Barriers to Cervical Cancer Screening by Sexual Orientation Among Low-Income Women in North Carolina.

We sought to examine cervical cancer screening barriers by sexual orientation among low-income women in North Carolina. The MyBodyMyTest-3 Trial recruited low-income women (< 250% of federal poverty level) aged 25-64 years who were 1+ year overdue for cervical cancer screening. We compared perceptions of cervical cancer screening among those who self-identified as lesbian, gay, bisexual, or queer (LGBQ; n = 70) to straight/heterosexual women (n = 683). For both LGBQ and straight respondents, the greatest barriers to screening were lack of health insurance (63% and 66%) and cost (49% and 50%). LGBQ respondents were more likely than straight respondents to report forgetting to screen (16% vs. 8%, p = .05), transportation barriers (10% vs. 2%, p = .001), and competing mental or physical health problems (39% vs. 27%, p = .10). Addressing access remains important for improving cervical cancer screening among those under-screened. For LGBQ women, additional attention may be needed for reminders, co-occurring health needs, and transportation barriers.

Cervical Cancer Screening Knowledge, Perceptions, and Behaviors in a Multiracial Cohort of Low-Income, Underscreened Women in North Carolina.

Background: Underscreened, low-income, and uninsured or publicly insured women in the United States bear a greater burden of cervical cancer morbidity and mortality and may face unique barriers that preclude screening adherence. Methods: Participants were 710 My Body My Test-3 clinical trial participants who were publicly insured or uninsured with incomes ≤250% of the U.S. Federal Poverty Level, aged 25-64 years, and not up to date on cervical cancer screening as per national guidelines. Using Health Belief Model constructs, we assessed screening-related knowledge, perceptions, and behaviors-overall and stratified by race and ethnicity-and estimated associations with past-year attempted screening using multivariable regression models. Results: Overall, knowledge was low about the human papillomavirus, purpose of a Pap test, and recommended screening interval. Perceived severity of cervical cancer was high (3.63 on a 4-point scale). Black and Latina/Hispanic women were more likely to perceive screening as lowering their risk of cervical cancer than White women. Black women reported lower perceived risk of cervical cancer compared with White women (p = 0.03), but Black women were more likely to have sought screening in the past year (p = 0.01). Having at least three doctor visits in the past year was associated with a screening attempt. Greater perceived risk of cervical cancer, more positive perceptions of screening, and feeling more nervousness about screening were also associated with a screening attempt (all p < 0.05). Conclusions: Addressing knowledge gaps and misconceptions about cervical cancer screening and leveraging positive perceptions of screening may improve screening uptake and adherence among diverse underscreened U.S. women. Clinical Trial Registration Number: NCT02651883.

Effect of HPV self-collection kits on cervical cancer screening uptake among under-screened women from low-income US backgrounds (MBMT-3): a phase 3, open-label, randomised controlled trial.

