Low incidence and prevalence of hepatitis C in two cohorts of HIV pre-exposure prophylaxis adherence interventions in men who have sex with men in Southern California.

HIV pre-exposure prophylaxis (PrEP) has been associated with incident hepatitis C virus (HCV) infection in men who have sex with men (MSM) due to decreased condom use. We examined rates of HCV among MSM and transgender women at high-risk of HIV on PrEP in Southern California using data from two trials (NCT01761643 and NCT01781806). Five of 599 participants (0.84%, 95% CI, 0.27-1.93) had HCV antibodies detected at entry. Factors associated with HCV seropositivity included being older (p = .002) and lower education level (p < .001). HCV-positive participants had no reported cases of sexually transmitted infection (rectal, urethral or pharyngeal gonorrhoea and/or chlamydia) at entry while HCV-negative participants had a prevalence of 18% (95% CI, 15%-21%). There were no significant differences in substance use and sexual risk behaviour between HCV-positive and HCV-negative participants 1-3 months prior to entry. Among early PrEP adopters, incident HCV did not occur despite ongoing condomless intercourse. Screening intervals for HCV in MSM on PrEP should be led by a risk behaviour assessment.

The Relationship Between the Human Immunodeficiency Virus-1 Transmission Network and the HIV Care Continuum in Los Angeles County.

BACKGROUND: Public health action combating human immunodeficiency virus (HIV) includes facilitating navigation through the HIV continuum of care: timely diagnosis followed by linkage to care and initiation of antiretroviral therapy to suppress viral replication. Molecular epidemiology can identify rapidly growing HIV genetic transmission clusters. How progression through the care continuum relates to transmission clusters has not been previously characterized. METHODS: We performed a retrospective study on HIV surveillance data from 5226 adult cases in Los Angeles County diagnosed from 2010 through 2014. Genetic transmission clusters were constructed using HIV-TRACE. Cox proportional hazard models were used to estimate the impact of transmission cluster growth on the time intervals between care continuum events. Gamma frailty models incorporated the effect of heterogeneity associated with genetic transmission clusters. RESULTS: In contrast to our expectations, there were no differences in time to the care continuum events among individuals in clusters with different growth dynamics. However, upon achieving viral suppression, individuals in high growth clusters were slower to experience viral rebound (hazard ratio 0.83, P = .011) compared with individuals in low growth clusters. Heterogeneity associated with cluster membership in the timing to each event in the care continuum was highly significant (P < .001), with and without adjustment for transmission risk and demographics. CONCLUSIONS: Individuals within the same transmission cluster have more similar trajectories through the HIV care continuum than those across transmission clusters. These findings suggest molecular epidemiology can assist public health officials in identifying clusters of individuals who may benefit from assistance in navigating the HIV care continuum.

Effect of rectal douching/enema on rectal gonorrhoea and chlamydia among a cohort of men who have sex with men on HIV pre-exposure prophylaxis.

OBJECTIVES: Rectal douching/enema (RD) is a common practice among men who have sex with men (MSM) in preparation for sex. RD can break down the rectal mucosal barrier and potentially affect the rectal microbiome. The objective of this study was to understand if RD is associated with acquiring rectal infections (RI) with rectal gonorrhoea (NG) and/or chlamydia (CT). METHODS: From 2013 to 2015, 395 adult HIV-uninfected MSM were enrolled in a randomised controlled study for pre-exposure prophylaxis (PrEP) adherence with routine sexual risk survey and testing. Using data from this cohort, baseline differences by RI were assessed using Pearson's χ² and Wilcoxon-Mann-Whitney test. Association between RD and RI was modelled using multivariable logistic regression adjusted for potential confounders (sexual behaviour, substance use and age) selected a priori. Effect modification by number of male partners and sensitivity analysis to rule out reverse causality were also conducted. RESULTS: Of 395 participants, 261 (66%) performed RD and 133 (33%) had at least one NG/CT RI over 48 weeks. Number of condomless anal receptive sex (med: 4, p<0.001), male partners (med:6, p<0.001) and substance use (any of methamphetamine/hallucinogens/dissociative/poppers) (p<0.001) were associated with increased odds of RI. Controlling for potential confounders, odds of prevalent RI were 3.59 (p<0.001, 95% CI 1.90 to 6.78) and incident RI 3.87 (p=0.001, 95% CI 1.78 to 8.39) when douching weekly or more compared with not douching. MSM with more than six male partners had 5.34 (p=0.002, 95% CI 1.87 to 15.31) increased odds of RI when douching weekly or more compared with not douching. CONCLUSION: Rectal hygiene with RD is a common practice (66%) among HIV-uninfected MSM on PrEP in this study, which increases the odds of acquiring rectal NG and/or CT independent of sexual risk behaviour, substance use and other factors. This suggests interventional approaches targeting rectal hygiene products and practices could reduce sexually transmitted infections.

