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HIV infection and in utero exposure, common in Sub-Saharan Africa, are associated with pediatric neurocognitive impairment. Cognitive screening can identify impairments, but it is rarely used in this setting. The Penn Computerized Neurocognitive Battery (PennCNB), an evidence-based cognitive screening tool, was adapted for use in Botswana. To facilitate future implementation, 20 semi-structured interviews were conducted to elicit key stakeholders' perspectives on factors likely to be related to successful uptake of the PennCNB in clinical settings. An integrated analytic approach combining constructs from the Consolidated Framework for Implementation Research and modified grounded theory was used. Results underscore the need for cognitive screening in Botswana and the acceptability of the PennCNB. Implementation barriers include limited time and resources, whereas facilitators include standard procedures for introducing new tools into medical settings and for training implementers. Recommended implementation strategies include integrating screening into the existing workflow, implementing the tool in the medical and educational sectors, and targeting selection of children for assessment. This research addresses the research-to-practice gap by engaging in pre-implementation inquiry and designing for implementation. Results will inform the development of strategies to maximize the likelihood of successful implementation of the PennCNB to identify neurocognitive impairment in children in this high-need setting.

Current literature suggests an increased risk of venous thromboembolism (VTE) in people living with HIV (PLWH) with poorly controlled viraemia and immunodeficiency. VTE treatment guidelines do not specifically address anticoagulation management in PLWH. We report a case of a 33-year-old woman diagnosed with an unprovoked pulmonary embolism (PE) and deemed protein S deficient. Three years later, she was diagnosed with AIDS. Antiretroviral therapy (ART) was promptly initiated with viral suppression and immune reconstitution within 12 months. Eight years after her initial PE, the patient self-discontinued warfarin. Multiple repeat protein S values were normal. ART without anticoagulation has continued for 3 years with no thrombotic events. This case describes a patient with VTE presumably secondary to undiagnosed HIV with possible consequent acquired protein S deficiency. Additional research is needed to understand the characteristics of PLWH with VTE who may warrant long-term anticoagulation as opposed to shorter courses.

Chronic pain is highly prevalent among persons with HIV (PWH), as is depression. Both comorbidities might contribute to, as well as be maintained by, avoidance-based coping. A promising alternative to avoidance-based coping is acceptance. Acceptance of pain is associated with improved functioning and quality of life in chronic pain patients, but this relationship has not been substantially explored among PWH. Cross-sectional data from 187 adult outpatients enrolled in a randomized trial for depressed PWH with chronic pain were analyzed. Controlling for pain severity and demographics, the relationships among pain acceptance and indicators of activity, functioning, and emotional distress (i.e., anxiety and anger) were assessed in seven regression models. No significant relationships were found between self-reported physical activity or objective measurement of mean steps/day with pain acceptance. Results revealed an inverse relationship between chronic pain acceptance and pain-related functional interference (b

Social networks and social support are important factors in medication adherence among people living with HIV (PLWH). Social networks can provide emotional, logistic, and material support leading to increased overall engagement in care. Certain populations of PLWH may have more limited access to social support, including those reentering community settings from correctional facilities. During periods of incarceration, social connections with family and friends may be frayed, reduced, or lost. This study, conducted in South Africa, explored the role of social support during community reentry among PLWH being released from correctional facilities. We conducted in-depth interviews with 41 community reentrants living with HIV. Qualitative analysis identified the challenges with establishing social support during reentry and the greater need for social support to remain engaged in HIV care in the community compared to in the correctional facility. These findings highlight challenges during community reentry and the importance of social support for these individuals.

Among people who inject drugs (PWID), 60% have HCV and 50-90% of HIV-infected PWID are co-infected with HCV. Data comparing adherence to direct-acting antiviral (DAA) therapy among HCV mono-infected and HIV/HCV co-infected PWID is limited. The impact of HCV treatment initiation on HIV antiretroviral therapy (ART) adherence is also poorly understood. We assessed DAA adherence in HCV mono-infected and HIV/HCV co-infected PWID and examined changes in ART adherence and HIV outcomes following HCV treatment. Study was conducted in three Medication for Opioid use Disorder (MOUD) programs in Bronx, New York. HCV treatment adherence was measured using electronic blister packs. 2-week DAA adherence rates were compared and controlled for study arm, psychiatric illness and alcohol intoxication within the past 30 days. ART adherence was measured using participant self-report and dichotomized to "excellent" or "other". ART adherence, CD4 count, and HIV viral load were identified six months prior to, during, and six months after HCV treatment. Statistical significance was assessed with mixed-effects regression linear or logistic models. Overall DAA adherence rates among HCV mono-infected and HIV/HCV co-infected PWID were 74% (95% CI=71-78%) and 76% (95%CI=70-83%), respectively (p=.55). There were no significant changes in ART adherence, CD4 counts, or HIV viral loads prior to, during, or after HCV treatment. This is the first study assessing the impact of DAA therapy on ART adherence and HIV treatment outcomes among PWID. It is one of the first to compare DAA adherence among HCV and HIV/HCV co-infected PWID. Our data demonstrate no significant difference in DAA adherence and no significant impact of HCV treatment on ART adherence or HIV outcomes.

