▲ HIV Clinician ▲
DELTA REGION AIDS EDUCATION & TRAINING CENTER
formerly FACULTY NOTES
Educating health care providers about HIV/AIDS
Marco Ruiz, MD, MPH
T
he incidence of AIDS-defining cancers has decreased with the use of antiretroviral therapy, while the incidence of non-AIDS defining malignancies has increased,1,2,3,4,5 as has the proportion of mortality associated with non-AIDS defining malignancies in HIV-infected patients.6 In fact, cancer is responsible for 7%-15% of mortality in the HIV population.7 Malignancies in the HIV-infected population have an earlier onset and worse prognosis compared to the general cancer population.6 Lung cancer is prevalent in the HIVinfected population; it is more frequently diagnosed when locally advanced or metastatic, diagnosed at a younger age, more aggressive with higher rates of relapse, and has decreased progression-free survival when compared to lung cancer
7 Legal 9 Consultation 10 Nursing 12 Journal Articles 12 CE Programs
Winter 2010 • Vol. 22, No. 1
Early lung cancer detection in HIV: The role of CT screening in high risk cases A PEER-REVIEWED ARTICLE
Inside
ISSN: 1551-885X
in the general population.8,9 The oncogenic roles of HIV, smoking, age, and increased susceptibility of carcinogens have all been correlated to a higher risk of developing lung cancer.9 Human papilloma virus may also be associated with certain cases of bronchial squamous cell carcinoma.10 The efficacy of screening remains controversial and current guidelines do not recommend screening for lung cancer for the general population.11 Previous trials using chest X-rays and sputum cytology have failed to show early detection and reduction in mortality in patients not affected by HIV.11 However, new reports suggest these two tools combined may have a modest benefit in early detection of lung cancer.11,17 CT scanning has proven to be cost-effective,11,12,13,14 but advantages in terms of morbidity, mortality, or longterm outcomes in patients with lung cancer have not been demonstrated.15 See Lung cancer detection, next page
From our consultation files
Hepatitis B co-infection in pregnancy Ronald D. Wilcox, MD, FAAP Chronic hepatitis is often found in HIVinfected persons. Chronic hepatitis C co-infection is found in approximately 30% of HIVpositive people and chronic hepatitis B in 10%; triple infection with all three viruses occurs in about 1% of HIV-infected persons. Recently we received a consultation on the appropriate treatment of hepatitis B in an HIV-
infected woman who is pregnant in the middle of her second trimester. The patient was currently on no HIV medications but had a long history of prior HIV therapy and had a multiply-resistant strain of virus on her most recent resistance assay. Her CD4 count was in the 500 range, HIV viral load about 15,000 copies/ml, and hepatitis B viral load was over 1,000,000 copies/ml. See Hepatitis B in pregnancy, page 5
Louisiana State •University Health Sciences Center • University of Mississippi Medical Center • Jefferson Comprehensive Care System, Arkansas HIV Clinician Winter 2010
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▲ Lung cancer risk is 3-4 times higher in HIV-infected patients Lung cancer detection, from page 1 CT scanning may, however, be a potential tool for early detection and survival in high-risk HIV populations. This article will explore the relevance and potential utility of CT scanning in early lung cancer detection in HIV-infected patients. Trials of CT scanning in high-risk non-HIV-populations will be reviewed. Recommendations for the use of CT scanning as a means of screening for early detection in HIV-infected patients will be explored. Lung cancer in HIV-infected patients Lung cancer is one of the most common non-AIDS-defining malignancies among HIV-infected patients.15 Recent studies suggest that lung cancer risk is three to four times higher in HIV-infected patients than in uninfected persons, after adjusting for other factors such as smoking intensity and duration.15 One study calculated the incidence as 6.7/100,000 HIV-infected patients in the post-antiretroviral period.9 All major cancer subtypes are equally increased (adenocarcinoma, squamous cell carcinoma, and small cell carcinoma), making the HIV-infected population a high risk group.15,36 The most significant risk factor is smoking but other factors have been identified: potential oncogenic activity of the HIV virus, prolonged moderate or severe immunosuppression, and aging.9,15,16 Other studies have suggested that men who have sex
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with men and intravenous drug users should also be included as high-risk groups.8,9,29,30 In vitro studies have shown that tat (transactivator of transcription) gene product from HIV can increase the expression of the proto-oncogenes c-myc, c-fos and c-jun, and downregulate the tumor suppression gene p53 in lung adenocarcinoma cell lines.16 The role of a possible increase in genomic instability in the increased risk of lung cancer among HIV-infected patients has been suggested by a study of sixteen polymorphic markers on eight chromosome arms frequently deleted in lung cancer.9 This study pointed out that microsatellite instability was six times more frequent in the HIV-infected patients.9 A recent study showed that overexpression of Pokemon, a transcription factor that is a central regulation gene of the important tumor suppressor alternative reading frame (ARF), is present in nonsmall cell lung cancer (NSCLC). Pokemon causes carcinogenesis by inhibiting ARF and its detection may be useful for the prognostic evaluation of patients with NSCLC. The role of Pokemon in HIV-infected patients has not been studied.9,33 The relationship of chronic immunodepression to the excessive risk of lung cancer among HIV-infected patients is difficult to determine.9 This hypothesis has been studied in transplant patients who share the same risk of lung cancer development independent of smoking.9,15 Lung cancer, however, may develop at any point in the course of HIV disease.9,15,31,34,35
