Urban Human Immunodeficiency Virus Clinic Research Articles

The Impact of Telemedicine on Human Immunodeficiency Virus (HIV)-Related Clinical Outcomes During the COVID-19 Pandemic

The coronavirus disease of 2019 (COVID-19) pandemic exacerbated barriers to care for people living with human immunodeficiency virus (HIV) (PLWH). The quick uptake of telemedicine in the outpatient setting provided promise for care continuity. In this study, we compared appointment and laboratory no-show rates in an urban outpatient HIV clinic during three time periods: (1) Pre-COVID-19: 9/15/2019–3/14/2020 (predominately in-person), (2) “Early” COVID-19: 3/15/2020-9/14/2020 (predominately telemedicine), and (3) “Later” COVID-19: 9/15/2020-3/14/2021 (mixed in-person/telemedicine). Multivariable logistic regression models evaluated the two study hypotheses: (i) equivalence of Period 2 with Period 1 and of Period 3 with Period 1 and (ii) improved outcomes with telemedicine over in-person visits. No-show rates were 1% in Period 1, 4% in Period 2, and 18% in Period 3. Compared to the pre-pandemic period, individuals had a higher rate of appointment no-shows during Period 2 [OR (90% CI): 7.67 (2.68, 21.93)] and 3 [OR (90% CI): 30.91 (12.83 to 75.06). During the total study period, those with telemedicine appointments were less likely to no-show than those with in-person appointments [OR (95% CI): 0.36 (0.16–0.80), p = 0.012]. There was no statistical difference between telemedicine and in-person appointments for laboratory completion rates. Our study failed to prove that no-show rates before and during the pandemic were similar; in fact, no-show rates were higher during both the early and later pandemic. Overall, telemedicine was associated with lower no-show rates compared to in-person appointments. In future pandemics, telemedicine may be a valuable component to maintain care in PLWH.

Microalbuminuria in Perinatally HIV-Infected Children and Adolescents in the United States.

The kidney is a common target for human immunodeficiency virus (HIV), making renal disease a common noninfectious complication of HIV. Microalbuminuria is an important marker that can detect early renal damage. Timely detection of microalbuminuria is important to initiate renal management and stop the progression of renal dysfunction in people with HIV. Limited data are available about renal abnormalities in people with perinatal HIV infection. The objective of this study was to determine the prevalence of microalbuminuria in a cohort of perinatally HIV-infected children and young adults receiving combination antiretroviral therapy and investigate correlations between microalbuminuria and clinical and laboratory findings. This was a retrospective study of 71 patients with HIV followed in an urban pediatric HIV clinic in Houston, Texas, between October 2007 and August 2016. Demographic, clinical, and laboratory data were compared between subjects with persistent microalbuminuria (PM) and those without. PM is defined as a microalbumin-to-creatinine ratio ≥30 mg/g on at least 2 occasions separated by at least 1 month. Sixteen of 71 patients (23%) met the definition of PM. In univariate analysis, patients with PM had significantly higher CD8+ T-cell activation and lower CD4+ T-cell nadir. Multivariate analysis demonstrated increased microalbuminuria to be independently associated with older age and CD8+ T-cell activation measured as CD8+HLA-DR+ T-cell percentage. Older age and increased activation of CD8+HLA-DR+ on T cells correlate with presence of microalbuminuria in this cohort of HIV-infected patients.

First Demonstration Project of Long-Acting Injectable Antiretroviral Therapy for Persons With and Without Detectable Human Immunodeficiency Virus (HIV) Viremia in an Urban HIV Clinic.

