T cells.

Background: Histologic and serologic studies suggest the induction of local and systemic Treponema pallidum ( Tp )-specific CD4+ T cell responses to Tp infection. We hypothesized that Tp -specific CD4+ T cells are detectable in blood and in the skin rash of secondary syphilis and persist in both compartments after treatment. Methods: PBMC collected from 67 participants were screened by IFNγ ELISPOT response to Tp sonicate. Tp -reactive T cell lines from blood and skin were probed for responses to 88 recombinant Tp antigens. Peptide epitopes and HLA class II restriction were defined for selected antigens. Results: We detected CD4+ T cell responses to Tp sonicate ex vivo. Using Tp -reactive T cell lines we observed recognition of 14 discrete proteins, 13 of which localize to bacterial membranes or the periplasmic space. After therapy, Tp -specific T cells persisted for at least 6 months in skin and 10 years in blood. Conclusions: Tp infection elicits an antigen-specific CD4+ T cell response in blood and skin. Tp -specific CD4+ T cells persist as memory in both compartments long after curative therapy. The Tp antigenic targets we identified may be high priority vaccine candidates.

Association of Tecovirimat Therapy With Mpox Symptom Improvement: A Cross-sectional Study-King County, Washington, May-October 2022.

Background: Data on tecovirimat effectiveness for human mpox are limited. We conducted a retrospective cross-sectional interview-based study to identify associations between tecovirimat treatment and the mpox clinical course. Methods: Using public health surveillance data from King County, Washington, we recruited and interviewed persons diagnosed with mpox during May-October 2022. We calculated descriptive statistics on demographics, vaccination status, comorbidities, and symptoms including 3 self-reported dates (symptom onset, first date of symptom improvement, and illness resolution). We used multivariable linear regression, stratified by illness severity, to evaluate the association of tecovirimat treatment with time to symptom improvement and time to illness resolution. We compared individuals who did not receive tecovirimat to participants who started tecovirimat early (≤5 days from symptom onset) and late (>5 days and ≤28 days from symptom onset) in their illness. Results: Of 465 individuals diagnosed with mpox, 115 (25%) participated in this study. Eighty participants (70%) received tecovirimat and 43 (37%) initiated tecovirimat early. Sixty-eight (59%) reported severe symptoms during their illness, including proctitis (n = 38 [33%]), rectal bleeding (n = 27 [24%]), or severe pain (n = 24 [21%]). In the multivariable analysis, early tecovirimat was associated with shorter time to symptom improvement (-5.5 days, P = .04) among participants with severe illness but not among those with nonsevere illness (0.9 day, P = .66). Early tecovirimat was not associated with faster illness resolution, regardless of severity. Conclusions: Our small study suggests that early tecovirimat initiation may hasten subjective symptomatic improvement in people with severe mpox. Larger randomized trials are needed to evaluate this finding.

Trends in Chlamydia trachomatis Treatment Prescribing Practices in King County, Washington, 2010-2018.

BACKGROUND: In 2021, national Chlamydia trachomatis (CT) treatment guidelines changed from recommending either azithromycin (1 g; single dose) or doxycycline (100 mg twice daily for 7 days) to recommending only doxycycline as first-line treatment. The distribution and trends in CT prescribing practices before the guidelines change is largely unknown. METHODS: We conducted a trends analysis using Washington STD surveillance data. We included all female cases of urogenital CT 15 years or older who resided in King County and were diagnosed between 2010 and 2018. Surveillance data included information on demographics, sexual history, clinical features, diagnosing facility (eg, emergency department, family planning), and treatment regimen. We conducted descriptive analyses to examine trends in prescribing practices over time and by facility type. We used Poisson regression to examine the association between CT case characteristics and receipt of receipt of azithromycin. RESULTS: There were 36,830 cases of female urogenital CT during the study period. The percent of cases receiving azithromycin increased significantly from 86% in 2010 to 94% in 2018; the percent receiving doxycycline decreased from 13% to 5%. Five of the 8 facility types prescribed azithromycin to >95% of CT cases by 2018. Cases who were younger or cases of color were more likely to receive azithromycin (versus doxycycline) compared with older and White cases, respectively. CONCLUSIONS: A substantial shift in CT prescribing practices will be needed to adhere to new CT treatment guidelines. Our findings highlight the need for targeted provider education and training to encourage the transition to doxycycline use.