The role of prolonged immunosuppression before the start of antiretroviral therapy has been linked to the development of lung cancer in HIV-infected patients.9,34,35 Some studies have indicated that the risk may be maximal in periods immediately before AIDS and subsequent to an AIDS diagnosis.9,15,34 Recent studies have shown that in the post-antiretroviral period, the degree of immunodepression was less severe and the risk of lung cancer nonetheless higher in this period.9 Therefore, the presence of immunosuppression may not fully explain the behavior of certain lung cancers in HIV-infected patients. Furthermore, the risk of lung cancer has been shown not to be closely related to CD4 cell count or HIV viral load.15 The role of antiretroviral therapy with regards to lung cancer risk is controversial at this time.15 Despite improved immune function on antiretroviral therapy, cancer immune surveillance is still inadequate in patients with HIV.15,30 Two potential HIV-related immunologic mechanisms associated with lung cancer risk have been described: the presence of chronic pulmonary inflammation and repeated infections. These two mechanisms might explain the increased incidence of lung cancer in HIV-infected individuals.15 Clinical trials of CT scanning as early detection tool Numerous trials have been conducted using low-radiationdose CT (LDCT) scanning. This technique is faster and less expensive than helical CT scanning and its capacity to detect small
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▲ lung nodules is superior to chest X-ray.15,29,37 Among the trials reviewed and their conclusions: • The Danish Randomized Lung Cancer CT screening trial concluded screening may facilitate minimal invasive treatment with a low rate of false-positive results.18 • A Canadian study confirmed LDCT identified small, earlystage, resectable lung cancer in high-risk individuals.19 • A study from Spain concluded that the use of low-dose computed tomography in risk groups is valid for early diagnosis of lung cancer.20 • An Italian assessment of efficacy with low-dose CT concluded that LDCT results are substantially in line with other international studies.21 • A New York study concluded annual CT screening for lung cancer resulted in identification of a high proportion of patients with early-stage disease.22 • A study in Italy found, despite promising data from other studies, that evidence from randomized controlled trials is needed to support the use of low-dose computed tomography for early detection of lung cancer.23 • A Japanese study showed the potential for overdiagnosis in CT screening-detected cases.24 • The authors of a large collaborative study, the International Early Lung Cancer Action Program (I-ELCAP), concluded that annual spiral CT screening could detect lung cancer that was curable.25 Though this study showed surprising results, some detractors felt it had many problems, including its lack of a control group, lack of an unbiased outcome measure, lack of consideration of what is already known about this topic from
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previous studies, and that it did not address the potential harms of screening.26 Others mention that potential interobserver agreement among radiologists who read chest CT scans could be moderate to substantial and that this factor needs to be taken into account in the evaluation of results from these trials.27 • A Japanese study concluded low-dose CT screening substantially improves the 10-year survival for lung cancer with minimal use of invasive treatment procedures.28 The paucity of studies in HIV-infected patients is surprising. To the best of this author’s knowledge, no trials of CT scanning in early lung cancer diagnosis in HIV-infected individuals have been published. Guidelines Gomez et al. (2008)29 compiled the available guidelines for CT scanning in early lung cancer detection. The American College of Chest Physicians in 2003 recommended against the use of single or serial low-dose CT scanning, pending the results of the National Lung Screening Trial (NLST). The United States Prevention Service Task Force in 2004 concluded that there was not sufficient evidence to recommend for or against screening of asymptomatic persons for lung cancer with either low-dose CT scanning, chest radiograph, or any other tests or combinations of them. In 2005, the American Cancer Society recommended against testing for early lung cancer detection in asymptomatic individuals.29 No guidelines have been published for early lung cancer detection in HIV-infected patients or other high risk groups.
Who should be screened The construction of a highrisk group is difficult in the case of the HIV-infected population since the majority of these patients present late to primary care and have multiple co-morbidities. Immunosuppression, smoking history, age, and history of antiretroviral therapy may all be useful in defining a risk group that would benefit from screening. The majority of studies agree that lung cancer in the HIV-infected population is not fully explained by immunosuppression but the latter could still play a role in the development of lung cancer. In fact, recent studies are looking into length of suppression before treatment as one potential variable to consider in the development of lung cancer.15, 30, 34 Patients considered to be in a high-risk group may include individuals with an HIV history of more than five years with prolonged immunosuppression exposure, potentially defined by the appearance of an opportunistic infection. Recent reports challenging the definition of non-AIDS-defining cancer suggest that the length of time of this immunosuppressive state is critical to the development of certain non-AIDS-malignancies, including lung cancer.15, 30, 34 Controversy remains over the relationship between immune surveillance system failure, chronic infections, chronic inflammation, and lung cancer risk in the HIVinfected population. Prolonged and significant smoking history represents one of the main risk factors for lung cancer in non-HIV patients. The majority of studies included patients with smoking histories between 10-20 packs per year See Lung cancer detection, next page
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▲ Better screening tool needed; is CT scanning the answer? Lung cancer detection, from preceding page
