Matthew R. Beymer

Sex on demand: geosocial networking phone apps and risk of sexually transmitted infections among a cross-sectional sample of men who have sex with men in Los Angeles county

Background Geosocial networking applications (GSN apps) used for meeting sexual partners have become increasingly popular with men who have sex with men (MSM) since 2009. The current study aimed to determine if self-identified HIV-negative, MSM clinic attendees who used GSN apps have an increased incidence of sexually transmitted infections (STI) compared to self-identified HIV-negative, MSM attendees who met sexual partners via in-person venues, such as bars or clubs or through MSM-specific hook-up websites. Methods Data were collected between August 2011 and January 2013 on all self-identified HIV-negative, MSM clients visiting the L.A. Gay & Lesbian Center for STI screening. A total of 7184 individuals tested for STIs and self-reported behaviours on drug use and social networking methods to meet sexual partners. Multivariate logistic regression models were used to analyse the results. Results Individuals who used GSN apps for meeting sexual partners had greater odds of testing positive for gonorrhoea (OR: 1.25; 95% CI 1.06 to 1.48) and for chlamydia (OR: 1.37; 95% CI 1.13 to 1.65) compared to individuals who met partners through in-person methods only. There were no significant differences in syphilis and HIV incidence between those who met partners via in-person venues only, on the internet or through GSN apps. Conclusions The present study concludes that sexual health clinic MSM attendees who are meeting on GSN apps are at greater risk for gonorrhoea and chlamydia than MSM attendees who meet in-person or on the internet. Future interventions should explore the use of these novel technologies for testing promotion, prevention and education.

Doxycycline Prophylaxis to Reduce Incident Syphilis among Hiv-infected Men Who Have Sex With Men Who Continue to Engage in High-risk Sex: A Randomized, Controlled Pilot Study

Background Incident syphilis infections continue to be especially prevalent among a core group of HIV-infected men who have sex with men (MSM). Because of synergy between syphilis and HIV infections, innovative means for controlling incident syphilis infections are needed. Methods Thirty MSM who had syphilis twice or more since their HIV diagnosis were randomized to receive either daily doxycycline prophylaxis or contingency management (CM) with incentive payments for remaining free of sexually transmitted diseases (STDs). Participants were tested for the bacterial STDs gonorrhea (Neisseria gonorrhoeae), chlamydia (Chlamydia trachomatis) and syphilis at weeks 12, 24, 36, and 48 and completed a behavioral risk questionnaire during each visit to assess number of partners, condom use, and drug use since the last visit. Generalized linear mixed models were used to analyze differences between arms in STD incidence and risk behaviors at follow-up. Results Doxycycline arm participants were significantly less likely to test positive for any selected bacterial STD during 48 weeks of follow-up (odds ratio, 0.27; confidence interval, 0.09–0.83) compared with CM arm participants (P = 0.02).There were no significant self-reported risk behavior differences between the doxycycline and CM arms at follow-up. Conclusions Daily doxycycline taken prophylactically was associated with a decreased incidence of N. gonorrhoeae, C. trachomatis, or syphilis incident infections among a core group of HIV-infected MSM at high risk for these infections. Safe and effective biomedical tools should be included in the efforts to control transmission of syphilis, especially in this population. A randomized clinical trial should be conducted to confirm and extend these findings.

Are Centers for Disease Control and Prevention Guidelines for Preexposure Prophylaxis Specific Enough? Formulation of a Personalized HIV Risk Score for Pre-Exposure Prophylaxis Initiation.

Background Preexposure prophylaxis (PrEP) has emerged as a human immunodeficiency virus (HIV) prevention tool for populations at highest risk for HIV infection. Current US Centers for Disease Control and Prevention (CDC) guidelines for identifying PrEP candidates may not be specific enough to identify gay, bisexual, and other men who have sex with men (MSM) at the highest risk for HIV infection. We created an HIV risk score for HIV-negative MSM based on Syndemics Theory to develop a more targeted criterion for assessing PrEP candidacy. Methods Behavioral risk assessment and HIV testing data were analyzed for HIV-negative MSM attending the Los Angeles LGBT Center between January 2009 and June 2014 (n = 9481). Syndemics Theory informed the selection of variables for a multivariable Cox proportional hazards model. Estimated coefficients were summed to create an HIV risk score, and model fit was compared between our model and CDC guidelines using the Akaike Information Criterion and Bayesian Information Criterion. Results Approximately 51% of MSM were above a cutpoint that we chose as an illustrative risk score to qualify for PrEP, identifying 75% of all seroconverting MSM. Our model demonstrated a better overall fit when compared with the CDC guidelines (Akaike Information Criterion Difference = 68) in addition to identifying a greater proportion of HIV infections. Conclusions Current CDC PrEP guidelines should be expanded to incorporate substance use, partner-level, and other Syndemic variables that have been shown to contribute to HIV acquisition. Deployment of such personalized algorithms may better hone PrEP criteria and allow providers and their patients to make a more informed decision prior to PrEP use.

