Exploring Individual and Contextual Factors Associated With Sexual Risk and Substance Use Among Underserved GBQMSM and Transgender and Nonbinary Persons in South Central Appalachia.

Gay, bisexual, queer, and other men who have sex with men (GBQMSM) and transgender and nonbinary persons are at elevated risk for HIV, sexually transmitted infections (STIs), and hepatitis C (HCV); in Appalachia, these communities experience more disease burden. However, little is known about the factors influencing risk. Sixteen semistructured in-depth interviews were conducted examining factors influencing prevention and care. Data were analyzed using constant comparison methodology. Fifteen themes emerged within four domains: social environment (e.g., microaggressions across gender, sexual orientation, and racial identities), substance use (e.g., high prevalence, use as coping mechanism), sexual health (e.g., misinformation and denial of risk for HIV and STIs), and access to health care (e.g., cost and transportation barriers, lack of local respectful care). Findings highlighted salient barriers and assets influencing prevention and care and suggest that multilevel interventions are needed to improve access to and use of HIV, STI, and HCV prevention and care services.

Human monkeypox virus infection in women and non-binary individuals during the 2022 outbreaks: a global case series.

BACKGROUND: Between May and November, 2022, global outbreaks of human monkeypox virus infection have been reported in more than 78 000 people worldwide, predominantly in men who have sex with men. We describe the epidemiological and clinical characteristics of monkeypox virus infection in cisgender (cis) and transgender (trans) women and non-binary individuals assigned female sex at birth to improve identification and understanding of risk factors. METHODS: International collaborators in geographical locations with high numbers of diagnoses of monkeypox virus infection were approached and invited to contribute data on women and non-binary individuals with confirmed monkeypox virus infection. Contributing centres completed deidentified structured case-report spreadsheets, adapted and developed by participating clinicians, to include variables of interest relevant to women and non-binary individuals assigned female at birth. We describe the epidemiology and clinical course observed in the reported infections. FINDINGS: Collaborators reported data for a total of 136 individuals with monkeypox virus infection who presented between May 11 and Oct 4, 2022, across 15 countries. Overall median age was 34 years (IQR 28-40; range 19-84). The cohort comprised 62 trans women, 69 cis women, and five non-binary individuals (who were, because of small numbers, grouped with cis women to form a category of people assigned female at birth for the purpose of comparison). 121 (89%) of 136 individuals reported sex with men. 37 (27%) of all individuals were living with HIV, with a higher proportion among trans women (31 [50%] of 62) than among cis women and non-binary individuals (six [8%] of 74). Sexual transmission was suspected in 55 (89%) trans women (with the remainder having an unknown route of transmission) and 45 (61%) cis women and non-binary individuals; non-sexual routes of transmission (including household and occupational exposures) were reported only in cis women and non-binary individuals. 25 (34%) of 74 cis women and non-binary individuals submitted to the case series were initially misdiagnosed. Overall, among individuals with available data, rash was described in 124 (93%) of 134 individuals and described as anogenital in 95 (74%) of 129 and as vesiculopustular in 105 (87%) of 121. Median number of lesions was ten (IQR 5-24; range 1-200). Mucosal lesions involving the vagina, anus, or oropharynx or eye occurred in 65 (55%) of 119 individuals with available data. Vaginal and anal sex were associated with lesions at those sites. Monkeypox virus DNA was detected by PCR from vaginal swab samples in all 14 samples tested. 17 (13%) individuals were hospitalised, predominantly for bacterial superinfection of lesions and pain management. 33 (24%) individuals were treated with tecovirimat and six (4%) received post-exposure vaccinations. No deaths were reported. INTERPRETATION: The clinical features of monkeypox in women and non-binary individuals were similar to those described in men, including the presence of anal and genital lesions with prominent mucosal involvement. Anatomically, anogenital lesions were reflective of sexual practices: vulvovaginal lesions predominated in cis women and non-binary individuals and anorectal features predominated in trans women. The prevalence of HIV co-infection in the cohort was high. FUNDING: None.

Outcomes From a Randomized Trial of a Bilingual mHealth Social Media Intervention to Increase Care Engagement Among Young Gay, Bisexual, and Other Men Who Have Sex With Men and Transgender Women With HIV.