COVID-19 is the disease caused by SARS-CoV-2 which has led to 2,643,000 deaths worldwide, a number which is rapidly increasing. Urgent studies to identify new antiviral drugs, repurpose existing drugs, or identify drugs that can target the overactive immune response are ongoing. Antiretroviral drugs (ARVs) have been tested in past human coronavirus infections, and also against SARS-CoV-2, but a trial of lopinavir and ritonavir failed to show any clinical benefit in COVID-19. However, there is limited data as to the course of COVID-19 in people living with HIV, with some studies showing a decreased mortality for those taking certain ARV regimens. We hypothesized that ARVs other than lopinavir and ritonavir might be responsible for some protection against the progression of COVID-19. Here, we used chemoinformatic analyses to predict which ARVs would bind and potentially inhibit the SARS-CoV-2 main protease (Mpro) or RNA-dependent-RNA-polymerase (RdRp) enzymes in silico. The drugs predicted to bind the SARS-CoV-2 Mpro included the protease inhibitors atazanavir and indinavir. The ARVs predicted to bind the catalytic site of the RdRp included Nucleoside Reverse Transcriptase Inhibitors, abacavir, emtricitabine, zidovudine, and tenofovir. Existing or new combinations of antiretroviral drugs could potentially prevent or ameliorate the course of COVID-19 if shown to inhibit SARS-CoV-2 in vitro and in clinical trials. Further studies are needed to establish the activity of ARVs for treatment or prevention of SARS-CoV-2 infection . Communicated by Ramaswamy H. Sarma

Hepatitis C virus (HCV) infection is common among people living with HIV. HIV and HCV coinfected patients have higher overall mortality rates compared with HIV mono-infected patients. With its high cure rate of HCV infection, direct-acting antiviral (DAA) treatment provides an opportunity to improve the survival of the HIV/HCV coinfected population. The objective of this study is to investigate the association between DAA treatment and all-cause mortality among HIV/HCV coinfected people. The study included 7103 Medicare beneficiaries in the United States who were infected with both HIV and HCV between 2014 and 2017. Cox proportional hazards regression model was used to estimate adjusted hazard ratios (aHRs) of death for patients with and without DAA treatment while controlling for patient characteristics. During the study period, 1675 patients initiated DAA treatment (23.6%). The adjusted hazard ratio (aHR) of all-cause mortality between patients with and without DAA treatment was 0.37 (95% CI, 0.29-0.48), regardless of cirrhosis status. DAA treatment was associated with a smaller reduction in all-cause mortality for females (aHR, 0.50 [95% CI, 0.30-0.85]) compared with males (aHR, 0.34 [95% CI, 0.25-0.46]). DAA treatment was associated with improved survival among all HIV/HCV coinfected patients regardless of sex or HCV disease progression.

Understanding factors related to suboptimal adherence to antiretroviral therapy (ART) and detectable viral load (VL), especially among vulnerable populations, is needed to improve HIV outcomes. The Caribbean is highly impacted by HIV and socioeconomic inequalities, but few studies have been conducted there to explore food insecurity among people with HIV and factors associated with viral suppression in this vulnerable population. Using baseline data from a pilot intervention trial among people living with HIV and food insecurity in the Dominican Republic, we examined psychosocial and behavioral factors associated with viral suppression, ART adherence, and competing needs. Among participants (n = 115), 61% had a detectable VL; the strongest factor associated with detectable VL was having missed taking ART in the last six months due to not having food (OR = 2.68, p = 0.02). Greater odds of reporting missed ART doses due to not having food were associated with severe food insecurity (OR = 4.60, p = 0.006), clinical depression (OR = 2.76, p = 0.018), Haitian background (OR = 6.62 p = 0.017), and internalized HIV stigma (OR = 1.09, p = 0.041), while lower odds were associated with social support (OR = 0.89, p = 0.03) and having health insurance (OR = 0.27, p = 0.017). Ensuring that people with HIV and food insecurity have food to take with their ART is essential for viral suppression.

HIV and substance use interact synergistically to exacerbate disease progression and contribute to poorer engagement in treatment. There is a lack of qualitative research exploring the complexity of systems that impact HIV patients' linkage to and retention in both substance use and HIV care. Data from qualitative individual interviews with 16 HIV and 13 substance use providers were analyzed using applied thematic analysis. Four themes emerged as barriers to linkage to care providers limited knowledge with appropriate referrals; limited access to treatment options within the community; difficult admission criteria to substance use facilities; and communication challenges across providers including power differential. Emergent themes as barriers to treatment retention were: unstable life of people who use drugs; providers' negative attitude and stigma towards patients; and transportation challenges. Interventions are needed to increase provider cross-training in HIV and substance use disorders, reduce barriers to accessing treatment, and improve communication across providers are needed.

Objectives To reduce the number of new HIV infections and improve HIV health care outcomes, the social conditions in which people live and work should be assessed. The objective of this study was to describe linkage to HIV medical care by selected demographic characteristics and social determinants of health (SDH) among US adults with HIV at the county level. Methods We used National HIV Surveillance System data from 42 US jurisdictions and data from the American Community Survey to describe differences in linkage to HIV medical care among adults aged ≥18 with HIV infection diagnosed in 2017. We categorized SDH variables into higher or lower levels of poverty (where Results Of 33 204 adults with HIV infection diagnosed in 2017, 78.4% were linked to HIV medical care ≤1 month after diagnosis. Overall, rates of linkage to care were significantly lower among men and women living in counties with higher versus lower poverty (PR = 0.96; 95% CI, 0.94-0.97), with lower versus higher health insurance coverage (PR = 0.93; 95% CI, 0.92-0.94), and with lower versus higher education levels (PR = 0.97; 95% CI, 0.96-0.98). Conclusions Increasing health insurance coverage and addressing economic and educational disparities would likely lead to better HIV care outcomes in these areas.