BACKGROUND: Most cervical cancer in the USA occurs in under-screened women. The My Body, My Test-3 (MBMT-3) trial sought to assess the efficacy of mailed human papillomavirus (HPV) self-collection kits with appointment-scheduling assistance to increase uptake of cervical cancer screening among under-screened women from low-income backgrounds compared with scheduling assistance alone. METHODS: MBMT-3 is a phase 3, open-label, two-arm, randomised controlled trial. Participants were recruited from 22 counties in North Carolina state, USA, and we partnered with 21 clinics across these counties. Participants were eligible for inclusion if they were aged 25-64 years, had an intact cervix, were uninsured or enrolled in Medicaid or Medicare, had an income of 250% or less of the US Federal Poverty Level, were living within the catchment area of a trial-associated clinic, and were overdue for screening (ie, Papanicolaou test ≥4 years ago or high-risk HPV test ≥6 years ago). Participants were randomly assigned (2:1) to receive a mailed HPV self-collection kit and assistance for scheduling a free screening appointment (intervention group) or to receive scheduling assistance alone (control group). Randomisation was conducted by county using permuted blocks of nine patients and assignment to group was not masked. Participants in the intervention group were mailed HPV self-collection kits to collect a cervical-vaginal sample and return it by mail for testing. Samples were tested with the Aptima HPV assay (Hologic, San Diego, CA, USA), and participants were informed of high-risk HPV results by telephone call. Trial staff made up to three telephone call attempts to provide scheduling assistance for in-clinic screening for all participants. The primary outcome was cervical cancer screening uptake (ie, attending an in-clinic screening appointment or testing negative for high-risk HPV with a returned self-collected sample) within 6 months of enrolment in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02651883, and has been completed. FINDINGS: Recruitment occurred between April 11, 2016, and Dec 16, 2019. 4256 women contacted the trial to participate, of whom 899 (21%) were eligible for inclusion and 697 (78%) returned consent forms. Of those who consented, 461 (66%) women were randomly assigned to the intervention group and 236 (34%) women were randomly assigned to the control group. We excluded 32 ineligible women post-randomisation, leaving 665 for primary analysis. Screening uptake was higher in the intervention group (317 [72%] of 438) than control group (85 [37%] of 227; risk ratio 1·93, 95% CI 1·62-2·31). Among intervention participants, 341 (78%) of 438 returned a self-collection kit. Three participants reported hurt or injury when using the self-collection kit; no participants withdrew due to adverse effects. INTERPRETATION: Among under-screened women from low-income backgrounds, mailed HPV self-collection kits with scheduling assistance led to greater uptake of cervical cancer screening than scheduling assistance alone. At-home HPV self-collection testing has the potential to increase screening uptake among under-screened women. FUNDING: National Cancer Institute.

Recruitment strategies and HPV self-collection return rates for under-screened women for cervical cancer prevention.

In the United States, medically underserved women carry a heavier burden of cancer incidence and mortality, yet are largely underrepresented in cancer prevention studies. My Body, My Test is a n observational cohort, multi-phase cervical cancer prevention study in North Carolina that recruited low-income women, aged 30-65 years and who had not undergone Pap testing in ≥ 4 years. Participants were offered home-based self-collection of cervico-vaginal samples for primary HPV testing. Here, we aimed to describe the recruitment strategies utilized by study staff, and the resulting recruitment and self-collection kit return rates for each specific recruitment strategy. Participants were recruited through different approaches: either direct (active, staff-effort intensive) or indirect (passive on the part of study staff). Of a total of 1,475 individuals screened for eligibility, 695 were eligible (47.1%) and 487 (70% of eligible) participants returned their self-collection kit. Small media recruitment resulted in the highest number of individuals found to be study eligible, with a relatively high self-collection kit return of 70%. In-clinic in-reach resulted in a lower number of study-eligible women, yet had the highest kit return rate (90%) among those sent kits. In contrast, 211 recruitment which resulted in the lowest kit return of 54%. Small media, word of mouth, and face-to-face outreach resulted in self-collection kit return rates ranging from 72 to 79%. The recruitment strategies undertaken by study staff support the continued study of reaching under-screened populations into cervical cancer prevention studies.

Racial and ethnic differences in cervical cancer screening barriers and intentions: The My Body My Test-3 HPV self-collection trial among under-screened, low-income women.