Asymptomatic and Subclinical Mpox: An Association With Modified Vaccinia Ankara Vaccine.

BACKGROUND: How often mpox causes asymptomatic infections, particularly among persons who have received the Modified Vaccinia Ankara (MVA) vaccine, is unknown. METHODS: We performed mpox polymerase chain reaction testing on rectal and pharyngeal specimens collected from symptomatic and asymptomatic patients at a sexual health clinic in Seattle, WA, between May 2022 and May 2023. Analyses evaluated the prevalence of asymptomatic or subclinical infection and, among persons with polymerase chain reaction-positive tests, the association of MVA vaccination status with the symptomatic infection. RESULTS: The study population included 1663 persons tested for mpox during 2353 clinic visits. Ninety-three percent of study participants were cisgender men and 96% were men who have sex with men. A total of 198 symptomatic patients (30%) had a first mpox-positive test during 664 visits. Eighteen patients (1.1%) tested during 1689 visits had asymptomatic or subclinical mpox based on a positive rectal or pharyngeal test done in the absence of testing done because of clinical suspicion for mpox. Fourteen (78%) of 18 persons with asymptomatic/subclinical mpox and 53 (26%) of 198 persons with symptomatic mpox had received at least 1 dose of the MVA vaccine ( P < 0.0001). Controlling for calendar month, study subjects who received 1 and 2 doses of MVA vaccine were 4.4 (95% confidence interval, 1.3-15) and 11.9 (3.6-40) times more likely to have asymptomatic versus symptomatic mpox, respectively, than persons who were unvaccinated. CONCLUSIONS: Asymptomatic mpox is uncommon. Modified Vaccinia Ankara vaccination is associated with an asymptomatic/subclinical infection among persons with mpox.

Clinical Diagnosis Is Highly Predictive of Laboratory-Confirmed Mpox in a Sexual Health Clinic.

BACKGROUND: Promptly recognizing mpox can facilitate earlier diagnosis and appropriate treatment. How accurately clinicians can diagnose mpox based on clinical data and before receiving molecular test results is not known. METHODS: Leveraging public health and clinical data collected in Seattle-King County's Sexual Health Clinic (SHC) from July 29, 2022, to September 30, 2022, we analyzed the proportion of patients who received presumptive versus results-based tecovirimat when clinicians had a high, intermediate, or low suspicion for mpox after clinical evaluation. We calculated the sensitivity, specificity, and positive (PPV) and negative predictive value (NPV) of this approach against criterion standard mpox polymerase chain reaction (PCR) results. RESULTS: Of 321 patients evaluated for mpox in the SHC, median age was 34.5 years and 88% were cisgender men. Overall, 121 of 319 (38%) tested positive by mpox PCR. Clinicians had high suspicion for mpox in 122 patients and offered empiric tecovirimat to 92 (88%), of whom 85 (92%) tested PCR positive. Of 13 intermediate suspicion patients offered presumptive therapy, all accepted but none tested positive by PCR. The sensitivity, specificity, PPV, and NPV of high/intermediate clinical suspicion for mpox were 99%, 90%, 86%, and 99%, respectively. A higher proportion of people with HIV were diagnosed with mpox (57% vs. 36%, P = 0.01, χ2 test), and sensitivity and PPV of high/intermediate clinical suspicion in this subgroup were 100% and 86%, respectively. CONCLUSIONS: Clinical providers working in a high-volume, public SHC were able to both accurately identify and rule out mpox based on clinical examination before receiving PCR test results.

STI partner services outcomes before and during the SARS-CoV-2 pandemic in King County, WA.

