San Francisco's Citywide COVID-19 Response: Strategies to Reduce COVID-19 Severity and Health Disparities, March 2020 Through May 2022.

San Francisco implemented one of the most intensive, comprehensive, multipronged COVID-19 pandemic responses in the United States using 4 core strategies: (1) aggressive mitigation measures to protect populations at risk for severe disease, (2) prioritization of resources in neighborhoods highly affected by COVID-19, (3) timely and adaptive data-driven policy making, and (4) leveraging of partnerships and public trust. We collected data to describe programmatic and population-level outcomes. The excess all-cause mortality rate in 2020 in San Francisco was half that seen in 2019 in California as a whole (8% vs 16%). In almost all age and race and ethnicity groups, excess mortality from COVID-19 was lower in San Francisco than in California overall, with markedly diminished excess mortality among people aged >65 years. The COVID-19 response in San Francisco highlights crucial lessons, particularly the importance of community responsiveness, joint planning, and collective action, to inform future pandemic response and advance health equity.

Effects of Mirtazapine for Methamphetamine Use Disorder Among Cisgender Men and Transgender Women Who Have Sex With Men: A Placebo-Controlled Randomized Clinical Trial.

Importance: Methamphetamine use is increasingly prevalent and associated with HIV transmission. A previous phase 2a study of mirtazapine demonstrated reductions in methamphetamine use and sexual risk behaviors among men who have sex with men. Objective: To determine the efficacy of mirtazapine for treatment of methamphetamine use disorder and reduction in HIV risk behaviors. Design, Setting, and Participants: This double-blind randomized clinical trial of mirtazapine vs placebo took place from August 2013 to September 2017 in an outpatient research clinic in San Francisco, California. Participants were community-recruited adults who were sexually active; cisgender men, transgender men, and transgender women who (1) had sex with men, (2) had methamphetamine use disorder, and (3) were actively using methamphetamine were eligible. Participants were randomized to receive the study drug or placebo for 24 weeks, with 12 more weeks of follow-up. Data analysis took place from February to June 2018. Exposures: Mirtazapine, 30 mg, or matched placebo orally once daily for 24 weeks, with background counseling. Main Outcomes and Measures: Positive urine test results for methamphetamine over 12, 24, and 36 weeks (primary outcomes) and sexual risk behaviors (secondary outcomes). Sleep, methamphetamine craving, dependence severity, and adverse events were assessed. Results: Of 241 persons assessed, 120 were enrolled (5 transgender women and 115 cisgender men). The mean (SD) age was 43.3 (9.8) years; 61 (50.8%) were white, 31 (25.8%) were African American, and 15 (12.5%) were Latinx. A mean (SD) of 66% (47%) of visits were completed overall. By week 12, the rate of methamphetamine-positive urine test results significantly declined among participants randomized to mirtazapine vs placebo (risk ratio [RR], 0.67 [95% CI, 0.51-0.87]). Mirtazapine resulted in reductions in positive urine test results at 24 weeks (RR, 0.75 [95% CI, 0.56-1.00]) and 36 weeks (RR, 0.73 [95% CI, 0.57-0.96]) vs placebo. Mean (SD) medication adherence by WisePill dispenser was 38.5% (27.0%) in the mirtazapine group vs 39.5% (26.2%) in the placebo group (P = .77) over 2 to 12 weeks and 28.1% (23.4%) vs 38.5% (27.0%) (P = .59) over 13 to 24 weeks. Changes in sexual risk behaviors were not significantly different by study arm at 12 weeks, but those assigned to receive mirtazapine had fewer sexual partners (RR, 0.52 [95% CI, 0.27-0.97]; P = .04), fewer episodes of condomless anal sex with partners who were serodiscordant (RR, 0.47 [95% CI, 0.23-0.97]; P = .04), and fewer episodes of condomless receptive anal sex with partners who were serodiscordant (RR, 0.37 [95% CI, 0.14-0.93]; P = .04) at week 24. Participants assigned to mirtazapine had net reductions in depressive symptoms (Center for Epidemiologic Studies Depression Scale score, 6.2 [95% CI, 1.3-11.1] points lower; P = .01) and insomnia severity (Athens score, 1.4 [95% CI, 0.1-2.7] points lower; P = .04) at week 24. There were no serious adverse events associated with the study drug. Conclusions and Relevance: In this expanded replication trial, adding mirtazapine to substance use counseling reduced methamphetamine use and some HIV risk behaviors among cisgender men and transgender women who have sex with men, with benefits extending after treatment despite suboptimal medication adherence. Trial Registration: ClinicalTrials.gov identifier: NCT01888835.

