Kathy Goggin

Highly active antiretroviral treatment in Hiv infection: benefits for neuropsychological function

Objectives:To determine whether highly active antiretroviral therapy (HAART) is associated with reduced HIV-associated neuropsychological impairment. Design:Cross-sectional analysis in a natural history study of adaptation to HIV/AIDS. Method:A sample of 130 homo-/bisexual men with HIV/AIDS (mean age, 41 years; 42% non-white) were evaluated with a neuropsychological battery assessing attention, concentration, psychomotor speed, learning, memory and executive function. Subjects taking HAART were compared with those not taking HAART on demographics, CD4 cell count, viral load, scores on individual neuropsychological tests and proportion with neuropsychological impairment. Results:Sixty-nine (53%) subjects were taking HAART, and 48 (37%) were neuropsychologically impaired. Subjects taking HAART had lower mean CD4 cell counts than those not taking HAART (254 versus 342 × 106/l; P < 0.05), although they were more likely to have undetectable viral load (42 versus 20%; P < 0.01) and were less likely to be neuropsychologically impaired (22 versus 54%; P < 0.0001). Subjects taking HAART performed significantly better on tests of attention, concentration, learning, memory, and psychomotor speed. After excluding subjects with potential non-HIV confounders of neuropsychological function, those without neuropsychological impairment had significantly lower mean viral load levels and were more likely to have undetectable viral load than those with impairment. Conclusion:These preliminary findings suggest that HAART benefits neuropsychological function through the reduction of viral load.

Taking it to the Pews: A CBPR-Guided HIV Awareness and Screening Project with Black Churches

Utilizing a community-based participatory research (CBPR) approach is a potentially effective strategy for exploring the development, implementation, and evaluation of HIV interventions in African American churches. This CBPR-guided study describes a church-based HIV awareness and screening intervention (Taking It to the Pews [TIPS]) that fully involved African American church leaders in all phases of the research project. Findings from the implementation and evaluation phases indicated that church leaders delivered TIPS Tool Kit activities on an ongoing basis (about twice a month) over a 9-month period. TIPS church members were highly exposed to TIPS activities (e.g., 91% reported receiving HIV educational brochures, 84% heard a sermon about HIV). Most (87%) believed that the church should talk about HIV, and 77% believed that the church should offer HIV screening. These findings suggest that implementing an HIV intervention in Black church settings is achievable, particularly when a CBPR approach is used.

Fatigue in Hiv Illness: Relationship to Depression, Physical Limitations, and Disability

Objective This study was conducted to investigate the prevalence of clinical fatigue reported by gay/bisexual men at all HIV illness stages, and whether fatigue, while associated with depression, independently contributes to limitations in physical function and disability. Method HIV- men, HIV+ men with CD4 counts >500, HIV+ men with CD4 counts 200 to 500, and men with AIDS were compared on prevalence of clinical fatigue, as defined by a standardized instrument. Among HIV+ men, the relationships among fatigue, depressed mood, major depressive disorder, HIV illness markers (including CD4 count and HIV RNA viral load), physical limitations, and disability were assessed at baseline and after 1 year. Results The prevalence of clinical fatigue in men with CD4 counts <500 was 14%, significantly higher than HIV- men and HIV+ men with CD4 counts >500. However, fatigue was not directly correlated with CD4 count or HIV RNA. Fatigue was a chronic symptom that was associated with depressed mood, major depressive disorder, physical limitations, and disability. After 1 year, an increase in depressive symptoms predicted a small amount of variance in fatigue; however, depressive symptoms were not associated with physical limitations or disability after controlling for fatigue. Conclusion Fatigue is a chronic symptom that is more prevalent in advanced HIV illness, and which, although associated with depression, does not seem to be merely a symptom of depression. Because fatigue contributes independently to physical limitations and disability, it should be assessed and treated.

A Closer Look at Depression and Its Relationship to HIV Antiretroviral Adherence

BackgroundDepression consistently predicts nonadherence to human immunodeficiency virus antiretroviral therapy, but which aspects of depression are most influential are unknown. Such knowledge could inform assessments of adherence readiness and the type of depression treatment to utilize.PurposeWe examined how depression severity, symptom type, and change over time relate to adherence.MethodsMicroelectronic adherence and self-reported depression data from 1,374 participants across merged studies were examined with cross-sectional and longitudinal analyses. Depression variables included a continuous measure, categorical measure of severity, cognitive and vegetative subscales, and individual symptoms.ResultsAt baseline, mean adherence was 69%, and 25% had mild/moderate and 18% had severe depression. In cross-sectional multivariate analyses, continuous depression, cognitive depressive symptoms, and severe depression were associated with lower adherence. In longitudinal analysis, reductions in both continuous and categorical depression predicted increased adherence.ConclusionsThe relationship between global continuous depression and nonadherence was statistically significant, but relatively weak compared to that of cognitive depressive symptoms and severe depression, which appear to pose strong challenges to adherence and call for the need for early detection and treatment of depression.