BACKGROUND: SARS-CoV-2 pandemic mitigation efforts resulted in reallocation of public health personnel, likely impacting provision of timely sexually transmitted infection (STI) partner services (PS). We describe PS outcomes before and during the pandemic in King County, WA. METHODS: We examined PS outcomes for syphilis and gonorrhea cases diagnosed in 2019 and three periods in 2020 (pre-lockdown:1/1/2020-3/23/2020; lockdown: 3/24/2020-6/5/2020, post-lockdown: 6/6/2020-12/31/20). We described changes over time in three PS outcomes: cases initiated, interviewed, and with named sex partners. We calculated adjusted prevalence ratios (aPRs) with Poisson regression comparing these outcomes in the 2020 periods to 2019. RESULTS: Reported gonorrhea (4,611 vs. 4,179) and syphilis (665 vs. 586) cases declined from 2019 to 2020. In 2019, 60.7% of cases were initiated, compared with 42.1% before lockdown (aPR:0.74, 95% CI:0.70-0.78%), 41.7% during lockdown (aPR:0.79; 95% CI:0.73-0.85), and 41.7% after lockdown (aPR:0.81, 95% CI:0.77-0.85). Among initiated cases, the proportion interviewed also appeared to drop in the three lockdown periods (52.4%, 41.0%, 44.1%) compared to 2019 (55.7%). However, in adjusted analyses, the prevalence of interview among case patients was only lower pre-lockdown (aPR:0.91; 95% CI:0.85-0.99), and higher during (aPR:1.10; 95% CI:1.01-1.20) and after (aPR:1.12; 95% CI:1.06-1.19). Interviewed patients named partners more often during (21.4%, aPR:1.35; 95% CI:1.05-1.74) and less often after lockdown (16.0%, aPR:0.63; 95% CI:0.51-0.79), compared to 2019 (26.6%). CONCLUSIONS: These results underscore the need for a trained public health worker reserve, and plans for deployment of existing workers and prioritization of cases to continue essential STI public health activities during public health crises.

Impact of Text-Based Monthly Check-Ins on Pre-Exposure Prophylaxis Retention at a Sexual Health Clinic.

ABSTRACT: We conducted a retrospective cohort study of preexposure prophylaxis patients at the municipal Sexual Health Clinic in Seattle-King County, Washington from 2019 to 2021 to determine whether monthly check-in text messages impacted 4- and 6-month pre-exposure prophylaxis retention. Monthly check-ins did not appear to improve retention above and beyond open-ended texting and appointment reminders.

Cost Analysis of Implementing a 12-Month Recertification Criterion for Ryan White HIV/AIDS Program's AIDS Drug Assistance Program in Washington State.

OBJECTIVE: AIDS Drug Assistance Programs (ADAPs) are state-administered programs that pay for medical care and medication for people living with HIV (PLWH) in the United States. In October 2021, the federal policy requiring that clients recertify for the program every 6 months was repealed, giving states the authority to set their own recertification policies. However, little data exist on the costs and health effects of alternative recertification schedules. We assessed the cost of changing the legacy 6-month recertification to a 12-month schedule in Washington State to inform policy decisions on recertification. METHODS: We used a Markov model to simulate the population of PLWH in Washington State who are eligible or enrolled in ADAP. We obtained model inputs and validation data from the Washington State Ryan White database. We estimated the cost of 12-month and 6-month criteria over a 5-year time horizon. Model outputs included annual program costs, population sizes, and number of people virally suppressed, by scenario. RESULTS: Under a continuation of the legacy 6-month recertification criteria, the annual cost of Washington ADAP would be $37 663 000 (95% CI, $34 570 000-$41 686 000) during the next 5 years, with a per-client cost of $7966 (95% CI, $7478-$8494). Under 12-month criteria, the annual cost would be $40 217 000 (95% CI, $36 243 000-$44 401 000) and the per-client cost would be $7543 (95% CI, $7084-$8042). Under the 12-month scenario, 245 more people will have been virally suppressed by the end of 2025. CONCLUSIONS: Switching to a less frequent recertification process may improve health outcomes at a modest increase in cost in Washington State.

Associations between adverse childhood experiences, viral suppression, and quality of life among persons living with HIV in Washington state.