Plasma Tenofovir Levels to Support Adherence to Tdf/ftc Preexposure Prophylaxis for Hiv Prevention in Msm in Los Angeles, California

Background: Tenofovir disoproxil fumarate/emtricitabine preexposure prophylaxis (PrEP) is effective against HIV acquisition when taken as prescribed. Strategies that identify and intervene with those challenged by adherence to daily medication are needed. Setting: PATH-PrEP was an open-label single-arm interventional cohort study conducted at 2 community-based clinical sites in Los Angeles, CA. Methods: We enrolled self-identified men who have sex with men and transgender women ≥18 years of age at an elevated risk of HIV acquisition. Participants received a postexposure prophylaxis (PEP)–based or PrEP-based HIV prevention package for at least 48 weeks. Plasma tenofovir levels from each PrEP visit assessed as below the limit of quantitation (<10 ng/mL) triggered increased adherence support. Results: Three hundred one participants enrolled. Forty-eight–week retention in the PrEP cohort was 75.1%. Biomarker evidence of PrEP adherence consistent with ≥4 doses per week at weeks 4, 12, 24, 36, and 48 was found in 83.1%, 83.4%, 75.7%, 71.6%, and 65.5% of participants, respectively; younger and African American participants were less likely to have protective drug levels. Most of those with suboptimal adherence had adherence improvement after brief intervention. One seroconversion occurred in a participant who discontinued PrEP. Nearly half (46.4%) of participants were diagnosed with at least 1 incident sexually transmitted infection during 48 weeks of study follow-up. Conclusions and Relevance: PrEP was acceptable and well tolerated in a diverse population of men who have sex with men in Los Angeles. A brief intervention triggered from biomarkers of poor adherence was associated with improved adherence. Drug level monitoring has the potential to allow targeting of additional adherence support to those struggling with daily tablet adherence.

Disparities Within the Disparity-Determining HIV Risk Factors Among Latino Gay and Bisexual Men Attending a Community-Based Clinic in Los Angeles, CA.

Background:Latino gay, bisexual, and other men who have sex with men (MSM) in the United States have a 50% greater incidence of HIV when compared with White MSM. Previous studies have analyzed factors contributing to condomless anal intercourse among Latino MSM, but few studies have followed cohorts of HIV-negative Latino MSM to determine circumstances for HIV infection. Informed by Syndemics theory, we examine behavioral, biological, and contextual factors associated with HIV infection for Latino MSM. Methods:Risk assessment and HIV testing data were analyzed for all initially HIV negative, Latino MSM (n = 3111) visiting a community-based clinic in Los Angeles, CA from January 2009 to June 2014. Survival analyses were used to determine characteristics of Latino MSM who became HIV positive during the study time frame. Results:Similar to previous studies of MSM, self-reported history of chlamydia, gonorrhea, and/or syphilis (adjusted hazard ratio (aHR): 1.97; CI: 1.28 to 3.04), receptive condomless anal intercourse (aHR: 1.7; CI: 1.16 to 2.49), and methamphetamine use (aHR: 1.99; CI: 1.15 to 3.43) predicted HIV infection. In addition, originating from Central America (aHR: 2.31; CI: 1.41 to 3.79), Latino ethnicity of the last sex partner (aHR: 1.67; CI: 1.16 to 2.39) and experiencing intimate partner violence (IPV) (aHR: 1.73; CI: 1.13 to 2.64) were also associated with HIV infection among Latino MSM. Conclusions:This is the first study to show independent associations between IPV and HIV infection among Latino MSM. This study shows that psychosocial conditions such as IPV fuel HIV incidence among Latino MSM, and psychosocial interventions should be considered to reduce HIV disparities among Latino MSM.

Evaluation of gonorrhea test of cure at 1 week in a Los Angeles community-based clinic serving men who have sex with men.

