Kristen Stafford

Indicators of adherence to antiretroviral therapy treatment among HIV/AIDS patients in 5 African countries.

As the HIV epidemic threatens the social fabric of countries struggling with HIV prevalence rates as high as 10% to 30%, access to antiretroviral therapy (ART) alone is only the beginning of the clinical challenge. There is a need to identify adherence indicators that will ensure long-term treatment success. A cross-sectional review of 921 adult patients on ART for at least 1 year was conducted. Through an administered adherence survey, key indicators were found to be highly correlated with patient adherence. The adherence rate in this sample was 72% after being on treatment for an average of 15 months. This data suggest that having a high perceived quality of care and owning one’s own home positively affected patients’ adherence. Indicators such as alcohol use in the last month and a high level of depression negatively affected patients’ adherence. Targeting specific indicators for specific interventions will guard against nonadherence, leading to treatment failure.

The effects of acupuncture on rates of clinical pregnancy among women undergoing in vitro fertilization: a systematic review and meta-analysis

BACKGROUND Recent systematic reviews of adjuvant acupuncture for IVF have pooled heterogeneous trials, without examining variables that might explain the heterogeneity. The aims of our meta-analysis were to quantify the overall pooled effects of adjuvant acupuncture on IVF clinical pregnancy success rates, and evaluate whether study design-, treatment- and population-related factors influence effect estimates. METHODS We included randomized controlled trials that compared needle acupuncture administered within 1 day of embryo transfer, versus sham acupuncture or no adjuvant treatment. Our primary outcome was clinical pregnancy rates. We obtained from all investigators additional methodological details and outcome data not included in their original publications. We analysed sham-controlled and no adjuvant treatment-controlled trials separately, but since there were no large or significant differences between these two subsets, we pooled all trials for subgroup analyses. We prespecified 11 subgroup variables (5 clinical and 6 methodological) to investigate sources of heterogeneity, using single covariate meta-regressions. RESULTS Sixteen trials (4021 participants) were included in the meta-analyses. There was no statistically significant difference between acupuncture and controls when combining all trials [risk ratio (RR) 1.12, 95% confidence interval (CI), 0.96-1.31; I(2) = 68%; 16 trials; 4021 participants], or when restricting to sham-controlled (RR 1.02, 0.83-1.26; I(2) = 66%; 7 trials; 2044 participants) or no adjuvant treatment-controlled trials (RR 1.22, 0.97-1.52; I(2) = 67%; 9 trials; 1977 participants). The type of control used did not significantly explain the statistical heterogeneity (interaction P = 0.27). Baseline pregnancy rate, measured as the observed rate of clinical pregnancy in the control group of each trial, was a statistically significant effect modifier (interaction P < 0.001), and this covariate explained most of the heterogeneity of the effects of adjuvant acupuncture across all trials (adjusted R(2) = 93%; I(2) residual = 9%). Trials with lower control group rates of clinical pregnancy showed larger effects of adjuvant acupuncture (RR 1.53, 1.28-1.84; 7 trials; 1732 participants) than trials with higher control group rates of clinical pregnancy (RR 0.90, 0.80-1.01; 9 trials; 2289 participants). The asymmetric funnel plot showed a tendency for the intervention effects to be more beneficial in smaller trials. CONCLUSIONS We found no pooled benefit of adjuvant acupuncture for IVF. The subgroup finding of a benefit in trials with lower, but not higher, baseline pregnancy rates (the only statistically significant subgroup finding in our earlier review) has been confirmed in this update, and was not explained by any confounding variables evaluated. However, this baseline pregnancy rate subgroup finding among published trials requires further confirmation and exploration in additional studies because of the multiple subgroup tests conducted, the risk of unidentified confounders, the multiple different factors that determine baseline rates, and the possibility of publication bias.

Treatment outcomes of recommended first-line antiretroviral regimens in resource-limited clinics.

Background:Although used globally, little data exist on the efficacy of nevirapine (NVP) used in combination with tenofovir (TDF)/emtricitabine or lamivudine (XTC), and no large randomized prospective control trials exists comparing this combination with efavirenz (EFV)/TDF/(XTC). Methods:As part of the AIDSRelief program, a retrospective review of patient medical chart information along with a cross-sectional viral load, and adherence measurement was conducted between 2004 and 2009. An on-treatment analysis excluded patients who died, transferred out of care, or were lost to follow-up. A switch of antiretrovirals for any reason was considered a failure in the intent-to-treat analysis. Patients with only clinically relevant reasons for switching such as toxicity, adverse effects, viral failure or clinical/immunological failure, lost to follow-up, and death were considered failures as part of the modified-intent-to-treat analysis. Step-wise multiple regression analysis was used to identify variables that were associated with viral suppression. Results:A random sample of 3862 patients met criteria and were included in this analysis. In the on-treatment analysis, older age (P < 0.004) and baseline CD4 <100 cells per cubic millimeter (P < 0.021) were the most significant variables impacting viral load. Patients on TDF/XTC/EFV achieved higher rates of viral suppression compared with patients on TDF/XTC/NVP or azidothymidine (AZT)/lamivudine (3TC)/NVP. Conclusion:Our data show that patients on TDF/XTC/EFV had better outcomes than patients on TDF/XTC/NVP, AZT/3TC/EFV, or AZT/3TC/NVP. High rates of virologic suppression seen in patients on this regimen are consistent with previous studies and indicate the need to increase use of this regimen in HIV programs to promote sustainable viral suppression over time.