and smokers with recent quitting history. Even though smoking is not the only cause for lung cancer in HIV-patients, this criterion needs to be included in the highrisk group category.9,15,16-28 Age is well known to represent the most common cause for development of all types of cancers. In the trials studied, groups ranged from 45-60 years old. Although there is no consensus about the cut-off age for HIV-infected patients at higher risk for lung cancer, the majority of studies of lung cancer in HIV populations have found an increased prevalence in patients older than 45 years of age.8, 9,30,31,32 The effect of antiretroviral therapy in HIV-infected patients with lung cancer has been a matter of debate. Initial reports claimed that antiretrovirals had no effect on progression or even survival of patients with lung cancer and HIV. Recent studies indicate that antiretroviral therapy may have a positive effect on the progression of lung cancer. For purposes of building up a high-risk group, antiretrovirals might not matter; therefore patients who fall into the previous categories regardless of use of antiretrovirals should be included in the definition of highrisk group.9, 15, 16 Conclusions Lung cancer is one of the most common malignancies in HIV-infected individuals. Risk factors such as smoking, age, moderate prolonged immunosup-
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pression, and increased susceptibility to carcinogens have been linked to development of lung cancer. The role of HIV virus itself and its interaction with other oncogenic viruses, such as HPV, in the pathogenesis and biology of lung cancer has not yet been deciphered. Other suspected high-risk groups, such as intravenous drug users and men who have sex with men (MSM), may benefit from screening. Lung cancer is generally aggressive and detected late in non-HIV-infected populations. The same might apply to HIV patients. Some studies have even suggested that aggressiveness and relapse might be higher in HIV-infected persons. Undoubtedly, a better screening tool is needed. CT scanning may be the potential answer. It is interesting to note that, even though advocating bodies do not recommend single or serial CT scanning, HIV-infected patients may represent a very high-risk group with potential increased mortality compared to traditional high-risk lung cancer groups. This issue is still a matter of debate. Trials need to be conducted in HIV-infected individuals. The design should include patients who fall in the high-risk group. Inclusion criteria could consider extensive smoking history (defined as current active smoking with more than 10 pack/year history or recent quitting history), individuals over the age of 45, subjects who have been exposed to moderate or severe long periods of immunosuppression (defined as T-cell counts less than 200 for more than
five years), and individuals currently on antiretroviral treatment regardless of their T-cell count. The initial CT scanning could be followed over three years with morbidity and mortality outcomes analyzed. New trials will hopefully show the real impact of CT screening in early lung cancer detection in HIV-infected patients. Thorough analysis of short- and long-term outcomes, morbidity and mortality rates, survival with early treatment and interventions, progression-free survival, and quality of life are issues to consider in further analysis of the impact of CT scanning in early detection of lung cancer.v Dr. Ruiz is Assistant Professor, LSUHSC Section of Infectious Disease; staff physician, Interim LSU Hospital HIV Outpatient Program (HOP) Clinic; and faculty, Delta Region AETC. REFERENCES 1. Long J, Engels E, Moore R, Gebo K. Incidence and outcomes of malignancy in the HAART era in an urban cohort of HIV-infected individuals. AIDS.2008; February 19; 22(4): 489-496 2. Martinez LJ, Lynch GR, Grimes RM. Non-Kaposi’s cancers in HIV-infected patients at an urban teaching hospital. International Conference AIDS 1998; 12: 1104 3. Hainsworth JD, Greco FA. Treatment of patients with cancer of an unknown primary site. The New England Journal of Medicine. Volume 329: 257-263 4. Pentheroudakis G, Briasoulis E, Plavidis N. Cancer of unknown primary site: Missing primary or missing biology? The Oncologist. 2007; 12; 418-425 5. Van de Woux AJ, Jansen RLH, Speel EJM, HIllen HFP. The unknown biology of the unknown primary tumour: a literature review. Annals of Oncology 14: 191-196, 2003 6. Barbaro G, Barbarini G. HIV infection and cancer in the era of highly active antiretroviral therapy. Oncology Reports 17: 1121-1126, 2007. 7. Uhlenkott MC, Buskin S, Kahle E, Barash E, Aboulafia DM. Causes of death in the era of highly active antiretroviral therapy: A retrospective analysis of a hybrid hematology-oncology and HIV practice and the Seattle/ King County Adult/Adolescent Spectrum of HIV-related Diseases Project. The American Journal of the Medical Sciences. September 2008 Volume 336 Number 3 8. White JD, Bowman CA, Woll PJ. Lung cancer as the presenting feature of AIDS. Lung Cancer 33 (2001), 81-87. 9. Lavole A, Wislez M, Antoine M, et al. Lung cancer, a new challenger in the HIV-infected population. Lung Cancer (2006), 51, 1-11. 10. Klein F, Waleed FM, Kotb A, et al. Incidence of human papilloma virus in lung cancer. Lung Cancer 65 (2009), 13-18
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▲ 11. Henschke CI, Yankelevitz DF. CT screening for lung cancer: Update 2007. The Oncologist 2008; 13: 65-78 12. Bazoes A, Bower M, Powles T. Smoke and mirrors: HIV-related cancer. Current Opinion in Oncology 2008, 20:529-533. 13. Kirk JD, Merlo C, Driscoll PO, et al. HIV infection is associated with increased risk for lung cancer, independent of smoking. Clinical Infectious Diseases 2007:45 1 July; 103-110. 14. Phillips AA, Justman JE. Screening HIV-infected patients for non-AIDS-defining malignancies. Current HIV/AIDS reports. 2009. May; 6 (2):83-92 15. Engels E. Non-AIDS-defining malignancies in HIVinfected persons: etiologic puzzles, epidemiologic perils, prevention opportunities. AIDS 2009, 23: 875-885 16. Pantanowitz, L, Schlecht H, Dezube B. The growing problem of non-AIDS-defining malignancies in HIV. Current Opinion in Oncology 2006, 18: 469-478. 17. Doria-Rose VP, Marcus PM, Szabo E, et al. Randomized controlled trials of the efficacy of lung cancer screening by sputum cytology revisited. Cancer 2009. Published ahead of print. 18. Pedersen J, Ashraf H, Dirksen A, et al. The Danish randomized lung cancer CT screening trial: Overall design and results of the prevalence round. Journal of Thoracic Oncology, Volume 4, Number 5, May 2009. 19. Roberts H, Patsios D, Paul N et al. Lung cancer screening with low-dose computed tomography: Canadian experience. JCAR vol 58, No 4, October 2007. 20. Callol L, Roig F, Cuevas, et al. Low-dose CT: A useful and accessible tool for the early diagnosis of lung cancer in selected patients. Lung Cancer (2007), 56; 217-221. 21. Lopes Pegna A, Picozzi G, Mascalchi M, et al. Design, recruitment and baseline results of the ITALUNG