Correlates of Validity of Self-Reported Methamphetamine Use among a Sample of Dependent Adults.

BACKGROUND: Self-reported data are widely used in substance-use research, yet few studies have assessed the validity of self-reported methamphetamine use compared to biological assays. OBJECTIVES: We sought to assess the validity and correlates of validity of self-reported methamphetamine use compared to urine toxicology (UTOX). METHODS: Using a sample of methamphetamine-dependent individuals enrolled in a randomized controlled pharmacotherapy trial in the United States (n = 327 visits among 90 participants), we calculated sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and the kappa coefficient of self-reported methamphetamine use in the past 3 days compared to UTOX, as well as the NPV of self-reported methamphetamine use over an extended recall period of 1 month. We used multivariable logistic regression models to assess correlates of concordance between self-reported methamphetamine use and UTOX. RESULTS: The sensitivity of self-reported methamphetamine use in the past 3 days was 86.7% (95% confidence intervals (95%CI): 81.4%-91.4%), the specificity was 85.3% (77.7-91.3), the PPV was 91.5% (86.9-94.8), and the NPV was 78.0% (69.4-86.1), compared to UTOX (kappa = 0.71). The NPV over the extended recall period was 70.6% (48.0-85.7). In multivariable analyses, validity of self-reported methamphetamine use was higher for older participants but lower during follow-up compared to baseline and when polysubstance use or depressive symptoms were reported. Conclusions/Importance: Our sample of methamphetamine-dependent adults reported recent methamphetamine use with high validity compared to UTOX. Validity increased with age but decreased when participants reported depressive symptoms or polysubstance use as well as later in the study timeline and during longer recall periods.

Extended-release naltrexone for methamphetamine dependence among men who have sex with men: a randomized placebo-controlled trial.

BACKGROUND AND AIMS: Methamphetamine use is increasingly prevalent and associated with HIV transmission. Early-phase human studies suggested naltrexone reduced amphetamine use among dependent individuals. We tested if extended-release naltrexone (XRNTX) reduces methamphetamine use and associated sexual risk behaviors among high-risk methamphetamine-dependent men who have sex with men (MSM). DESIGN: Double-blind, placebo-controlled, randomized trial of XRTNX versus placebo over 12 weeks from 2012 to 2015. SETTING: San Francisco Department of Public Health, California, USA. PARTICIPANTS: One hundred community-recruited, sexually-active, actively-using methamphetamine-dependent MSM. Mean age was 43.2 years; 96% were male, 3% transfemale, and 1% transmale; 55.0% were white, 19.0% African American, and 18.0% Latino. INTERVENTIONS: XRNTX 380 mg (n = 50) or matched placebo (n = 50) administered by gluteal injection at 4-week intervals. MEASUREMENTS: Regression estimated average level and change in level of positive urines during the period 2-12 weeks (primary outcomes) and sexual risk behaviors (secondary outcome). FINDINGS: Ninety per cent of visits were completed. By intent-to-treat, participants assigned to XRNTX had similar differences during 2-12 weeks in methamphetamine-positive urines as participants assigned to placebo [incidence rate ratio (IRR) = 0.95, 95% confidence interval (CI) = 0.76-1.20; Bayes factor < 0.3]. Observed urine positivity declined from 78 to 70% in the XRNTX arm and 74 to 64% in the placebo arm. Adherence to injections was 96.7% in the XRNTX arm and 91.3% in the placebo arm. Sexual risk behaviors declined similarly among participants in both arms (all P > 0.05). There were no serious adverse events related to study drug and no differences in frequency of adverse events by treatment arm. CONCLUSIONS: Notwithstanding very high medication adherence for this study, extended-release naltrexone does not appear to reduce methamphetamine use or sexual risk behaviors among methamphetamine-dependent men who have sex with men compared with placebo.

Substance use and STI acquisition: Secondary analysis from the AWARE study.