Difficulties in Demonstrating Superiority of an Antibiotic for Multidrug-Resistant Bacteria in Nonrandomized Studies

The discovery and development of new antimicrobials is critically important, especially as multidrug-resistant bacteria continue to emerge. Little has been written about the epidemiological issues in nonrandomized trials aiming to evaluate the superiority of one antibiotic over another. In this manuscript, we outline some of the methodological difficulties in demonstrating superiority and discuss potential approaches to these problems. Many of the difficulties arise due to confounding by indication, which we define and explain. Epidemiological methods including restriction, matching, stratification, multivariable regression, propensity scores, and instrumental variables are discussed.

Clinical Presentation and Outcomes of Prostate Cancer in an Urban Cohort of Predominantly African American, Human Immunodeficiency Virus–infected Patients

OBJECTIVE To determine the clinical presentation and outcomes of prostate cancer in human immunodeficiency virus (HIV)-infected men compared with HIV-uninfected men in an urban setting. METHODS A retrospective cohort study of prostate cancer stage at diagnosis and mortality comparing HIV-infected patients with HIV-uninfected patients from 2000 to 2011 was carried out. Clinical features, HIV history, cancer presentation, and outcomes were reviewed. Cox proportional hazards analysis was performed to estimate the association between HIV status and mortality. RESULTS A total of 54 HIV-infected subjects were identified and reviewed, and 49 of them had complete data available; they were compared with 1496 HIV-uninfected subjects with prostate cancer. HIV-infected subjects were younger (median age, 60.7 vs 64 years) and had a higher proportion of African Americans (92% vs. 45%). An elevated prostate-specific antigen (PSA) level (76%) was the predominant indication for biopsy; 10 patients (27%) with an elevated PSA level had normal findings on digital rectal examination. Eighteen men (37%) presented with stage III and IV disease compared with 14% in the general population (P <.001). Eight patients (16%) died of prostate cancer. Subjects with HIV progressed to death at a significantly faster rate than those in the general population (adjusted hazard ratio, 2.02; 95% confidence interval, 1.14-3.58). CONCLUSION HIV-infected patients in this cohort presented with more advanced stage disease compared with the general population even though the majority were detected by screening PSA. The overall mortality rate was higher for HIV-infected patients with prostate cancer after controlling for race, tumor stage at diagnosis, and age. Prostate cancer screening methods may need to be individualized for HIV-infected men.

Estimated Change in Prevalence of Hypertension in Nepal Following Application of the 2017 ACC/AHA Guideline

Key Points Question What is the change in prevalence of hypertension among adults in Nepal due to lowering the blood pressure threshold in the 2017 American College of Cardiology/American Heart Association (ACC/AHA) hypertension guideline? Findings Using data from the nationally representative 2016 Nepal Demographic and Health Survey, the estimated prevalence of hypertension was 44.2% according to the 2017 ACC/AHA guideline, 23% higher than the estimate under previous guidelines (21.2%). Meaning The new estimates suggest that nearly half of adults in Nepal may have hypertension; these results support the need for public health programs to increase awareness and minimize complications of hypertension.

Effectiveness of Protease Inhibitor/Nucleos(t)ide Reverse Transcriptase Inhibitor-Based Second-line Antiretroviral Therapy for the Treatment of Human Immunodeficiency Virus Type 1 Infection in Sub-Saharan Africa: A Systematic Review and Meta-analysis

In sub-Saharan Africa, second-line ritonavir-boosted protease inhibitor–based antiretroviral therapy led to virological suppression in 69.3% of participants at week 48 and 61.5% at week 96, based on an intention-to-treat meta-analysis of 4558 participants (14 studies) and 2145 participants (8 studies), respectively.

Long-Term Outcome of Second-Line Antiretroviral Therapy in Resource-Limited Settings

There is limited information on efficacy and durability of second-line antiretroviral therapy (2NL) beyond 12 months in resource-limited settings. A total of 73 patients were enrolled into a prospective 2NL observational cohort in Nigeria. Second-line antiretroviral therapy consisted of lopinavir/ritonavir plus nucleoside reverse transcriptase inhibitors. Time on 2NL ranged from 15 to 31 months. Genotypes were retrospectively done and not available to guide second-line regimen choice. At enrollment, median CD4 count was 121 cells/mm3, and median time on first-line antiretroviral therapy (1SL) was 24 months. At 6 to 9 months on 2NL, 72.6% (intention to treat [ITT]) and 88.3% (on treatment [OT]) had an undetectable viral load (UDVL). At 12 months, 65.8% (ITT) and 90.57% (OT) had UDVL. At >12 to 24 months and at >24 months, 57.5% (ITT) and 91.3% (OT) had UDVL. No statistically significant association was observed between CD4 at 2NL start, sex, genotypic sensitivity score of 2NL, or tenofovir (TDF) use in 1SL and viral suppression. Two patients developed major protease inhibitor mutations while on 2NL. We observed a high degree of viral suppression at 12 months and little loss of viral suppression thereafter.