Under-screened women are more likely to be diagnosed with invasive cervical cancer at later stages and have worse survival outcomes. Under- or un-insured women, low-income women, and minoritized groups face barriers to screening. Intention to screen is an indicator of future screening behavior, yet is understudied among low-income, under-screened women. Participants were 710 low-income, uninsured or publicly insured women ages 25-64 years in North Carolina who were not up to date on cervical cancer screening according to national guidelines. Participants were asked about barriers to screening and intention to screen. We estimated reported barriers to cervical cancer screening stratified by race and ethnicity (categorized as White, Black, and Hispanic) and assessed predictors of intention to screen. Sixty-one percent of all participants reported 5 or more barriers to screening. The most commonly reported reasons for not getting screened were lack of insurance (White: 71%, Black: 62%, Hispanic/Latina: 63%) and cost (White: 55%, Black: 44%, Hispanic/Latina: 61%). Women were more likely to have an intention to screen if they reported "it was not hard to get screening" (OR: 1.47 (1.00, 2.15)). Older women reported being less likely to intend to screen. Black women reported being more likely to intend to screen than White women. Lack of health insurance and cost were frequently reported barriers to cervical cancer screening. Increasing knowledge of affordable clinics and expanding access to Medicaid may reduce barriers and increase cervical cancer screening uptake.

Prevalence of High-Risk Human Papillomavirus by RNA Assay in Home Self-Collected Samples Among Underscreened People in North Carolina.

BACKGROUND: Low-income and uninsured people with a cervix (PWC) are at the highest risk of being underscreened for cervical cancer. We evaluated the prevalence of high-risk human papillomavirus (hrHPV) on home self-collected samples, as well as rates of in-clinic follow-up and risk factors associated with hrHPV positivity in this at-risk population. METHODS: My Body My Test 3 was conducted between 2016 and 2019 in North Carolina among individuals aged 25 to 64 years, overdue for cervical cancer screening, and with incomes of <250% of the US Federal Poverty Level. Our analytic sample included participants randomized to the self-collection arm who returned self-collected cervicovaginal brush samples for HPV testing (n = 329). Samples were tested for 14 hrHPV types by an HPV RNA assay and further genotyped for HPV-16 and HPV-18/45. We examined behavioral risk factors for hrHPV positivity using logistic regression and between-subject t tests. RESULTS: High-risk HPV RNA prevalence was 16% (n = 52/329) in self-collected samples. Of the hrHPV-positive participants, 24 (46%) presented for in-clinic cervical cancer screening, compared with 56 (20%) of hrHPV-negative participants. Those with ≥2 sexual partners in the past year were twice as likely to be hrHPV positive in adjusted analyses (adjusted odds ratio, 2.00 [95% confidence interval, 1.03-3.88]). High-risk HPV-positive and HPV-negative participants had similar attitudes toward screening, with the exception of hrHPV-positive participants who reported a lower perceived risk of cervical cancer than those who were hrHPV negative (P < 0.05). CONCLUSION: The hrHPV RNA prevalence was similar to findings in other underscreened PWC in the United States. Efforts to reach underscreened PWC are critical for cervical cancer prevention. Future studies aimed at home self-collection should address methods of increasing clinic attendance and completion of treatment among those with HPV-positive results.

Perceived Financial Barriers to Cervical Cancer Screening and Associated Cost Burden Among Low-Income, Under-Screened Women.

Background: Despite screening's effectiveness in reducing cervical cancer incidence and mortality, disparities in cervical cancer screening uptake remain, with lower rates documented among uninsured and low-income individuals. We examined perceived financial barriers to, and the perceived cost burden of, cervical cancer screening. Materials and Methods: We surveyed 702 low-income, uninsured or publicly insured women ages 25-64 years in North Carolina, U.S., who were not up to date on cervical cancer screening according to national guidelines. Participants were asked about perceived financial barriers to screening and how much they perceived screening would cost. We used multivariable logistic regression to assess the sociodemographic predictors of perceived financial barriers. Results: Seventy-two percent of participants perceived financial barriers to screening. Screening appointment costs (71%) and follow-up/future treatment costs (44%) were most commonly reported, followed by lost pay due to time missed from work (6%) and transportation costs (5%). In multivariable analysis, being uninsured (vs. publicly insured), younger (25-34 vs. 50-64 years), White (vs. Black), and not reporting income data were associated with perceiving screening costs and future treatment costs as barriers to screening. Participants reported wide-ranging estimates of the perceived out-of-pocket cost of screening ($0-$1300), with a median expected cost of $245. Conclusions: The majority of our sample of low-income women perceived substantial financial barriers to screening, particularly related to screening appointment costs and potential follow-up/future treatment costs. Providing greater cost transparency and access to financial assistance may reduce perceived financial barriers to screening, potentially increasing screening uptake among this underserved population. Clinicaltrials.gov registration number NCT02651883.