Background Because of the decreasing susceptibility of Neisseria gonorrhoeae to cephalosporin therapy, the Centers for Disease Control and Prevention recommends test of cure (TOC) 1 week after gonorrhea (GC) treatment if therapies other than ceftriaxone are used. In addition, the Centers for Disease Control and Prevention asks clinicians, particularly those caring for men who have sex with men (MSM) on the west coast, to consider retesting all MSM at 1 week. However, it is unclear if this is acceptable to providers and patients or if nucleic acid amplification tests (NAATs) are useful for TOC at 7 days. Methods Between January and July 2012, MSM with GC were advised to return 1 week after treatment for TOC using NAAT. A multivariate logistic regression model was used to determine demographic and behavioral differences between MSM who returned for follow-up and MSM who did not. Results Of 737 men with GC, 194 (26.3%) returned between 3 and 21 days of treatment. Individuals who returned were more likely to have no GC history (P = 0.0001) and to report no initial symptoms (P = 0.02) when compared with individuals who did not return for TOC. Of those who returned, 0% of urethral samples, 7.4% of rectal samples, and 5.3% of pharyngeal samples were NAAT positive at TOC. Conclusions Although TOC may be an important strategy in reducing complications and the spread of GC, low return rates may make implementation challenging. If implemented, extra efforts should be considered to enhance return rates among individuals with a history of GC. If TOCs are recommended at 1 week and NAATs are used, the interpretation of positive results, particularly those from extragenital sites, may be difficult.

P3.430* Doxycycline prophylaxis for syphilis in a persistently high risk HIV infected population

Background Syphilis infections increase spread of HIV. This pilot study investigated the feasibility of conducting a large, randomised trial to determine whether prophylactic doxycycline can reduce incident syphilis among HIV+ men who have sex with men having two or more syphilis infections since HIV diagnosis. Methods Thirty subjects from the L.A. Gay & Lesbian Center were randomised to doxycycline 100 mg daily (Doxy) or Contingency Management (CM). Behavioral and biomedical measurements were taken at baseline, 12, 24, 36 and 48 weeks. Binomial Random Effects Logistic Regression Models assessed changes in behavioural measurements and analysed STI contraction at follow-up visits. Fisher Exact Tests compared dropout rates. Given small sample size, an alpha level of 0.1 was chosen. Results Study retention did not differ significantly between groups: 12 and 11 subjects in the Doxy and CM groups, respectively, completed the 48 week study (Fisher Exact p-value = 1.0). On intent-to-treat basis 12 (80%), 11 (73.3%) and 11 (73.3%) subjects had detectable doxycycline levels at 12, 24, and 36 weeks, respectively. New STIs for Doxy vs. CM groups during 9 month on-drug study portion were: syphilis 2 vs. 6, Neisseria gonorrhoea 1 vs. 2, Chlamydia trachomatis 1 vs.3. CM subjects reported more condom use than Doxy subjects (p = 0.09), however CM group subjects had 3.47 greater odds (p-value = 0.037; CI: 1.09 – 11.03) for a new STI compared to Doxy group subjects. Behavioral outcomes for drug use (p = 0.91), anonymous partners (p = 0.45), and number of regular partners (p = 0.14) were not significantly different. Conclusion No safety concerns were associated with daily administration of doxycycline. High retention and drug adherence rates suggest this high risk population will participate in an effectiveness study using doxycycline to reduce syphilis incidence. Efficacy of doxycycline in decreasing incidence of STIs in this pilot study further justifies a definitive study.

Differences in Risk Behavior and Demographic Factors between Men who have Sex with Men with Acute and Non-Acute Human Immunodeficiency Virus Infection in a Community-Based Testing Program in Los Angeles.

Introduction: High viremia combined with HIV-infection status unawareness and increased sexual risk behavior contributes to a disproportionate amount of new HIV infections. Methods: From August 2011 to July 2015, the Los Angeles Lesbian, Gay, Bisexual, and Transgender Center conducted 66,546 HIV tests. We compared factors, including the presence of concomitant sexually transmitted infections, number of recent sex partners and reported condomless anal intercourse between men who have sex with men (MSM) diagnosed with an acute HIV infection and a nonacute HIV infection using multivariable logistic regression. Results: Of 1082 unique MSM who tested HIV-infected for the first time, 165 (15%) had an acute infection and 917 had a nonacute infection. HIV rapid antibody testing was 84.8% sensitive for detecting HIV infection (95% confidence interval (CI): 82.9% to 87.1%). Median HIV viral load among acutely infected MSM was 842,000 copies per milliliter (interquartile range = 98,200–4,897,318). MSM with acute infection had twice the number of sex partners in the prior 30 days (median = 2) and prior 3 months (median = 4) before diagnosis compared with those diagnosed with nonacute infection (P ⩽ 0.0001). The odds of acute HIV infection were increased with the numbers of recent sex partners after controlling for age and race/ethnicity (adjusted odds ratio (aOR) >5 partners in past 30 days = 2.74; 95% CI: 1.46 to 5.14; aOR >10 partners in past 3 months = 2.41; 95% CI: 1.36 to 4.25). Non-African American MSM had almost double the odds of being diagnosed with an acute HIV infection compared with African American MSM (aOR = 1.97; 95% CI: 1.10 to 3.52). Conclusions: MSM with acute HIV infection had nearly twice as many sex partners in the past 30 days and 3 months compared with MSM with newly diagnosed nonacute HIV infection. Those diagnosed with acute HIV infection had decreased odds of being African American MSM.

