SummaryThe HIV clinic at Jackson Memorial Hospital in Miami, FL, encourages men with HIV to be screened annually for anal cancer and makes it easy and convenient for them to do so by offering all aspects of the screening process within the clinic. Trained primary care physicians and nurses have frank discussions with patients to encourage them to agree to screening. Physicians refer those who consent to a clinic-based nurse practitioner, who then performs an anal Papanicolaou screening. Men with an abnormal anal Papanicolaou screening are referred for further evaluation of the anal canal, achieved with high-resolution anoscopy. The program has enhanced access to anal cancer screening for HIV-positive men, enabling the identification and removal of many precancerous growths.Suggestive: The evidence consists of post-implementation data on the number of patients screened and estimates about patients testing positive for dysplasia and having precancerous growths removed.
Developing OrganizationsUniversity of Miami/Jackson Memorial Hospital
Use By Other OrganizationsNew York, San Francisco, and Tampa are among U.S. cities with HIV clinics that offer similar anal Pap smear screening programs.
Date First Implemented2011
Patient PopulationApproximately 63 percent of the clinic's patients are African American and 32 percent are Hispanic.Vulnerable Populations > Lesbian/gay/bisexual/transgender; Gender > Male
Problem AddressedPeople with HIV face an elevated risk of anal cancer, and this risk has risen steadily over time. Annual screening via an anal Papanicolaou screening (anal Pap smear) is an easy, effective way to detect precancerous lesions that can progress to anal cancer, but few people with HIV get this test.
- High (and growing) risk of anal cancer: People with HIV have a higher risk of developing anal cancer, possibly because of impaired T-cell function. One study showed that as many as 49 percent of HIV-infected gay men developed high-grade anal dysplasia within 4 years, compared with 17 percent of gay men not infected with HIV.1 The incidence of anal cancer in individuals with HIV has more than tripled in the last several decades, rising from 19.0 per 100,000 person-years during the period between 1992 and 1995 to 72.2 per 100,000 person-years between 2000 and 2003.2
- Unrealized potential of screening: Before anal cancer develops, precancerous lesions can usually be detected and excised before progressing to anal cancer. Through a painless, inexpensive test known as an anal Pap smear, a sample of cells is collected and then examined under a microscope to identify any abnormal cell change that could indicate precancerous or cancerous cells. Research has found this test to be as effective as the cervical Pap smear,3 and that incorporating it into routine visits at HIV clinics might reduce the incidence, morbidity, and mortality of anal cancer in patients with HIV.4 Although no formal guidelines exist for the screening of anal cancer, experts in the field recommend that people at elevated risk for anal cancer be screened every 1 to 2 years. However, the percentage of patients with HIV who routinely get screened is believed to be low, because of factors such as lack of awareness of anal cancer and the screening test, the perceived intolerability of the diagnostic procedure that follows a positive result (anoscopy), fear of a cancer diagnosis, and difficulties in maintaining clinical appointments.5
Description of the Innovative ActivityThe HIV clinic at Jackson Memorial Hospital in Miami, FL, encourages men with HIV to be screened annually for anal cancer and makes it easy and convenient for them to do so by offering all aspects of the screening process within the clinic. Trained primary care physicians and nurses have frank discussions with patients to encourage them to agree to screening. Physicians refer those who consent to a clinic-based nurse practitioner who performs an anal Pap smear. Men with abnormal Pap smears are referred for further evaluation of the anal canal, completed with high-resolution anoscopy. Key program elements are outlined below:
- Proactive education to encourage screening: The clinic's goal is to screen all men every year. To that end, the clinic encourages its primary care physicians and nurses to discuss the risk for anal cancer and the screening process with patients during checkups and other visits if time permits. During these discussions, trained physicians and nurses talk about this potentially sensitive topic in a frank fashion designed to convince the patient to be screened. In addition, examination rooms include a small sign that reads: "Warning: You may be at risk for anal cancer. Ask your doctor how you can prevent this disease."
- Easy, convenient screening and followup within the clinic: The clinic offers all aspects of the screening process and most followup care within the clinic, as outlined below:
- Quick scheduling of initial screen: Patients who have not previously been screened who consent to doing so are scheduled for a followup appointment, typically within a few weeks. Those who have been screened previously schedule their next screening as part of the annual checkup.
- Routine screening through anal Pap smear: Patients receive instructions in advance of the screening on how to prepare for the visit, including any behaviors to avoid. A nurse practitioner performs the test, which takes just a few seconds. A hospital pathologist analyzes the sample, with four possible results: negative for dysplasia, atypical cells of unknown significance, low-grade squamous intraepithelial lesion, and high-grade squamous intraepithelial lesion. Patients usually learn their results within 2 weeks by telephone or find out at their next clinic visit. Those with negative results are offered screening on a yearly basis. Patients with abnormal results are scheduled for further evaluation with high-resolution anoscopy, generally within a few months.
