Increasing rates of sexually transmitted infections (STIs) in the United States among men who have sex with men (MSM) have raised concerns that pre-exposure prophylaxis (PrEP) has been associated with higher engagement in condomless anal intercourse (CAI). While partnership characteristics have previously been found to influence condom use, the extent to which PrEP use may modify their effect on CAI remains unknown. A secondary analysis of 535 sexual partnerships from a cross-sectional study in San Francisco was conducted to evaluate interactions between PrEP use and partnership characteristics on CAI. Bivariate and multivariate generalized estimating equation (GEE) logistic regression models were used to estimate relative measures of association, adjusted for confounding by seroconcordance and partnership type, as well as account for repeated partnerships per respondent. Partnerships where both partners used biomedical prevention had significantly greater odds of CAI [odds ratio (OR) = 5.19, 95% confidence interval (CI): 2.27-11.9] compared to those where only one partner used biomedical prevention, while those where neither partner used biomedical prevention had significantly lower odds of CAI (OR = 0.61, 95% CI: 0.40-0.93). There was no significant association between meeting place (online vs. offline) and sexual risk taking (OR = 1.03, p = 0.894). Having one partner disclose their HIV status (compared to neither partner having disclosed) was associated with significantly higher odds of CAI among partnerships of PrEP-using MSM [adjusted OR (aOR) = 5.28, 95% CI: 1.91-14.61], while the association was not significant among the partnerships of non-PrEP-using MSM (aOR = 1.29, 95% CI: 0.75-2.21). Differences in condom use among MSM using PrEP may not be well explained by differences in the effect of partnership characteristics. MSM using PrEP appear to commonly practice biomedical matching and high engagement in CAI with other biomedical prevention users, which could indicate relatively concentrated sexual networks and partly explain their disproportionate risk for STIs. Future studies should further investigate biomedical matching to develop interventions that further promote the sexual health of those using PrEP.

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.

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.

Objectives

To describe heavy alcohol use patterns and correlates in a diverse sample of MSM.

Methods

We 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.

Results

RDS-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.

Conclusion

Among 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.