Predictors of Cervical Cancer Screening Among Infrequently Screened Women Completing Human Papillomavirus Self-Collection: My Body My Test-1.

Background: Approximately one-half of cervical cancer cases in the United States occur in underscreened or never-screened women. We examined predictors to completing Papanicolaou (Pap) testing and whether a positive human papillomavirus (HPV) self-collection result affects Pap testing adherence among underscreened women. Materials and Methods: Low-income women aged 30-65 years who reported no Pap testing in ≥4 years were recruited in North Carolina. Knowledge, attitudes, and barriers regarding cervical cancer and Pap testing were assessed by telephone questionnaires. We mailed self-collection kits for HPV testing and provided information regarding where to obtain affordable Pap testing. Participants received $45 for completing all activities. We used multivariable logistic regression to assess the predictors of longer reported time since last Pap (≥10 vs. 4-9 years) and of completion of Pap testing following study enrollment (follow-up Pap). Results: Participants (n = 230) were primarily black (55%), uninsured (64%), and with ≤high school education (59%). Cost and finding an affordable clinic were the most commonly reported barriers to screening. White women and those with ≤high school education reported longer intervals since last Pap test. Half of the participants reported completing a follow-up Pap test (55%). Women with a positive HPV self-collection were five times more likely to report completing a follow-up Pap test than those with negative self-collection (odds ratio = 5.1, 95% confidence interval 1.4-25.7). Conclusions: Improving awareness of resources for affordable screening could increase cervical cancer screening in underserved women. Home-based HPV self-collection represents an opportunity to re-engage infrequently screened women into preventive screening services.

Home Self-Collection by Mail to Test for Human Papillomavirus and Sexually Transmitted Infections.

OBJECTIVE: To evaluate the validity and acceptability of at-home self-collection to test for high-risk human papillomavirus (HPV) and sexually transmitted infections among women overdue for cervical cancer screening by national guidelines. METHODS: Low-income, infrequently screened women were recruited from the general population in North Carolina to participate in an observational study. Participants provided two self-collected cervicovaginal samples (one at home and one in the clinic) and a clinician-collected cervical sample. Samples were tested for high-risk HPV, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium. Cervical samples were also tested by liquid-based cytology. RESULTS: Overall, 193 women had conclusive high-risk HPV results for all three samples and cytology results. Prevalence of high-risk HPV within self-home samples (12.4%) was not different from that within clinician samples (11.4%; P=.79) and from that within self clinic samples (15.5%; P=.21). Positivity for high-risk HPV in all sample types increased with increasing grades of cervical abnormality (P<.001). Self-home samples detected high-risk HPV in all identified cases of high-grade squamous intraepithelial lesions and of cervical intraepithelial neoplasia 2 or worse. Detection was comparable across sample types for T vaginalis (range 10.2-10.8%), M genitalium (3.3-5.5%), C trachomatis (1.1-2.1%), and N gonorrhoeae (0-0.5%). Kappa values between sample types ranged from 0.56 to 0.66 for high-risk HPV, 0.86-0.91 for T vaginalis, and 0.65-0.83 for M genitalium. Most participants reported no difficulty understanding self-collection instructions (93.6%) and were willing to use self-collection in the future (96.3%). CONCLUSION: Mail-based, at-home self-collection for high-risk HPV and sexually transmitted infection detection was valid and well accepted among infrequently screened women in our study. These findings support the future use of high-risk HPV self-collection to increase cervical cancer screening rates among higher risk women in the United States.