Virologic and Immunologic Outcomes in HIV-Infected Patients with Cancer.

Achievement and maintenance of virologic suppression after cancer diagnosis have been associated with improved outcomes in HIV-infected patients, but few studies have analyzed the virologic and immunologic outcomes after a cancer diagnosis. All HIV-infected patients with a diagnosis of cancer between 2000 and 2011 in an urban clinic population in Baltimore, MD, were included for review. HIV-related outcomes (HIV-1 RNA viral load and CD4 cell count) were abstracted and compared for patients with non-AIDS-defining cancers (NADCs) and AIDS-defining cancers (ADCs). Four hundred twelve patients with baseline CD4 or HIV-1 RNA viral load data were analyzed. There were 122 (30%) diagnoses of ADCs and 290 (70%) NADCs. Patients with NADCs had a higher median age (54 years vs. 43 years, p < .0001) and a higher frequency of hepatitis C coinfection (52% vs. 36%, p = .002). The median baseline CD4 was lower for patients with ADCs (137 cells/mm3 vs. 314 cells/mm3) and patients with NADCs were more likely to be suppressed at cancer diagnosis (59% vs. 25%) (both p < .0001). The median CD4 for patients with NADCs was significantly higher than patients with ADCs at 6 and 12 months after diagnosis and higher at 18 and 24 months, but not significantly. Patients with an NADC had 2.19 times (95% CI 1.04-4.62) the adjusted odds of being suppressed at 12 months and 2.17 times the odds (95% CI 0.92-5.16) at 24 months compared to patients with an ADC diagnosis. For patients diagnosed with ADCs and NADCs in this urban clinic setting, both virologic suppression and immunologic recovery improved over time. Patients with NADCs had the highest odds of virologic suppression in the 2 years following cancer diagnosis.Abstract Achievement and maintenance of virologic suppression after cancer diagnosis have been associated with improved outcomes in HIV-infected patients, but few studies have analyzed the virologic and immunologic outcomes after a cancer diagnosis. All HIV-infected patients with a diagnosis of cancer between 2000 and 2011 in an urban clinic population in Baltimore, MD, were included for review. HIV-related outcomes (HIV-1 RNA viral load and CD4 cell count) were abstracted and compared for patients with non-AIDS-defining cancers (NADCs) and AIDS-defining cancers (ADCs). Four hundred twelve patients with baseline CD4 or HIV-1 RNA viral load data were analyzed. There were 122 (30%) diagnoses of ADCs and 290 (70%) NADCs. Patients with NADCs had a higher median age (54 years vs. 43 years, p < .0001) and a higher frequency of hepatitis C coinfection (52% vs. 36%, p = .002). The median baseline CD4 was lower for patients with ADCs (137 cells/mm3 vs. 314 cells/mm3) and patients with NADCs were more likely to be ...

Continuous quality improvement in AIDSRelief supported HIV treatment clinics in Uganda: an evaluation of "See-Try-Observe- Continue" (STOC) model in patient care

Aim: To evaluate the effectiveness of the STOC model for continuous quality improvement in improving patient care in two AIDSRelief (AR) HIV treatment facilities in Uganda Methods: In the initial stages, health workers in 17 AIDS Relief HIV treatment facilities were trained in continuous quality improvement (CQI). Consequently, the health workers built CQI teams and used a See Try Observe Continue (STOC) model adapted from the Plan Do Study Act (PDSA) approach to improve gaps identified for change and evaluated their success. A simple excel tracking tool was developed to follow up on the progress of the use of paediatric pharmacy order forms in Bushenyi Medical Centre (BMC) as well as missed ARV pick up in Kabarole hospital. Both descriptive and graphical findings were recorded during the pre and post follow ups. Results: The different clinics implemented at least one cycle of STOC for specific problems and registered improvements in patient care. At BMC, there was an improvement of usage of the paediatric pharmacy order forms from 50% of the paediatric patients seen in each month as well as improved recording of childrens weight and height, parameters crucial in growth monitoring. There was a significant reduction in number of patients who missed picking their ARVs from 28/1000 in Month 1 to 5/1000 in month 7 to 1/1000 patients in month 10. Conclusion: STOC model encourages and enhances evidence-based practices in the AR clinics. CQI activities enhanced by implementation of STOC to improve identified gaps at the facilities are imperative to achieving effective patient care.