BACKGROUND: The North Carolina Community Research Partnership developed, implemented, and tested weCare, a 12-month bilingual mHealth social media intervention designed to reduce missed HIV care appointments and increase viral suppression among racially/ethnically diverse gay, bisexual, and other men who have sex with men (GBMSM) and transgender women living with HIV by harnessing established social media platforms (i.e., Facebook, texting, and dating apps). METHODS: We randomized 198 GBMSM and transgender women (mean age = 26) living with HIV to the weCare intervention (n = 100) or usual-care (n = 98) group. Inclusion criteria included being newly diagnosed or not in care. Participants completed structured assessments at baseline and 6-month postintervention follow-up (18 months after baseline data collection). HIV care appointment and viral load data were abstracted from each participant's electronic health record at baseline and follow-up. Follow-up retention was 85.5%. RESULTS: Among participants, 94% self-identified as cisgender men, 6% as transgender, 64% as African American/Black, and 13% as Latine. Participants in both groups significantly reduced missed HIV care appointments and increased viral suppression at follow-up compared with baseline. However, there were no significant differences between weCare and usual-care participants for either outcome at follow-up. CONCLUSIONS: An intervention effect was not identified for our two primary outcomes. Several factors may have influenced the lack of significant differences between weCare and usual-care participants at follow-up, including intervention implementation (e.g., staffing changes and lack of fidelity to the intervention as originally designed by the partnership), data collection (e.g., data collection time points and retention strategies), and clinical (e.g., contamination) factors.

A Rapid Qualitative Assessment of the Impact of the COVID-19 Pandemic on a Racially/Ethnically Diverse Sample of Gay, Bisexual, and Other Men who Have Sex with Men Living with HIV in the US South.

Persons living with HIV (PLWH) may be at increased risk for severe COVID-19-related illness. Our community-based participatory research partnership collected and analyzed semi-structured interview data to understand the early impact of the COVID-19 pandemic on a sample of racially/ethnically diverse gay, bisexual, and other men who have sex with men living with HIV. Fifteen cisgender men participated; their mean age was 28. Six participants were Black/African American, five were Spanish-speaking Latinx, and four were White. Seventeen themes emerged that were categorized into six domains: knowledge and perceptions of COVID-19; COVID-19 information sources and perceptions of trustworthiness; impact of COVID-19 on behaviors, health, and social determinants of health; and general COVID-19-related concerns. Interventions are needed to ensure that PLWH have updated information and adhere to medication regimens, and to reduce the impact of COVID-19 on social isolation, economic stability, healthcare access, and other social determinants of health within this vulnerable population.

RESUMEN: Las personas que viven con VIH (PLWH por sus siglas en inglés) pueden tener mayor riesgo de contraer serias enfermedades relacionadas con el COVID-19. Nuestra investigación participativa basada en la comunidad recopiló y analizó datos de entrevistas semiestructuradas para entender el impacto inicial de la pandemia COVID-19 en una muestra de hombres gay, bisexuales y otros hombres que tienen sexo con hombres de diversos grupos étnicos y raciales que viven con VIH. Participaron quince hombres cisgénero con un promedio de edad de 28 años. Seis participantes fueron negros/afroamericanos, cinco latinx hispanohablantes y cuatro blancos. Emergieron diecisiete temas que fueron categorizados en seis ámbitos: conocimiento y percepciones de COVID-19; fuentes de información sobre COVID-19 y percepciones de confiabilidad; impacto de COVID-19 en comportamientos, salud y determinantes sociales de la salud e inquietudes generales relacionadas con COVID-19. Se necesitan intervenciones para garantizar que las personas que viven con VIH tengan información actualizada y cumplan con adherirse a su régimen de tratamiento y reducir el impacto de COVID-19 en lo que respecta a aislamiento social, estabilidad económica, acceso a los servicios de atención médica y otros determinantes sociales de la salud en estas poblaciones vulnerables.

A rapid qualitative assessment of the impact of the COVID-19 pandemic on a racially/ethnically diverse sample of gay, bisexual, and other men who have sex with men living with HIV in the US South.