Long-acting injectable antiretroviral therapy (LAI-ART) is approved for treatment-naive or experienced people with human immunodeficiency virus (HIV; PWH) based on trials that only included participants with viral suppression. We performed the first LAI-ART demonstration project to include PWH unable to achieve or maintain viral suppression due to challenges adhering to oral ART. Ward 86 is a large HIV clinic in San Francisco that serves publicly insured and underinsured patients. We started patients on LAI-ART via a structured process of provider referral, multidisciplinary review (MD, RN, pharmacist), and monitoring for on-time injections. Inclusion criteria were willingness to receive monthly injections and a reliable contact method. Between June 2021 and April 2022, 51 patients initiated LAI-ART, with 39 receiving at least 2 follow-up injections by database closure (median age, 46 years; 90% cisgender men, 61% non-White, 41% marginally housed, 54% currently using stimulants). Of 24 patients who initiated injections with viral suppression (median CD4 cell count, 706 cells/mm3), 100% (95% confidence interval [CI], 86%-100%) maintained viral suppression. Of 15 patients who initiated injections with detectable viremia (median CD4 cell count, 99 cells/mm3; mean log10 viral load, 4.67; standard deviation, 1.16), 12 (80%; 95% CI, 55%-93%) achieved viral suppression, and the other 3 had a 2-log viral load decline by a median of 22 days. This small demonstration project of LAI-ART in a diverse group of patients with high levels of substance use and marginal housing demonstrated promising early treatment outcomes, including in those with detectable viremia due to adherence challenges. More data on LAI-ART in hard-to-reach populations are needed.

Medication beliefs among people living with HIV taking antiretroviral treatment in Zimbabwe: a qualitative study

# Background The beliefs that patients hold about their medicines are known to influence treatment adherence. This study’s objective was to explore and identify specific antiretroviral (ART) beliefs from human immunodeficiency virus (HIV) positive patients in Zimbabwe. # Methods In-depth qualitative interviews were conducted with 21 (female = 9; 42.9%) purposively sampled HIV-positive adults attending an urban HIV clinic. All participants had been prescribed ART for at least one month. Two additional key informant interviews were conducted with healthcare professionals. Data were analysed inductively using grounded theory framework. # Results Participants’ beliefs about ART were grouped into two themes: perceived importance, and concerns about ART. The majority of participants viewed ART as necessary for staying alive and healthy. Participants who had attempted alternative treatments experienced health deterioration and subsequently returned to using ART. There were several medication concerns, including: the short- and long-term effects of the medication; the number of doses; potential interactions with other medications; and fear of stigma. However, the more necessary ART was perceived to be, the less these concerns affected self-reported adherence behaviour. # Conclusions Healthcare professionals need to be aware of these beliefs so they can provide tailored, adequate adherence support. Further research is needed to explore whether reducing concerns and enhancing necessity beliefs improve adherence in this population.

Performance of 4 Molecular Assays for Detection of Chlamydia and Gonorrhea in a Sample of Human Immunodeficiency Virus-Positive Men Who Have Sex With Men.

Nucleic acid amplification testing (NAAT) is the preferred method to detect Chlamydia trachomatis and Neisseria gonorrhoeae, but information regarding performance of currently available assays is needed. This study evaluated the performance of the Aptima Combo 2, GeneXpert, cobas4800, and ProbeTec Q (CTQ/GCQ) to detect chlamydia and gonorrhea in pharyngeal, rectal, and urine specimen. Adult male patients seen at an urban human immunodeficiency virus clinic in Birmingham, Alabama who reported sex with men (men who have sex with men) and no antibiotic use in the past 30 days were enrolled between November 2014 and December 2016. Following a baseline survey, rectal and initial void urine specimens were self-collected. A composite infection standard was used, where 1 assay was compared with 3 others to determine sensitivity and specificity estimates for rectal and urine samples. Two pharyngeal samples were clinician-collected for chlamydia and gonorrhea testing and both had to be positive to be considered a true positive. Among the 181 men enrolled into the study, 15.5% and 7.2% had at least 1 positive chlamydia and gonorrhea result at any site, respectively. Among all 4 assays, chlamydia sensitivity rates ranged from 82% to 96% among rectal samples. Rectal gonorrhea sensitivity estimates ranged from 67% to 99%. The GCQ assay was less sensitive in detecting rectal gonorrhea compared with the other assays (P = 0.02). More than 80% of chlamydia and gonorrhea infections would have been missed with urine-only screening, highlighting the importance in using NAATs to detect chlamydia and gonorrhea infections among men who have sex with men.

