Background. The pilot phase IIb VIKING study suggested that dolutegravir (DTG), a human immunodeficiency virus (HIV) integrase inhibitor (INI), would be efficacious in INI-resistant patients at the 50 mg twice daily (BID) dose.Methods. VIKING-3 is a single-arm, open-label phase III study in which therapy-experienced adults with INI-resistant virus received DTG 50 mg BID while continuing their failing regimen (without raltegravir or elvitegravir) through day 7, after which the regimen was optimized with ≥1 fully active drug and DTG continued. The primary efficacy endpoints were the mean change from baseline in plasma HIV-1 RNA at day 8 and the proportion of subjects with HIV-1 RNA <50 c/mL at week 24.Results. Mean change in HIV-1 RNA at day 8 was −1.43 log10 c/mL, and 69% of subjects achieved <50 c/mL at week 24. Multivariate analyses demonstrated a strong association between baseline DTG susceptibility and response. Response was most reduced in subjects with Q148 + ≥2 resistance-associated mutations. DTG 50 mg BID had a low (3%) discontinuation rate due to adverse events, similar to INI-naive subjects receiving DTG 50 mg once daily.Conclusions. DTG 50 mg BID–based therapy was effective in this highly treatment-experienced population with INI-resistant virus.Clinical Trials Registration.  (NCT01328041) and (112574).

BackgroundBlack men who have sex with men (MSM) in the United States (US) are affected by HIV at disproportionate rates compared to MSM of other race/ethnicities. Current HIV incidence estimates in this group are needed to appropriately target prevention efforts.MethodsFrom July 2009 to October 2010, Black MSM reporting unprotected anal intercourse with a man in the past six months were enrolled and followed for one year in six US cities for a feasibility study of a multi-component intervention to reduce HIV infection. HIV incidence based on HIV seroconversion was calculated as number of events/100 person-years. Multivariate proportional hazards modeling with time-dependent covariates was used to identify correlates of HIV acquisition.ResultsOf 1,553 Black MSM enrolled, 1,164 were HIV-uninfected at baseline and included in follow-up. Overall annual HIV incidence was 3.0% (95% confidence interval (CI): 2.0, 4.4%) and 5.9% among men ≤30 years old (95% CI: 3.6, 9.1%). Men ≤30 years old reported significantly higher levels of sexual risk and were more likely to have a sexually transmitted infection diagnosed during follow-up. Younger men also were more likely to not have a usual place for health care, not have visited a health care provider recently, and to have unmet health care needs. In multivariate analysis, age ≤30 years (hazard ratio (HR): 3.4; 95% CI: 1.4, 8.3) and unprotected receptive anal intercourse with HIV-positive or unknown status partners (HR: 4.1; 95% CI: 1.9, 9.1) were significantly associated with HIV acquisition.ConclusionIn the largest cohort of prospectively-followed Black MSM in the US, HIV incidence was high, particularly among young men. Targeted, tailored and culturally appropriate HIV prevention strategies incorporating behavioral, social and biomedical based interventions are urgently needed to lower these rates.

Future prevention research and program designs should specifically address the differential impact of social discrimination and financial hardship on lack of social support and risky sexual situations among Latino and Black MSM.

BackgroundAmerican Black men who have sex with men (MSM) are disproportionately affected by HIV, but the factors associated with this concentrated epidemic are not fully understood.MethodsBlack MSM were enrolled in 6 US cities to evaluate a multi-component prevention intervention, with the current analysis focusing on the correlates of being newly diagnosed with HIV compared to being HIV-uninfected or previously diagnosed with HIV.ResultsHPTN 061 enrolled 1553 Black MSM whose median age was 40; 30% self-identified exclusively as gay or homosexual, 29% exclusively as bisexual, and 3% as transgender. About 1/6th (16.2%) were previously diagnosed with HIV (PD); of 1263 participants without a prior HIV diagnosis 7.6% were newly diagnosed (ND). Compared to PD, ND Black MSM were younger (p<0.001); less likely to be living with a primary partner (p<0.001); more likely to be diagnosed with syphilis (p<0.001), rectal gonorrhea (p = 0.011) or chlamydia (p = 0.020). Compared to HIV-uninfected Black MSM, ND were more likely to report unprotected receptive anal intercourse (URAI) with a male partner in the last 6 months (p<0.001); and to be diagnosed with syphilis (p<0.001), rectal gonorrhea (p = 0.004), and urethral (p = 0.025) or rectal chlamydia (p<0.001). They were less likely to report female (p = 0.002) or transgender partners (p = 0.018). Multivariate logistic regression analyses found that ND Black MSM were significantly more likely than HIV-uninfected peers to be unemployed; have STIs, and engage in URAI. Almost half the men in each group were poor, had depressive symptoms, and expressed internalized homophobia.ConclusionsND HIV-infected Black MSM were more likely to be unemployed, have bacterial STIs and engage in URAI than other Black MSM. Culturally-tailored programs that address economic disenfranchisement, increase engagement in care, screen for STIs, in conjunction with safer sex prevention interventions, may help to decrease further transmission in this heavily affected community.

