Comparison of No-Test Telehealth and In-Person Medication Abortion.

Importance: In the US, access to medication abortion using history-based (no-test) eligibility assessment, including through telehealth and mailing of mifepristone, has grown rapidly. Additional evidence on the effectiveness and safety of these models is needed. Objective: To evaluate whether medication abortion with no-test eligibility assessment and mailing of medications is as effective as in-person care with ultrasonography and safe overall. Design, Setting, and Participants: Prospective, observational study with noninferiority analysis. Sites included 4 abortion-providing organizations in Colorado, Illinois, Maryland, Minnesota, Virginia, and Washington from May 2021 to March 2023. Eligible patients were seeking medication abortion up to and including 70 days' gestation, spoke English or Spanish, and were aged 15 years or older. Exposure: Study groups reflected the model of care selected by the patient and clinicians and included: (1) no-test (telehealth) eligibility assessment and mailing of medications (no-test + mail) (n = 228); (2) no-test eligibility assessment and pickup of medications (no-test + pickup) (n = 119); or (3) in-person with ultrasonography (n = 238). Main Outcomes and Measures: Effectiveness, defined as a complete abortion without the need for repeating the mifepristone and misoprostol regimen or a follow-up procedure, and safety, defined as an abortion-related serious adverse event, including overnight hospital admission, surgery, or blood transfusion. Outcomes were derived from patient surveys and medical records. Primary analysis focused on the comparison of the no-test + mail group with the in-person with ultrasonography group. Results: The mean age of the participants (N = 585) was 27.3 years; most identified as non-Hispanic White (48.6%) or non-Hispanic Black (28.1%). Median (IQR) gestational duration was 45 days (39-53) and comparable between study groups (P = .30). Outcome data were available for 91.8% of participants. Overall effectiveness was 94.4% (95% CI, 90.7%-99.2%) in the no-test + mail group and 93.3% (95% CI, 88.3%-98.2%) in the in-person with ultrasonography group in adjusted models (adjusted risk difference, 1.2 [95% CI, -4.1 to 6.4]), meeting the prespecified 5% noninferiority margin. Serious adverse events included overnight hospitalization (n = 4), blood transfusion (n = 2), and emergency surgery (n = 1) and were reported by 1.1% (95% CI, 0.4%-2.4%) of participants, with 3 in the no-test + mail group, 3 in the in-person with ultrasonography group, and none in the no-test + pickup group. Conclusions and Relevance: This prospective, observational study found that medication abortion obtained following no-test telehealth screening and mailing of medications was associated with similar rates of complete abortion compared with in-person care with ultrasonography and met prespecified criteria for noninferiority, with a low prevalence of adverse events.

Changes in the Frequency and Type of Barriers to Reproductive Health Care Between 2017 and 2021.