OBJECTIVES: Sexually transmitted infections (STIs) are significant public health and financial burdens in the United States. This manuscript examines the relationship between substance use and prevalent and incident STIs in HIV-negative adult patients at STI clinics. METHODS: A secondary analysis of Project AWARE was performed based on 5012 patients from 9 STI clinics. STIs were assessed by laboratory assay and substance use by self-report. Patterns of substance use were assessed using latent class analysis. The relationship of latent class to STI rates was investigated using Poisson regression by population groups at high risk for STIs defined by participant's and partner's gender. RESULTS: Drug use patterns differed by risk group and substance use was related to STI rates with the relationships varying by risk behavior group. Substance use treatment participation was associated with increased STI rates. CONCLUSIONS: Substance use focused interventions may be useful in STI clinics to reduce morbidity associated with substance use. Conversely, gender-specific sexual health interventions may be useful in substance use treatment.

Effect of Patient Navigation With or Without Financial Incentives on Viral Suppression Among Hospitalized Patients With HIV Infection and Substance Use: A Randomized Clinical Trial.

IMPORTANCE: Substance use is a major driver of the HIV epidemic and is associated with poor HIV care outcomes. Patient navigation (care coordination with case management) and the use of financial incentives for achieving predetermined outcomes are interventions increasingly promoted to engage patients in substance use disorders treatment and HIV care, but there is little evidence for their efficacy in improving HIV-1 viral suppression rates. OBJECTIVE: To assess the effect of a structured patient navigation intervention with or without financial incentives to improve HIV-1 viral suppression rates among patients with elevated HIV-1 viral loads and substance use recruited as hospital inpatients. DESIGN, SETTING, AND PARTICIPANTS: From July 2012 through January 2014, 801 patients with HIV infection and substance use from 11 hospitals across the United States were randomly assigned to receive patient navigation alone (n = 266), patient navigation plus financial incentives (n = 271), or treatment as usual (n = 264). HIV-1 plasma viral load was measured at baseline and at 6 and 12 months. INTERVENTIONS: Patient navigation included up to 11 sessions of care coordination with case management and motivational interviewing techniques over 6 months. Financial incentives (up to $1160) were provided for achieving targeted behaviors aimed at reducing substance use, increasing engagement in HIV care, and improving HIV outcomes. Treatment as usual was the standard practice at each hospital for linking hospitalized patients to outpatient HIV care and substance use disorders treatment. MAIN OUTCOMES AND MEASURES: The primary outcome was HIV viral suppression (≤200 copies/mL) relative to viral nonsuppression or death at the 12-month follow-up. RESULTS: Of 801 patients randomized, 261 (32.6%) were women (mean [SD] age, 44.6 years [10.0 years]). There were no differences in rates of HIV viral suppression versus nonsuppression or death among the 3 groups at 12 months. Eighty-five of 249 patients (34.1%) in the usual-treatment group experienced treatment success compared with 89 of 249 patients (35.7%) in the navigation-only group for a treatment difference of 1.6% (95% CI, -6.8% to 10.0%; P = .80) and compared with 98 of 254 patients (38.6%) in the navigation-plus-incentives group for a treatment difference of 4.5% (95% CI -4.0% to 12.8%; P = .68). The treatment difference between the navigation-only and the navigation-plus-incentives group was -2.8% (95% CI, -11.3% to 5.6%; P = .68). CONCLUSIONS AND RELEVANCE: Among hospitalized patients with HIV infection and substance use, patient navigation with or without financial incentives did not have a beneficial effect on HIV viral suppression relative to nonsuppression or death at 12 months vs treatment as usual. These findings do not support these interventions in this setting. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01612169.

The incidence of Trichomonas vaginalis infection in women attending nine sexually transmitted diseases clinics in the USA.