2523. Optimizing Disclosure of HIV Status to a Diverse Population of HIV-Positive Pediatric Patients at an Urban HIV Clinic in the Southeastern United States

BackgroundDevelopmentally-appropriate disclosure of human immunodeficiency virus (HIV) status to children living with HIV (CLWH) is essential to achieve optimal health outcomes, but stigma and fear result in delaying disclosure into adolescence. The American Academy of Pediatrics recommends disclosure of HIV status to school-age children. The objective of this quality improvement (QI) project was to increase the proportion of CLWH > 10 years of age who are disclosed about their HIV status from 57% to 80% by 18 months.MethodsThe Institute for Healthcare Improvement’s Model for Improvement was utilized for this QI project. This model accelerates quality improvement by implementing Plan-Do-Study-Act (PDSA) cycles to determine whether changes lead to improvement. The target population included CLWH followed at an urban pediatric HIV clinic. The primary outcome measure was the proportion of children > 10 years of age who are disclosed about their HIV status. PDSA cycles included monthly clinic check-ins to discuss new disclosures, quarterly team meetings to discuss implementation of new changes to improve disclosure and modifying a note template to prompt providers to document disclosure status and plan for undisclosed patients. Our process measure was the proportion of undisclosed children who have a documented disclosure status/plan. Annotated run charts were used to track the data.ResultsPrior to our first PDSA cycle, 57% of CLWH > 10 years of age were disclosed to about their HIV status, and none of the undisclosed children had a disclosure status/plan documented in their medical record. The proportion of CLWH disclosed to about their HIV status increased to 66% since meeting with the team regularly to discuss disclosure status (figure). Four months after introduction of the modified note template, the proportion of CLWH with documentation of their disclosure status and plan increased to 54%.ConclusionTeam awareness of the importance of disclosure and a modified clinic note template were associated with increases in the proportion of CLWH with age-appropriate HIV disclosure and documentation of disclosure status. Future interventions will include adapting methods of step-wise disclosure which have been proven effective in other settings. Disclosures All authors: No reported disclosures.

Low sero-prevalence of hepatitis delta antibodies in HIV/ hepatitis B co-infected patients attending an urban HIV clinic in Uganda.

Co-infection with hepatitis B (HBV) and hepatitis D (HDV) is common among human immunodeficiency virus (HIV) infected individuals in developing countries and it aggressively accelerates progression of liver disease to cirrhosis and other complications. There is scarcity of data on HDV in sub-Saharan Africa .We investigated the sero-prevalence and factors associated with HDV antibody among HIV/HBV co-infected patients attending a large urban HIV clinic in Uganda. We screened 189 HIV/HBV co-infected individuals for anti-HDV immunoglobulin G (IgG) and performed logistic regression to determine the associated factors. Socio-demographic, clinical data, immunological status, and liver fibrosis (as determined by the Aspartate transaminase to platelet ratio index and transient elastography) were included. Participants were predominately young and of sound immunologic status (median age 40 years, median CD4 440 cells/µl). 98% were on ART regimens containing anti-HBV active medications (95.2% were on TDF/3TC while 4.8% on 3TC containing regimen). Median duration on ART was 36 months (IQR 22-72). Anti-HDV was detected in 6/198, 3.2% (95% CI 1.14-6.92%), associated with male gender and a duration of more than 5 years since HIV diagnosis. The sero-prevalence of HDV antibodies among the HIV/HBV co-infected patients is low in a Ugandan urban cohort.

Low sero-prevalence of hepatitis delta antibodies in HIV/ hepatitis B co-infected patients attending an urban HIV clinic in Uganda.