Adverse childhood experiences (ACEs) have been linked to numerous negative health outcomes in adulthood and have been recognized as a hurdle to participating in HIV care. However, few studies have examined the cumulative impact that different types of childhood trauma have on HIV care engagement and HIV outcomes. This study characterized the relationship between ACEs, viral suppression, and health-related quality of life (HRQOL) among persons living with HIV (PLWH). We used HIV surveillance data and self-reported information on ACEs and HRQOL from PLWH in Washington State from 2018-2020. Logistic regression was used to assess the relationship between the quantity and type of ACEs and viral suppression. We used Poisson regression to examine the relationship between ACEs and HRQOL as measured by unhealthy days. The majority of PLWH experienced ≥1 ACE (86.8%). ACEs were not significantly associated with the likelihood of viral suppression (OR ≥4 vs 0 ACEs: 0.49, 95% CI: 0.12-2.09), but ACEs were associated with more unhealthy days experienced in a 30-day period (RR ≥4 vs 0 ACEs: 3.19, 95% CI: 1.59-6.40). These findings provide support that trauma is common among PLWH, and efforts to address the impact of childhood trauma may work to improve quality of life.

Racial and Ethnic Differences in Chlamydia and Gonorrhea Testing Locations Among Medicaid-Insured Youth.

PURPOSE: Chlamydia trachomatis (CT) and Neisseria gonorrhea (GC) infections are common among 15- to 24-year-olds, with Black and Hispanic youth disproportionately affected. Understanding where youth receive CT/GC testing is necessary to address disparities in CT/GC care. Our objective was to identify if differences exist in CT/GC testing locations by race and ethnicity. METHODS: We used 2019 MarketScan Medicaid data to examine CT/GC testing location by youth race and ethnicity. RESULTS: There were 418,623 CT/GC tests during the study period. Tests were most frequently ordered at medical offices for all races and ethnicities, although less frequently for Black (37.6%) and Hispanic (37.3%) than for White youth (49.3%). Black youth were frequently tested in emergency departments (19.6%), while Hispanic youth were frequently tested in Federally Qualified Health Centers (19.0%). DISCUSSION: We found significant racial and ethnic disparities in the location of CT/GC testing among Medicaid-insured-youth; these findings should be used to guide strategies that address inequities in CT/GC care.

Effectiveness of the Modified Vaccinia Ankara Vaccine Against Mpox in Men Who Have Sex With Men: A Retrospective Cohort Analysis, Seattle, Washington.

Background: Data on modified Vaccinia Ankara (MVA) vaccine effectiveness against mpox in real-world settings are limited. Methods: We performed a retrospective cohort analysis using Cox proportional hazards regression to estimate the association between vaccination and laboratory-confirmed mpox incidence. Study subjects included all men who have sex with men seen in a sexual health clinic in Seattle, Washington, between 1 January 2020 and 31 December 2022. Subjects' receipt of vaccine and diagnosis with mpox were ascertained from public health vaccine registry and surveillance data. Analyses were adjusted for demographic factors, human immunodeficiency virus (HIV) status, and sexual risk behaviors. Results: The incidence of mpox per 100 person-years was 8.83 among patients with 0 doses, 3.32 among patients with 1 dose, and 0.78 among patients with 2 doses of MVA vaccine. Mpox diagnosis was significantly associated with age category 30-39 and 40-51 years, HIV positivity, syphilis diagnosis in the prior year, >10 sex partners in the last year, and having a clinic visit in the last year. In the multivariate model adjusting for these factors, vaccine effectiveness was 81% for 1 dose and 83% for 2 doses. Conclusions: These data support the effectiveness of the MVA vaccine-including a single dose of the vaccine-in preventing mpox disease and highlight the appropriateness of risk factor-based prioritization of immunization early in the epidemic. The durability of MVA vaccine-induced immunity is unknown, and at-risk persons should receive 2 doses of MVA.

Adaptation of the collaborative care model to integrate behavioral health care into a low-barrier HIV clinic.

Background: The collaborative care management (CoCM) model is an evidence-based intervention for integrating behavioral health care into nonpsychiatric settings. CoCM has been extensively studied in primary care clinics, but implementation in nonconventional clinics, such as those tailored to provide care for high-need, complex patients, has not been well described. Method: We adapted CoCM for a low-barrier HIV clinic that provides walk-in medical care for a patient population with high levels of mental illness, substance use, and housing instability. The Exploration, Preparation, Implementation, and Sustainment model guided implementation activities and support through the phases of implementing CoCM. The Framework for Reporting Adaptations and Modifications to Evidence-Based Interventions guided our documentation of adaptations to process-of-care elements and structural elements of CoCM. We used a multicomponent strategy to implement the adapted CoCM model. In this article, we describe our experience through the first 6 months of implementation. Results: The key contextual factors necessitating adaptation of the CoCM model were the clinic team structure, lack of scheduled appointments, high complexity of the patient population, and time constraints with competing priorities for patient care, all of which required substantial flexibility in the model. The process-of-care elements were adapted to improve the fit of the intervention with the context, but the core structural elements of CoCM were maintained. Conclusions: The CoCM model can be adapted for a setting that requires more flexibility than the usual primary care clinic while maintaining the core elements of the intervention.