OBJECTIVES: Trichomoniasis (TV) is associated with an increased risk of acquisition of sexually transmitted diseases (STDs) and HIV. The purpose of this study is to evaluate factors associated with incidence TV among female STD clinic attendees in the USA. METHODS: Data were collected from women participating in a randomised controlled trial evaluating brief risk reduction counselling at the time of HIV testing to reduce sexually transmitted infections (STIs) incidence in STD clinics. Participants recruited from STD clinics underwent STI testing at baseline and 6-month follow-up. TV testing was performed using Nucleic Acid Amplification Test. RESULTS: 1704 participants completed study assessments. Prevalence of TV was 14.6%, chlamydia 8.6%, gonorrhoea 3.0%, herpes simplex virus 2 44.7% and HIV 0.4%. Cumulative 6-month incidence of TV was 7.5%. Almost 50% of the incident TV cases had TV at baseline and had received treatment. Factors associated with incidence of TV were having chlamydia, TV and HIV at baseline: TV relative risk (RR)=3.37 (95% CI 2.35 to 4.83, p<0.001); chlamydia RR=1.92 (95% CI 1.23 to 2.99, p=0.04); and HIV=1.59 (95% CI 1.01 to 2.50, p=0.047). CONCLUSIONS: Prevalent and incident TV is common among STD clinic attendees; and baseline TV is the main risk factor for incident TV, suggesting high rates of reinfection or treatment failures. This supports the importance of rescreening women after treatment for TV, evaluating current treatment regimens and programmes to ensure treatment of sexual partners. CLINICAL TRIAL NUMBER: NCT01154296.

Applying innovative approaches for reaching men who have sex with men and female sex workers in the Democratic Republic of Congo.

BACKGROUND: In the Democratic Republic of Congo (DRC), men who have sex with men (MSM) and female sex workers (FSW) have the highest HIV prevalence but have the least access to services due to their marginalization within Congolese society. METHODS: The Projet Intégré de VIH/SIDA au Congo (ProVIC) aims to reduce the risk and impact of HIV in the DRC through community- and facility-based prevention, counseling and testing, and treatment strategies aimed at high-risk populations, including MSM and FSW. To more effectively meet the needs of key populations, ProVIC tailored the existing interventions to better suit MSM and FSW by offering mobile counseling and rapid HIV testing services at night in MSM and FSW "hotspots," targeting outreach to and mobilizing key populations through social networks of MSM and FSW peer educators and recruiters, and referring MSM and FSW who test HIV positive to "friendly" clinics. RESULTS: Through these approaches, ProVIC was able to reach 2,621 MSM and 12,746 FSW with targeted prevention messaging in 2013 and provide testing and counseling services to 4,366 MSM and 21,033 FSW from October 2012 to June 2014. CONCLUSIONS: By applying innovative adaptations geared toward key populations, ProVIC has been able to better reach MSM and FSW in the DRC. ProVIC's targeted interventions for MSM and FSW provide promising examples of programming that can be used to meet the HIV prevention and testing needs of key populations and improve referrals for care and treatment, particularly in complex and unstable settings similar to the DRC.

Internalised homophobia is differentially associated with sexual risk behaviour by race/ethnicity and HIV serostatus among substance-using men who have sex with men in the United States.

OBJECTIVES: There is a continuing need to identify factors associated with risk for HIV transmission among men who have sex with men (MSM), including a need for further research in the ongoing scientific debate about the association of internalised homophobia and sexual risk due partly to the lack of specificity in analysis. We assess the association of internalised homophobia by race/ethnicity within HIV serostatus for a large sample of substance-using MSM at high risk of HIV acquisition or transmission. METHODS: Convenience sample of substance-using (non-injection) MSM reporting unprotected anal sex in the prior 6 months residing in Chicago, Los Angeles, New York and San Francisco. The analytic sample included HIV-negative and HIV-positive black (n=391), Latino (n=220), and white (n=458) MSM. Internalised homophobia was assessed using a published four-item scale focusing on negative self-perceptions and feelings of their own sexual behaviour with men, or for being gay or bisexual. Analyses tested associations of internalised homophobia with recent risk behaviour, stratified by laboratory-confirmed HIV serostatus within race/ethnicity, and controlling for other demographic variables. RESULTS: In multivariate analysis, internalised homophobia was inversely associated (p<0.05) with recent unprotected anal sex among black MSM, and not significantly associated with sexual risk behaviour among white and Latino MSM. CONCLUSIONS: More research is needed to further identify nuanced differences in subpopulations of MSM, but these results suggest differentially targeted intervention messages for MSM by race/ethnicity.

Event-level relationship between methamphetamine use significantly associated with non-adherence to pharmacologic trial medications in event-level analyses.

