Sherri L. Pals

Low Vitamin D among HIV-Infected Adults: Prevalence of and Risk Factors for Low Vitamin D Levels in a Cohort of HIV-Infected Adults and Comparison to Prevalence among Adults in the US General Population

BACKGROUND we explored serum 25-hydroxyvitamin D (25[OH]D) levels and associated factors for insufficiency or deficiency in an adult human immunodeficiency virus (HIV) cohort and compared 25(OH)D levels with those in the general US population. METHODS using baseline data from the Study to Understand the Natural History of HIV and AIDS in the Era of Effective Therapy (SUN), a prospective, observational cohort study of HIV-infected adults enrolled at 7 HIV specialty clinics in 4 US cities from March 2004 to June 2006, we estimated the prevalence of vitamin D insufficiency or deficiency (defined as 25(OH)D levels <30 ng/mL), standardized by age, race, and sex. Using multiple logistic regression, we examined risk factors for vitamin D insufficiency or deficiency. RESULTS among 672 SUN participants with baseline serum 25(OH)D determinations who were not receiving vitamin D supplements, 70.3% (95% confidence interval [CI], 68.1%-74.9%) were vitamin D insufficient or deficient, compared with 79.1% (95% CI, 76.7-81.3) of US adults. Factors associated with vitamin D insufficiency or deficiency included black race (adjusted odds ratio [aOR], 4.51; 95% CI, 2.59-7.85), Hispanic ethnicity (aOR, 2.78; 95% CI, 1.31-5.90), higher body mass index (aOR, 1.04; 95% CI, 1.00-1.09), hypertension (aOR, 1.88; 95% CI, 1.10-3.22), lack of exercise (aOR, 3.14; 95% CI, 1.80-5.47), exposure to efavirenz (aOR, 1.98; 95% CI, 1.18-3.34), higher exposure to ultraviolet light (aOR, .78; 95% CI, .71-.86), renal insufficiency (aOR, .55; 95% CI, .36-.83), and exposure to ritonavir (aOR, .56; 95% CI, .35-0.89). CONCLUSIONS similar to findings in US adults generally, vitamin D insufficiency or deficiency is highly prevalent among HIV-infected adults and is associated with known risk factors. Observed associations of vitamin D levels with renal insufficiency and with use of ritonavir- and efavirenz-containing regimens are consistent with both HIV-related and therapy-mediated alterations in vitamin D metabolism. Clinicians should consider screening all patients for vitamin D insufficiency or deficiency.

Development of a clinical screening index predictive of incident HIV infection among men who have sex with men in the United States.

Background: To implement biomedical and other intensive HIV prevention interventions cost-effectively, busy care providers need validated, rapid, risk screening tools for identifying persons at highest risk of incident infection. Methods: To develop and validate an index, we included behavioral and HIV test data from initially HIV-uninfected men who have sex with men who reported no injection drug use during semiannual interviews in the VaxGen VAX004 study and Project Explore HIV prevention trials. Using generalized estimating equations and logistic regression analyses, we identified significant predictors of incident HIV infection, then weighted and summed their regression coefficients to create a risk index score. Results: The final logistic regression model included age, and the following behaviors reported during the past 6 months: total number of male sex partners, total number of HIV-positive male sex partners, number of times the participant had unprotected receptive anal sex with a male partner of any HIV status, number of times the participant had insertive anal sex with an HIV-positive male partner, whether the participant reported using poppers, and whether they reported using amphetamines. The area under the receiver operating characteristic curve was 0.74, possible scores on index range from 0 to 47 and a score ≥10 had as sensitivity of 84% and a specificity of 45%, levels appropriate for a screening tool. Conclusions: We developed an easily administered and scored 7-item screening index with a cutoff that is predictive of HIV seroconversion in 2 large prospective cohorts of US men who have sex with men. The index can be used to prioritize patients for intensive HIV prevention efforts (eg, preexposure prophylaxis).