From our consultation files Hepatitis B in pregnancy, from page 1 Her hepatitis B e antigen (HBeAg) was positive in 2005 but her liver transaminases recently were not markedly elevated. As defined by her lab work-up, the patient likely has chronic active hepatitis B, although a more recent HBeAg needs to be assessed. Hepatitis B is very concerning in pregnancy. Without intervention, a child exposed to a mother with both hepatitis B surface antigen (HBsAg) and HBeAg positivity has approximately a 70-90% chance of chronic hepatitis B infection within the first six months of life with nearly 10% in utero transmission. With receipt of hepatitis B immune globulin at birth and all three doses of the standard regimen of hepatitis B vaccination, this chance of chronic infection is decreased by
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trial for lung cancer screening with low-dose CT. Lung Cancer 64 (2009), 34-40. 22. New York Early Lung Cancer Action Project Investigators. CT screening for lung cancer: Diagnoses resulting from the New York Early Lung Cancer Action Project. Radiology: Volume 243: Number1 April 2007. 23. Novello S, Fava C, Borasio P, et al. Three-year findings of an early lung cancer detection feasibility study with low-dose spiral computed tomography in heavy smokers. Annals of Oncology 16: 1662-1666, 2005. 24. Toyoda Y, Nakayama T, Kusunoli Y et al. Sensitivity and specificity of lung cancer screening using chest low-dose computed tomography. British Journal of Cancer (2008), 98, 1602-1607. 25. The International Early Lung Cancer Action Program Investigators. Survival of patient with stage I lung cancer detected on CT screening. New England Journal of Medicine. October 26, 2006. Vol 355 No 17. 1763-1771 26. Welch HG, Woloshin S, Schwartz LM, et al. Overstating the evidence for lung cancer screening. Archives of Internal Medicine.2007; 167(21):2289-2295. 27. Gierarda DS, Pilgram TK, Ford M, et al. Lung cancer: Interobserver agreement on interpretation of pulmonary findings at low-dose CT screening. Radiology. Volume 246: Number 1, January 2008. 28. Sone S, Takayama T, Honda T, et al. Long-term follow up study of a population-based 1996-1998 mass screening programme for lung cancer using mobile lowdose spiral computed tomography. Lung Cancer (2007), 58, 329-341. 29. Gomez M, Silvestri G. Lung cancer screening. The American Journal of Medical Sciences. January 2008 Volume 335 No 1.
30. Lavole A, Chouaid C, Baudrin L, et al. Effect of highly active antiretroviral therapy on survival of HIV infected patients with non-small-cell lung cancer. Lung Cancer 2009 Published ahead of print. 31. Bazot M, Cadranel J, Khalil A, Benayoun S, et al. Computed tomographic diagnosis of bronchogenic carcinoma in HIV-infected patients. Lung Cancer 28 (2000); 203-209. 32. Massera F, Rocco G, Rossi G, et al. Pulmonary resection for lung cancer in HIV-positive patients with low (108-109 copies/ml. For those with a positive history for previous perinatal transmission, the recommended level is >106 copies/ ml. Medications should be held after delivery if the mother decides to breast-feed the infant but the woman must be monitored closely for a flare-up of transaminase elevation after discontinuation of the medications. The Opportunistic Infections treatment guidelines released by DHHS in June, 2008, state “treatment of chronic HBV infection is generally not indicated in pregnancy (DIII)” but also that in “women having indications for ART for their own health and expected to continue antiretrovirals postpartum, a regimen including two agents with activity against hepatitis B should be used (AIII).” In general, lamivudine is used as a part of the HAART and hepatitis B therapy unless resistance to lamivudine has previously been demonstrated and tenofovir may be added as a second agent.
The case patient had previously been on many different HIV medications. Her latest genotype showed possible resistance to tenofovir and resistance to most of the nucleoside reverse transcriptase inhibitors. Although the latest genotype did not show the M184V mutation which gives resistance to lamivudine and emtricitabine, the patient likely is harboring a resistant strain that is not the most prevalent strain. This author/consultant recommended the use of tenofovir + emtricitabine to decrease the hepatitis B viral load to be used with a boosted protease inhibitor regimen and possibly an integrase inhibitor (although there is very limited data on integrase inhibitor use in pregnancy) that could be added after delivery. This will hopefully decrease the chances of transmission, both of the hepatitis B and the HIV, to the infant.v Dr. Wilcox is Director/Principal Investigator, Delta Region AETC; Associate Professor, Infectious Disease and Pediatrics, LSUHSC; Staff Physician, Interim LSU Hospital HIV Outpatient Program (HOP) Clinic. REFERENCES Department of Health and Human Services. “Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents.” Released June 18, 2008. Pages 113-126. Jonas MM. “Hepatitis B and pregnancy: an underestimated issue.” Liver International 2009; 29(s1): 133-9. Santiago-Munoz P et al. “Prevalence of hepatitis B and C in pregnant women who are infected with human immunodeficiency virus.” Am J Obstet Gynecol 2005; 193(s1): 1270-3. Tran TT. “Management of hepatitis B in pregnancy: weighing the options.” Cleveland Clin J Med 2009 May; 76(s3): S25-9. van Zonneveld M et al. “Lamivudine treatment during pregnancy to prevent perinatal transmission of hepatitis B virus infection.” J Viral Hepat 2003; 10: 294-7. Xu WM et al. “Efficacy and safety of lamivudine in late pregnancy for the prevention of mother-child transmission of hepatitis B: a multicentre, randomized, doubleblind, placebo-controlled study [AASLD abstract 246]. Hepatology 2004; 40: 272A.