Co-infection with hepatitis B (HBV) and hepatitis D (HDV) is common among human immunodeficiency virus (HIV) infected individuals in developing countries and it aggressively accelerates progression of liver disease to cirrhosis and other complications. There is scarcity of data on HDV in sub-Saharan Africa .We investigated the sero-prevalence and factors associated with HDV antibody among HIV/HBV co-infected patients attending a large urban HIV clinic in Uganda. We screened 189 HIV/HBV co-infected individuals for anti-HDV immunoglobulin G (IgG) and performed logistic regression to determine the associated factors. Socio-demographic, clinical data, immunological status, and liver fibrosis (as determined by the Aspartate transaminase to platelet ratio index and transient elastography) were included. Participants were predominately young and of sound immunologic status (median age 40 years, median CD4 440 cells/µl). 98% were on ART regimens containing anti-HBV active medications (95.2% were on TDF/3TC while 4.8% on 3TC containing regimen). Median duration on ART was 36 months (IQR 22-72). Anti-HDV was detected in 6/198, 3.2% (95% CI 1.14-6.92%), associated with male gender and a duration of more than 5 years since HIV diagnosis. The sero-prevalence of HDV antibodies among the HIV/HBV co-infected patients is low in a Ugandan urban cohort.

Prevalence of Gonorrhea and Chlamydia Infections Among Human Immunodeficiency Virus-Infected Men by Anatomic Site and Presence or Absence of Symptoms

Background. The Infectious Diseases Society of America (IDSA) and Centers for Disease Control and Prevention (CDC) guidelines recommend annual urine testing for Gonorrhea and Chlamydia (GC/CT) for human immunodeficiency virus (HIV)-infected individuals, with the addition of rectal and pharyngeal screening based on report of sexual practice. We explored GC/CT positivity rates by body site and reason for testing in an urban HIV clinic population.

The Impact of Direct-Acting Antivirals in the Hepatitis C-Sustained Viral Response in Human Immunodeficiency Virus-Infected Patients With Ongoing Barriers to Care.

Background. Access to hepatitis C virus (HCV) medications for human immunodeficiency virus (HIV)-infected patients with ongoing barriers to care is restricted by healthcare payers in the absence of HCV treatment outcomes data in the era of direct-acting antivirals (DAA). Methods. Retrospective analysis of HCV treatment outcomes using interferon (IFN)-free DAA regimens and an inclusive treatment protocol in an urban HIV clinic where ongoing barriers to care (drug or alcohol use, psychiatric disease, and/or unstable housing) are common. Then, using logistic regression analysis, we compared the proportion of HIV-infected patients who achieved HCV sustained viral response (SVR) in the pegylated-IFN plus ribavirin (PEG-IFN/RBV, 2008-2011), pegylated-IFN plus ribavirin and telaprevir (PEG-IFN/RBV/PI, 2011-2013), and IFN-free DAA therapy eras (2014). Results are displayed using forest plots. Results. The proportion of patients who achieved HCV SVR in the PEG-IFN/RBV, PEG-IFN/RBV/PI, and IFN-free DAA therapy eras increased from 38.4% (95% confidence interval [CI], 23.2-53.7) and 48% (95% CI, 28.4-67.6) to 83.3% (95% CI, 70.0-96.7), respectively. Similar proportions of patients with ongoing barriers to care were treated during the PEG-IFN/RBV (25 of 39 [64%]), PEG-IFN/RBV/PI (14 of 25 [56%]), and IFN-free DAA (16 of 30 [53%]) eras. Hepatitis C virus SVR among patients with ongoing barriers to care improved from 40% (95% CI, 21-59) to 76.5% (95% CI, 56-97) in the PEG-IFN/RBV and IFN-free DAA eras, respectively. After stratification for factors associated with HCV SVR such as HCV genotype and cirrhosis, HCV SVR were similar in patients regardless of the presence of ongoing barriers to care. Conclusions. Using IFN-free DAA and an inclusive HCV treatment protocol, 76.5% of HIV/HCV-treated patients with ongoing barriers to care achieved HCV SVR.

Immunization costs and programmatic barriers at an urban HIV clinic.