What is already known about this topic? Collaborative care management is an evidence-based intervention to integrate behavioral health care into primary medical care. The model uses a task-sharing approach in which a behavioral health care manager who is supervised by a remote psychiatrist works with the primary medical team. What does this paper add? We describe adaptation of the collaborative care management model for a low-barrier HIV care clinic. Adaptation was necessary because the clinic provides all care on a walk-in basis, the team structure differs from usual primary care, and the patient population has complex medical and social needs. What are the implications for practice, research or policy? Our experience can inform implementation of collaborative care management into other medical settings that are designed to provide care for high-need, complex patient populations.

A Peer-Based Intervention to Increase HIV and Sexually Transmitted Infection Testing Among Latinx Immigrant Sexual Minority Men in the US Pacific Northwest: Pilot Randomized Controlled Trial Conducted During the COVID-19 Pandemic.

BACKGROUND: Hispanic and Latinx gay, bisexual, and other sexual minority men (SMM) are disproportionately affected by HIV in the United States. With the availability of self-testing services, HIV and sexually transmitted infection (STI) testing may be more accessible for Latinx immigrant SMM who face obstacles to obtaining HIV-related services. Combining the potential of self-testing kits and the influence of peer educators may present an opportunity to increase HIV and STI testing and preexposure prophylaxis (PrEP) uptake or linkage to HIV care among Latinx immigrant SMM. OBJECTIVE: This study aimed to develop and pilot a peer intervention to distribute HIV and STI self-testing kits and provide peer counseling based on the information-motivation-behavioral skills model to increase PrEP uptake and HIV and STI testing among Latinx immigrant SMM. Our evaluation focused on determining the differences in HIV testing, STI testing, and PrEP uptake outcomes between the intervention and control groups. METHODS: We conducted semistructured interviews with community stakeholders to elicit factors to consider for training and intervention. The interview findings informed the development of the intervention and peer training protocols. We piloted the intervention with Latinx immigrant SMM and randomly assigned participants to the intervention group, who received peer counseling and HIV and STI self-testing kits, or the control group, who only received peer counseling. We administered baseline, 1-week, 6-week, and 12-week follow-up surveys to assess behaviors related to HIV testing, STI testing, and PrEP uptake. Owing to the COVID-19 pandemic, the intervention components were delivered via web-based modalities. Chi-square tests were performed to examine the associations between HIV testing, STI testing, and PrEP motivation and behaviors across the study arms (intervention vs control). We conducted Cramer V test to determine the strength of the association between study arm and each of the outcome variables. We also assessed the impact of the COVID-19 pandemic on participants. RESULTS: Overall, 50 (intervention, n=30 and control, n=20) Latinx immigrant SMM participated in the program. Participants reported life disruptions owing to COVID-19, with 68% (34/50) reporting job loss after the declaration of the pandemic. After intervention participation, a higher proportion of participants in the intervention group reported having been tested for STIs (76% vs 36.8%; P=.01; Cramer V=0.394). Among the participants in the intervention group, 91% (21/23) reported being motivated to use PrEP compared with 59% (10/17) in the control group (P=.02; Cramer V=0.385). CONCLUSIONS: By facilitating access to HIV and STI testing through peer-delivered information, motivational support, and behavioral skills training as well as the provision of self-testing kits, our intervention demonstrated the potential to increase HIV prevention behaviors in Latinx immigrant SMM. Peer-based programs that offer self-testing and internet-based modes of accessing information may be a feasible strategy for reaching Latinx immigrant SMM. TRIAL REGISTRATION: ClinicalTrials.gov NCT03922126; https://clinicaltrials.gov/ct2/show/NCT03922126.

Substance Use and Mental Health Comorbidities and Receipt of Specialty Care Among Patients Enrolled in a Low-Barrier HIV Clinic.