Persons living with HIV (PLWH) may be at increased risk for severe COVID-19-related illness. Our community-based participatory research partnership collected and analyzed semi-structured interview data to understand the early impact of the COVID-19 pandemic on a sample of racially/ethnically diverse gay, bisexual, and other men who have sex with men living with HIV. Fifteen cisgender men participated; their mean age was 28. Six participants were Black/African American, five were Spanish-speaking Latinx, and four were White. Seventeen themes emerged that were categorized into six domains: knowledge and perceptions of COVID-19; COVID-19 information sources and perceptions of trustworthiness; impact of COVID-19 on behaviors, health, and social determinants of health; and general COVID-19-related concerns. Interventions are needed to ensure that PLWH have updated information and adhere to medication regimens, and to reduce the impact of COVID-19 on social isolation, economic stability, healthcare access, and other social determinants of health within this vulnerable population.

Las personas que viven con VIH (PLWH por sus siglas en inglés) pueden tener mayor riesgo de contraer serias enfermedades relacionadas con el COVID-19. Nuestra investigación participativa basada en la comunidad recopiló y analizó datos de entrevistas semiestructuradas para entender el impacto inicial de la pandemia COVID-19 en una muestra de hombres gay, bisexuales y otros hombres que tienen sexo con hombres de diversos grupos étnicos y raciales que viven con VIH. Participaron quince hombres cisgénero con un promedio de edad de 28 años. Seis participantes fueron negros/afroamericanos, cinco latinx hispanohablantes y cuatro blancos. Emergieron diecisiete temas que fueron categorizados en seis ámbitos: conocimiento y percepciones de COVID-19; fuentes de información sobre COVID-19 y percepciones de confiabilidad; impacto de COVID-19 en comportamientos, salud y determinantes sociales de la salud e inquietudes generales relacionadas con COVID-19. Se necesitan intervenciones para garantizar que las personas que viven con VIH tengan información actualizada y cumplan con adherirse a su régimen de tratamiento y reducir el impacto de COVID-19 en lo que respecta a aislamiento social, estabilidad económica, acceso a los servicios de atención médica y otros determinantes sociales de la salud en estas poblaciones vulnerables.

Week 96 subgroup analyses of the phase 3, randomized AMBER and EMERALD trials evaluating the efficacy and safety of the once daily darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) single-tablet regimen in antiretroviral treatment (ART)-naïve and -experienced, virologically-suppressed adults living with HIV-1.

BACKGROUND: Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg was investigated in AMBER (treatment-naïve adults; NCT02431247) and EMERALD (treatment-experienced, virologically-suppressed adults; NCT02269917). OBJECTIVE: To describe a Week 96 pre-planned subgroup analysis of D/C/F/TAF arms by demographic characteristics (age ≤/>50 years, gender, black/non-black race), and baseline clinical characteristics (AMBER: viral load [VL], CD4+ count, WHO clinical stage, HIV-1 subtype and antiretroviral resistance; EMERALD: prior virologic failure [VF], antiretroviral experience, screening boosted protease inhibitor [PI], and boosting agent). METHODS: Patients in D/C/F/TAF and control arms could continue on/switch to D/C/F/TAF in a single-arm, open-label extension phase after Week 48 until Week 96. Efficacy endpoints were percentage cumulative confirmed VL ≥50 copies/mL (virologic rebound; EMERALD), and VL <50 (virologic response), or ≥50 copies/mL (VF) (FDA snapshot; both trials). RESULTS: D/C/F/TAF demonstrated high Week 96 virologic responses (AMBER: 85% [308/362]; EMERALD: 91% [692/763]) and low VF rates (AMBER: 6% [20/362]; EMERALD: 1% [9/763]). In EMERALD, D/C/F/TAF showed low virologic rebound cumulative through Week 96 (3% [24/763]). Results were consistent across subgroups, including prior antiretroviral experience in EMERALD. No darunavir, primary PI, or tenofovir resistance-associated mutations were observed post-baseline. Study-drug-related serious adverse events (AEs) and AE-related discontinuations were <1% and 2%, respectively (both D/C/F/TAF arms), and similar across subgroups. eGFRcyst and bone mineral density improved or were stable and lipids increased through Week 96 across demographic subgroups, with small changes in total-cholesterol/HDL-cholesterol ratio. CONCLUSIONS: D/C/F/TAF was effective with a high barrier to resistance and bone/renal safety benefits, regardless of demographic or clinical characteristics for treatment-naïve and treatment-experienced, virologically-suppressed adults.