BACKGROUND: Methamphetamine use has been previously associated with poor medication adherence, but, to date, there have been no studies that have conducted event-level analyses on correlates of medication adherence in studies of pharmacologic agents for methamphetamine dependence. METHODS: We pooled data from two previous, randomized controlled trials (using bupropion and mirtazapine, respectively) for methamphetamine dependence and used a mixed effects logistic model to examine correlates of daily opening of the medication event monitoring system (MEMS) cap as a repeated measure. We explored whether periods of observed methamphetamine use via urine testing were associated with study medication adherence based on MEMS cap openings. RESULTS: We found a significant negative association between methamphetamine-urine positivity and event-level study medication adherence as measured by MEMS cap openings (AOR: 0.69; 95% CI: 0.49-0.98). In addition, age (AOR: 1.07; 95% CI: 1.02-1.11) and depressive symptoms (AOR: 0.78; 95% CI: 0.64-0.90) were significantly associated with adherence. Finally, participants were more likely to open their study medication bottles on days when they presented for in-person urine testing. CONCLUSIONS: Our event-level analysis shows that methamphetamine use can be associated with reduced medication adherence as measured by MEMS cap openings in pharmacologic trials, which corroborates prior research. These findings may suggest that medication adherence support in pharmacologic trials among methamphetamine users may be needed to improve study compliance and could be targeted towards periods of time when there are more likely to not open their study medication pill bottles.

The cost of implementing rapid HIV testing in sexually transmitted disease clinics in the United States.

INTRODUCTION: Rapid HIV testing in high-risk populations can increase the number of persons who learn their HIV status and avoid spending clinic resources to locate persons identified as HIV infected. METHODS: We determined the cost to sexually transmitted disease (STD) clinics of point-of-care rapid HIV testing using data from 7 public clinics that participated in a randomized trial of rapid testing with and without brief patient-centered risk reduction counseling in 2010. Costs included counselor and trainer time, supplies, and clinic overhead. We applied national labor rates and test costs. We calculated median clinic start-up costs and mean cost per patient tested, and projected incremental annual costs of implementing universal rapid HIV testing compared with current testing practices. RESULTS: Criteria for offering rapid HIV testing and methods for delivering nonrapid test results varied among clinics before the trial. Rapid HIV testing cost an average of US $22/patient without brief risk reduction counseling and US $46/patient with counseling in these 7 clinics. Median start-up costs per clinic were US $1100 and US $16,100 without and with counseling, respectively. Estimated incremental annual costs per clinic of implementing universal rapid HIV testing varied by whether or not brief counseling is conducted and by current clinic testing practices, ranging from a savings of US $19,500 to a cost of US $40,700 without counseling and a cost of US $98,000 to US $153,900 with counseling. CONCLUSIONS: Universal rapid HIV testing in STD clinics with same-day results can be implemented at relatively low cost to STD clinics, if brief risk reduction counseling is not offered.

Substance use and drinking outcomes in Personalized Cognitive Counseling randomized trial for episodic substance-using men who have sex with men.

BACKGROUND: Non-dependent alcohol and substance use patterns are prevalent among men who have sex with men (MSM), yet few effective interventions to reduce their substance use are available for these men. We evaluated whether an adapted brief counseling intervention aimed at reducing HIV risk behavior was associated with secondary benefits of reducing substance use among episodic substance-using MSM (SUMSM). METHODS: 326 episodic SUMSM were randomized to brief Personalized Cognitive Counseling (PCC) intervention with rapid HIV testing or to rapid HIV testing only control. Both arms followed over 6 months. Trends in substance use were examined using GEE Poisson models with robust standard errors by arm. Reductions in frequency of use were examined using ordered logistic regression. RESULTS: In intent-to-treat analyses, compared to men who received rapid HIV testing only, we found men randomized to PCC with rapid HIV testing were more likely to report abstaining from alcohol consumption (RR=0.93; 95% CI=0.89-0.97), marijuana use (RR=0.84; 95% CI=0.73-0.98), and erectile dysfunction drug use (EDD; RR=0.51; 95% CI=0.33-0.79) over the 6-month follow-up. PCC was also significantly associated with reductions in frequency of alcohol intoxication (OR=0.58; 95% CI=0.36-0.90) over follow-up. Furthermore, we found PCC was associated with significant reductions in number of unprotected anal intercourse events while under the influence of methamphetamine (RR=0.26; 95% CI=0.08-0.84). CONCLUSION: The addition of adapted PCC to rapid HIV testing may have benefits in increasing abstinence from certain classes of substances previously associated with HIV risk, including alcohol and EDD; and reducing alcohol intoxication frequency and high-risk sexual behaviors concurrent with methamphetamine use.