Decision-making task performance and patterns of methamphetamine use in people assigned male at birth who have sex with men.

This study aims to determine whether performance on the Iowa Gambling Task (IGT), a simulation of risk-taking when faced with loss, is associated with greater frequency of methamphetamine (MA) use and challenges reducing or stopping MA use. The parent mSTUDY is a Los Angeles County-based longitudinal study of substance use and HIV risk in predominately Black/African American and Latinx people assigned male at birth who have sex with men. The IGT was offered for a limited timeframe to mSTUDY participants, of whom 192 consented to and completed this one-time task. Separate random intercept binary logistic regressions tested whether the IGT total score and subscore for Blocks 4 and 5 (last 40 card draws) were associated with the outcomes, testing positive for MA in urine and self-reported inability to control or cease MA use in the past 6 months. Separate random intercept ordered logistic regressions tested whether IGT total score and subscore were associated with self-reported frequency of MA use in past 6 months. Higher IGT subscores for Blocks 4 and 5 (lower risk-taking) were associated with lower odds of testing MA-positive (adjusted odds ratio, AOR = 0.97, 95% CI [0.95, 0.99], p = .025) and less frequent MA use in the past 6 months (AOR = 0.96, 95% CI [0.94, 0.99], p = .006). Higher IGT total scores (lower risk-taking) were also associated with less frequent MA use (AOR = 0.99, 95% CI [0.97, 0.99], p = .038). Findings from this analysis suggest that IGT performance may be a useful indicator of MA use severity in nontreatment-seeking people. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Sexually transmitted infections among participants in an HIV PrEP adherence trial.

BACKGROUND: HIV PrEP effectiveness is highly dependent on adherence. High STI incidence has been reported among PrEP users. We assessed the relationship between STI incidence (CT, NG, and syphilis) and PrEP adherence. METHODS: We performed a subanalysis of a controlled, open-label, two-arm, randomized clinical demonstration project of a text-message based adherence intervention. Participants had 48 weeks of follow-up and had STI testing every 12 or 24 weeks. PrEP adherence was measured at week 48 using intracellular tenofovir-diphosphate drug concentrations. We calculated incidence rate ratios for STIs among those adherent as compared with those not adherent to PrEP. RESULTS: Of the 381 assessed for CT, NG and syphilis at one or more follow-up visits, there were 16 cases of syphilis or 5.0 per 100 person years (95% CI: 2.6, 7.5); 63 cases of NG or 26.3 per 100 person years (95% CI: 19.8, 32.8); and 81 cases of CT or 36.3 per 100 person years (95% CI: 28.4, 44.2). We found no association between adequate PrEP adherence and STI incidence (aIRR: 0.97 95% CI: 0.67, 1.40). CONCLUSIONS: We found that the incidence of STIs was not significantly different between those adherent to PrEP and those non-adherent. Further research is needed to assess how PrEP use may impact STIs over time.

Association of Concussion With the Risk of Suicide: A Systematic Review and Meta-analysis.