Importance: Previous research has documented individual-level barriers to reproductive health services, but few studies have examined national trends. Objective: To determine whether the number and type of barriers to reproductive health care experienced by US women of reproductive age changed from 2017 to 2021. Design, Setting, and Participants: This cross-sectional study used serial survey data, weighted to be nationally representative, collected in August 2017 and December 2021 from members of Ipsos's KnowledgePanel who were aged 18 to 49 years and assigned female at birth. Exposures: Having experienced barriers to reproductive health care over the past 3 years. Main Outcomes and Measures: The primary outcome was number and type of barriers to reproductive health care services, including Papanicolaou tests or birth control, experienced in the past 3 years. Increases in barriers to reproductive health care were measured using multivariable linear regressions adjusted for age, race and ethnicity, education level, employment status, metropolitan area, geographic region, household income, and language (English vs Spanish). Results: Of 29 496 KnowledgePanel members invited, 7022 (mean [SD] age, 33.9 [9.0] years) and 6841 (mean [SD] age, 34.2 [8.6] years) completed the 2017 and 2021 surveys (50% and 45% response rates, respectively). Among 12 351 participants who indicated that they had ever tried accessing reproductive health services, 35.9% (95% CI, 34.8%-37.0%) were aged 30 to 39 years; 5.5% (95% CI, 4.9%-6.2%) were Asian or Pacific Islander, 13.7% (95% CI, 12.8%-14.6%) were Black, 19.1% (95% CI, 18.1%-20.1%) were Hispanic, 58.2% (95% CI, 57.0%-59.5%) were White, and 3.5% (95% CI, 3.1%-4.0%) were multiracial or of other race or ethnicity; and 11.7% (95% CI, 11.0%-12.5%) were living below 100% of the federal poverty level. Covariate distribution was similar across years. In bivariable analyses, participants were more likely to report experiencing a given barrier in the past 3 years in 2021 than in 2017 for all but 2 barriers. More people experienced 3 or more barriers in 2021 (18.6%; 95% CI, 17.3%-20.0%) than in 2017 (16.1%; 95% CI, 14.9%-17.4%) (P = .008). In multivariable analyses, the mean number of barriers increased significantly from 1.09 (95% CI, 1.02-1.14) in 2017 to 1.29 (95% CI, 1.22-1.37) (P < .001) in 2021. Participants who were aged 25 to 29 years (0.42; 95% CI, 0.37-0.47), identified as Hispanic (0.41; 95% CI, 0.38-0.45), had no high school diploma or General Educational Development test (0.62; 95% CI, 0.53-0.72), lived below 100% of the federal poverty level (0.65; 95% CI, 0.55-0.73), and took the survey in Spanish (0.87; 95% CI, 0.73-1.01) saw the greatest increases in mean number of barriers between 2017 and 2021. Conclusions and Relevance: The study findings suggest that barriers to reproductive health care increased between 2017 and 2021, with the largest increases observed among individuals from historically disadvantaged populations. Efforts are needed to ensure that reproductive health care access remains a priority.

Pulmonary exposure of mice to ammonium perfluoro(2-methyl-3-oxahexanoate) (GenX) suppresses the innate immune response to carbon black nanoparticles and stimulates lung cell proliferation.

BACKGROUND: Per- and polyfluoroalkyl substances (PFAS) have been associated with respiratory diseases in humans, yet the mechanisms through which PFAS cause susceptibility to inhaled agents is unknown. Herein, we investigated the effects of ammonium perfluoro(2-methyl-3-oxahexanoate) (GenX), an emerging PFAS, on the pulmonary immune response of mice to carbon black nanoparticles (CBNP). We hypothesized that pulmonary exposure to GenX would increase susceptibility to CBNP through suppression of innate immunity. METHODS: Male C57BL/6 mice were exposed to vehicle, 4 mg/kg CBNP, 10 mg/kg GenX, or CBNP and GenX by oropharyngeal aspiration. Bronchoalveolar lavage fluid (BALF) was collected at 1 and 14 days postexposure for cytokines and total protein. Lung tissue was harvested for histopathology, immunohistochemistry (Ki67 and phosphorylated (p)-STAT3), western blotting (p-STAT3 and p-NF-κB), and qRT-PCR for cytokine mRNAs. RESULTS: CBNP increased CXCL-1 and neutrophils in BALF at both time points evaluated. However, GenX/CBNP co-exposure reduced CBNP-induced CXCL-1 and neutrophils in BALF. Moreover, CXCL-1, CXCL-2 and IL-1ß mRNAs were increased by CBNP in lung tissue but reduced by GenX. Western blotting showed that CBNP induced p-NF-κB in lung tissue, while the GenX/CBNP co-exposed group displayed decreased p-NF-κB. Furthermore, mice exposed to GenX or GenX/CBNP displayed increased numbers of BALF macrophages undergoing mitosis and increased Ki67 immunostaining. This was correlated with increased p-STAT3 by western blotting and immunohistochemistry in lung tissue from mice co-exposed to GenX/CBNP. CONCLUSIONS: Pulmonary exposure to GenX suppressed CBNP-induced innate immune response in the lungs of mice yet promoted the proliferation of macrophages and lung epithelial cells.