Preference for Human Papillomavirus Self-Collection and Papanicolaou: Survey of Underscreened Women in North Carolina.

OBJECTIVES: Self-collection of samples for human papillomavirus (HPV) testing (self-collection) has the potential to increase cervical cancer screening among underscreened women. We assessed attitudes toward at-home HPV self-collection compared with clinic-based Pap testing in this higher-risk population. MATERIALS AND METHODS: Participants were low-income women in North Carolina overdue for cervical cancer screening. Women self-collected samples at home, returned samples by mail for HPV testing, and completed phone questionnaires about at-home HPV self-collection. Participants were referred to clinic-based Pap testing and invited to complete a second questionnaire about Pap testing. A cross-sectional questionnaire compared attitudes, experiences, and preferences for self-collection versus Pap testing and assessed predictors of preference for HPV self-collection. RESULTS: Half (51%) of 221 women reported a preference for HPV self-collection, 19% preferred Pap testing, and 27% reported no preference. More women reported difficulty finding time to do the Pap test (31%) than the self-test (13%, p = .003) and being afraid of the self-test results (50%) than the Pap test results (36%, p = .02). There were relatively fewer reports of physical discomfort and pain from self-collection than Pap testing (discomfort: 18% self; 48% Pap; pain: 8% self; 30% Pap, p = .001). No differences were found in positive versus negative thoughts about the tests, trust in the tests' safety and accuracy, or willingness to do tests again. CONCLUSIONS: Overall positive attitudes toward HPV self-collection compared with Pap testing among underscreened women suggest that self-collection is a promising option to increase cervical cancer screening in this high-risk population.

Acceptability and ease of use of mailed HPV self-collection among infrequently screened women in North Carolina.

OBJECTIVES: Self-collection of cervico-vaginal samples for human papillomavirus (HPV) testing has the potential to make cervical cancer screening more accessible to underscreened women. We evaluated the acceptability and ease of use of home-based HPV self-collection within a diverse population of low-income, infrequently screened women. METHODS: Participants were low-income women from North Carolina who had not received Pap testing in 4 or more years. Eligible women received a self-collection kit containing instructions and a brush for home-based sample collection. A total of 227 women returned a self-collected sample by mail and completed a questionnaire to assess their experiences with HPV self-collection. We described acceptability measures and used logistic regression to identify predictors of overall positive thoughts about the self-collection experience. RESULTS: Nearly all women were willing to perform HPV self-collection again (98%) and were comfortable receiving the self-collection kit in the mail (99%). Overall, 81% of participants reported positive thoughts about home-based self-collection. Women with at least some college education and those who were divorced, separated or widowed were more likely to report overall positive thoughts. Aspects of self-collection that participants most commonly reported liking included convenience (53%), ease of use (32%) and privacy (23%). The most frequently reported difficulties included uncertainty that the self-collection was done correctly (16%) and difficulty inserting the self-collection brush (16%). CONCLUSIONS: Home-based self-collection for HPV was a highly acceptable screening method among low-income, underscreened women and holds the promise to increase access to cervical cancer screening in this high-risk population.

Mailed Human Papillomavirus Self-Collection With Papanicolaou Test Referral for Infrequently Screened Women in the United States.

