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 PARTICIPANTSThis 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 MEASURESPositive 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. RESULTSOf 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 RELEVANCEIn this e...

Aims The advent of direct-acting antivirals for hepatitis C virus (HCV) and limited effectiveness of prevention have generated interest in “Treatment as Prevention” (TasP), in which those most likely to transmit HCV (i.e. people who inject drugs [PWID]) are treated to reduced secondary transmission. However, there are scant data regarding the feasibility of treating PWID at high risk for secondary transmission or the optimal approach to treatment delivery. Methods We conducted a 2:1 randomized trial of modified directly-observed (mDOT) versus unobserved HCV treatment with ledipasvir-sofosbuvir daily for 8 weeks among PWID with 36 weeks of follow-up in San Francisco from 2015–2017. We evaluated recruitment-enrollment, treatment completion, end-of-treatment and 12-week response, and reinfection rate. Results Of 83 individuals eligible for screening, 72 (87.6%) attended the screening visit, 33 were eligible, and 31 enrolled; mean age was 42 years, 81% were male, 74% white. All but one participant (in the mDOT arm) completed treatment and 89.4% of mDOT and 96.6% of unobserved arm visits were attended. HCV was undetectable for 96.8% (30/31) at end of treatment and 89.7% (26/29) 12 weeks later (1 relapse, 1 reinfection), with no differences by arm. Two additional reinfections were subsequently identified, for a reinfection rate of 16.3 (95% CI 5.3–50.5) per 100 person-years of observation. Conclusions It was feasible to recruit active PWID for HCV treatment and achieve high retention, viral response, and satisfaction with either mDOT or unobserved protocols, supporting treatment of PWID at risk of transmitting HCV to others. The reinfection rate suggests we successfully reached a high-risk population and that successful HCV TasP initiatives may aim to be sufficient in scope to significantly lower prevalence in the community. Trial registration clinicaltrials.gov NCT02609893 .

ObjectivesTo describe heavy alcohol use patterns and correlates in a diverse sample of MSM.MethodsWe used respondent-driven sampling (RDS) to enroll 252 alcohol-using MSM in San Francisco from March 2015-July 2017. We examined heavy alcohol use patterns and conducted RDS-adjusted multivariable analyses to characterize correlates of hazardous alcohol consumption and binge drinking.ResultsRDS-adjusted prevalence of weekly and at least weekly binge drinking was 24.9% and 19.3%, respectively. Hazardous consumption was common; prevalence of mid- and high-levels of hazardous drinking was 11.4% and 29.9%, respectively. In multivariable analyses, identifying as Hispanic/Latino or mixed/other race; being moderately or extremely interested in reducing alcohol use; ever receiving alcohol treatment; using ecstasy; reporting syphilis diagnosis; and having more than 5 male partners were independently associated with hazardous alcohol consumption. Less hazardous consumption was associated with having a bachelor's degree or completing post-graduate studies; and not being in a relationship. Reporting chlamydia infection; being somewhat, moderately or extremely interested in reducing alcohol use; and having multiple male sex partners were associated with higher odds of at least weekly binge drinking. Lower odds of binge drinking were associated with completing post-graduate studies. Moreover, for the outcomes of hazardous alcohol consumption and binge-drinking, we observed significant interaction effects between race/ethnicity and interest in reducing alcohol, past receipt of alcohol treatment, use of ecstasy, syphilis diagnosis, and number of male partners.ConclusionAmong alcohol-using MSM in San Francisco, heavy drinking patterns were common and independently associated with greater number of male sexual partners and sexually transmitted infections (STI). Moreover, significant racial/ethnic and socioeconomic disparities related to heavy alcohol use were observed and race/ethnicity modified the effect of the risk factors associated with these outcomes. These findings underscore the need to develop more MSM-specific interventions that jointly address heavy alcohol use and HIV/STI risk, as well as culturally-tailored and targeted strategies to alleviate health disparities.

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.

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