Although the increasing number of recommended immunizations is essential for patients infected with human immunodeficiency virus (HIV), the potentially uncompensated costs of expanded immunizations will present significant challenges for clinics and health systems serving HIV-infected patients. We estimated costs of providing Gardasil, Prevnar, and Zostavax to eligible patients at a US Ryan White Part C academically affiliated HIV clinic in 2013. Clinic expenditures were calculated using vaccine price and administrative fees. Revenue was calculated using insurance reimbursement data for vaccination and administration. Three scenarios were used: 100% uptake of vaccines, adjusted uptake based on published rates, and adjusted reimbursement according to pre-Affordable Care Act (ACA) insurance status. 2887 patients (27% Medicare, 13% Alabama Medicaid, 26% Commercial, 34% Uninsured), received care with wide variation in immunization reimbursement ($0 to $210) by insurance and vaccine. The net yield (revenue minus expenditure) was calculated for each vaccine. Prevnar was most costly: annual net yield of -$60 691. Provision of all 3 vaccines would lead to a net yield of -$97 122. Adjusting for reduced uptake led to annual clinic losses of $44 119. Using pre-ACA reimbursement for immunization of the uninsured led to reduced clinic losses (-$62 326), attributable to reimbursement via Ryan White funds. A cost analysis of 3 vaccines shows great variation in insurance coverage, with potential losses of almost $100 000 for one HIV clinic if eligible patients received vaccinations in one calendar year. Adequate, cost neutral reimbursement should be instituted if medical providers and health systems are to achieve Advisory Committee on Immunization Practices immunization recommendations for both HIV positive and negative adults.

Improving cervical cancer screening rates in an urban HIV clinic

Human immunodeficiency virus (HIV)-infected women are at increased risk of invasive cervical cancer; however, screening rates remain low. The objectives of this study were to analyze a quality improvement intervention to increase cervical cancer screening rates in an urban academic HIV clinic and to identify factors associated with inadequate screening. Barriers to screening were identified by a multidisciplinary quality improvement committee at the Washington University Infectious Diseases clinic. Several strategies were developed to address these barriers. The years pre- and post-implementation were analyzed to examine the clinical impact of the intervention. A total of 422 women were seen in both the pre-implementation and post-implementation periods. In the pre-implementation period, 222 women (53%) underwent cervical cancer screening in the form of Papanicolaou (Pap) testing. In the post-implementation period, 318 women (75.3%) underwent cervical cancer screening (p < 0.01). Factors associated with lack of screening included fewer visits attended (pre: 4.2 ± 1.5; post: 3.4 ± 1.4; p < 0.01). A multidisciplinary quality improvement intervention was successful in overcoming barriers and increasing cervical cancer screening rates in an urban academic HIV clinic.

Long-term outcomes of a cell phone-delivered intervention for smokers living with HIV/AIDS.

People living with human immunodeficiency virus (HIV)/AIDS (PLWHA) have a substantially higher prevalence of cigarette smoking compared to the general population. In addition, PLWHA are particularly susceptible to the adverse health effects of smoking. Our primary objective was to design and test the efficacy over 12 months of a smoking cessation intervention targeting PLWHA. Participants were enrolled from an urban HIV clinic with a multiethnic and economically disadvantaged patient population. Participants received smoking cessation treatment either through usual care (UC) or counseling delivered by a cell phone intervention (CPI). The 7-day point prevalence abstinence was evaluated at 3, 6, and 12 months using logistic regression and generalized linear mixed models. We randomized 474 HIV-positive smokers to either the UC or CPI group. When evaluating the overall treatment effect (7-day abstinence outcomes from 3-, 6-, and 12-month follow-ups), participants in the CPI group were 2.41 times (P = .049) more likely to demonstrate abstinence compared to the UC group. The treatment effect was strongest at the 3-month follow-up (odds ratio = 4.3, P < .001), but diminished at 6 and 12 months (P > .05). Cell phone-delivered smoking cessation treatment has a positive impact on abstinence rates compared to a usual care approach. Future research should focus on strategies for sustaining the treatment effect in the long term.