Adolescents with suboptimal medication taking may deceive caregivers about non-adherence. We conducted a 5-year longitudinal study of adolescents monitored simultaneously with both easily manipulated (e.g., self-report) and hard to manipulate (e.g., microelectronic data) strategies. Adolescents with repeatedly high adherence on the former and low adherence on the latter were invited along with their parental figures ("parents") to participate. We conducted focus groups and semi-structured interviews, separately for adolescents and parents, to elucidate drivers of discordant measures. Forty-seven adolescents and 26 parents participated in focus groups and 4 adolescents were interviewed. Adolescents described hiding pills, discarding pills, and lying. Their motivations included fear of disappointing those who care about them, desire to avoid admonishment by parents and clinic staff, and desire to avoid remedial adherence counseling. Both adolescents and parents considered negative feedback for prior poor adherence to be key motivation to hide current poor adherence from clinic staff. Providing positive feedback for truth-telling, rather than for "evidence" of excellent adherence, might help adolescent patients and their parents to develop stronger treatment alliances with each other and with clinic staff. Such alliances would allow adherence interventions to be better targeted and more fruitful in increasing adherence.

Youth living with perinatally acquired HIV (YLPHIV) have been found to have a range of mental disorders. Some adult HIV studies have linked mental health to adverse metabolic outcomes due to dysregulation of the sympathetic nervous system and hypothalamic-pituitary-adrenal axis, but this association has not previously been explored in YLPHIV.We investigated the association of mental health measures with metabolic outcomes in YLPHIV and HIV-uninfected youth (HIV-U) and linear regression was used to assess the adjusted associations.Overall, 203 YLPHIV (median age = 10.7years; 52% female; mean duration on ART 8 years, 12% CD4 count 50 copies/mL) and 44 HIV-U (median age = 10.3 years; 55% female) were enrolled. YLPHIV had higher median total cholesterol (4.2 vs 3.9 mmol/L, p = 0.049) and triglyceride (0.9 vs 0.7 mmol/L, p < 0.001) compared to HIV-U. We found higher percentage of poor functional competence (40% vs 25%, p = 0.02) and self-concept (23% vs 9%, p = 0.03) and higher depression (6% vs 2%, p < 0.01), anger (6% vs 2%, p = 0.04) and disruptive behaviour (4% vs 0%, p < 0.01) in YLPHIV as compared to HIV-U. Among YLPHIV, higher scores of anger were associated with higher total cholesterol and higher low-density lipoprotein (s = 0.010, p = 0.041 and s = 0.012, p = 0.048 respectively) and disruptive behaviour with higher low-density lipoprotein (s = 0.010, p = 0.043) after adjusting for age, sex and BMIZ.This is the one of first study to investigate the association of mental health with metabolic outcomes among YLPHIV. The association of increased anger and disruptive behaviour with increased lipid concentration is a novel finding. Further longitudinal studies are needed to evaluate the causal relationships between mental health and metabolic outcomes.

HIV prevalence is high among transgender women, but little is known about cisgender men who have sex with transgender women (MSTW). The objective of this study was to investigate characteristics and behavior of MSTW compared to transgender women and men who have sex with men (MSM) using a modified respondent-driven sampling design. Seed participants completed a survey and invited up to three sex partners. Forward recruitment continued in waves through the referral of sex partners. Cross-sectional data were assessed using mixed effects models. From February to July 2018, 479 participants in Lima, Peru enrolled (

In the seven years since the HIV Organ Policy Equity (HOPE) Act made HIV-positive organ donation to HIV-positive recipients legally permissible in the United States, there have been fewer HIV-positive organ donations than expected. Organ procurement organizations (OPOs) play a key role in the transplant system and barriers at OPOs may be partly responsible for the relatively low number of HIV-positive donors. To understand potential OPO barriers, we conducted semi-structured interviews with 20 OPO staff members. Interviews were recorded, transcribed, and analyzed using a conventional content analytic approach with two coders. OPO staff had high levels of knowledge about HOPE. Many had evaluated referrals of HIV-positive donors and approached families for authorization. Barriers to HIV-positive organ recovery identified included obtaining authorization for donation, potentially disclosing HIV status to next-of-kin, and fear of HIV infection among those engaged in organ recovery. Strategies to overcome these barriers include providing continuing education about the specific tasks required to procure organs from HIV-positive donors, implementing targeted interventions to reduce fear of infection, and developing partnerships with HIV advocacy and care organizations. Given the central role OPOs play, HIV-positive donations are unlikely to occur in significant numbers unless these barriers can be overcome.