Alcohol and substance use among transgender women in San Francisco: prevalence and association with human immunodeficiency virus infection.

INTRODUCTION AND AIMS: Alcohol and substance use can have negative health consequences among both human immunodeficiency virus (HIV)-positive and -negative individuals, and are associated with behaviors that facilitate HIV transmission and acquisition. The relationship of substance use and HIV is well documented among key populations at risk for HIV. However, although transwomen (male-to-female transgender) are disproportionately impacted by HIV, this overlap remains understudied in this population. We sought to evaluate the association between HIV, alcohol and substance use among transwomen. DESIGN AND METHODS: We conducted a secondary data analysis of Respondent Driven Sampling study which collected information on self-reported alcohol and substance use among 314 transwomen. We used multivariable logistic regression to assess relationship between HIV infection and classes and patterns of alcohol and substance use. RESULTS: We found that 58% of transwomen used alcohol, and 43.3% used substances. The most common substances used were: marijuana (29%), methamphetamine (20.1%), crack cocaine (13.4%), and 'club drugs' (13.1%). Transwomen who reported any methamphetamine use [adjusted odds ratio (AOR) 3.02 (95% confidence interval (CI) = 1.51-6.02)], methamphetamine use before or during anal intercourse [AOR 3.27 (95% CI = 1.58-6.77)], and at least weekly methamphetamine use [AOR 3.89 (95% CI = 1.64-9.23)] had significantly greater odds of testing positive for HIV. DISCUSSION AND CONCLUSIONS: Transfemales have high prevalence of alcohol and substance use; those tested positive for HIV used significantly more methamphetamine in general, and in conjunction with sex. Given the disproportionate prevalence of HIV and substance use in this population, interventions aimed at addressing both substance use and HIV risk among transwomen are urgently needed.

Adapted personalized cognitive counseling for episodic substance-using men who have sex with men: a randomized controlled trial.

Episodic drug use and binge drinking are associated with HIV risk among substance-using men who have sex with men (SUMSM), yet no evidence-based interventions exist for these men. We adapted personalized cognitive counseling (PCC) to address self-justifications for high-risk sex among HIV-negative, episodic SUMSM, then randomized men to PCC (n = 162) with HIV testing or control (n = 164) with HIV testing alone. No significant between-group differences were found in the three primary study outcomes: number of unprotected anal intercourse events (UAI), number of UAI partners, and UAI with three most recent non-primary partners. In a planned subgroup analysis of non-substance dependent men, there were significant reductions in UAI with most recent non-primary partners among PCC participants (RR = 0.56; 95 %CI 0.34-0.92; P = 0.02). We did not find evidence that PCC reduced sexual risk behaviors overall, but observed significant reductions in UAI events among non-dependent SUMSM. PCC may be beneficial among SUMSM screening negative for substance dependence.

A roadmap for adapting an evidence-based HIV prevention intervention: personal cognitive counseling (PCC) for episodic substance-using men who have sex with men.

Episodic (less than weekly) drug use and binge drinking increase HIV-related sexual risk behaviors among men who have sex with men (MSM), yet no evidence-based interventions exist for these men. We describe an adaptation process of the Personalized Cognitive Counseling (PCC) intervention for utilization with high-risk, HIV-negative episodic, substance-using MSM. Participants (N = 59) were racially diverse, and reported unprotected anal intercourse and concurrent binge drinking (85%), use of poppers (36%), methamphetamine (20%) and cocaine (12%). Semi-structured interviews with 20 episodic, substance-using MSM elicited sexual narratives for engaging in unprotected anal intercourse while using alcohol or drugs. Emergent qualitative themes were translated into self-justifications and included in a revised PCC self-justification elicitation instrument (SJEI). The adapted SJEI was pretested with 19 episodic, substance-using MSM, and the final adapted PCC was pilot-tested for acceptability and feasibility with 20 episodic, substance-using MSM. This process can be used as a roadmap for adapting PCC for other high-risk populations of MSM.

Effect of risk-reduction counseling with rapid HIV testing on risk of acquiring sexually transmitted infections: the AWARE randomized clinical trial.