Randomized Controlled Trial of an Intervention to Prevent Adherence Failure Among HIV-Infected Patients Initiating Antiretroviral Therapy

OBJECTIVE Compare the efficacy of a multicomponent social support intervention to standard-of-care counseling on medication adherence among HIV-infected patients initiating antiretroviral therapy. DESIGN Randomized controlled trial. Generalized estimating equations tested for differences in the percentage of participants achieving 90% adherence. MAIN OUTCOME MEASURES Pill-taking, electronically monitored over 6 consecutive months; plasma viral load (VL), assessed at 3 and 6 months following initiation of therapy. RESULTS Of 226 participants who were randomized and began the trial, 87 (38%) were lost to the study by 6 months. The proportion of adherent participants declined steadily over time, with no time by group interaction. Sustained adherence was associated with increased odds of achieving an undetectable VL (OR=1.78; 95% CI=1.01, 3.13). In intention-to-treat analyses, a larger proportion of the intervention group than the control group was adherent (40.15% vs. 27.59%, p=.02) and achieved an undetectable VL p=.04). However, the majority of participants who remained on study experienced some reduction in VL (>or=1-log drop or undetectable), regardless of experimental condition. CONCLUSION The multicomponent social support intervention significantly improved medication adherence over standard-of-care counseling; evidence for improved virologic outcomes was inconsistent. Early discontinuation of care and treatment may be a greater threat to the health of HIV patients than imperfect medication-taking.

Factors associated with adherence to highly active antiretroviral therapy in homeless or unstably housed adults living with HIV

Abstract The aim of this study is to investigate adherence to highly active antiretroviral therapy (HAART) in persons living with HIV/AIDS (PLWHA) who are homeless or unstably housed. We evaluated homeless or unstably housed PLWHA (n=644) in three US cities were enrolled in the Housing and Health Study. Using baseline data and controlling for gender, race, age, and education, we examined associations between self-reported two- and Seven-day adherence and access to healthcare, mental health, substance use, and attitudes toward HIV medical therapy. Of the 644 participants, 358 (55%) were currently on HAART. For two-day adherence, 280 (78%) reported missing no prescribed doses (100% adherence), and for seven-day adherence, 291 (81%) reported ≥90% adherence. Logistic regression analyses indicated being younger, not having health insurance, and drug use were associated with missing ≥1 dose over the past two days. Scoring lower on SF-36 mental component summary scale and having greater risk of depression (CES-D) and stress (Perceived Stress Scale) were associated with poorer adherence for both two- and seven-day outcomes. Negative attitudes toward HIV treatment were also associated with lower adherence. Adherence to HIV medications in this population is similar to other groups. Coexisting problems of access to healthcare, higher risk of mental health problems, along with poorer attitudes toward treatment are associated with increased likelihood of missing doses. Comprehensive models of HIV care that include a continuum of medical and social services are essential for treating this population.

Sexual Transmission Risk Behavior of Adolescents With HIV Acquired Perinatally or Through Risky Behaviors

Objective: To describe the prevalence and predictors of the transmission-related behaviors of adolescents with HIV acquired perinatally (perinatal) or through risky behaviors (behavioral). Methods: HIV-positive adolescents (n = 166) aged 13-21, receiving care in 3 US cities, reported sexual behaviors, drug use, and psychosocial and demographic characteristics. HIV-related data were abstracted from medical records. Results: Of 105 sexually experienced adolescents reporting risk history (42 perinatal, 63 behavioral), 49 had engaged in unprotected sex since learning their diagnosis (12 perinatal, 37 behavioral). Of sexually experienced girls, 19 had been pregnant (5 of 24 perinatal, 14 of 31 behavioral). Risk information was provided for 115 of 132 recent sex partners, 61 of whom had unprotected sex with study participants (10 with 8 perinatal participants; 51 with 33 behavioral participants). Recent unprotected sex was associated with sexual abuse during adolescence (adjusted odds ratio = 9.61, 95% CI: 1.07 to 86.12) and greater HIV knowledge (adjusted odds ratio = 1.29, 95% CI: 1.00 to 1.66) when transmission category, age, and sexual orientation were controlled. Conclusions: To limit HIV transmission and prevent unplanned pregnancies, developmentally appropriate risk-reduction interventions, and screening and treatment referral for sexual abuse, must be integrated into the care of both perinatally and behaviorally HIV-infected adolescents.