Racial/Ethnic Disparities in Engagement in Care and Viral Suppression in a Large Urban HIV Clinic

To the Editor—We read with great interest the study by Moore et al [1], which showed that among human immunodeficiency virus (HIV)–infected adults followed at Moore Clinic during 1996–2012, there were no significant differences in virologic, immunologic, or HIV clinical outcomes by race/ethnicity. The study was of particular interest because the Moore clinic population is analogous to ours. We report findings from the CORE Center, Chicago, that describe differences in the rate of engagement in care and virologic suppression by demographic characteristics. The CORE Center is the largest HIV care center in the Midwest and provides care to a large number of ethnic minorities, many uninsured. The CORE Center provides comprehensive primary care including extensive psychosocial support. Access to visits and antiretrovirals are available regardless of insurance status or ability to pay. We performed a cross-sectional electronic medical record review of patients ≥13 years of age who had ≥1 clinic visit at the CORE Center in 2010. Engagement in care was defined as having ≥2 HIV RNA measurements in 2010 and viral suppression as having ≥2 undetectable HIV RNA measurements (<75 copies/mL) in 2010. Factors associated with nonengagement and viral nonsuppression (VNS) were assessed by multivariable logistic regression controlling for age, race/ethnicity, and sex. Engagement in Care A total of 4810 HIV-infected patients had ≥1 clinic visit at the CORE center in 2010; 3572 (74%) were male, 65% non-Hispanic black, 20% Hispanic, and 12% non-Hispanic white. The median age was 45 years, the median CD4 count was 401 cells/mm3, and 71% had undetectable HIV RNA; 1286 (27%) were not actively engaged in care. Nonengaged patients were younger and more likely to be black (Table ​(Table1).1). They also had lower rates of virologic suppression (50% vs 78%; P < .0001), and lower CD4 counts (335 vs 412 cells/mm3; P < .0001). Table 1. Multivariable Logistic Regression: Factors Associated With Not Being Actively Engaged in Care Among HIV-Infected Patients at CORE in 2010 (n = 4577) Virologic Suppression Of the 3524 patients engaged in care, 2499 (71%) were suppressed. Patients who had VNS were more likely to be young, female, and black compared to suppressed patients (Table ​(Table2).2). Patients with VNS had lower median CD4 counts (300 vs 456 cells/mm3; P < .0001). Table 2. Multivariable Logistic Regression: Factors Associated With Viral Nonsuppression Among Patients in Care at CORE in 2010 (n = 3342) While overall rates of viral suppression were relatively high at 71%, we found significant differences in rates of engagement in care and viral suppression by demographic characteristics. The lower rate of active engagement among young, non-Hispanic black patients contributes to the documented racial disparities in HIV prevalence in Chicago and other communities across the United States. Among patients engaged in care, non-Hispanic black race, younger age, and being female were independently associated with viral nonsuppression. In both analyses, age 13–24 years was independently associated with poor outcomes, highlighting the need for new and innovative methods for engaging and retaining HIV-infected young adults in care. This initial study allows us to define subgroups within the larger CORE population who require targeted interventions. Our clinic model and diverse population, similar to the Moore clinic, allows us to actively study and address these disparities. Interventions to improve engagement in care and viral suppression are necessary to reduce health-related disparities and achieve the full salutary effect of treatment as prevention in Chicago.

Total lymphocyte count is a good marker for HIV-related mortality and can be used as a tool for starting HIV treatment in a resource-limited setting

Total lymphocyte counts (TLC) may be used as an alternative for CD4 cell counts to monitor HIV infection in resource-limited settings, where CD4 cell counts are too expensive or not available. We used prospectively collected patient data from an urban HIV clinic in Indonesia. Predictors of mortality were identified via Cox regression, and the relation between TLC and CD4 cell counts was calculated by linear regression. Receiver operating characteristics (ROC) curves were used to choose the cut-off values of TLC corresponding with CD4 cell counts <200 and ≤350 cells/μl. Based on these analyses, we designed TLC-based treatment algorithms. Of 889 antiretroviral treatment (ART)-naïve subjects included, 66% had CD4 cell counts <200 and 81% had 350 ≤ cells/μl at baseline. TLC and CD4 cell count were equally strong predictors of mortality in our population, where ART was started based on CD4 cell count criteria. The correlation coefficient (R) between TLC and √CD4 was 0.70. Optimal cut-off values for TLC to identify patients with CD4 cell counts <200 and ≤350 cells/μl were 1500 and 1700 cells/μl, respectively. Treatment algorithms based on a combination of TLC, gender, oral thrush, anaemia and body mass index performed better in terms of predictive value than WHO staging or TLC alone. In our cohort, such an algorithm would on average have saved $14.05 per patient. Total lymphocyte counts is a good marker for HIV-associated mortality. Simple algorithms including TLC can prioritize patients for HIV treatment in a resource-limited setting, until affordable CD4 cell counts will be universally available.