HIV status may influence survival from non-small cell lung cancer (NSCLC). Among NSCLC patients in the Bronx, NY, we assessed (1) associations of CD4 count, CD4/CD8 ratio and HIV viral load (VL) with survival and (2) prognostic factors among persons living with HIV (PLWH). We compared survival from NSCLC diagnosis (2004-2017) between HIV-negative persons (HIV-, n=2,881) and PLWH (n=88) accounting for clinical and sociodemographic factors. HIV-survival was also compared with PLWH, dichotomized by CD4 (

HIV incidence remains high among US youth, especially among sexual minority youth. However, only half of youth with HIV are aware of their status. One potential explanation for low HIV testing rates is that restrictive policies may prevent minors from access HIV testing due to parental consent requirements. Using pooled data from the local Youth Risk Behavior Survey, we assessed whether state HIV testing laws, including age restrictions and explicit inclusion of HIV in STI testing consent laws, were associated with differences in HIV testing rates; differences by sexual behavior were also examined. Among female youth, policies were not associated with HIV testing. However, among male youth, both the presence of age restrictions and explicit inclusion in STI services were significantly associated with increased odds of HIV testing. Results indicate that policy changes may be effective at increasing testing among male youth who have sex with other males.

Performance-enhancing substance (PES) use is common among young men and prior research has documented cross-sectional associations between anabolic-androgenic steroid (AAS) use and sexual risk behaviors. However, this relationship remains understudied among a longitudinal cohort of young adult men, and research on prospective associations between legal PES (e.g., creatine) use and sexual risk behaviors is lacking. The current study addressed these oversights using data from the National Longitudinal Study of Adolescent to Adult Health (N = 5,451). AAS use and legal PES use were assessed at Wave III (ages 18-26) and 10 indicators of sexual risk behavior were assessed at seven-year follow up (Wave IV; ages 24-32). Linear and logistic regression analyses were conducted adjusting for demographic and behavioral confounders. Participants who reported AAS use and legal PES use had significantly higher number of one-time sexual partners and higher odds of multiple sex partners around the same time in the past 12 months. Participants who reported AAS use had higher odds of any STI in the past 12 months. These results extend prior research on the risk behaviors and adverse effects of PES use. Health care professionals should assess for PES use among young adult men and provide guidance on healthful sexual behaviors.

Treating diseases such as Muscular dystrophy (MD) and HIV/AIDS pose several challenges to the rapidly evolving field of regenerative medicine. Previously, stem cell therapy has been said to affect the clinical courses of HIV/AIDS and MD, but, in practice, eradication or control of these diseases was not achievable. The introduction of gene editing into stem cell therapy has stimulated HIV/AIDS and MD cell therapy research studies substantially. Here, we review current methods of treating HIV/AIDS and MD using stem cell therapy. This review also details the use of different types of cells and methods in cell therapy and the modeling of new cell-based therapies to treat Duchenne muscular dystrophy. We speculate that the effective use of stem cell therapy in conjunction with other treatment therapies , such as steroids and rehabilitation , could improve livelihood.

Treatment with RNAi against HIV-1 transcripts efficiently inhibits viral replication but induces selection of escape mutants; therefore, the CCR5 coreceptor was suggested as an additional target. Blocking viral and host transcripts improved the antiviral effect. We have used short hairpin RNA (shRNA) targeting the human CCR5 (shCCR5) or the HIV-1 rev (shRev) transcripts to demonstrate distinctive properties of anti-CCR5 shRNA: shCCR5 induced more sustained protection than shRev; partial reduction in CCR5 expression substantially decreased HIV-1 infection, and shCCR5 performed better than shRev in the mixed shRNA-treated and untreated cultures. These observations indicate that CCR5 inhibitors should be conveniently included in HIV-1 gene silencing treatment schedules when only a certain cell fraction is protected to further reduce endogenous virus in a properly ART-treated HIV-1 infected individual.

Objectives: Pulmonary nocardiosis is a rare opportunistic infection that is often encountered in immunocompromised patients, in particular those with the HIV infection and in solid organ transplant recipients. As the number of immunocompromised patients increase, the number of patients with pulmonary nocardiosis is also expected to increase. This study aimed to analyse both the chest high resolution computed tomography (HRCT) findings of patients with confirmed pulmonary nocardiosis and review the imaging features of pulmonary nocardiosis in the literature. Methods: This retrospective study was conducted at The Royal Hospital, Muscat, Oman, to identify patients with a diagnosis of pulmonary nocardiosis between January 2006 and January 2019. Accordingly, nine patients with pulmonary nocardiosis were identified, but three patients were excluded as no chest HRCT images were available. Patient clinical presentation was recorded and chest HRCT images were retrospectively reviewed. Results: A total of six patients were enrolled in this study. All were male and with a mean age of 41 ± 11 years. Three patients were immunocompromised, two of whom had undergone a renal transplant. The main HRCT findings were cavitary nodules/masses, non-cavitary nodules/masses, septal thickening, centrilobular nodules, ground glass opacities, consolidation, pleural effusion, pleural thickening, enlarged lymph nodes and necrotic lymph nodes. Conclusion: Pulmonary nocardiosis shows various findings in a chest CT, the most common of which are pulmonary nodules and masses. Awareness of these findings can help radiologists with a diagnosis in the appropriate clinical settings. Keywords: Pulmonary Nocardiosis; Computed Tomography; Oman.