- High-resolution anoscopy with possible biopsy: Using a small, thin round tube called an anoscope, a clinic physician examines the anal canal with a high-resolution magnifying instrument called a colposcope. Application of a mild acidic liquid (vinegar) onto the anal canal facilitates evaluation of abnormal tissue such as anal dysplasia. If indicated, the physician obtains a biopsy, and if a biopsy is done, the sample is sent to the laboratory for evaluation by a pathologist. The pathologist determines if there are precancerous lesions or warts that may require further followup or treatment.
- Followup procedures: Followup options depend on the results of the anoscopy. Patients with low-grade lesions typically return to the clinic for a followup anoscopy within 3 to 6 months, while those with higher grade lesions may require therapy and will be closely monitored and referred to proctology for removal of lesions as needed. In rare cases where the examination reveals carcinomas, the patient receives a referral to an oncologist for further evaluation and treatment.
Context of the InnovationUniversity of Miami/Jackson Memorial Hospital in Miami, FL, is an accredited, nonprofit, tertiary care hospital and the major teaching facility for the university's Leonard M. Miller School of Medicine. It includes an HIV clinic (divided into men's and women's branches) that provides primary care and screening services to roughly 4,000 patients a year, including HIV testing, mammograms, prostate examinations, and colonoscopies.
The impetus for the anal cancer screening program came from a growing awareness among clinic physicians and hospital administrators that HIV-positive patients faced an increased risk of anal cancer, that anal Pap smears can be effective in identifying those at high risk of the disease, and that several other clinics—including one at the Department of Veterans Affairs (VA) Medical Center in Miami, which is also affiliated with the Miller School of Medicine—had successfully implemented similar programs. (See the Planning and Development Process section for more information on the VA program and its ties to this one.)
ResultsThe program has enhanced access to anal cancer screening for HIV-positive men, enabling the identification and removal of many precancerous growths.
Suggestive: The evidence consists of post-implementation data on the number of patients screened and estimates about patients testing positive for dysplasia and having precancerous growths removed.
- Enhanced access to screening: In 2011 and 2012, close to 200 HIV-positive men received anal Pap smears at the clinic, and close to 100 subsequently had high-resolution anoscopies. Few of these patients likely would have received such screening in the absence of this program.
- Many testing positive for dysplasia: Many patients who have had anoscopies have had some degree of dysplasia. These patients are receiving appropriate followup care, including additional anal Pap smears and anoscopies and, in a small number of cases, referral to proctology for removal of visible anal lesions. Once again, these cases would likely not have been identified in the absence of this program. As of the beginning of 2013, no patient tested at the clinic has been found to have anal cancer.
Planning and Development ProcessKey steps included the following:
- Conducting study of existing VA program: The VA Medical Center in Miami started its anal cancer screening program in late 2005. At the time, Dr. Rosa-Cunha—an infectious disease specialist who later transferred to University of Miami/Jackson Memorial Hospital—was doing her medical fellowship at the VA; she played a key role in setting up the screening program there, in collaboration with the VA's infectious disease, pathology, and proctology departments. While at the VA, Dr. Rosa-Cunha conducted a pilot study that found that more than one-half (53 percent) of 131 patients screened had abnormal cytology results. Among those undergoing a followup anoscopy, 55 percent had high-grade anal neoplasia, including two cases of carcinoma in situ. These results provided evidence that the screening program could be an effective tool for preventing anal cancer.
- Securing approval and preparing for program launch: After completing her fellowship and establishing her practice as an infectious disease physician at University of Miami/Jackson Memorial Hospital, Dr. Rosa-Cunha expressed interest in extending the program to patients attending the hospital's HIV clinic. Based on her experience at the VA, hospital administrators agreed that such a program would be beneficial. In preparation for the program's launch, Dr. Rosa-Cunha was trained in high-resolution anoscopy, trained a nurse practitioner to perform the initial screening via anal Pap smear, and educated primary care physicians about their role in encouraging patients to get screened.
- Program expansion: The clinic has started to offer screening to women, with an emphasis on those who face an elevated risk for anal cancer because they are positive for both HIV and human papillomarvirus.
Resources Used and Skills Needed
- Staffing: The program did not require the hiring of additional clinic staff, as existing staff perform program-related services as part of their regular duties. As noted earlier, the program requires a nurse practitioner who can perform anal Pap smears and a physician who can perform anoscopies. The clinic's primary care physicians and hospital-based pathologists and proctologists also play important roles, as described earlier.