Incidence and Risk Factors for Steatosis Progression in Adults Coinfected With HIV and Hepatitis C Virus

Hepatic steatosis is a common histologic finding in patients coinfected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV), although little is known about its natural history. We prospectively examined the natural history of steatosis in patients coinfected with HIV and HCV who attended an urban HIV clinic. The study cohort consisted of 222 coinfected patients (87% black, 94% with HCV genotype 1 infection) who had at least 2 liver biopsies performed between 1993 and 2008. Biopsy specimens were scored by a single pathologist; samples were classified as having trivial (<5% of hepatocytes affected) or significant (>5%) levels of fat (steatosis). We characterized progression to significant levels of fat among patients whose first biopsy samples had no or trivial levels of fat, and regression among those with significant fat, using logistic regression. Initial biopsy specimens from most patients (88%) had no or trivial amounts of fat. Among second biopsy samples, 74% had no or trivial fat and 13% had significant amounts of fat. The strongest risk factors for progression of steatosis were alcohol abuse and overweight/obesity; cumulative exposure to antiretroviral therapy between biopsies and high counts of CD4(+) T cells were associated with reduced progression of steatosis. Among the 28 patients whose initial biopsy specimen had significant fat levels, most (75%) regressed. Antiretroviral therapy and high counts of CD4(+) T cells are associated with reduced progression of steatosis in patients coinfected with HIV and HCV. Efforts to diagnose and prevent steatosis should focus on persons with a high body mass index and excessive alcohol intake.

Prevalence of Bone Mineral Density Abnormalities and Related Risk Factors in an Ambulatory HIV Clinic Population

Bone mineral density (BMD) abnormalities are observed frequently among human immunodeficiency virus (HIV)-infected patients. Risk factors for reduced BMD in the setting of HIV have been previously studied, but detailed antiretroviral treatment history is often not available. A cross-sectional observational study was conducted between 2005 and 2007 among unselected HIV-infected adults attending an ambulatory urban HIV clinic. Dual-energy X-ray absorptiometry (DXA) scans of lumbar spine and femoral neck, full laboratory profile, detailed questionnaire, and antiretroviral history were obtained. Univariate and multivariate logistic regression analyses were performed to investigate factors associated with BMD below the expected range for age. Two hundred ninety patients completed the study: 80% Caucasians, 89% males, with median age of 49 yr. Low BMD as assessed by Z-score was present in 19.7% of the patients. By multivariate analysis, only lower body mass index (BMI) was an independent risk factor for low BMD. Cumulative exposure to protease inhibitors, non-nucleosides, and individual nucleoside and nucleotide analogs were not independently associated with low BMD. In conclusion, a 19.7% prevalence of abnormal BMD by DXA scan was identified in an unselected group of HIV-infected adults. Lower BMI was independently associated with low BMD. No correlation was found between abnormal BMD and cumulative exposure to any antiretroviral agents.