Despite availability of effective antiretroviral therapy (ART), many HIV patients still have a detectable viral load (VL). Predictive factors of detectable VL are not well documented. This study was done at two large multidisciplinary HIV outpatient clinics at the Centre hospitalier de l'Université de Montréal (CHUM) and the McGill University Health Centre (MUHC). This is a retrospective case-control study of patients treated between 2016 and 2018. Cases had a VL ≥50 copies/mL in 2018. Controls had an undetectable VL from 2016 to 2018. Matching was based on gender and year of HIV diagnosis. Primary objective was to identify predictive factors of detectable VL. Secondary objectives included to identify predictive factors of virologic failure, low persistent viremia, and viral blip. A forward stepwise model selection by the Akaike Information Criterion of the conditional logistic regression was used to identify predictive factors. Two hundred cases were identified and matched with 200 controls. The cohort was mostly male (68.0%) with a median age of 54 years (21-83 years). Among cases, viral blip was the most common type of detectable VL (43.0%). The strong predictive factors for a detectable VL were adherence to ART and seeking health care services. Asylum seekers were less at risk of detectable VL. Adherence to ART was the only strong predictive factor for virologic failure. Three main predictive factors of detectable VL were identified in two ambulatory clinic hospitals in Montreal. Ascertaining these factors will allow for identification of patients more at risk of detectable VL.

Given the large numbers of people with HIV (PWH) with Medicaid coverage, it is important to understand the patient experience with Medicaid. Understanding experiences with and attitudes around the program have important policy and clinical implications. The objective was to understand the patient perspective of PWH in Virginia, who transitioned to Medicaid in 2019 due to Medicaid expansion. English-speaking PWH who gained Medicaid due to Medicaid expansion in 2019 were recruited at one Virginia Ryan White HIV/AIDS Program clinic. The goal was to enroll33% of those who newly were on Medicaid for 2019. Participants were surveyed about demographic characteristics, and semistructured interviews were performed. Descriptive analyses were performed for cohort characteristics. Using qualitative description and an open coding strategy, codebooks were generated for the interviews and themes were identified. The cohort (

Dual compartment suppositories are being developed to prevent HIV and other sexually transmitted infections. Such products, for use in the rectum, the vagina, or both, could have a significant public health impact by decreasing global incidence of these diseases. In this study, 16 women each used two rheologically distinct suppositories in their vagina and rectum. User Sensory Perception and Experience (USPE) scales assessed sensory experiences during sexual activity to understand whether, and how, women perceive formulation properties in the vagina and rectum. Qualitative data from individual in-depth interviews captured women's descriptions and comparisons of the experiences. Significant differences and large Cohen's d effect sizes between vaginal and rectal experiences of suppository-A were found for three scales: Application (APP): Product Awareness, SEX: Initial Penetration; and SEX: Effortful. Qualitative data provided user experience details that credibly align with these score differences. Near significant differences and large effect sizes were found for two additional scales: SEX: Perceived Wetness with suppository-A and SEX: Messiness with suppository-B. In addition, other scale scores showed medium-to-large effect sizes that correspond to hypothesized sensations associated with biophysical properties of the suppositories. Statistical significance combined with large effect sizes and qualitative data accurately represent the hypothesized perceptibility of suppository properties and identifies performance characteristics relevant to acceptability and adherence; together these data provide discernment of factors that can guide the development of dual compartment products. The Clinical Trial Registration number: NCT02744261.

Background: The monthly dapivirine vaginal ring provides partial protection against HIV, and a longer duration ring may reduce user burden and improve adherence. We examined acceptability and prefe...

A 52-year-old woman with HIV and recent antiretroviral therapy non-adherence presented with a 5-day history of widespread painful vesicular skin lesions. Direct fluorescent antibody testing of the skin lesions was positive for varicella zoster virus (VZV). On day 3, she developed profound right upper extremity weakness. MRI of the brain and cervical spine was suggestive of VZV myelitis. Lumbar puncture was positive for VZV PCR in the cerebrospinal fluid (CSF) and CSF HIV viral load was detected at 1030 copies/mL, indicating ‘secondary’ HIV CSF escape. She was treated with intravenous acyclovir for 4 weeks and subsequent oral therapy with famciclovir then valacyclovir for 6 weeks. She also received dexamethasone. The patient had an almost full recovery at 6 months. Myelitis is a rare complication of reactivated VZV infection that can have atypical presentation in immunocompromised patients. Such ‘secondary’ HIV CSF escape should be considered in immunosuppressed patients with concomitant central nervous system infection.

Chronic pain commonly occurs in people living with HIV (PLWH). Many PLWH in the United States (U.S.) continue to obtain opioids for chronic pain management. In addition to the known risk of opioid misuse, evidence from non-HIV populations suggest that opioid use is associated with poor sleep and negative mood. Whether insomnia severity and depressive symptoms might be exacerbated by chronic pain and opioid use in PLWH remains to be determined. This study examined insomnia severity and depressive symptoms in 85 PLWH with chronic pain and 35 PLWH without chronic pain. Among PLWH with chronic pain, reported opioid use was examined in relation to severity of insomnia and depressive symptoms. PLWH with chronic pain reported significantly greater severity of insomnia symptoms (p = .033) and greater depressive symptoms (p = .025) than PLWH without chronic pain. Among PLWH with chronic pain who reported opioid use (n = 36), insomnia severity was greater compared to those who denied opioid use (n = 49), even after controlling for and pain severity and number of comorbidities (p = .026). Greater pain severity was significantly associated with greater insomnia severity (p < .001) and possibly greater depressive symptoms (p = .048) among PLWH with chronic pain who reported opioid use; however, these same associations were not significant among those PLWH with chronic pain who denied opioid use. Findings suggest that PLWH with chronic pain are likely to experience poor sleep (i.e., insomnia) and depressed mood. Furthermore, poor sleep was associated with opioid use among PLWH with chronic pain.