Racial/Ethnic Disparities in ART Adherence in the United States: Findings From the MACH14 Study

Background:Minority race/ethnicity is generally associated with antiretroviral therapy nonadherence in US-based studies. Limitations of the existing literature include small samples, subjective adherence measures, and inadequate control for potential confounders such as mental health and substance use, which have been consistently associated with poorer adherence. Methods:Individual-level data were pooled from 13 US-based studies employing electronic drug monitoring to assess adherence. Adherence was operationalized as percent of prescribed doses taken from the first 12 (monthly) waves of data in each study. Depression symptoms were aggregated from several widely used assessments, and substance use was operationalized as any use of cocaine/stimulants, heroin/opiates, ecstasy, hallucinogens, or sedatives in the 30–365 days preceding baseline. Results:The final analytic sample of 1809 participants ranged in age from 18 to 72 years and was 67% male. Participants were 53% African American, 14% Latino, and 34% White. In a logistic regression adjusting for age, gender, income, education, and site, race/ethnicity was significantly associated with adherence (P < 0.001) and persisted in a model that also controlled for depression and substance use (P < 0.001), with African Americans having significantly lower adherence than Latinos [odds ratio (OR) = 0.72, P = 0.04] and whites (OR = 0.60, P < 0.001). Adherence did not differ between whites and Latinos (OR = 0.84, P = 0.27). Conclusions:Racial/ethnic differences in demographics, depression, and substance abuse do not explain the lower level of antiretroviral therapy adherence in African Americans observed in our sample. Further research is needed to explain the persistent disparity and might examine factors such as mistrust of providers, health literacy, and inequities in the health care system.

Adherence to HIV Medications: Utility of the Theory of Self-Determination

The utility of self-determination theory in predicting adherence to antiviral therapy (ART) was investigated in 205 HIV+ (85% male) patients. Participants completed brief structured adherence interviews and measures of perceived autonomy support, autonomous motivation, and perceived competence, specific to ART. Adherence measures included percentage of doses administered and precision of dose scheduling. As hypothesized, greater autonomy support predicted greater autonomous motivation for adherence, which predicted adherence through an indirect relationship mediated by perceived competence. Autonomy support from health care providers was most predictive of autonomous motivation. Psychological distress also contributed to the variance in adherence. Study results demonstrate the importance of psychological factors in predicting ART adherence, and emphasize the role of internal motivations and competencies.

Patterns of antiretroviral therapy adherence and impact on HIV RNA among patients in North America

Objective:Adherence to antiretroviral therapies (ART) is the strongest predictor of viral suppression among individuals infected with HIV, however, limited data exists to understand the patterns of adherence that confer the greatest benefit across different ART regimens. Design:Longitudinal data pooled from 16 studies conducted between 1997 and 2009 across the United States. Methods:Adherence was measured using Medication Event Monitoring System. Percentage of time with sufficient drug concentrations (covered time) and the length of the longest treatment interruption during the 28 days prior to plasma HIV-RNA measurements were calculated. Logistic regression with generalized estimating equations was used to estimate medication-specific adherence estimates on detectable HIV-RNA (>400 copies/ml). Results:One thousand and eighty-eight participants with 3795 HIV-RNA measures were studied. Both lower covered time and greater longest interruption showed dose–response relationships with the odds of detectable HIV-RNA; however, estimates did not vary by medication regimen. Compared with 93–100% coverage, periods of 0–25% covered time had a three-fold increased risk of detectable HIV-RNA [odds ratio (OR) = 3.22, 95% confidence interval (CI): 2.48–4.19]. Similarly, compared to longest interruptions of 0–48 h, longest interruptions of 21–28 days had a nearly four-fold increased risk of detectable HIV-RNA (OR = 3.65, 95% CI: 2.77, 4.81). Conclusion:We found that adherence was consistently strongly associated with treatment response across ART regimens. Of the patterns of adherence, longer interruptions may have greater impact than covered time. Future research should investigate additional methods for examining adherence patterns, understanding the determinants of consecutive missed doses and the evaluation of interventions designed to address interruptions in treatment.

Strong relationship between oral dose and tenofovir hair levels in a randomized trial: hair as a potential adherence measure for pre-exposure prophylaxis (PrEP).