A Qualitative Systematic Review of Cigarette Smoking Cessation Interventions for Persons Living with HIV.

Persons living with HIV (PLWH) have disproportionately high rates of both cigarette smoking and tobacco-induced negative health outcomes. The goal of this qualitative systematic review was to identify gaps in the existing literature and future directions for smoking cessation support for PLWH. Three online databases were searched from their inception through December 31, 2017, using designated search terms. Peer-reviewed English-language articles that documented an intervention designed to increase smoking cessation among PLWH were reviewed. Data were abstracted using a standardized form to document study and intervention characteristics and results. Thirty-two articles, describing 28 unique intervention studies, met inclusion criteria. Interventions consisted primarily of combinations of counseling, pharmacotherapy, and the use of information and communications technology; few interventions were implemented at the clinic level. Thirteen interventions resulted in significant improvements in cessation-related outcomes. Information and communications technology and clinic-level interventions had the greatest potential for increasing smoking cessation among PLWH. Efficacious interventions designed for PLWH in the US South, and for groups of PLWH facing additional health disparities (e.g., communities of color and sexual and gender minorities), are needed. There is also a need for more rigorous research designs to test the efficacy of interventions designed to increase cessation-related outcomes among PLWH.

Physical Functioning Among Patients Aging With Human Immunodeficiency Virus (HIV) Versus HIV Uninfected: Feasibility of Using the Short Physical Performance Battery in Clinical Care of People Living With HIV Aged 50 or Older.

BACKGROUND: The Short Physical Performance Battery (SPPB) is a well regarded physical functioning assessment including balance, gait speed, and chair-stand tests. Its use has not been widely assessed in human immunodeficiency virus (HIV) care. We evaluated the feasibility of integrating the SPPB into care of aging people living with HIV (PLWH) and compared SPPB performance with aged HIV-uninfected individuals. METHODS: We enrolled PLWH aged ≥50 at 3 HIV clinics and compared their SPPB scores and subscores with older HIV-uninfected adults in the Health, Aging, and Body Composition (Health ABC) study. We conducted regression analyses on age stratified by sex and adjusting for site, and we calculated percentage variance explained by age among PLWH and HIV-uninfected adults. RESULTS: The SPPB was feasible to implement in clinical care and did not require licensed professionals; 176 PLWH completed it with a mean completion time of 7.0 minutes (standard deviation = 2.6). Overall mean SPPB score among PLWH was 10.3 (median 11.0, 25th percentile 9.0, 75th percentile 12.0). People living with HIV were younger than HIV-uninfected individuals (55 vs 74 years old). Mean SPPB scores and most subscores were similar among PLWH and older HIV-uninfected individuals despite the ~20-year age difference. Regression analyses of gait speed revealed similar slopes in PLWH and HIV-uninfected individuals; however, separate intercepts were needed for PLWH. Mean gait speeds were faster in older HIV-uninfected men and women (P < .01), yet relationships with age within PLWH and HIV uninfected were similar. CONCLUSIONS: The SPPB can be implemented into busy HIV clinics. Despite the ~20-year age difference, mean scores were similar among PLWH and older HIV-uninfected individuals, although gait speed was faster among HIV-uninfected individuals.

Characteristics of Out-of-Care Patients Who Required a Referral for Re-engagement Services by Public Health Bridge Counselors Following a Brief Clinic-Based Retention Intervention.

The NC-LINK Project initiated both clinic-based retention services and state public health bridge counselor-based (SBCs) re-engagement services to retain and re-engage people living with HIV infection (PLWH) in care. The goal of this project is to compare efforts between clinic-based retention and SBC re-engagement services to determine whether patients are more or less likely to remain in HIV care services. Clinic appointment data were used to identify patients who were last seen more than 6-9 months prior. Patients either received clinic-based retention services only or were subsequently referred to the SBC re-engagement intervention if the retention services were unsuccessful. The frequency of re-engagement in care (180 days) and HIV suppression (VLS, within 1 year) was examined for patients in these two groups. The SBC group was less likely to have VLS at the visit prior to referral (adjusted OR 2.04, 95% CI 1.53, 2.72). Patients who were referred to the SBC were less likely to re-engage in care within 180 days as compared to those who received clinic-based retention services only (adjusted OR 0.29, 95% CI 0.21, 0.41).