Evidence for a relationship between polysubstance use, depression, and adherence to antiretroviral therapy (ART) is limited. The objectives of this study were to examine the associations of depression, illicit drug and alcohol use with adherence to ART. People living with HIV (PLHIV) from the Miami Adult Studies on HIV (MASH) cohort were asked about the number of doses of their ART medication missed to assess adherence to ART. Harmful alcohol drinking was evaluated using the Alcohol Use Disorders Identification Test and illicit substance use assessed with self-report and urine screen. The Center for Epidemiologic Studies Depression Scale was used to assess depression symptoms. Of 391 PLHIV, 16.6% missed at least one dose (Range 1–5) in the past four days. Cocaine/crack, opiate use and depression were significantly independently associated with a bigger mean number of doses missed. The mean number of doses missed was significantly bigger among participants who used alcohol in combination with cocaine/crack, marijuana, and tobacco compared to non-users. In conclusion, polysubstance use increased risk for poor ART adherence among PLHIV. The use of cocaine/crack or opiates individually, and depressive symptoms also promote poor adherence to ART. An integrated approach is needed to address substance disorders and depression in order to achieve better ART adherence.

The impact of preexposure prophylaxis uptake on sexual and injection-related behaviors among women who inject drugs is poorly understood. Over 24 weeks, preexposure prophylaxis uptake among women who inject drugs was associated with increased sharing of injection equipment but not syringes and no changes in condomless sex, providing limited evidence of risk compensation in this vulnerable population.

OBJECTIVES: Asian Americans have poor HIV-related outcomes, yet culturally salient barriers to care remain unclear, limiting development of targeted interventions for this group. We applied the “what matters most” theory of stigma to identify structural and cultural factors that shape the nature of stigma before and after immigration from China to the US. DESIGN: Semi-structured interviews were conducted with 16 immigrants to New York from China, recruited from an HIV clinic and community centers. Deductive followed by focal inductive qualitative analyses examined how Chinese cultural values (lian, guanxi, renqing) and structural factors influenced stigma before and after immigration. RESULTS: In China, HIV stigma was felt through the loss of lian (moral status) and limited guanxi (social network) opportunities. A social structure characterized by limited HIV knowledge, discriminatory treatment from healthcare systems, and human rights violations impinged on the ability of people living with HIV to fulfill culturally valued goals. Upon moving to the US, positions of structural vulnerability shifted to enable maintenance of lian and formation of new guanxi, thus ameliorating aspects of stigma. CONCLUSIONS: HIV prevention and stigma reduction interventions among Chinese immigrants may be most effective by both addressing structural constraints and facilitating achievement of cultural values through clinical, peer, and group interventions.

Introduction Dapivirine (DPV), formulated as vaginal ring, demonstrated HIV risk reduction. MTN-026 explored DPV, formulated as rectal gel, for safety, pharmacokinetics, and acceptability. Methods HIV-uninfected men and women aged 18-45 years were enrolled at United States and Thailand sites and randomized 2:1 to receive DPV 0.05% or placebo gel via rectal applicator. A single dose phase was followed by 7 observed daily doses. Plasma, and fluid and tissue from both rectum and cervix were collected at baseline and after the final dose over 72 hours for pharmacokinetics, ex-vivo HIV-1 biopsy challenge, histology, and flow cytometry. Results 28 participants were randomized; 2 terminated early; 9 were female and 19 male; 12 were white, 11 Asian, 4 black and 1 other race/ethnicity. Mean age was 28.5 and 34.2 years in the DPV and placebo arms, respectively. Thirty adverse events occurred (all Grade 1 or 2, except one unrelated Grade 3) without study arm differences. DPV rectal tissue concentrations (median [interquartile range]) 0.5-1 and 2 hours after a single dose were 256 ng/gm (below limit of quantitation [BLQ], 666) and BLQ (BLQ, 600), respectively, then BLQ (BLQ, BLQ) from 24-72 hours; concentrations following multiple doses were similar. The largest median DPV plasma concentrations were 0.33 ng/mL (0.15, 0.48) after one dose and 0.40 (0.33, 0.49) after seven doses. Conclusions The DPV rectal gel was acceptable and without safety concerns. While DPV plasma concentrations were similar to the vaginal ring, rectal tissue concentrations were well below vaginal ring tissue concentrations, suggesting need for reformulation.

The Combination HIV Antiretroviral Rectal Microbicide-3 (CHARM-03) study was a randomized, open-label, crossover Phase 1 safety and pharmacokinetic (PK) study of oral maraviroc (MVC) and MVC 1% gel. At a single site, healthy HIV-uninfected men and women were enrolled and randomized to an open label crossover sequence of eight consecutive daily exposures to MVC 300 mg dosed orally, MCV 1% gel dosed rectally, and MVC 1% gel dosed vaginally. Male participants received oral and rectal dosing and female participants received oral, rectal, and vaginal dosing. Assessments were undertaken at baseline and following each 8-day period and included collection of plasma, rectal/cervical tissue (CT), and rectal/endocervical/vaginal fluids. Eleven men and nine women were enrolled. Two participants withdrew from the study before receiving study product. There were 25 adverse events, of which 24 were Grade 1 (G1) and one was G2 (unrelated). After eight doses, MVC was quantifiable in all samples following oral, rectal, or vaginal product administration. The highest drug concentrations in plasma, rectal tissue (RT), and CT were associated with oral, rectal, and vaginal drug delivery, respectively. There were significant reductions in tissue drug concentrations when rectal and cervical biopsies were incubated in media before tissue processing for PK (p