Importance: Concussion is the most common form of traumatic brain injury (TBI). While most patients fully recover within 1 week of injury, a subset of patients might be at a higher risk of suicide. Objective: To assess the risk of suicide after concussion. Data Sources: We performed a systematic search of Medline (PubMed), Embase, PsycINFO, and Published International Literature on Traumatic Stress (PILOTS) from 1963 to May 1, 2017. We also searched Google Scholar and conference proceedings and contacted experts in the field to seek additional studies. Study Selection: Studies that quantified the risk of suicide, suicide attempt, or suicidal ideation after a concussion and/or mild TBI were included. Studies that included children and adults, including military and nonmilitary personnel, were included. Two authors independently reviewed all titles and abstracts to determine study eligibility. Data Extraction and Synthesis: Study characteristics were extracted independently by 2 trained investigators. Study quality was assessed using the Newcastle-Ottawa Scale. Study data were pooled using random-effects meta-analysis. Main Outcomes and Measures: The primary exposure was concussion and/or mild TBI, and the primary outcome was suicide. Secondary outcomes were suicide attempt and suicidal ideation. Results: Data were extracted from 10 cohort studies (n = 713 706 individuals diagnosed and 6 236 010 individuals not diagnosed with concussion and/or mild TBI), 5 cross-sectional studies (n = 4420 individuals diagnosed and 11 275 individuals not diagnosed with concussion and/or mild TBI), and 2 case-control studies (n = 446 individuals diagnosed and 8267 individuals not diagnosed with concussion and/or mild TBI). Experiencing concussion and/or mild TBI was associated with a 2-fold higher risk of suicide (relative risk, 2.03 [95% CI, 1.47-2.80]; I2 = 96%; P < .001). In 2 studies that provided estimates with a median follow-up of approximately 4 years, 1664 of 333 118 individuals (0.50%) and 750 of 126 114 individuals (0.59%) diagnosed with concussion and/or mild TBI died by suicide. Concussion was also associated with a higher risk of suicide attempt and suicide ideation. The heightened risk of suicide outcomes after concussion was evident in studies with and without military personnel. Conclusions and Relevance: Experiencing concussion and/or mild TBI was associated with a higher risk of suicide. Future studies are needed to identify and develop strategies to decrease this risk.

Characteristics of a cohort of high-risk men who have sex with men on pre-exposure prophylaxis reporting transgender sexual partners.

Transgender people continue to be at high-risk for HIV acquisition, but little is known about the characteristics of their sexual partners. To address this gap, we examined sociodemographic and sexual characteristics of cisgender men who have sex with men (MSM) on pre-exposure prophylaxis (PrEP) reporting transgender sexual partners.A cohort of 392 MSM in southern California in a randomized clinical trial for PrEP adherence were followed from 2013 to 2016. Multivariable generalized estimating equation and logistic models identified characteristics of MSM reporting transgender sexual partners and PrEP adherence.Only 14 (4%) MSM reported having transgender sexual partners. MSM were more likely to report transgender partners if they were African American, had incident chlamydia, reported injection drug-using sexual partners, or received items for sex. Most associations remained significant in the multivariable model: African American (adjusted odds ratio [AOR] 11.20, P = .01), incident chlamydia (AOR 3.71, P = .04), and receiving items for sex (AOR 5.29, P = .04). There were no significant differences in PrEP adherence between MSM reporting transgender partners and their counterpart.MSM who report transgender sexual partners share characteristics associated with individuals with high HIV prevalence. Identifying this group distinct from larger cohorts of MSM could offer new HIV prevention opportunities for this group of MSM and the transgender community.

Predictors of Long-Term HIV Pre-exposure Prophylaxis Adherence After Study Participation in Men Who Have Sex With Men.

BACKGROUND: Efficacy of HIV pre-exposure prophylaxis (PrEP) among men who have sex with men is well documented in randomized trials. After trial completion, participants are challenged with acquiring PrEP on their own and remaining adherent. METHODS: This was a follow-up study of the TAPIR randomized controlled multicenter PrEP trial. Participants were contacted after their last TAPIR visit (ie, after study-provided PrEP was discontinued) to attend observational posttrial visits 24 and 48 weeks later. Adherence during TAPIR and posttrial visits was estimated by dried blood spot intracellular tenofovir diphosphate levels (adequate adherence defined as tenofovir diphosphate levels >719 fmol/punch). Binary logistic regression analysis assessed predictors of completing posttrial visits and PrEP adherence among participants completing ≥1 visit. RESULTS: Of 395 TAPIR participants who were on PrEP as part of the TAPIR trial for a median of 597 days (range 3-757 days), 122 (31%) completed ≥1 posttrial visit (57% of University of California San Diego participants completed posttrial visits, whereas this was 13% or lower for other study sites). Among participants who completed ≥1 posttrial visit, 57% had adequate adherence posttrial. Significant predictors of adequate adherence posttrial were less problematic substance use, higher risk behavior, and adequate adherence in year 1 of TAPIR. CONCLUSION: More than half of PrEP users followed after trial completion had successfully acquired PrEP and showed adequate adherence. Additional adherence monitoring and intervention measures may be needed for those with low PrEP adherence and problematic substance use during the first year of trial.