Results of a Social Network Testing Intervention for HIV in Infectious Disease Clinics.

Social networks can be leveraged to identify undiagnosed HIV-infected individuals. The NC-LINK clinic-based testing initiative utilized these networks to achieve a 5% (95% CI 1.1-8.9%) positivity rate by providing free HIV testing to anyone who accompanied an HIV-infected patient to their clinic appointment. During 2013-2015, 120 individuals were tested at two clinics (N > 1000 patients each) in North Carolina, with 5 new and 6 total positive results. Of these, three linked to care within 30 days and all within 365 days. If expanded further, this initiative could significantly increase the number of HIV-infected individuals aware of their status.

Safety of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in HIV-1-infected adults with end-stage renal disease on chronic haemodialysis: an open-label, single-arm, multicentre, phase 3b trial.

BACKGROUND: Current treatment for HIV-infected individuals with renal failure on haemodialysis frequently requires complex regimens with multiple pills. A daily single-tablet regimen of coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide is approved in Europe, the USA, and in other regions for use in HIV-1-infected individuals with mild-to-moderate chronic kidney disease (creatinine clearance 30-69 mL/min). We aimed to assess the safety, efficacy, and pharmacokinetics of this regimen in HIV-infected adults with end-stage renal disease on chronic haemodialysis. METHODS: We did an open-label, single-arm, multicentre, phase 3b trial at 26 outpatient clinics in Austria, France, Germany, and the USA. Participants were HIV-1-infected adults with end-stage renal disease (creatinine clearance <15 mL/min), on chronic haemodialysis for at least 6 months before screening. Virological suppression (ie, plasma HIV-1 RNA <50 copies per mL) on a stable antiretroviral regimen was required for at least 6 months before screening with a CD4 count of at least 200 cells per µL. We switched all participants to coformulated elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg once daily, taken after haemodialysis for up to 96 weeks. We did assessments at study visits at weeks 2, 4, 8, 12, 24, 36, and 48, and every 12 weeks thereafter up to 96 weeks. The primary endpoint was the incidence of treatment-emergent adverse events of grade 3 or higher up to week 48. All participants who received at least one dose of study drug were included in the primary analysis. This study is registered with ClinicalTrials.gov (NCT02600819) and is closed to new participants. FINDINGS: Between Feb 1, and Nov 3, 2016, 55 participants were enrolled and received at least one dose of study drug. Through week 48, 18 of 55 participants (33%, 95% CI 20-45) had an adverse event of grade 3 or higher on study treatment. Treatment-emergent grade 3 or higher adverse events that occurred in more than one participant included anaemia, osteomyelitis, prolonged electrocardiogram QT, fluid overload, hyperkalaemia, hypertension, and hypotension (all n=2). No adverse event of grade 3 or higher was considered by the site investigators to be treatment related. Three participants (5%, 95% CI 0-11) discontinued treatment because of adverse events; one of these (grade 1 allergic pruritus) was considered treatment related. Treatment-related adverse events were reported for six individuals (11%, 95% CI 3-19), the most common of which was nausea (in four individuals [7%]); all treatment-related adverse events were grade 1 or 2 in severity. INTERPRETATION: At 48 weeks, switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide was well tolerated. This regimen might provide a tolerable and convenient option for ongoing treatment of HIV-1 infection in adults with end-stage renal disease on chronic haemodialysis. FUNDING: Gilead Sciences.

Past Care Predicts Future Care in Out-of-Care People Living with HIV: Results of a Clinic-Based Retention-in-Care Intervention in North Carolina.

Poor retention in care is associated with higher viral load (VL) results and decreased rates of viral load suppression (VS) in people living with HIV (PLWH). Therefore, improving retention in HIV care is a priority of national significance. The NC-LINK Retention Project utilized a systematic approach to identify, locate, and attempt to return to care patients who did not attend a clinic appointment for 6-9 months. Clinical and surveillance data were used to evaluate associations between patient characteristics and VL outcomes. Between January 1, 2013 and December 31, 2014, 1118 patients at participating clinics were identified as out-of-care and referred to retention staff. Of these, 712 (64%) were located in North Carolina. Patients with recent prior medical care (aPR 1.43, 95% CI 1.25, 1.66) and recent VS (aPR 1.28, 95% CI 1.16, 1.41) were more likely to be located. Of located patients, 58% re-engaged in care within 90 days of retention referral. Patients who achieved VS within 180 days were more likely to be 40-49 years (aPR 1.19 95% CI 1.01-1.40; compared with 18-29 age group), had insurance at their last visit (aPR 1.19 95% CI 1.01-1.77), had a care visit in the prior year (aPR 1.37 95% CI 1.05-1.77), and had VS at the prior care visit (aPR 2.54 95% CI 1.98-3.25). Clinic-based retention efforts may be effective at helping PLWH decrease out-of-care periods, but prior patterns of care usage persist.