Race and HIV Clinical Trial Participation

PurposeThis study was designed to examine at the role race/ethnicity plays in human immunodeficiency virus (HIV) clinical trial enrollment. BackgroundHIV clinical trials are vitally important for improving knowledge about medications and their impact on the pathogenesis of HIV/AIDS. African Americans are disproportionately underrepresented in HIV clinical trials. MethodsA 49-item survey was administered to 145 patients at an urban HIV clinic to explore race and HIV clinical trial participation. ResultsStudy participants were 56% Caucasian, 19% other, 16% African American, and 13% Hispanic. Fewer African Americans had been asked to participate in a trial compared to other groups (8% vs 24%) (p < .05). African Americans were less likely to volunteer for a trial compared to Hispanics and Caucasians, but African Americans did not differ significantly in their willingness participate in clinical trials vs other racial groups. In a regression model age, past trial participation, monetary gain, and comfort with the clinical setting predicted willingness to participate in a trial across racial groups (p < .05). DiscussionThere is a strong need to identify strategies to increase African American enrollment in trials. Such strategies need to begin with trial recruiters actively seeking out African Americans for clinical trial enrollment.

DEVELOPMENT OF A CERVICAL CANCER SCREENING PROGRAM FOR HIV-INFECTED WOMEN IN NAIROBI, KENYA.

Purpose/Background Cervical carcinoma is both the number one cancer killer of women in the developing world and the most common malignancy found in human immunodeficiency virus (HIV)-positive women. Yet many resource-poor regions, which are heavily burdened with HIV, offer little cervical cancer education or screening to their populations. Objectives To assess the need and determine the feasibility of establishing a cervical cancer screening program for HIV-positive women in a resource-constrained setting and to raise funds to support such a project. Methods Implement a multitiered fundraising effort, perform a systematic examination of screening programs in similar settings, assess established medical infrastructure on the ground in Nairobi, and design an appropriate, sustainable cervical cancer screening program for HIV-positive women. Results/Conclusions $8000 US was raised before departure and additional funds were acquired while in Nairobi. Medical infrastructure at an urban hospital-based HIV clinic was deemed an appropriate setting for the establishment of a Pap smear-based screening program. Women in need of additional diagnostics and possible treatment would be referred for further assessment at the national hospital. To address this need, a treatment subsidy and follow-up program linking the HIV clinic with the national hospital was proposed. A detailed proposal was presented to and accepted by clinic administrators.

Hepatitis C and progression of HIV disease.

Conflicting reports exist regarding the effect of hepatitis C virus (HCV) on the progression of human immunodeficiency virus (HIV) disease. To assess the effect of HCV infection on clinical and immunologic progression of HIV disease and immunologic response to highly active antiretroviral therapy (HAART). Prospective cohort study. University-based, urban HIV clinic in the United States. There were 1955 patients enrolled between January 1995 and January 2001 who were eligible for analysis because of having at least 1 return visit to the clinic and being free of acquired immunodeficiency syndrome (AIDS) at enrollment. Median (interquartile range) length of follow-up was 2.19 (1.00-3.50) years for HCV-infected and 2.00 (1.00-3.00) years for HCV-uninfected patients. Progression to an AIDS-defining illness, survival, and progression to a CD4 cell count below 200/microL; CD4 cell count change following initiation of effective HAART (resulting in a viral load of <400 copies/mL recorded at > or = 75% of measurements). No difference was detected in the risk of acquiring an AIDS-defining illness (HCV-infected patients, 231 events [26.4%] and HCV-uninfected patients, 264 events [24.4%]; relative hazard [RH], 1.03; 95% confidence interval [CI], 0.86-1.23) or in the risk of death (HCV-infected patients, 153 deaths [17.5%] and HCV-uninfected patients, 168 deaths [15.5%]; RH, 1.05; 95% CI, 0.85 -1.30). Although an increased risk of death was detected in the subgroup of 429 HCV-infected patients with a baseline CD4 cell count of 50/microL through 200/microL (RH, 1.51; 95% CI, 1.01-2.27), after adjustment for exposure to HAART and its effectiveness in a multivariate Cox regression analysis, death was not independently associated with HCV infection in this subgroup (RH, 1.01; 95% CI, 0.65-1.56). Similarly, in those receiving effective HAART (n = 208), there was no difference in the increase in CD4 cell count or CD4 percentage during HAART in HCV-infected compared with HCV-uninfected patients. Among patients in this urban US cohort, we did not detect evidence that HCV infection substantially alters the risk of dying, developing AIDS, or responding immunologically to HAART, especially after accounting for differences in its administration and effectiveness.