- Costs: Program costs are minimal, consisting primarily of staff time and supplies to perform and analyze the various tests. Because the hospital already had colposcopes (for use in Pap smears for women), no upfront investment was required to launch the screening program. Once the program was up and running, the hospital used grant funding to purchase additional colposcopes with enhanced image viewing and photographic capability.
Funding SourcesPatients' health insurance plans typically cover the cost of the screening.
Getting Started with This Innovation
- Recognize ease and benefits of screening: HIV providers often inaccurately perceive that screening for anal cancer consumes significant time and resources and provides limited value to patients. For this clinic, setting up the program proved to be easy and it has generated significant health benefits for patients.
- Educate primary care physicians: Clinic physicians may initially be reluctant to discuss anal cancer screening during time-pressed appointments. The person running the screening program should meet with physicians to educate them about the risks of anal cancer and the benefits of regular screening and discuss the best way to incorporate the topic into their patient interactions.
- Make referrals for anoscopies if necessary: Although this clinic has a physician who performs anoscopies, other clinics offering this program may find it easier to begin by referring patients to proctologists.
Sustaining This Innovation
- If feasible, have staff physician perform anoscopies: Once the program is established, it may be possible to train a staff physician or nurse practitioner to perform the procedure or hire a physician already trained to do so. Having a staff member perform anoscopies can reduce the time between the initial screening test and the anoscopy, and make it easier for patients to access care. If necessary, however, the referral approach described above can continue over the long term if it proves impractical to train or hire someone to perform this procedure.
- Emphasize need for followup: Patients with Pap smears showing abnormal cells may be reluctant to go to the anoscopy appointment, for many of the reasons cited previously (e.g., perceived discomfort, lack of awareness, fear of a cancer diagnosis). To minimize the no-show rate, make sure that staff who perform the Pap smear and schedule the anoscopy take the time needed to address any concerns the patient may have about the procedure.
- Evaluate and share data on program impact: Clinics with screening programs should closely track data demonstrating the positive impact of the program, such as the number of patients screened, the number testing positive, and the number with high-grade dysplasia. The clinics should also monitor patient characteristics, such as history of sexually transmitted diseases, number of sex partners in the past year, and viral load. This information can be used to demonstrate the program's effectiveness to key stakeholders (e.g., hospital leaders, clinic-based physicians) and to identify high-risk patients who should be the target of other screening initiatives.
Use By Other OrganizationsNew York, San Francisco, and Tampa are among U.S. cities with HIV clinics that offer similar anal Pap smear screening programs.
Contact the InnovatorIsabella Rosa-Cunha, MD
Assistant Professor of Clinical Medicine
Division of Infectious Diseases
University of Miami School of Medicine
Clinical Research Building
1120 NW 14th Street, Room 847 (D-90A)
Miami, FL 33136
Innovator DisclosuresDr. Rosa-Cunha reported that the clinic has received a grant from the AIDS Malignancy Clinical Trials Consortium, a group funded by the National Cancer Institute that supports innovative trials on AIDS-related cancers.
References/Related ArticlesRosa-Cunha I, Degennaro VA, Hartmann R, et al. Description of a pilot anal Pap smear screening program among individuals attending a Veteran's Affairs HIV clinic. Aids Patient Care STDS. 2011;25(4):213-9. [PubMed]
Palefsky JM, Holly EA, Ralston ML, et al. High incidence of anal high-grade squamous intra-epithelial lesions among HIV-positive and HIV-negative homosexual and bisexual men. AIDS. 1998;12:495-503. [PubMed]
Patel P, Hanson DL, Sullivan PS, et al. Incidence of types of cancer among HIV-infected persons compared with the general population in the United States, 1992–2003. Ann Intern Med. 2008;148:728-36. [PubMed]
Nathan M, Singh N, Garrett N, et al. Performance of anal cytology in a clinical setting when measured against histology and high-resolution anoscopy findings. AIDS. 2010;24(3):373-9. [PubMed]
Rosa-Cunha I, Degennaro VA, Hartmann R, et al. Description of a pilot anal Pap smear screening program among individuals attending a Veteran's Affairs HIV clinic. Aids Patient Care STDS. 2011;25(4):213-9. [PubMed]
Scott H, Khoury J, Moore BA, et al. Routine anal cytology screening for anal squamous intraepithelial lesions in an urban HIV clinic. Sex Transm Dis. 2008;35:197-202. [PubMed]
|Disclaimer: The inclusion of an innovation in the Innovations Exchange does not constitute or imply an endorsement by the U.S. Department of Health and Human Services, the Agency for Healthcare Research and Quality, or Westat of the innovation or of the submitter or developer of the innovation. Read more.|
Original publication: April 10, 2013.
Original publication indicates the date the profile was first posted to the Innovations Exchange.
Last updated: April 17, 2013.
Last updated indicates the date the most recent changes to the profile were posted to the Innovations Exchange.