Case Report: Strongyloides stercoralis Hyperinfection in a Patient with Chronic Lymphocytic Leukemia.

Strongyloides stercoralis is an intestinal nematode that can cause disseminated infection in an immunocompromised host. It is most commonly acquired in developing countries. It was previously a common infection in many parts of the United States, particularly in the Appalachian region, but is rarely identified currently. Here, we describe a patient born and raised in Appalachia, with no history of travel outside the United States, who presented with chronic lymphocytic leukemia and S. stercoralis hyperinfection characterized by acute respiratory failure, altered mental status, and extended-spectrum-beta-lactamase Klebsiella pneumoniae bacteremia. Despite prompt identification of the parasite on sputum microscopy and initiation of therapy with oral ivermectin and meropenem, the patient subsequently died. This case highlights the continued possibility of S. stercoralis infection in patients from Appalachia.

Effect of immediate initiation of antiretroviral therapy on risk of severe bacterial infections in HIV-positive people with CD4 cell counts of more than 500 cells per µL: secondary outcome results from a randomised controlled trial.

BACKGROUND: The effects of antiretroviral therapy on risk of severe bacterial infections in people with high CD4 cell counts have not been well described. In this study, we aimed to quantify the effects of immediate versus deferred ART on the risk of severe bacterial infection in people with high CD4 cell counts in a preplanned analysis of the START trial. METHODS: The START trial was a randomised controlled trial in ART-naive HIV-positive patients with CD4 cell count of more than 500 cells per µL assigned to immediate ART or deferral until their CD4 cell counts were lower than 350 cells per µL. We used Cox proportional hazards regression to model time to severe bacterial infection, which was defined as a composite endpoint of bacterial pneumonia (confirmed by the endpoint review committee), pulmonary or extrapulmonary tuberculosis, or any bacterial infectious disorder of grade 4 severity, that required unscheduled hospital admissions, or caused death. This study is registered with ClinicalTrials.gov, number NCT00867048. FINDINGS: Patients were recruited from April 15, 2009, to Dec 23, 2013. The data cutoff for follow-up was May 26, 2015. Of 4685 HIV-positive people enrolled, 120 had severe bacterial infections (immediate-initiation group n=34, deferred-initiation group n=86; median 2·8 years of follow-up). Immediate ART was associated with a reduced risk of severe bacterial infection compared with deferred ART (hazard ratio [HR] 0·39, 95% CI 0·26-0·57, p<0·0001). In the immediate-initiation group, average neutrophil count over follow-up was 321 cells per µL higher, and average CD4 cell count 194 cells per µL higher than the deferred-initiation group (p<0·0001). In univariable analysis, higher time-updated CD4 cell count (0·78, 0·71-0·85, p=0·0001) was associated with reduced risk of severe bacterial infection. Time-updated neutrophil count was not associated with severe bacterial infection. After adjustment for time-updated factors in multivariable analysis, particularly the CD4 cell count, the HR for immediate-initiation group moved closer to 1 (HR 0·84, 0·50-1·41, p=0·52). These results were consistent when subgroups of the severe bacterial infection composite were analysed separately. INTERPRETATION: Immediate ART reduces the risk of several severe bacterial infections in HIV-positive people with high CD4 cell count. This is partly explained by ART-induced increases in CD4 cell count, but not by increases in neutrophil count. FUNDING: National Institute of Allergy and Infectious Diseases National Institutes of Health, Agence Nationale de Recherches sur le SIDA et les Hépatites Virales, Bundesministerium für Bildung und Forschung, European AIDS Treatment Network, Australian National Health and Medical Research Council, UK National Institute for Health Research and Medical Research Council, Danish National Research Foundation.