IMPORTANCE: To increase human immunodeficiency virus (HIV) testing rates, many institutions and jurisdictions have revised policies to make the testing process rapid, simple, and routine. A major issue for testing scale-up efforts is the effectiveness of HIV risk-reduction counseling, which has historically been an integral part of the HIV testing process. OBJECTIVE: To assess the effect of brief patient-centered risk-reduction counseling at the time of a rapid HIV test on the subsequent acquisition of sexually transmitted infections (STIs). DESIGN, SETTING, AND PARTICIPANTS: From April to December 2010, Project AWARE randomized 5012 patients from 9 sexually transmitted disease (STD) clinics in the United States to receive either brief patient-centered HIV risk-reduction counseling with a rapid HIV test or the rapid HIV test with information only. Participants were assessed for multiple STIs at both baseline and 6-month follow-up. INTERVENTIONS: Participants randomized to counseling received individual patient-centered risk-reduction counseling based on an evidence-based model. The core elements included a focus on the patient's specific HIV/STI risk behavior and negotiation of realistic and achievable risk-reduction steps. All participants received a rapid HIV test. MAIN OUTCOMES AND MEASURES: The prespecified outcome was a composite end point of cumulative incidence of any of the measured STIs over 6 months. All participants were tested for Neisseria gonorrhoeae, Chlamydia trachomatis, Treponema pallidum (syphilis), herpes simplex virus 2, and HIV. Women were also tested for Trichomonas vaginalis. RESULTS: There was no significant difference in 6-month composite STI incidence by study group (adjusted risk ratio, 1.12; 95% CI, 0.94-1.33). There were 250 of 2039 incident cases (12.3%) in the counseling group and 226 of 2032 (11.1%) in the information-only group. CONCLUSION AND RELEVANCE: Risk-reduction counseling in conjunction with a rapid HIV test did not significantly affect STI acquisition among STD clinic patients, suggesting no added benefit from brief patient-centered risk-reduction counseling. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01154296.

Correlates of HIV infection among transfemales, San Francisco, 2010: results from a respondent-driven sampling study.

OBJECTIVES: We evaluated the use of respondent-driven sampling (RDS) among a high-risk population of transfemales. We also obtained up-to-date epidemiological data on HIV infection and related correlates among this population. METHODS: We evaluated the utility of RDS in recruiting a sample of 314 transfemales in San Francisco, California, from August to December 2010 by examining patterns of recruitment and assessing network sizes and equilibrium. We used RDS weights to conduct bivariate and multivariate analyses of correlates of HIV infection. RESULTS: The sample had moderate homophily and reached equilibrium at the eighth wave of recruitment. Weighted HIV prevalence among transfemales was 39.5%. Being a transfemale of color, using injection drugs, and having low educational attainment were independently associated with HIV infection and having a high number of sexual partners and identifying as female were not. CONCLUSIONS: RDS performed well and allowed for analyses that are generalizable to the population from which the sample was drawn. Transfemales in San Francisco are disproportionately affected by HIV compared with all other groups except men who have sex with men who also inject drugs.

Dose-response associations between number and frequency of substance use and high-risk sexual behaviors among HIV-negative substance-using men who have sex with men (SUMSM) in San Francisco.

We evaluated the relationship between frequency and number of substances used and HIV risk [ie, serodiscordant unprotected anal intercourse (SDUAI)] among 3173 HIV-negative substance-using MSM. Compared with nonusers, the adjusted odds ratio (AOR) for SDUAI among episodic and at least weekly users, respectively, was 3.31 [95% confidence interval (CI), 2.55 to 4.28] and 5.46 (95% CI, 3.80 to 7.84) for methamphetamine, 1.86 (95% CI, 1.51 to 2.29) and 3.13 (95% CI, 2.12 to 4.63) for cocaine, and 2.08 (95% CI, 1.68 to 2.56) and 2.54 (95% CI, 1.85 to 3.48) for poppers. Heavy alcohol drinkers reported more SDUAI than moderate drinkers [AOR, 1.90 (95% CI, 1.43 to 2.51)]. Compared with nonusers, AORs for using 1, 2, and ≥3 substances were 16.81 (95% CI, 12.25 to 23.08), 27.31 (95% CI, 18.93 to 39.39), and 46.38 (95% CI, 30.65 to 70.19), respectively. High-risk sexual behaviors were strongly associated with frequency and number of substances used.