Publications

HIV pre-exposure prophylaxis (PrEP) is highly efficacious at preventing HIV acquisition. This review discusses ways to identify candidates for PrEP, recommended PrEP regimens, baseline and follow-up evaluations, applications of PrEP for HIV-serodiscordant couples, resources to address financial barriers, investigational strategies for PrEP, and educational resources for clinicians and patients.

BACKGROUND

Authors of clinical practice guidelines (CPGs) disclose financial conflicts of interest (FCOIs) to promote transparency ethics. Typically, they do so on standard declaration forms containing generic open-ended questions on FCOIs. Yet, the literature is scant on the format and effect of alternative disclosure forms. Does supplementing a standard form with subsequent detailed disclosure forms tailored to the context of the CPG improve the yield or accuracy of FCOIs declarations?

METHODS

For an international CPG in gastroenterology on the endoscopic surveillance for colorectal neoplasia in inflammatory bowel disease, we compared the use of a standard FCOIs disclosure form with a contextual FCOIs disclosure form that detailed commercial relations related to the CPG topic. This included manufacturers of endoscopes, endoscopy equipment and accessories. Participants completed the generic form early, and the supplementary contextual form six months later. We then compared the FCOI disclosures obtained.

FINDINGS

26 participants provided FCOIs disclosures using both disclosure forms. We found discrepancies regarding (1) the disclosure of FCOIs (presence/absence), and (2) the listing of financial entities. While the number of participants who disclosed a FCOI remained the same (30.8%) using the two forms, disclosures were not from the same individuals: two additional participants disclosed a FCOI, whereas two participants withdrew previous disclosures. Among those who reported a FCOI in either form, we noted inconsistencies in disclosures for 70% of the participants. This included changes in FCOIs disclosure status or modifications of "their commercial relations".

DISCUSSION

Accurate reporting of FCOIs advances the transparency and ethical integrity of CPGs. Our experience suggests that a contextual FCOIs disclosure form tailored to content of the CPG with narrow, detailed questions provides supplementary, more complete FCOIs declarations than generic forms alone. The finding raises challenges on how forms are best written and formatted, optimally timed, and more effectively processed with sensitivity to professional behaviour, so as to heighten transparency.

BACKGROUND

Symptom-based screening for tuberculosis is recommended for all people living with HIV. This recommendation results in unnecessary Xpert MTB/RIF testing in many individuals living in tuberculosis-endemic areas and thus poor implementation of intensified case finding and tuberculosis preventive therapy. Novel approaches to tuberculosis screening are needed to help achieve global targets for tuberculosis elimination. We assessed the performance of C-reactive protein (CRP) measured with a point-of-care assay as a screening tool for active pulmonary tuberculosis.

METHODS

For this prospective study, we enrolled adults (aged ≥18 years) living with HIV with CD4 cell count less than or equal to 350 cells per μL who were initiating antiretroviral therapy (ART) from two HIV/AIDS clinics in Uganda. CRP concentrations were measured at study entry with a point-of-care assay using whole blood obtained by fingerprick (concentration ≥10 mg/L defined as screen positive for tuberculosis). Sputum samples were collected for Xpert MTB/RIF testing and culture. We calculated the sensitivity and specificity of point-of-care CRP and WHO symptom-based screening in reference to culture results. We repeated the sensitivity analysis with Xpert MTB/RIF as the reference standard.

FINDINGS

Between July 8, 2013, and Dec 15, 2015, 1237 HIV-infected adults were enrolled and underwent point-of-care CRP testing. 60 (5%) patients with incomplete or contaminated cultures were excluded from the analysis. Of the remaining 1177 patients (median CD4 count 165 cells per μL [IQR 75-271]), 163 (14%) had culture-confirmed tuberculosis. Point-of-care CRP testing had 89% sensitivity (145 of 163, 95% CI 83-93) and 72% specificity (731 of 1014, 95% CI 69-75) for culture-confirmed tuberculosis. Compared with WHO symptom-based screening, point-of-care CRP testing had lower sensitivity (difference -7%, 95% CI -12 to -2; p=0·002) but substantially higher specificity (difference 58%, 95% CI 55 to 61; p<0·0001). When Xpert MTB/RIF results were used as the reference standard, sensitivity of point-of-care CRP and WHO symptom-based screening were similar (94% [79 of 84] vs 99% [83 of 84], respectively; difference -5%, 95% CI -12 to 2; p=0·10).

INTERPRETATION

The performance characteristics of CRP support its use as a tuberculosis screening test for people living with HIV with CD4 count less than or equal to 350 cells per μL who are initiating ART. HIV/AIDS programmes should consider point-of-care CRP-based tuberculosis screening to improve the efficiency of intensified case finding and increase uptake of tuberculosis preventive therapy.

FUNDING

National Institutes of Health; President's Emergency Plan for AIDS Relief; University of California, San Francisco, Nina Ireland Program for Lung Health.

OBJECTIVES

To compare rates of postpartum care and contraception provided to women with gestational or preconception diabetes mellitus to women with no known diabetes mellitus.

METHODS

A retrospective cohort study of 199,860 women aged 15-44 years who were continuously enrolled in California's Medicaid program, Medi-Cal, from 43 days prior to 99 days after delivering in 2012. Claims for postpartum clinic visits and contraceptive supplies were compared for 11,494 mothers with preconception diabetes, 17,970 mothers with gestational diabetes, and 170,396 mothers without diabetes. Multivariable logistic regression was used to control for maternal age, race/ethnicity, primary language, residence in a primary care shortage area, state-funded healthcare program and Cesarean delivery, when examining the effects of diabetes on postpartum care and contraception.

RESULTS

Although postpartum clinic visits were more common with diabetes (55% preconception, 55% gestational, 48% no diabetes, p=<.0001), almost half did not receive any postpartum care within 99 days of delivery. Women with pregnancies complicated by diabetes were more likely to receive permanent contraception than women without diabetes (preconception diabetes, aOR: 1.39, 95% CI: 1.31-1.47; gestational diabetes, aOR: 1.20, 95% CI: 1.14-1.27). However, among women without permanent contraception, less than half received any reversible contraception within 99 days of delivery (44% preconception, 43% gestational, 43% no diabetes) and less effective, barrier contraceptives were more commonly provided to women with preconception diabetes than women without diabetes (aOR: 1.24, 95% CI:1.16-1.33).

CONCLUSIONS

Low-income Californian women with pregnancies complicated by diabetes do not consistently receive postpartum care or contraception that may prevent complication of future pregnancies.

IMPLICATIONS

Efforts are needed to improve rates of provision of postpartum care and high quality contraceptive services to low income women in California, particularly following pregnancies complicated by diabetes.