Low-barrier care is one model of a differentiated service delivery approach for people with HIV (PWH) who are not engaged in conventionally-organized HIV care. Although psychiatric and substance use disorders are common among patients in low-barrier clinics, approaches to behavioral health service delivery within this context have not been well-described. We conducted a descriptive analysis using retrospective review of medical records to evaluate substance use and psychiatric comorbidities and receipt of behavioral health services among patients in the Max Clinic in Seattle, Washington. Among 227 patients enrolled from 2015 to mid-2020, most had a history of hazardous substance use (85%), a psychiatric diagnosis (69%) or unstable housing (69%) documented in the medical record. Less than half of patients referred for depression treatment (33%) or for opioid use disorder treatment (40%) completed even one specialty care visit. More effective approaches are needed to engage patients in behavioral health services within the context of low-barrier HIV care.

AIDS Drug Assistance Program disenrollment is associated with loss of viral suppression beyond differences in homelessness, mental health, and substance use disorders: An evaluation in Washington state 2017-2019.

AIDS Drug Assistance Programs (ADAPs) are state-administered programs that pay for medical care for people living with HIV in the US. Maintaining enrollment in the programs is challenging, and a large proportion of clients in Washington state (WA) fail to recertify and are disenrolled. In this study we sought to quantify the impact of disenrollment from ADAPs on viral suppression. We conducted a retrospective cohort study of the 5238 clients in WA ADAP from 2017 to 2019 and estimated the risk difference (RD) of viral suppression before and after disenrollment. We performed a quantitative bias analysis (QBA) to assess the effect of unmeasured confounders, as the factors that contribute to disenrollment and medication discontinuation may overlap. Of the 1336 ADAP clients who disenrolled ≥1 time, 83% were virally suppressed before disenrollment versus 69% after (RD 12%, 95%CI 9-15%). The RD was highest among clients with dual Medicaid-Medicare insurance (RD 22%, 95%CI 9-35%) and lowest among privately insured individuals (RD 8%, 95%CI 5-12%). The results of the QBA suggest that unmeasured confounders do not negate the overall RD. The ADAP recertification procedures negatively impact the care of clients who struggle to stay in the program; alternative procedures may reduce this impact.

PrEP Acceptance among Eligible Patients Attending the Largest PrEP Clinic in Jackson, Mississippi.

Compared to other states in the United States, Mississippi has the lowest uptake of PrEP relative to the number of people newly diagnosed with HIV in the state. Open Arms Healthcare Center is the largest provider of PrEP in Mississippi, and has systematically documented PrEP eligibility, offers, and acceptance (ie, agreed to undergo a clinical PrEP evaluation) from 2017 to mid-2020. In encounter-based analyses, we examined factors associated with PrEP acceptance. Among 721 encounters where patients were eligible for PrEP, staff offered PrEP at 680 (94%) of encounters (526 unique individuals); individuals accepted a PrEP offer at 58% of encounters. Accepting a PrEP offer was lowest (15.8%) among transgender/non-binary individuals and highest (93.3%) among individuals who reported having sex partners living with HIV. This clinic's model worked to offer PrEP to a highly impacted population, though there is a need to enhance PrEP acceptance for key groups such as transgender/non-binary individuals.

Postexposure Doxycycline to Prevent Bacterial Sexually Transmitted Infections.