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▲ How to protect medical confidentiality when under subpoena Stacy Morris, JD; Jevan Fleming, JD; Stacey LaFleur, JD The principle that physicians should not divulge the medical confidences of their patients dates back to the Oath of Hippocrates which reads: Whatever, in connection with my professional service, or not in connection with it, I see or hear, in the life of men, which ought not to be spoken of abroad, I will not divulge, as reckoning that all such should be kept secret.
What happens when a doctor/ hospital receives a subpoena for medical records of a patient who is adamant about “not” having his/her confidential information exposed? How can the doctor/ hospital protect the patient and comply with the subpoena without violating both? Under the Health Insurance Portability and Accountability Act (HIPAA), “covered entities” must protect the privacy of individuals’ medical records. A covered entity includes doctors, nurses, hospitals, clinics, pharmacies, and nursing homes, among others. Violations of HIPAA, and/ or the state statues cited below, could result in criminal and civil consequences. Louisiana According to the Louisiana Statute that protects disclosure of HIV test results: “Except as otherwise provided by law, no person who obtains, retains, or becomes the recipient of confidential HIV test results…may disclose such information…when such authorization contains a
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refusal to release HIV test results…” 1300.14 (A) Confidentiality of HIV test result; disclosure. There are several procedural devices that doctors or hospitals can follow to both comply with the subpoena and protect patients’ confidentiality. These include: contacting the patients and informing them that their records are being subpoenaed; seeking to obtain the patients’ consent to speak with their attorneys of record; and explaining the situation to the patients’ attorneys. To prevent the disclosure of a client’s HIV status, a patient’s attorney may file one of the following: 1) a Motion to Quash the Subpoena; 2) a Motion for a Temporary Restraining Order/Permanent Injunction; and/or 3) a Motion for an InCamera Inspection of the records (whereby a judge reviews the medical records and determines whether those records have any value to the litigation). Arkansas The confidentiality of patients and their medical records in Arkansas is protected under special rules of physician and psychotherapist-patient privilege under Rule 503(a)(4)(5)(b)(c)(B) of the Arkansas Rules of Civil Procedure. In pertinent part, Rule 503 states, “…a communication is ‘confidential’ if not intended to be disclosed to third persons…A patient has a privilege to refuse to disclose and to prevent any other person from disclosing his medical records or confidential communications…the patient shall not be required, by court order or otherwise, to authorize
any communication with the physician…other than furnishing of medical records/communications in the context of formal discovery procedures.” Notwithstanding the patientprivilege provisions under Rule 503, medical records may be summoned using the legal discovery process. Under Rule 45(b) medical records may be subpoenaed. How can disclosure be prevented? Using techniques similar to those outlined in the preceding Louisiana section, Arkansas allows the following procedural outlets: the opposing party may file a Motion for a Protective Order (Rule 26); or the opposing party may also file a Motion to Quash and/or Modify the Subpoena (Rule 25). Please note that nothing prevents prosecuting attorneys in Arkansas from gaining access to patient’s medical records. Accordingly, under AR Title 20 §20-15-904 Reporting – Confidentiality – Subpoenas, “... any prosecuting attorney of the State of Arkansas may subpoena information as may be necessary to enforce the provisions of this section, provided that any information acquired pursuant to the subpoena shall not be disclosed except to the courts to enforce the provisions of this section.” Mississippi The State of Mississippi has a similar rule to protect the confidentiality of patients’ medical records. In an attempt to protect patient confidentiality when under a subpoena in Mississippi, See Confidentiality under subpoena, next page
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▲ Action by HIV patient’s attorney is critical to the process Confidentiality under subpoena, from pg 7 the medical practitioner’s legal counsel may do the following: 1) file timely written Objections to the subpoena (Miss. R. Civ. Proc. 45(d)(2)(B); or 2) timely file a Motion to Quash (Miss. R. Civ. Proc.45(d)(1)(A).
Confidentiality of privileged information is highly regarded by each of the states outlined above. An unnecessary breach of patient’s privileged information could be very costly. However, if the patient’s attorney does not take action to prevent the records from being subpoenaed, then you are legally obligated to produce the patient’s records.
If confronted with a situation where a patient’s medical records are under subpoena, please consult with legal counsel. Reacting quickly or doing nothing could have serious consequences.v Stacy Morris and Jevan Fleming are AIDSLaw attorneys; Stacey LaFleur is Executive Director, AIDSLaw of Louisiana, Inc.