Long-acting delivery modalities of HIV pre-exposure prophylaxis (PrEP), such as subdermal implants, are in development. To facilitate end-user uptake and sustained use, it is critical to understand potential consumers' and physician prescribers' preferences about, interest in, and relative importance of different implant features. The ordered identification of these key attributes allows implant developers to incorporate this feedback into product design, which theoretically improves acceptability, feasibility, and user experience with the device. In this study, n = 75 PrEP-prescribing physicians and n = 143 men having sex with men (MSM) at risk for HIV completed web-based surveys that directly compared the importance of eight to nine different implant features, respectively. Conjoint analysis determined the importance of these features, relative to each other. Implants presented in the study were well received, with a majority of physicians and MSM indicating that they were likely to recommend or use them. The implant was perceived as unique, reliable, and convenient, as well as able to deliver better compliance. The attributes most critical to the adoption of the implant among physicians and MSM were (1) the chance of becoming infected with HIV while on implant treatment, (2) the length of protection and size of the implant, and (3) the side effect advantages over current PrEP oral pill treatment. Some concerns about the implant included side effects and the product's safety (among MSM) and the cost or insurance coverage level for the implant (both physicians and MSM). There was also some resistance to the implantation procedure itself.

BACKGROUND Migrants from Africa are vulnerable to viral infections during their journey. METHODS Migrants who arrived in western Sicily were offered early screening for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) infection. A questionnaire was administered to evaluate risk factors, and antiviral therapy was offered to subjects with active infection. A multiple regression analysis and adjusted odds ratio were obtained to evaluate risk factors. RESULTS Overall, 2,639 of 2,751 (95.9%) migrants who arrived between 2015 and 2017 accepted screening and 1,911 (72.4%) completed the questionnaire. HBsAg was positive in 257 (9.7%) migrants, 24 (0.9%) were anti-HCV positive and 57 (2.2%) had HIV infection. The prevalence of HBV infection was higher in women (aOR 2.47,95%CI 1.90-3.20),p = 0.003) and in people who endured physical and/or sexual violence (aOR 2.24,95%CI 1.87-3.55,p

The aim of this study was to assess the effect of lipodystrophy (LD) associated to metabolic syndrome (MS) on oxidative stress and inflammation in a cohort of 243 HIV-infected patients with MS, all of them under three different antiretroviral regimens. We collected immunovirological, biochemical and metabolic data, as well as anthropometric measurements. In addition, cardiovascular risk was also assessed by means of Atherogenic Index of Plasma (API) and Framingham Risk Score. The MS-LD patient set was characterized by a lower initial lymphocyte CD4 count and CD4/CD8 ratio and a higher initial viral load than the group without LD. We also found worse lipidic and glycaemic profiles (with lower HDL-cholesterol and higher triglyceride and glucose levels) in the MS-LD group. BMI, systolic blood pressure and Framingham score were significantly increased compared to MS-Non LD. In addition, patients with MS and LD had significantly higher levels of carbonylated proteins, lipid peroxidation, IL-6 and IL-8, as well as a significant decrease in the levels of leptin, adiponectin and antioxidant activities of catalase, super oxide dismutase and glutathione associated enzymes. In MS-LD HIV-1 patients, a significant negative correlation was found between Framingham Risk Score and the antioxidant biomarkers, however a positive association was found between API and protein-C reactive and carbonylated proteins. Segregating by ART, the above-mentioned conditions were worse within the MS-LD group whose treatment contained protease inhibitors, such as lopinavir. In conclusion, HIV-1 infected patients treated for at least six months, especially with regimens including PIs, showed a worsening of inflammatory process and oxidative stress.

The impact of HIV antiretroviral therapy (ART) on immune dysregulation associated with hepatitis C virus (HCV)/HIV coinfection is incompletely understood. We serially assessed monocyte activation (neopterin, sCD14, and sCD163) and T cell activation (HLA-DR, CD38) and immune exhaustion [program cell death protein 1 (PD1), TIGIT] in HIV/HCV-coinfected individuals who participated in a randomized trial performed in Vietnam designed to assess the hepatotoxicity of raltegravir (RAL)- versus efavirenz (EFV)-based therapy when used as first-time ART in combination with tenofovir disoproxil fumarate and emtricitabine. Baseline pre-ART values were compared with those from ART-naive HIV-monoinfected and HIV-seronegative individuals. Before ART, HIV/HCV-coinfected individuals had higher levels of neopterin, sCD14, and sCD163, and increased frequencies of CD38(+)HLA-DR(+), PD1(+), and TIGIT(+) CD4 and CD8 T cells compared with ART-naive HIV-monoinfected or HIV-seronegative individuals (all p