BACKGROUND: Testing for high-risk human papillomavirus (HPV) infection using mailed, self-collected samples is a promising approach to increase screening in women who do not attend clinic screening at recommended intervals. METHODS: To assess this intervention among high-risk women in the United States, 429 women without a Papanicolaou (Pap) test in 4 or more years (overdue by US guidelines) were recruited from the general population. Participants aged 30 to 65 years were mailed a kit to self-collect a cervicovaginal sample at home, return the sample by mail, and receive HPV results by telephone, with referral to follow-up cytological Pap testing at a local clinic. Cervicovaginal self-samples were collected with a Viba brush, stored in Scope mouthwash, and tested by Hybrid Capture 2. Data were collected in 2010 to 2011 and analyzed in 2017. RESULTS: Two-thirds (64%) of participants returned a self-collected sample, of whom 15% tested HPV DNA positive. Human papillomavirus self-test-positive women reported higher rates of follow-up Pap tests (82%) than did those with self-test negative results (51%). No demographic differences were found in self-test return rate or HPV positivity. High acceptability was reported in participant surveys: most women (81%) had "mostly positive" overall thoughts about the self-test, and most reported being comfortable receiving the kit in the mail (99%), returning their self-collected sample by mail (82%), and receiving their test results by telephone (97%). CONCLUSIONS: Conducting HPV self-testing through population-based recruitment, mailed kit delivery and return by mail, and results delivery by telephone has the potential to reach a broad segment of US underscreened women.

The Need to Promote Sexual Health in America: A New Vision for Public Health Action.

Sexual health is considered to be a state of wellness with physical, emotional, mental, and social dimensions. Sexual health can contribute to our overall well-being in each of these dimensions. However, despite the intrinsic importance and positive aspects of sexuality in our lives, the United States presently faces significant challenges related to the sexual health of its citizens, including human immunodeficiency virus, other sexually transmitted infections, viral hepatitis, unintended pregnancies, sexual violence, sexual dysfunction, and cancers in reproductive tracts with serious disparities among the populations affected. In particular, high rates of poverty, income inequality, low educational attainment, stigma, racism, sexism, and homophobia can make it more difficult for some individuals and communities to protect their sexual health. Given that many pressing public health issues in the United States are related to sexual health and that sexual health has been increasingly recognized as an important national health priority, now is the time to energize and focus our efforts toward optimal sexual health of the population. In this paper, we outline the rationale for addressing sexual health as a means to better promote overall health and address sexuality related morbidities. In addition, we present a logic model outlining an approach for advancing sexual health in the United States, as well as a range of action steps for consideration by public health practitioners, researchers, and policymakers.

Cervical cancer screening in a sexually transmitted disease clinic: screening adoption experiences from a midwestern clinic.

OBJECTIVES: We examined whether a sexually transmitted disease (STD) clinic could reach women who had not received a Papanicolau (Pap) test in the past 3 years. We also explored staff attitudes and implementation of cervical cancer screening. METHODS: Women (n = 123) aged 30 to 50 years were offered cervical cancer screening in an Indiana STD clinic. We measured effectiveness by the patients' self-reported last Pap test. We explored adoption of screening through focus groups with 34 staff members by documenting their attitudes about cervical cancer screening and screening strategy adaptation. We also documented recruitment and screening implementation. RESULTS: Almost half (47.9%) of participants reported a last Pap test 3 or more years previously; 30% had reported a last Pap more than 5 years ago, and 11.4% had a high-risk test outcome that required referral to colposcopy. Staff supported screening because of mission alignment and perceived patient benefit. Screening adaptations included eligibility, results provision, and follow-up. CONCLUSIONS: Cervical cancer screening was possible and potentially beneficial in STD clinics. Future effectiveness-implementation studies should expand to include all female patients, and should examine the degree to which adaptation of selected adoption frameworks is feasible.

Perceptions of mailed HPV self-testing among women at higher risk for cervical cancer.