What does Delta AETC do with all those forms you fill out? Elisabeth Gleckler, DrPh, MBA, CHES Do you remember the “PIF form”? If you’ve ever attended a Delta Region AETC (DAETC) training or consulted our specialists, you likely were asked to complete a Participant Information Form (PIF). The information on the PIF gives our federal funding agency, Health Resources Services Administration (HRSA), documentation about our three sites (Arkansas, Louisiana, and Mississippi), justifying the funding levels that are part of yearly grant negotiations. In the past, PIF forms were mostly used to report activities to our funders. With the government’s increased interest in efficiency, and with a little manipulation, PIFs can now also provide useful marketing and project management information. DAETC’s website data management system makes real time analysis of training goal
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achievements possible, plus it has additional information on participants’ education needs and preferences. In fiscal year 2008-09, DAETC produced 1453 training events with 5372 participants. Didactic trainings totaled 80 (Level I) with 1557 attendees for 129.75 hours of training. Participants returned for an average of 1.7 Level I trainings. A total of 129 skills-building trainings took place (Level II) with 2430 participants for an average of 1.6 trainings per individual, producing 396.75 hours of training. Preceptorships or clinical trainings (Level III) are in-depth trainings; 93 participants generated 540.75 hours in intense clinical learning. Delta faculty engaged in a large number of consultations. For fiscal year 2008-09, 754 consults for 481.75 hours of consultation occurred, an average of a little more than a half an hour per consult. Delta also provides outreach to organizations with technical assistance, a total of 397 contacts for 560.25 hours on
non-clinical topics. Delta’s training targets six professions (often referred to as the “Big Six”): physicians, physician assistants, advanced practice nurses, nurses, pharmacists, and dental professionals. Much of modern HIV treatment is based on team systems. To improve patient care, support staff and other health professionals who are part of the team need to be upto-date on HIV care. The goal is to improve care to patients so team members are included in target audiences. A total of 6160 people attended either trainings or consultations in the region, and 83.1% (5119) of those completed a PIF. That means that Delta extended education to participants but was funded for 16.9% less of the true effort. When people attend trainings or consultations but do not complete a PIF, Delta is not credited by HRSA for those participants. In the coming year, Delta will institute two improvements. The first is for par-
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▲ Your answers are studied and used in planning programs ticipants with PIF identification numbers to be able to generate reports of their training in two ranges of time: all trainings and past year. The second will be an email prompt for people to check the information on their PIFs and file them electronically so all they have to do is write their PIF number on a sign-in sheet and it will be updated for them. The needs assessment and training information that are part of Delta’s routine data collection also provide valuable planning information. Delta found that the three top methods of training preferred in the region were lecture/presentation, clinical case discussions, and skills-building sessions. Interestingly, 10.4% of fiscal year 2007-08 participants noted that one of their three
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preferred methods was internetbased training and this past fiscal year it was 11.7%. Participants either preferred short trainings of one to two hours or noted that the content defined the length by choosing “no preferred duration.” Most participants wanted to have the training in their state or in the same city as their worksite. Over ten percent of participants noted that they wanted to learn more about the treatment and management topics of HIV primary care/HIV treatment guidelines. The second most mentioned topic was hepatitis and HIV. Digging a little deeper, we found that of the 4430 times participants noted they wanted HIV primary care/treatment guideline training in the past two
years in needs assessments, 36.4% (1614) received training in clinical manifestations of HIV. Similarly, of the 4315 mentions about wanting hepatitis training, 23.6% (1018) learned about it in training. Delta sites will use this kind of information to decide where to propose trainings and also to pick the topics requested but not received by clinical staff. Please rest assured that every question that faculty or participants answer on any of the forms or evaluations is carefully analyzed. Delta staff members are grateful for the honest answers that participants offer and seek to use their observations to guide Delta’s planning.v Elisabeth Gleckler is Evaluator, Delta Region AETC.
HIV Clinical Consultation for Health Care Providers
Delta AETC consultants are HIV specialists at state university medical centers. Requests for consultation are taken from 9:00-4:00 CST on weekdays and by voicemail on weekends. Consultants return calls within two business days. If you are a clinician and wish to discuss a case with one of our consultants, use these numbers to contact an HIV specialist:
STATE RESOURCES FOR HIV CONSULTATION In Louisiana: 504-903-0623
In Mississippi: 601-984-5542
In Arkansas: 870-535-3062 x104
NATIONAL RESOURCES FOR HIV CONSULTATION National HIV Telephone Consultation Service (Warmline) 800-933-3413
HIV Clinician • Winter 2010
National Perinatal HIV Consultation and Referral Service (Perinatal Hotline) 888-448-8765
National Clinicians’ Post-Exposure Prophylaxis Hotline (PEPline) 888-448-4911