Risk factors for delayed initiation of combination antiretroviral therapy in rural north central Nigeria.

BACKGROUND: Timely initiation of combination antiretroviral therapy (ART) in eligible HIV-infected patients is associated with substantial reduction in mortality and morbidity. Nigeria has the second largest number of persons living with HIV/AIDS in the world. We examined patient characteristics, time to ART initiation, retention, and mortality at 5 rural facilities in Kwara and Niger states of Nigeria. METHODS: We analyzed program-level cohort data for HIV-infected ART-naive clients (≥15 years) enrolled from June 2009 to February 2011. We modeled the probability of ART initiation among clients meeting national ART eligibility criteria using logistic regression with splines. RESULTS: We enrolled 1948 ART-naive adults/adolescents into care, of whom, 1174 were ART eligible (62% female). Only 74% of the eligible patients (n = 869) initiated ART within 90 days after enrollment. The median CD4 count for eligible clients was 156 cells/µL (interquartile range: 81-257), with 67% in WHO stage III/IV disease. Adjusting for CD4 count, WHO stage, functional status, hemoglobin, body mass index, sex, age, education, marital status, employment, clinic of attendance, and month of enrollment, we found that immunosuppression [CD4 350 vs. 200, odds ratio (OR) = 2.10, 95% confidence interval (CI): 1.31 to 3.35], functional status [bedridden vs. working, OR = 4.17 (95% CI: 1.63 to 10.67)], clinic of attendance [Kuta Hospital vs. referent: OR = 5.70 (95% CI: 2.99 to 10.89)], and date of enrollment [December 2010 vs. June 2009: OR = 2.13 (95% CI: 1.19 to 3.81)] were associated with delayed ART initiation. CONCLUSIONS: Delayed initiation of ART was associated with higher CD4 counts, lower functional status, clinic of attendance, and later dates of enrollment among ART-eligible clients. Our findings provide targets for quality improvement efforts that may help reduce attrition and improve ART uptake in similar settings.

Optimizing PMTCT service delivery in rural North-Central Nigeria: protocol and design for a cluster randomized study.

Nigeria has more HIV-infected women who do not receive needed services for the prevention of mother-to-child transmission of HIV (PMTCT) than any other nation in the world. To meet the UNAIDS/WHO goal of eliminating mother-to-child HIV transmission by 2015, multiple interventions will be required to scale up PMTCT services, especially to lower-level, rural health facilities. To address this, we are conducting a cluster-randomized controlled study to evaluate the impact and cost-effectiveness of a novel, family-focused integrated package of PMTCT services. A systematic re-assignment of patient care responsibilities coupled with the adoption of point-of-care CD4 + cell count testing could facilitate the ability of lower-cadre health providers to manage PMTCT care, including the provision and scale-up of antiretroviral therapy (ART) to pregnant women in rural settings. Additionally, as influential community members, male partners could support their partners' uptake of and adherence to PMTCT care. We describe an innovative approach to scaling up PMTCT service provision that incorporates considerations of where and from whom women can access services (task-shifting), ease of obtaining a CD4 + cell count result (point-of-care testing), the degree of HIV service integration for HIV-infected women and their infants, and the level of family and community involvement (specifically male partner involvement). This systematic approach, if proven feasible and effective, could be scaled up in Nigeria and similar resource-limited settings as a means to accelerate progress toward eliminating mother-to-child transmission of HIV and help women with HIV infection take ART and live long, healthy lives (Trial registration: NCT01805752).