Whether human papillomavirus (HPV) self-testing can expand access to cervical cancer screening will depend on making the test accessible and acceptable to higher-risk women. To evaluate a novel delivery mode, we mailed HPV self-test kits to low-income, under-screened women and assessed their perceptions of self-testing and cervical cancer prevention. We conducted a telephone survey of 199 women in North Carolina. Eligibility criteria included not having had a Pap test in 4 years and reporting 1 or more indicators of economic hardship, such as being uninsured. Over half (55 %) of women in the diverse sample were non-Hispanic black, and almost three-quarters (74 %) reported annual household incomes of $20,000 or less. Trust in HPV self-testing was moderate to high, with almost all women (98 %) agreeing the mailed test was safe. A few women (6 %) preferred HPV self-testing to Pap testing for protecting health, but most (75 %) had no preference. Trust in or preference for mailed self-testing did not vary by race or income. However, compared to white women, black women had lower HPV-related knowledge (OR 0.46, 95 % CI 0.23-0.92) and perceived lower cervical cancer risk in the absence of screening (OR 0.44, 95 % CI 0.22-0.86). We found similar patterns of disparities for women with very low (<$10,000) versus relatively higher incomes. Our findings suggest that, across racial and economic subgroups, under-screened women generally trust HPV self-tests delivered by mail. To succeed, programs for HPV self-testing must overcome disparities in knowledge and perceptions related to cervical cancer screening.

Pramipexole vs levodopa as initial treatment for Parkinson disease: a 4-year randomized controlled trial.

BACKGROUND: The best way to initiate dopaminergic therapy for early Parkinson disease remains unclear. OBJECTIVE: To compare initial treatment with pramipexole vs levodopa in early Parkinson disease, followed by levodopa supplementation, with respect to the development of dopaminergic motor complications, other adverse events, and functional and quality-of-life outcomes. DESIGN: Multicenter, parallel-group, double-blind, randomized controlled trial. SETTING: Academic movement disorders clinics at 22 sites in the United States and Canada. PATIENTS: Patients with early Parkinson disease (N = 301) who required dopaminergic therapy to treat emerging disability, enrolled between October 1996 and August 1997 and observed until August 2001. INTERVENTION: Subjects were randomly assigned to receive 0.5 mg of pramipexole 3 times per day with levodopa placebo (n = 151) or 25/100 mg of carbidopa/levodopa 3 times per day with pramipexole placebo (n = 150). Dosage was escalated during the first 10 weeks for patients with ongoing disability. Thereafter, investigators were permitted to add open-label levodopa or other antiparkinsonian medications to treat ongoing or emerging disability. MAIN OUTCOME MEASURES: Time to the first occurrence of dopaminergic complications: wearing off, dyskinesias, on-off fluctuations, and freezing; changes in the Unified Parkinson's Disease Rating Scale and quality-of-life scales; and adverse events. RESULTS: Initial pramipexole treatment resulted in a significant reduction in the risk of developing dyskinesias (24.5% vs 54%; hazard ratio, 0.37; 95% confidence interval [CI], 0.25-0.56; P<.001) and wearing off (47% vs 62.7%; hazard ratio, 0.68; 95% CI, 0.49-0.63; P =.02). Initial levodopa treatment resulted in a significant reduction in the risk of freezing (25.3% vs 37.1%; hazard ratio, 1.7; 95% CI, 1.11-2.59; P =.01). By 48 months, the occurrence of disabling dyskinesias was uncommon and did not significantly differ between the 2 groups. The mean improvement in the total Unified Parkinson's Disease Rating Scale score from baseline to 48 months was greater in the levodopa group than in the pramipexole group (2 +/- 15.4 points vs -3.2 +/- 17.3 points, P =.003). Somnolence (36% vs 21%, P =.005) and edema (42% vs 15%, P<.001) were more common in pramipexole-treated subjects than in levodopa-treated subjects. Mean changes in quality-of-life scores did not differ between the groups. CONCLUSIONS: Initial treatment with pramipexole resulted in lower incidences of dyskinesias and wearing off compared with initial treatment with levodopa. Initial treatment with levodopa resulted in lower incidences of freezing, somnolence, and edema and provided for better symptomatic control, as measured by the Unified Parkinson's Disease Rating Scale, compared with initial treatment with pramipexole. Both options resulted in similar quality of life. Levodopa and pramipexole both appear to be reasonable options as initial dopaminergic therapy for Parkinson disease, but they are associated with different efficacy and adverse-effect profiles.