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▲ How can we facilitate entry into and retention in HIV care? A PEER-REVIEWED ARTICLE Deborah J. Konkle-Parker, PhD, FNP As nurses, we all know many clients who have been diagnosed with HIV but chose not to enter care until very late in the course of their disease and who now have an AIDS diagnosis and opportunistic infections. Others, already in care and requiring maintenance therapy to continue doing well, inexplicably drop out of care for several months or years. In an effort to more fully understand these phenomena, we conducted a survey in 2007 at the University of Mississippi Medical Center clinic, with a convenience sample of all patients who attended clinic on the days that we had a data collector available (Konkle-Parker, Amico & Henderson, 2009). Eligible patients were those who selfreported a delay in entering HIV care for at least six months after diagnosis or at least one gap in care of six months or more since starting in HIV care. The survey was a qualitative semi-structured interview based on questions from the Centers for Disease Control and Prevention (CDC) Medical Monitoring Project (Table 1; Division of HIV/AIDS Prevention, 2008). Open-ended questions were used to ask about participants’ barriers and facilitators to entering and staying in HIV clinical care, responses were simultaneously coded by data collectors, and the data were analyzed quantitatively. See Figure 1 for enrollment description, showing that almost half of the patients who agreed to
HIV Clinician • Winter 2010
speak with the researcher had experienced a delay in entering care of at least six months after diagnosis and/or experienced at least one gap in care of six months or more since they started care. Characteristics of the sample are in Table 2 and very much reflected the clinic population from which the sample was drawn. An unexpected number of individuals described denial as a reason that they didn’t enter care (74% described it as a barrier with 43% as the main barrier) and kept them from staying in care (27% described it as a barrier), with worries about privacy being another frequently reported barrier to entering care (31% described it as a barrier with 13% as the main barrier). These personal attitudes or beliefs made up a greater percentage of the barriers reported by those who delayed entry into care (93% of these individuals reported at least one personal barrier) as compared to structural barriers, but also an important number of those with gaps in care (72% of those with gaps in care reported at least one personal barrier). When reporting facilitators to entering care, many were beyond the control of the nurse: 52% of those who delayed entry into care and 31% of those who had a gap in care said that an important facilitator for them was feeling worse or entering the hospital. An important minority of individuals, however, also reported that deciding to take care of their health was an important facilitator for entering or re-entering care (39% of those
who delayed entry into care and 50% of those who had a gap in care reported this as one of their facilitators; 19% and 33% respectively said that it was the main facilitator for getting them into or back into care). This is an area where nurses can be instrumental, in motivating our clients or clients’ friends to take care of themselves, and to see HIV care as an important coping mechanism in the process of taking care of themselves rather than as a burden. Other important facilitators that nurses can keep in mind for helping clients to enter and re-enter care were: a) accepting their diagnosis (facilitator for 11% of those delaying entry into care and 2% of those with a gap in care); b) stopping drinking or using drugs (facilitator for 7% of both those who delayed entry into care and those who had a gap in care); c) feeling less worried about their privacy (facilitator for 3% of both those who delayed entry into care and those who had a gap in care); d) health care provider reminding them (facilitator for 3% of those delaying entry into care and 2% of those with a gap in care; all these individuals also reported this as their main facilitator). What this information tells us is that personal attitudinal barriers were more important than structural barriers for keeping this group of individuals who successfully entered care from doing it in a timely manner and from doing it consistently. Personal barriers were more important than structural barriers in delaying these individuals in entering care, but were 10
▲ also important in keeping them from consistent care, though slightly less so than structural barriers. This may help us to avoid concentrating only on the structural facilitators (providing transportation, funding for care and medications, child care, etc.). Finding out the attitudes, beliefs, and mental health issues that get in the way of timely and uninterrupted care and addressing those barriers may be more useful in convincing our clients to accept their diagnosis, and helping them to take care of their health.v Debbie Konkle-Parker is a nurse practitioner in the outpatient HIV clinic at the University of Mississippi Medical Center, an adjunct Assistant Professor at the UMMC School of Nursing, and LPS Coordinator, Delta AETC.
Table 1: INTERVIEW QUESTIONS 1. What were the reasons you didn’t go to a health care provider soon after you learned of your HIV? 2. What was the main reason you didn’t go to the health care provider soon after you learned of your HIV? I am going to read a list of the reasons you just gave me. Please tell me which of these was your main reason. 3. What were the reasons you started going to a health care provider after waiting to enter care for your HIV? 4. What was the main reason you started going to the health care provider after waiting to enter care for your HIV? I am going to read a list of the reasons you just gave me. Please tell me which of these was your main reason. For those who reported a gap in care of six months or more: 1. What were the reasons you didn’t go to your health care provider for the period you were out of care for at least six months? 2. What was the main reason you didn’t go to your health care provider for the period you were out of care for at least six months? I am going to read a list of the reasons you just gave me. Please tell me which of these was your main reason. 3. What were the reasons you went back to your health care provider after the period you were out of care for at least six months? 4. What was the main reason you went back to your health care provider after the period you were out of care for at least six months? I am going to read a list of the reasons you just gave me. Please tell me which of these was your main reason.
Table 2: SAMPLE CHARACTERISTICS Characteristic
Number (%)
Eligibility criteria
62 (48% of eligible participants) delayed entry into HIV care >6 months 94 (72% of eligible participants) had a gap in HIV care of >6 months
Division of HIV/AIDS Prevention. (2008, June 28). Medical Monitoring Project (MMP). Retrieved April 21, 2007, from http://www.cdc.gov/hiv/topics/treatment/ mmp/index.htm
Race
81% Black; 18% White
Gender
62% male
Konkle-Parker, D. J., Amico, K. R., and Henderson, H. M. (2009). Barriers and facilitators to engagement in HIV clinical care in the Deep South: Results from semistructured patient interviews. Manuscript submitted for publication.
