Elizabeth T. Golub

Suboptimal adherence to antiretroviral (ARV) therapy among HIV-infected individuals is associated with increased risk of progression to AIDS and the development of HIV resistance to ARV medications. To examine whether the luteal phase of the menstrual cycle is independently associated with suboptimal adherence to single tablet regimen (STR) ARV medication, data were analyzed from a multicenter cohort study of HIV-infected women who reported regular menstrual cycles and were taking an STR. In a cross-sectional analysis, suboptimal adherence to an STR among women in their follicular phase was compared with suboptimal adherence among women in their luteal phase. In two-way crossover analyses, whereby the same woman was assessed for STR medication adherence in both her follicular and luteal phases, the estimated exact conditional odds of non-adherence to an STR was measured. In adjusted logistic regression analysis of the cross-sectional data (N=327), women with ≤12 years of education were more than three times more likely to have suboptimal adherence (OR=3.6, p=.04) compared to those with >12 years of education. Additionally, women with Center for Epidemiological Studies Depression Scale (CES-D) scores ≥23 were 2.5-times more likely to have suboptimal adherence (OR=2.6, p=.02) compared to those with CES-D scores N=184), having childcare responsibilities was associated with greater odds of ≤95% adherence. Menstrual cycle phase was not associated with STR adherence in either the cross-sectional or crossover analyses. The lack of association between phase of the menstrual cycle and adherence to an STR in HIV-infected women means attention can be given to other more important risk factors for suboptimal adherence, such as depression, level of education, and childcare responsibilities.

Rationale/statement of the problem : Acute and chronic stress is commonly reported by HIV-seropositive (HIV + ) individuals and may contribute to cognitive dysfunction that interferes with treatment adherence and daily functioning. Here we present data from two studies aimed at characterizing the effects of stress and stress hormones on cognition in HIV+ women. Methods : Six hundred and forty-five HIV+ and 345 at risk HIV-, predominantly African-American participants of the Womens Interagency HIV Study (WIHS), completed the 10 item Perceived Stress Scale (PSS-10) and a comprehensive neurocognitive test battery including measures of verbal learning and memory, verbal fluency, psychomotor speed, executive function, fine motor skills, working memory, attention, and concentration. High stress was defined by scores in the top quartile. Salivary cortisol levels were assessed concurrently with the neurocognitive battery and PSS-10 in 25 HIV+ women as a pilot at the Chicago WIHS. Results : After adjusting for relevant demographic and behavioral characteristics, HIV+ women performed worse than HIV- women on measures of verbal learning, memory and attention (ps < 0.05). High stress was negatively associated with measures of both attention and executive function (ps < 0.05). There was a significant interaction between HIV status and perceived stress on verbal memory (p=0.02). Among HIV+ women, those with high stress performed worse on verbal memory compared to women with low stress (β = 1.89, SE = 0.74, p=0.01). Conversely, among HIV- women, there was no difference in verbal memory performance by stress level (β = 0.73, SE = 0.99, p=0.46). There were no significant interactions between stress and HIV status on executive functioning, attention, fine motor skills, or processing speed. In HIV+ women, cortisol levels were not correlated with most outcomes, though levels were marginally associated with working memory (r = 0.37, p=0.08) which was likely attributable to women with high (r= 0.55, p=0.03) not low stress. Conclusion : Our findings indicate that HIV is associated with verbal memory difficulties among women and that high perceived stress may exacerbate the effect of HIV infection on poor memory performance. Longitudinal assessments are underway to determine the robustness of these associations

Background. Most hepatitis delta virus (HDV) prevalence estimates from the United States are >10 years old, and HDV has shown significant temporal

Antiretrovirals used to treat HIV-infected patients have the potential to adversely affect serum lipid profiles and increase the risk of cardiovascular disease which is an emerging concern among HIV-infected patients. Since boosted atazanavir and efavirenz are both considered preferred antiretrovirals a head to head comparison of their effects on serum lipids is needed.

Background. It is important to elucidate differences among initial highly active antiretroviral therapy (HAART) regimen types in comparative studies

Background: Sustained use of antiretroviral therapy has been consistently shown to be one of the primary predictors of long-term effectiveness. Switching and discontinuation reflect patient and provider decisions that may limit future treatment options. In this study, we utilize data reported at semi-annual study visits from three prospective cohort studies, the AIDS Link to IntraVenous Exposure (ALIVE), the Women's Interagency HIV Study (WIHS), and the Multicenter AIDS Cohort Study (MACS), to investigate determinants of HAART modification with a particular focus on reported injection drug use (IDU). Methods: Longitudinal data collected between 1996 and 2004 contributed from 2,266 participants (37% with a reported history of IDU) who reported initiating their first HAART regimen during follow-up were utilized. Separate proportional-hazards models were used to identify factors measured prior to HAART-initiation associated with the time to first HAART discontinuation and first switch of components of HAART among continuous HAART users. Results: The use of PI- vs. NNRTI-based regimens among HAART users with and without any history of IDU was similar over follow-up. The median time to a first report of discontinuation of HAART was 1.1 years for individuals with a history of IDU but 2.5 years for those without a history of IDU and multivariate analyses confirmed overall that individuals with a history of IDU were at greater risk for HAART discontinuation (adj RH = 1.24, 95% CI: 1.03–1.48). However, when restricting to data contributed after 1999, there was no longer any significant increased risk (adj RH = 1.05, 95% CI: 0.81–1.36). After adjusting for pre-HAART health status and prior ARV exposure, individuals who were ethnic/racial minorities, reported an annual income < $10,000/year, and were not employed were at significantly greater risk for HAART discontinuation. The median time to a first change in HAART regimen was approximately 1.5 years after first HAART report and was not elevated among those with a history of IDU (adj RH = 1.09, 95% CI: 0.89–1.34). Conclusion: Our analyses demonstrate that injection drug use by itself does not appear to be an independent risk factor for HAART switching or discontinuation in more recent years. However, as continued HAART use is of paramount importance for long-term control of HIV infection, efforts to improve maintenance to therapy among disadvantaged and minority populations remain greatly needed.

Injection drug users (IDUs) represent an important risk group for HIV infection. We assessed correlates of IDUs' willingness to participate (WTP) in HIV vaccine trials, and examined temporal changes in WTP. Participants were enrolled in ALIVE, a prospective study of HIV among IDUs in Baltimore; semi-annual visits include interviews and HIV serology. Questionnaires regarding WTP were administered in 1993–1994 and again in 2001–2002. Logistic regression was conducted to identify correlates of WTP. Wave 1 of the survey included 440 participants; Wave 2 included 582 participants (189 participated in both waves). WTP increased modestly over time (83.4 vs. 86.3%; p = 0.16). Monetary incentives were the strongest predictor of WTP (adjOR = 2.73; 95% CI: 1.72–4.35). High expectations of HIV treatment effectiveness did not predict WTP. In this cohort, WTP remained strong and modestly increased over the study period. These results should be considered in the planning of sampling and retention strategies for future vaccine trials.