Introduction The high cost of viral load (VL) testing limits its use for antiretroviral treatment (ART) adherence support. A low-cost lateral flow urine tenofovir (TFV) rapid assay predicts PrEP breakthroughs but has not yet been investigated in HIV treatment. We therefore evaluated its utility in a pilot cross-sectional study of TFV-containing ART recipients at increased risk of virologic failure. Methods Participants who had a treatment interruption ≥30 days or had ≥1 episode of viremia (VL≥400 copies/mL) in the previous year were recruited from a public health setting in Cape Town, South Africa. Self-reported adherence data were collected, the urine TFV assay performed, and concurrent TFV-diphosphate (DP) analysed in dried blood spots. VL testing was done concurrently and, if viremic, genotypic HIV drug resistance testing performed. Results Of 48 participants, 18 (37.5%) had virologic failure (VL>400 copies/mL) at the time of the study including 16 of 39 receiving efavirenz (EFV), 2 of 6 receiving protease inhibitors (PI) and 0 of 3 receiving dolutegravir (DTG). Resistance testing succeeded in 17/18, of which 14 had significant mutations compromising ≥2 agents of the current EFV-based regimen. Of these 14, all had detected urine TFV. Urine TFV was undetectable in 2 out of 3 without regimen-relevant resistance; p=0.02. Conclusion In participants on EFV-based regimens returning to care, virologic failure was largely due to viral resistance, where detectable urine TFV had 100% sensitivity (14/14 participants) in predicting resistance. Conversely, when undetectable, the urine-based assay could be used to preclude participants with poor adherence from undergoing costly HIV drug resistance testing.

Background Increasing the number of human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) providers expands PrEP access to more eligible patients to help end the HIV epidemic. Previous studies have noted providers perceive financial barriers as a limitation to prescribing PrEP. Objective Describe PrEP medication access and affordability in patients seen at a multidisciplinary PrEP clinic. Method We conducted a single-center, retrospective, cohort study of adults initiating tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in the Vanderbilt PrEP Clinic between 9/1/2016 and 3/31/2019 with prescriptions filled by Vanderbilt Specialty Pharmacy. Data were gathered from the electronic health records and pharmacy claims. We evaluated three different time periods: initial evaluation to PrEP initiation, prescription of PrEP to insurance approval, and insurance approval to initiation. Treatment initiation was considered delayed when >7 days from initial evaluation, and reasons for delay were recorded. Continuous variables are presented as median (interquartile range, IQR) and categorical variables are presented as percentages. Results We included 63 patients; most were male (97%), White (84%), commercially insured (94%) with a median age of 38 years (IQR 29—47). Primary indication for PrEP was men who have sex with men at high risk for acquiring HIV (97%). Median time from initial appointment to treatment initiation was 7 days (IQR 4—8). Treatment delays occurred in 25% of patients and were mostly driven by patient preference (50%). Insurance prior authorization was required in 27% of patients; all were approved. Median total out-of-pocket medication costs for the entire study period were $0 (IQR $0 – $0). Most patients (86%) used manufacturer copay cards. Conclusion In this cohort of mostly commercially insured men, the majority were able to access PrEP with low out-of-pocket costs facilitated by manufacturer assistance. Though generalizability beyond this population is limited, these results contradict perceived financial barriers to PrEP access.

Objectives Cryptococcal meningitis constitutes a significant source of mortality in the developing world. Annually, approximately 625 000 deaths occur worldwide among patients with human immunodeficiency virus (HIV) infection. This study aims to assess the cost-effectiveness of implementing cryptococcal antigen lateral flow assay (CRAG-LFA) screening in Brazil compared with the current practice. Methods An economic evaluation using a Monte Carlo microsimulation was conducted, considering the perspective of the Brazilian Public Health System, to calculate the cost-effectiveness of 4 diagnosis tests: (1) CRAG-LFA, (2) the cryptococcal antigen latex agglutination (CRAG-LA) test, (3) India ink, and (4) nontracking as a baseline. The time horizon comprised 1 year for the intervention and 5 years for the budgetary impact analysis. Two primary effectiveness outcomes were considered: years of life and quality-adjusted life-years. Results CRAG-LFA has extended dominance vis a vis CRAG-LA and India ink. CRAG-LFA would cost $418.46 more than CRAG-LA for the treatment of each symptomatic patient living with HIV, with an incremental cost effectiveness ratio of $2478.75/quality-adjusted life year. The budgetary impact analysis estimated that the incorporation of CRAG-LFA would have an additional cost of $1 959 236.50 in 5 years. Conclusions These findings suggest that, for patients living with HIV in the Brazilian Public Health System, the adoption of CRAG-LFA screening is cost-effective compared with the use of CRAG-LA and India ink. It represents an opportunity to prevent cryptococcal meningitis and its mortality in Brazil.

Introduction Youth aged 13–29 years represent 23% of the population but account for 40% of new HIV diagnoses, with risk peaking at ages 22–23 years. We assessed sexual behaviors, PrEP knowledge and attitudes among patients of 6 School-Based-Health-Centers (SBHCs) located in Northern Manhattan and the Bronx. Method 667 patients, aged 13–19 years, completed a survey in the SBHCs waiting rooms between 10/2018 – 4/2019 Results Of the survey respondents attending SBHCs, 32% reported ever having heard of PrEP and, upon learning of PrEP, 67% stated that would be very likely (35%) or somewhat likely (32%) to take PrEP if it was offered to them free of charge. Discussion Youth of color are disproportionately infected by HIV throughout the US. Efforts are needed to educate adolescents on the benefits of PrEP, SBHCs are well situated to reduce barriers in providing PrEP directly to those who would benefit from its protection..