Sexual identity
68% self-reported as heterosexual
Education
24% had less than a high school education
Employment status
42% were on disability
Income
57% were living on an income of less than $10,000 per year
Length of time with HIV diagnosis
43% had been diagnosed more than 10 years previously
REFERENCES
Figure 1: ENROLLMENT 437 patients asked
Have an interesting case? 270 (62%) agreed to talk to researcher (total sample)
130 (48% eligible: • 23% of total sample delayed entry into care • 35% of total sample had gap in care
HIV Clinician • Winter 2010
Submit your manuscript describing the case to HIV Clinician for possible publication. See author’s guidelines at http://www.deltaaetc.org/authorguidelines.htm
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HIV Clinician is published four times a year by Delta Region AIDS Education and Training Center (AETC), 136 S. Roman St., New Orleans, LA 70112. Phone 504-903-0623, Fax 504-903-7186 Executive Editor Ronald D. Wilcox, MD
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Stay current with the latest HIV/AIDS journal articles s Frailty among HIV-infected persons in an urban outpatient care setting. Onen NF. Agbebi A. Shacham E. Stamm KE. Overton ET. Journal of Infection. 59(5):346-52, 2009 Nov. s Effects of antidepressant treatment on antiretroviral regimen adherence among depressed HIV-infected patients. Kumar V. Encinosa W. Psychiatric Quarterly. 80(3):131-41, 2009 Sep. s Suppression of human immunodeficiency virus type 1 viral load during acute measles. Moss WJ. Scott S. Ndhlovu Z. Monze M. Cutts FT. Quinn TC. Griffin DE. Pediatric Infectious Disease Journal. 28(1):63-5, 2009 Jan. s Vitiligo in a patient associated with human immunodeficiency virus infection and repigmentation under antiretroviral therapy. Seyedalinaghi SA. Karami N. Hajiabdolbaghi M. Hosseini M. Journal of the European Academy of Dermatology & Venereology. 23(7):840-1, 2009 Jul. s Pregnancy as a window of opportunity for HIV prevention: effects of an HIV intervention delivered within prenatal care. Kershaw TS. Magriples U. Westdahl C. Rising SS. Ickovics J. American Journal of Public Health. 99(11):2079-86, 2009 Nov. s Increased chemokine signaling in a model of HIV1-associated peripheral neuropathy. Bhangoo SK. Ripsch MS. Buchanan DJ. Miller RJ. White FA. Molecular Pain. 5:48, 2009. s Fulminant hepatic failure associated with antiretroviral therapy in a pregnant woman. Stohl HE. Silva AM. Argani CH. Anderson JR. International Journal of Gynaecology & Obstetrics. 106(3):260-1, 2009 Sep. s Laryngeal cancer in acquired immunodeficiency syndrome. Shushan S. Cinamon U. Levy D. Sokolov M. Roth Y. International Journal of STD & AIDS. 20(8):582-4, 2009 Aug. s New antiretroviral drugs: a review of the efficacy, safety, pharmacokinetics, and resistance profile of tipranavir, darunavir, etravirine, rilpivirine, maraviroc, and raltegravir. Hughes CA. Robinson L. Tseng A. MacArthur RD. Expert Opinion on Pharmacotherapy. 10(15):2445-66, 2009 Oct.
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s Drug interactions between antineoplastic and antiretroviral therapies: Implications and management for clinical practice. Mounier N. Katlama C. Costagliola D. Chichmanian RM. Spano JP. Critical Reviews in Oncology-Hematology. 72(1):10-20, 2009 Oct. s Raltegravir, etravirine, and ritonavir-boosted darunavir: a safe and successful rescue regimen for multidrug-resistant HIV-1 infection. Imaz A. del Saz SV. Ribas MA. Curran A. Caballero E. Falco V. Crespo M. Ocana I. Diaz M. de Gopegui ER. Riera M. Ribera E. Journal of Acquired Immune Deficiency Syndromes: JAIDS. 52(3):382-6, 2009 Nov 1. s Gender differences in discontinuation of antiretroviral treatment regimens. Kempf MC. Pisu M. Dumcheva A. Westfall AO. Kilby JM. Saag MS. Journal of Acquired Immune Deficiency Syndromes: JAIDS. 52(3):336-41, 2009 Nov 1. s The association between food insecurity and mortality among HIV-infected individuals on HAART. Weiser SD. Fernandes KA. Brandson EK. Lima VD. Anema A. Bangsberg DR. Montaner JS. Hogg RS. Journal of Acquired Immune Deficiency Syndromes: JAIDS. 52(3):342-9, 2009 Nov 1. s Cardiovascular risk assessment in antiretroviralnaive HIV patients. Maggi P. Quirino T. Ricci E. De Socio GV. Gadaleta A. Ingrassia F. Perilli F. Lillo A. Bonfanti P. AIDS Patient Care & Stds. 23(10):809-13, 2009 Oct. s HIV-specific health care utilization and mortality among tuberculosis/HIV coinfected persons. Gadkowski LB. Hamilton CD. Allen M. Fortenberry ER. Luffman J. Zeringue E. Stout JE. AIDS Patient Care & Stds. 23(10):845-51, 2009 Oct. s Treat early or wait and monitor? A qualitative analysis of provider hepatitis C virus treatment decision-making in the context of HIV coinfection. Wagner G. Ryan G. Osilla KC. Bhatti L. Goetz M. Witt M. AIDS Patient Care & Stds. 23(9):715-25, 2009 Sep. s High concentrations of interleukin 15 in breast milk are associated with protection against postnatal HIV transmission. Walter J. Ghosh MK. Kuhn L. Semrau K. Sinkala M. Kankasa C. Thea DM. Aldrovandi GM. Journal of Infectious Diseases. 200(10):1498-502, 2009 Nov 15.
DELTA AETC’s ONGOING
CONTINUING EDUCATION PROGRAMS NEW ORLEANS, LOUISIANA Clinical preceptorship for physicians, nurse practitioners, physician assistants: Care and Management of the Patient with HIV Disease— March 8-9, 2010; September 13-14, 2010. 15.5 CMEs. Contact Danielle Pierce, 504-903-0788 or
[email protected]. Clinical preceptorship for nurses and clinical service providers: Comprehensive Management of the Patient with HIV Disease—May 3-4, 2010, November 1-2, 2010. 11 contact hours. Contact Danielle Pierce, 504-903-0788 or dpierc@ lsuhsc.edu. Clinical preceptorship for dentists and dental professionals: Oral Health Management for the HIV/AIDS Patient—October 11, 2010. Up to 6.7 CDEs. Contact Danielle Pierce, 504-903-0788 or
[email protected]. JACKSON, MISSISSIPPI Course for physicians, physician assistants, nurse practitioners, nurses, pharmacists, case managers, social workers: Care and Management Overview of HIV Infection—May 13-14, 2010. Discipline-specific CEUs. Contact Joan Bounds, 601-984-1300 or jbounds2@umsmed. edu. PINE BLUFF/LITTLE ROCK, ARKANSAS Clinical preceptorships for primary care providers—ongoing by request. To arrange, contact Derrick Newby, 870-535-3062 or dnewby700@ aol.com.
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