HIV patient retention: the implementation of a North Carolina clinic-based protocol.

Decreased visit attendance leads to poor health outcomes, decreased viral suppression, and higher mortality rates for persons living with HIV. Retention in care is an important factor in improving health status for people living with HIV but continues to be a challenge in clinical settings. This paper details the development and implementation of the NC-LINK Retention Protocol, a clinic-based protocol to locate and reengage out-of-care patients, as part of overall clinic retention efforts. The protocol was implemented as one of four interventions of the NC-LINK Systems and Linkages Project, a multi-site initiative funded by the HIV/AIDS Bureau and the Special Projects of National Significance. Lists of out-of-care patients who had not received HIV medical care in over nine months and did not have a future appointment were created each month. Patient navigators, case managers, and other staff then followed a standardized protocol to locate and reengage these patients in care. A total of 452 patients were identified for reengagement services. Of those, 194 (43%) returned to care, 108 (24%) had another definitive outcome (incarcerated, deceased, or relocated) and 150 (33%) were referred for additional follow-up to locate and reengage in care. In summary, 67% of patients were located through the efforts of the clinic staff. The results of this intervention indicate that it is possible to successfully integrate a protocol into the existing infrastructure of a clinic and reengage a majority of out-of-care patients into medical care.

Perspectives from the Field: HIV Testing and Linkage to Care in North Carolina.

BACKGROUND: HIV testing and linkage to care are critical first steps along the care continuum. Targeted efforts are needed in the South to achieve the goals of the National HIV/AIDS Strategy, and qualitative examination of testing and linkage to care from the perspective of professionals in the field can provide nuanced insight into the strengths and limitations of a care system to inform improvement efforts. These issues are explored in North Carolina (NC), with potential applicability to other Southern states. METHODS: Twenty-one interviews were conducted with professionals in the HIV prevention and care systems in NC. Interviews were analyzed for emergent themes. RESULTS: Individuals' access barriers, aspects of clinics and clinical care, challenges for community-based organizations, stigma, and the role of the NC Department of Health and Human Services were identified as themes affecting testing and linkage. DISCUSSION: These findings can inform efforts to address HIV testing and linkage to care in NC. This approach may provide beneficial insight for other systems of care.

Antiretroviral activity and safety of once-daily etravirine in treatment-naive HIV-infected adults: 48-week results.

BACKGROUND: Etravirine (ETR), a non-nucleoside reverse transcriptase inhibitor approved for 200 mg twice-daily dosing in conjunction with other antiretrovirals (ARVs), has pharmacokinetic properties which support once-daily dosing. METHODS: In this single-arm, open-label study, 79 treatment-naive HIV-infected adults were assigned to receive ETR 400 mg plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) 300/200 mg once daily to assess antiviral activity, safety and tolerability. ARV activity at 48 weeks was determined by proportion of subjects with HIV-1 RNA<50 copies/ml (intention-to-treat, missing = failure). RESULTS: Of 79 eligible subjects, 90% were men, 62% African-American and 29% Caucasian. At baseline, median (Q1, Q3) age was 29 years (23, 44) and HIV-1 RNA 4.52 log10 copies/ml (4.07, 5.04). A total of 69 (87%) completed a week 48 visit and 61 (77%, 95% CI 66%, 86%) achieved HIV-1 RNA<50 copies/ml at week 48. At time of virological failure, genotypic resistance-associated mutations were detected in three participants, two with E138K (one alone and one with additional mutations). Median (95% CI) CD4(+) cell count increase was 163 (136, 203) cells/µl. Fifteen (19.0%) participants reported a new sign/symptom or lab abnormality ≥ Grade 3 and three participants (3.8%) permanently discontinued ETR due to toxicity. Two participants had psychiatric symptoms of any grade. There were no deaths. CONCLUSIONS: In this study of ARV-naive HIV-positive adults, once-daily ETR with TDF/FTC had acceptable antiviral activity and was well-tolerated. Once-daily ETR may be a plausible option as part of a combination ARV regimen for treatment-naive individuals. ClinicalTrials.gov NCT00959894.

Effects of raltegravir combined with tenofovir/emtricitabine on body shape, bone density, and lipids in African-Americans initiating HIV therapy.