One Size Does Not Fit All: The Public Health Ramifications of Proposed Food and Drug Administration Premarket Review for Extragenital Gonorrhea and Chlamydia Testing.

In October 2014, the US Food and Drug Administration (FDA) announced a proposed new framework to extend their regulatory oversight of laboratory-developed tests (LDTs). An LDT is defined by the FDA as a diagnostic in vitro test developed by a clinical laboratory for use only in that laboratory. However, when a laboratory wishes to take a commercially manufactured device that has been FDA approved for a given diagnostic testing indication but use the device for a different indication (so-called off-label use), they must perform validation studies to demonstrate that the device performs accurately for this use.Manufacturers will pay for performing validation studies when they wish to market the test for a new use indication. However, if a manufacturer does not act and a laboratory performs the validation studies, the FDA considers the device an LDT for this off-label use. When several laboratories individually perform validations and publish their data in peer-reviewed journals, and if such data are in agreement with one another, then this new use can become standard of care. The FDAs appropriate concern is to ensure the quality and performance accuracy of LDTs so their use consistently guides correct clinical management. Nucleic acid amplification tests (NAATs) are FDA approved for detection of both Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) in urogenital sites. Although cultures were originally used to test for these organisms at extragenital sites (i.e., pharynx and rectum), poor culture sensitivity led various laboratories to adopt NAAT assays for such testing. Numerous public health laboratories and clinical sites have shown these assays to be more sensitive than culture for pharyngeal and rectal testing. Ota et al. compared the sensitivity of culture to NAAT assays in detecting extragenital NG and CT. The culture sensitivity was 0% for both the NG and CT pharyngeal sites, 41% for rectal NG, and 21% for rectal CT. In contrast, the NAAT assays had 80% to 100% sensitivity at all sites. Notably, culture detected only 16 cases of extragenital infections, whereas NAATs detected 73 such cases in this study. Similar results were found by Schachter et al., with NG and CT rectal and pharyngeal culture sensitivity ranging from 27% to 44% and NAAT assay sensitivity ranging from 63% to

Does HIV pre-exposure prophylaxis use lead to a higher incidence of sexually transmitted infections? A case-crossover study of men who have sex with men in Los Angeles, California

Background Pre-exposure prophylaxis (PrEP) is an effective method for reducing HIV incidence among at-risk populations. However, concerns exist over the potential for an increase in STIs following PrEP initiation. The objective of this study is to compare the STI incidence before and after PrEP initiation within subjects among a cohort of men who have sex with men in Los Angeles, California. Methods The present study used data from patients who initiated PrEP services at the Los Angeles LGBT Center between October 2015 and October 2016 (n=275). A generalised linear mixed model was used with a case-crossover design to determine if there was a significant difference in STIs within subjects 365 days before (before-PrEP period) and 365 days after PrEP initiation (after-PrEP period). Results In a generalised linear mixed model, there were no significant differences in urethral gonorrhoea (P=0.95), rectal gonorrhoea (P=0.33), pharyngeal gonorrhoea (P=0.65) or urethral chlamydia (P=0.71) between periods. There were modest increases in rectal chlamydia (rate ratio (RR) 1.83; 95% CI 1.13 to 2.98; P=0.01) and syphilis diagnoses (RR 2.97; 95% CI 1.23 to 7.18; P=0.02). Conclusions There were significant increases in rectal chlamydia and syphilis diagnoses when comparing the periods directly before and after PrEP initiation. However, only 28% of individuals had an increase in STIs between periods. Although risk compensation appears to be present for a segment of PrEP users, the majority of individuals either maintain or decrease their sexual risk following PrEP initiation.