No abstract

SYNOPSISObjectives. This article describes the demographic and behavioral characteristics, human immunodeficiency virus (HIV) testing history, and results of HIV testing of transgender (TG) people recruited for rapid HIV testing by community-based organizations (CBOs) in three cities.Methods. CBOs in Miami Beach, Florida, New York City, and San Francisco offered TG people rapid HIV testing and prevention services, and conducted a brief survey. Participants were recruited in outreach settings using various strategies. The survey collected information on demographic characteristics, HIV risk behaviors, and HIV testing history.Results. Among 559 male-to-female (MTF) TG participants, 12% were newly diagnosed with HIV infection. None of the 42 female-to-male participants were newly diagnosed with HIV. A large proportion of MTF TG participants reported high-risk behaviors in the past year, including 37% who reported unprotected receptive anal intercourse and 44% who reported commercial sex work. Several factors were independently associated with increased likelihood of being newly diagnosed with HIV infection among MTF TG participants, including having a partner of unknown HIV status in the past year; being 20-29 or 40 years of age; having last been tested for HIV more than 12 months ago; and having been recruited at the New York City site.Conclusions. Based on the high proportion of undiagnosed HIV infection among those tested, TG people represent an important community for enhanced HIV testing and prevention efforts. MTF TG people should be encouraged to have an HIV test at least annually or more often if indicated, based upon clinical findings or risk behaviors. Efforts should continue for developing novel strategies to overcome barriers and provide HIV testing and prevention services to TG people.

Introduction Randomized clinical trials have demonstrated the efficacy of antiretroviral pre‐exposure prophylaxis (Pr EP ) in preventing HIV acquisition among men who have sex with men ( MSM ). However, limited research has examined initiation and adherence to Pr EP among Black MSM ( BMSM ) in the United States ( US ) who are disproportionately represented among newly HIV infected and late to care individuals. This research reports on the HIV Prevention Trials Network 073 ( HPTN 073) study aimed to examine Pr EP initiation, utilization and adherence among Black MSM utilizing the theoretically principled, culturally informed and client‐centered care coordination (C4) model. Methods The HPTN 073 study enrolled and followed 226 HIV ‐uninfected Black MSM in three US cities (Los Angeles, CA ; Washington DC ; and Chapel Hill, NC ) from February 2013 through September 2015. Study participants were offered once daily oral emtricitabine/tenofovir ( FTC / TDF ) Pr EP combined with C4 and followed up for 52 weeks. Participants received HIV testing, risk reduction education and clinical monitoring. Results Of the 226 men enrolled, 178 participants initiated Pr EP (79%), and of these 64% demonstrated Pr EP utilization at week 26 (mid‐point of the study) based on pharmacokinetic testing. Condomless anal sex with an HIV ‐infected or unknown status casual male partner was statistically significantly associated with a greater likelihood of Pr EP initiation (adjusted odds ratio ( OR ) 4.4, 95% confidence interval ( CI ) 1.7, 11.7). Greater age (≥25 vs. <25, OR 2.95, 95% CI 1.37 –6.37), perception of having enough money ( OR 3.6, 95% CI 1.7 to 7.7) and knowledge of male partner taking Pr EP before sex ( OR 2.22, 95% CI 1.03 to 4.79) were statistically significantly associated with increased likelihood of Pr EP adherence at week 26. Annualized HIV incidence was 2.9 (95% CI 1.2 to 7.9) among those who init...

Many behavioral studies of Black men fail to differentiate between those who have sex exclusively with men (MSM) and those who have sex with both men and women (MSMW). Respondent-driven sampling was used to recruit a total of 1,154 Black MSM and MSMW in New York City and Philadelphia. In descriptive analyses, MSMW and MSM were compared on several demographic, health, and behavioral risk correlates using chi-square tests. Differences in prevalence of unprotected anal intercourse (UAI) between these two groups were examined in two multivariate logistic regressions. Age, country of birth, self-identified sexual orientation, experience of being forced to have sex, self-reported HIV status, exchange sex for money/food/ drug, and drug use in the past 3 months were significantly associated with either insertive or receptive UAI in the past 3 months. The strongest correlate of either insertive or receptive UAI among both groups of men was engaging in exchange sex. Differences between MSMW and MSM were found in the areas of forced sexual experiences, disclosure of same sex behavior, and history of being arrested or incarcerated. Findings from our study highlight the need for specific HIV prevention interventions targeting Black MSMW as distinguished from Black MSM.