BACKGROUND: Raltegravir (RAL) plus tenofovir/emtricitabine (TDF/FTC) is a recommended initial antiretroviral regimen. A substantial proportion of persons diagnosed with HIV infection and starting antiretrovirals in the U.S. are African-American (AA); however, the effects of this regimen on metabolic parameters have largely been studied in white patients. METHODS: Single-arm, open-label study of untreated AA HIV-infected patients administered RAL with TDF/FTC for 104 weeks. Changes in fasting lipids, insulin resistance, visceral adipose tissue (VAT), abdominal subcutaneous adipose tissue (SAT), limb and trunk fat, and bone mineral density (BMD) were assessed at weeks 56 and 104. RESULTS: Thirty (85% men) participants were included. Median entry characteristics included age of 38 years, CD4 323 cells/mm3, HIV RNA level 29,245 copies/ml, and body mass index 28.1 kg/m2. At 56 and 104 weeks, significant increases in VAT, trunk fat, limb fat, and overall fat were observed. Bone mineral density decreased by 1.5% by week 104.There were no significant changes in non-HDL-cholesterol, fasting triglycerides, or insulin resistance. A median CD4 cell count increase of 318 cells/mm3 (IQR 179, 403; full range 40, 749) (P<0.001) was observed. Assuming missing=failure, 78 and 70% had HIV RNA levels<40 copies/ml at weeks 56 and 104, respectively. There were no treatment-related discontinuations and no new antiretroviral resistance mutations were detected. CONCLUSIONS: In this cohort of AAs, initiation of RAL with TDF/FTC was associated with significant general increases in fat. Significant changes in lipids or insulin resistance were not observed and there was a small decline in BMD. Therapy was well tolerated and effective. These results are consistent with findings of studies of initial antiretroviral therapy in racially diverse cohorts and inform treatment selection for AA patients starting therapy for HIV infection.

Chronic pruritus in HIV-positive patients in the southeastern United States: its prevalence and effect on quality of life.

BACKGROUND: Prevalence of chronic pruritus in HIV-positive patients is an underevaluated topic in the United States. The characteristics, severity, and quality of life (QOL) in patients with HIV and chronic pruritus have not been well documented using validated tools. OBJECTIVES: We sought to assess the prevalence and intensity of chronic pruritus and its effect on QOL in HIV-positive patients in a US population. METHODS: HIV-positive patients (n = 201) were asked to complete a sociodemographic data form and 2 itch questionnaires. Patients with itching rated their itch intensity on a numeric visual analog scale. Laboratory parameters were obtained from patients' medical records. RESULTS: The prevalence of chronic itch in the study group was 45% with an average visual analog scale score of 5.93 during an itch episode. Patients with high visual analog scale score had significantly decreased QOL. Patients with HIV reported greater negative impact of pruritus on daily lives. LIMITATIONS: Because of the cross-sectional design, this study demonstrates an association between HIV and pruritus but cannot prove causation. CONCLUSION: Patients with HIV surveyed in a large clinic in the southeastern United States have a high prevalence of pruritus; HIV pruritus has a significant effect on QOL and itch is the most common skin manifestation found in this population.

Correlates of HAART adherence among immigrant Latinos in the Southeastern United States.

We explored the relationships between sociocultural and psychological constructs and adherence to antiretroviral therapy among predominantly Spanish-speaking immigrant Latinos in the southeastern United States. A cross-sectional clinic-based sample of immigrant Latino men and women participated in an interviewer-administered assessment. Self-reported prevalence of adherence was assessed along with demographic characteristics, acculturation, physician trust, social support, and theory of planned behavior (TPB) constructs: attitude, subjective norm (SN), and perceived behavioral control (PBC). A total of 66 respondents met inclusion criteria. Average age was 38 years old, 74% of respondents were male, 71% heterosexual, and 86% reported being from Mexico or Central America. Prevalence of "complete" adherence (i.e., not missing a single dose) in the past 30 days was 71%. Social support was significantly and inversely associated with adherence, PBC, and attitude. Positive correlates of adherence included attitude, PBC, and employment status. In multivariable analysis, SN and PBC were significantly associated with social support, controlling for acculturation, physician trust, and number of behavioral referents. TPB constructs have utility in explaining ART adherence among immigrant Latinos in the "Deep South." Further research is necessary to understand the complex relationships between social support, attribution processes, and ART adherence outcomes.