BACKGROUND: Interventions to reduce sexually transmitted infections (STIs) among men who have sex with men (MSM) are needed. METHODS: We conducted an open-label, randomized study involving MSM and transgender women who were taking preexposure prophylaxis (PrEP) against human immunodeficiency virus (HIV) infection (PrEP cohort) or living with HIV infection (persons living with HIV infection [PLWH] cohort) and who had had Neisseria gonorrhoeae (gonorrhea), Chlamydia trachomatis (chlamydia), or syphilis in the past year. Participants were randomly assigned in a 2:1 ratio to take 200 mg of doxycycline within 72 hours after condomless sex (doxycycline postexposure prophylaxis) or receive standard care without doxycycline. STI testing was performed quarterly. The primary end point was the incidence of at least one STI per follow-up quarter. RESULTS: Of 501 participants (327 in the PrEP cohort and 174 in the PLWH cohort), 67% were White, 7% Black, 11% Asian or Pacific Islander, and 30% Hispanic or Latino. In the PrEP cohort, an STI was diagnosed in 61 of 570 quarterly visits (10.7%) in the doxycycline group and 82 of 257 quarterly visits (31.9%) in the standard-care group, for an absolute difference of -21.2 percentage points and a relative risk of 0.34 (95% confidence interval [CI], 0.24 to 0.46; P<0.001). In the PLWH cohort, an STI was diagnosed in 36 of 305 quarterly visits (11.8%) in the doxycycline group and 39 of 128 quarterly visits (30.5%) in the standard-care group, for an absolute difference of -18.7 percentage points and a relative risk of 0.38 (95% CI, 0.24 to 0.60; P<0.001). The incidences of the three evaluated STIs were lower with doxycycline than with standard care; in the PrEP cohort, the relative risks were 0.45 (95% CI, 0.32 to 0.65) for gonorrhea, 0.12 (95% CI, 0.05 to 0.25) for chlamydia, and 0.13 (95% CI, 0.03 to 0.59) for syphilis, and in the PLWH cohort, the relative risks were 0.43 (95% CI, 0.26 to 0.71), 0.26 (95% CI, 0.12 to 0.57), and 0.23 (95% CI, 0.04 to 1.29), respectively. Five grade 3 adverse events and no serious adverse events were attributed to doxycycline. Of the participants with gonorrhea culture available, tetracycline-resistant gonorrhea occurred in 5 of 13 in the doxycycline groups and 2 of 16 in the standard-care groups. CONCLUSIONS: The combined incidence of gonorrhea, chlamydia, and syphilis was lower by two thirds with doxycycline postexposure prophylaxis than with standard care, a finding that supports its use among MSM with recent bacterial STIs. (Funded by the National Institutes of Health; DoxyPEP ClinicalTrials.gov number, NCT03980223.).

Implementation of Low-Barrier Human Immunodeficiency Virus Care: Lessons Learned From the Max Clinic in Seattle.

Low-barrier care (LBC) for people with human immunodeficiency virus (HIV) is a differentiated service delivery strategy to engage people in HIV treatment who are not well-engaged in conventionally organized HIV medical care. The LBC approach is flexible, but experience suggests that the intervention has distinct core components. This review summarizes our experience implementing one model of LBC, the Max Clinic in Seattle; describes the core components of the intervention; and presents a framework for implementing low-barrier HIV care with the goal of providing a practical guide for clinical and public health leaders seeking to implement a new LBC program. A systematic approach to addressing key factors during LBC implementation can support practitioners to design an LBC approach that fits the local context while maintaining essential elements of the intervention.

Partial-Oral Antibiotic Therapy for Bone and Joint Infections in People With Recent Injection Drug Use.

Background: Limited outcome data exist regarding partial-oral antibiotic therapy, defined as oral antibiotics as part of a patient's treatment, for bone and joint infections (BJIs) in people who inject drugs (PWID). Methods: We conducted a retrospective study of all PWID reporting drug use within 3 months and BJIs requiring ≥6 weeks of antibiotics in an urban safety-net hospital between February 1, 2019, and February 1, 2021. Treatment outcomes were assessed by chart review. Rates of failure, defined as death, symptoms, or signs concerning for worsening or recurrent infections, were assessed 90 and 180 days after completion of antibiotics. Univariate logistic regression was used to explore the association between covariates and failure. Results: Of 705 patients with BJI, 88 (13%) were PWID. Eighty-six patients were included in the final cohort. Forty-four (51%) were homeless, 50 (58%) had spine infection, 68 (79%) had surgery, and 32 of 68 (47%) had postoperatively retained hardware. Twelve (14%) of 86 patients received exclusively intravenous (IV) antibiotics, and 74 (86%) received partial-oral antibiotics. Twelve (14%) of 86 patients had patient-directed discharge. In those who received partial-oral antibiotics, the failure rate was 20% at 90 days and 21% at 180 days after completion of intended treatment. Discharge to a medical respite and follow-up with infectious diseases (ID) or surgery were negatively associated with odds of failure. Conclusions: Partial-oral treatment of BJI in PWID was a common practice and often successful when paired with medical respite and follow-up with ID or surgery.