Background Pre-exposure prophylaxis (PrEP) trials using tenofovir-based regimens have demonstrated that high levels of adherence are required to evaluate efficacy; the incorporation of objective biomarkers of adherence in trial design has been essential to interpretation, given the inaccuracy of self-report. Antiretroviral measurements in scalp hair have been useful as a marker of long-term exposure in the HIV treatment setting, and hair samples are relatively easy and inexpensive to collect, transport, and store for analysis. To evaluate the relationship between dose and tenofovir concentrations in hair, we examined the dose proportionality of tenofovir in hair in healthy, HIV-uninfected adults. Methods A phase I, crossover pharmacokinetic study was performed in 24 HIV-negative adults receiving directly-observed oral tenofovir tablets administered 2, 4, and 7 doses/week for 6 weeks, with a ≥3-week break between periods. Small samples of hair were collected after each six-week period and analyzed for tenofovir concentrations. Geometric-mean-ratios compared levels between each pair of dosing conditions. Intensive plasma pharmacokinetic studies were performed during the daily-dosing period to calculate areas-under-the-time-concentration curves (AUCs). Results Over 90% of doses were observed per protocol. Median tenofovir concentrations in hair increased monotonically with dose. A log-linear relationship was seen between dose and hair levels, with an estimated 76% (95% CI 60–93%) increase in hair level per 2-fold dose increase. Tenofovir plasma AUCs modestly predicted drug concentrations in hair. Conclusions This study found a strong linear relationship between frequency of dosing and tenofovir levels in scalp hair. The analysis of quantitative drug levels in hair has the potential to improve adherence measurement in the PrEP field and may be helpful in determining exposure thresholds for protection and explaining failures in PrEP trials. Hair measures for adherence monitoring may also facilitate adherence measurement in real-world settings and merit further investigation in upcoming PrEP implementation studies and programs. Trial Registration ClinicalTrials.gov +NCT00903084.

Mobile Technology for Obesity Prevention: A Randomized Pilot Study in Racial- and Ethnic-Minority Girls

BACKGROUND Mobile technologies have wide-scale reach and disseminability, but no known studies have examined mobile technologies as a stand-alone tool to improve obesity-related behaviors of at-risk youth. PURPOSE To test a 12-week mobile technology intervention for use and estimate effect sizes for a fully powered trial. METHODS Fifty-one low-income, racial/ethnic-minority girls aged 9-14 years were randomized to a mobile technology (n=26) or control (n=25) condition. Both conditions lasted 12 weeks and targeted fruits/vegetables (FVs; Weeks 1-4); sugar-sweetened beverages (SSBs; Weeks 5-8), and screen time (Weeks 9-12). The mobile intervention prompted real-time goal setting and self-monitoring and provided tips, feedback, and positive reinforcement related to the target behaviors. Controls received the same content in a written manual but no prompting. Outcomes included device utilization and effect size estimates of FVs, SSBs, screen time, and BMI. Data were collected and analyzed in 2011-2012. RESULTS Mobile technology girls used the program on 63% of days and exhibited trends toward increased FVs (+0.88, p=0.08) and decreased SSBs (-0.33, p=0.09). The adjusted difference between groups of 1.0 servings of FVs (p=0.13) and 0.35 servings of SSBs (p=0.25) indicated small to moderate effects of the intervention (Cohens d=0.44 and -0.34, respectively). No differences were observed for screen time or BMI. CONCLUSIONS A stand-alone mobile app may produce small to moderate effects for FVs and SSBs. Given the extensive reach of mobile devices, this pilot study demonstrates the need for larger-scale testing of similar programs to address obesity-related behaviors in high-risk youth.

“We Weren't Using Condoms Because We Were Trying to Conceive”: The Need for Reproductive Counseling for HIV-Positive Women in Clinical Care

Although a significant number of HIV-positive women intend to have children in the future, few work with providers to safely plan pregnancy. We conducted 20 semistructured in depth interviews with HIV-positive adolescent and adult women receiving HIV clinical care in an urban setting. Participants were purposively sampled to include diversity in age and childbearing plans. Interview transcripts were analyzed and coded independently by two study team members before reaching consensus on emergent themes. Among this sample of HIV-positive women (mean age=27.9, 95% African American, 50% on antiretroviral therapy [ART], 65% want a biological child), only 25% reported discussing their childbearing goals with their HIV provider. Women actively trying to conceive recognized the risk to themselves and their partner, but had not talked with their provider about safer conception strategies. Data regarding provider communication about childbearing were organized by the following emergent themes: (1) confusion and concern on how to conceive safely, (2) provider characteristics or dynamics that influenced communication, and (3) provider guidance offered regarding childbearing. Even in this unique study setting in which referrals for preconception counseling are possible, women were unaware of this specialized service. Provider initiated reproductive counseling is needed to strategically avoid or plan pregnancy and reduce risk of transmission to partners and infants rather than leaving it to chance, which can have major health implications.