Design and Analysis of Group-Randomized Trials in Cancer: A Review of Current Practices

BACKGROUND Previous reviews have identified problems in the design and analysis of group-randomized trials in a number of areas. Similar problems may exist in cancer research, but there have been no comprehensive reviews. METHODS We searched Medline and PubMed for group-randomized trials focused on cancer prevention and control that were published between 2002 and 2006. We located and reviewed 75 articles to determine whether articles included evidence of taking group randomization into account in establishing the size of the trial, such as reporting the expected intraclass correlation, the group component of variance, or the variance inflation factor. We also examined the analytical approaches to determine their appropriateness. RESULTS Only 18 (24%) of the 75 articles documented appropriate methods for sample size calculations. Only 34 (45%) limited their reports to analyses judged to be appropriate. Fully 26 (34%) failed to report any analyses that were judged to be appropriate. The most commonly used inappropriate analysis was an analysis at the individual level that ignored the groups altogether. Nine articles (12%) did not provide sufficient information. CONCLUSIONS Many investigators who use group-randomized trials in cancer research do not adequately attend to the special design and analytic challenges associated with these trials. Failure to do so can lead to reporting type I errors as real effects, mislead investigators and policy-makers, and slow progress toward control and prevention of cancer. A collaborative effort by investigators, statisticians, and others will be required to ensure that group-randomized trials are planned and analyzed using appropriate methods so that the scientific community can have confidence in the published results.

Intraclass Correlation Associated with Therapists: Estimates and Applications in Planning Psychotherapy Research

It is essential that outcome research permit clear conclusions to be drawn about the efficacy of interventions. The common practice of nesting therapists within conditions can pose important methodological challenges that affect interpretation, particularly if the study is not powered to account for the nested design. An obstacle to the optimal design of these studies is the lack of data about the intraclass correlation coefficient (ICC), which measures the statistical dependencies introduced by nesting. To begin the development of a public database of ICC estimates, the authors investigated ICCs for a variety outcomes reported in 20 psychotherapy outcome studies. The magnitude of the 495 ICC estimates varied widely across measures and studies. The authors provide recommendations regarding how to select and aggregate ICC estimates for power calculations and show how researchers can use ICC estimates to choose the number of patients and therapists that will optimize power. Attention to these recommendations will strengthen the validity of inferences drawn from psychotherapy studies that nest therapists within conditions.

Disclosure, Knowledge of Partner Status, and Condom Use Among HIV-Positive Patients Attending Clinical Care in Tanzania, Kenya, and Namibia

We describe the frequency of and factors associated with disclosure, knowledge of partners HIV status, and consistent condom use among 3538 HIV-positive patients attending eighteen HIV care and treatment clinics in Kenya, Namibia, and Tanzania. Overall, 42% of patients were male, and 64% were on antiretroviral treatment. The majority (80%) had disclosed their HIV status to their partners, 64% knew their partners HIV status, and 77% reported consistent condom use. Of those who knew their partners status, 18% reported their partner was HIV negative. Compared to men, women were significantly less likely to report disclosing their HIV status to their sex partner(s), to knowing their partners HIV status, and to using condoms consistently with HIV-negative partners. Other factors negatively associated with consistent condom use include nondisclosure, alcohol use, reporting a casual sex partner, and desiring a pregnancy. Health care providers should target additional risk reduction counseling and support services to patients who report these characteristics.

Cost-Utility Analysis of the Housing and Health Intervention for Homeless and Unstably Housed Persons Living with HIV

We present a cost-utility analysis based on data from the Housing and Health (H&H) Study of rental assistance for homeless and unstably housed persons living with HIV in Baltimore, Chicago and Los Angeles. As-treated analyses found favorable associations of housing with HIV viral load, emergency room use, and perceived stress (an outcome that can be quantitatively linked to quality of life). We combined these outcome data with information on intervention costs to estimate the cost-per-quality-adjusted-life-year (QALY) saved. We estimate that the cost-per-QALY-saved by the HIV-related housing services is

Risk Factors for Non-Adherence and Loss to Follow-Up in a Three-Year Clinical Trial in Botswana

62,493. These services compare favorably (in terms of cost-effectiveness) to other well-accepted medical and public health services.