The relationship between hormonal contraception and cervical dysplasia/cancer controlling for human papillomavirus infection: A systematic review.

OBJECTIVE: Studies on the effect of long-term use of combined oral contraceptives (COCs) on cervical dysplasia and/or cancer risk have been inconsistent. Less is known about the effects of other forms of hormonal contraception (HC). We examine whether HC use increases the risk of incident cervical intraepithelial neoplasia (CIN) 2, 3 and/or cancer after accounting for preexisting human papillomavirus (HPV) infection. STUDY DESIGN: Systematic review of prospective studies on HC use as risk factor for cervical dysplasia with HPV infection documented prior to outcome assessment including PubMed and EMBASE records between January 2000 and February 2020 (Prospero #CRD42019130725). RESULTS: Among nine eligible studies, seven described recency and type of HC use and therefore comprise the primary analysis; two studies limit comparisons to ever versus never use and are summarized separately. All seven studies explored the relationship between oral contraceptive (OC) use and cervical dysplasia/cancer incidence: two found increased risk (adjusted odds ratio, aOR = 1.5-2.7), one found no association but decreased risk when restricted to women with persistent HPV (adjusted hazard ratio = 0.5), and four found no association. None of the seven studies differentiated between COC and progestin-only pills (POPs) by use recency or duration. The only study that included injectable progestin-only contraception (DMPA) found increased CIN3 incidence among current versus never users (aOR = 1.6). The one study that included Norplant found no association. Two studies included intrauterine device (IUD) use, but did not differentiate between hormonal and copper IUDs, and found no association. CONCLUSION: We found no consistent evidence that OC use is associated with increased risk for cervical dysplasia/cancer after controlling for HPV infection. There were too few studies of progestin-only injectables, implants or IUDs to assess their effect on cervical dysplasia/cancer risk. IMPLICATIONS: Use of single self-reported HC measures and insufficient distinction by hormonal constituent cloud our understanding of whether some HCs increase risk for cervical cancer. Methodologically rigorous studies with distinct HCs measured as time-varying exposures are needed to inform cervical cancer prevention efforts and improve our understanding of cervical cancer etiology.

Hormonal Contraceptives and the Acquisition of Sexually Transmitted Infections: An Updated Systematic Review.

BACKGROUND: Evidence suggests that some forms of hormonal contraception (HC) increase women's risk of non-human immunodeficiency virus sexually transmitted infections (STIs), yet evidence has not been reviewed since 2008. We conducted an updated systematic review to incorporate studies published between January 2009 and June 2017 to examine the relationship between HCs and incident or recurrent STIs. METHODS: We searched PubMed and EMBASE to identify prospective studies comparing risk of Chlamydia trachomatis, Neisseria gonorrhoeae, human papillomavirus (HPV), herpes simplex virus type 2 (HSV-2), Treponema pallidum, or Trichomonas vaginalis, between women using HC versus nonhormonal methods or no methods. We summarize results by type of STI and HC and study quality using an adapted Newcastle-Ottawa Quality Assessment Scale. RESULTS: Thirty articles met the inclusion criteria. Depo-medroxyprogesterone acetate (DMPA) reduces the risk of trichomoniasis (consistent evidence) and may increase the risk of HSV-2 (strong effect, few studies); inconclusive evidence exists for HPV, chlamydia, gonorrhea, and syphilis. Data on oral contraceptive pills (OCPs; generally not differentiated whether combined or progestin-only pills) suggest that use is associated with a reduced risk of trichomoniasis with inconclusive findings for HSV-2, HPV, chlamydia, gonorrhea, and syphilis. Very few studies included norethisterone enanthate (Net-En) injectable, implants or the levonorgestrel intrauterine device. CONCLUSIONS: Depo-medroxyprogesterone acetate and OCPs reduce the risk of trichomoniasis and DMPA may increase the risk of HSV-2. However, the potential for confounding cannot be ruled out. Future studies should specify the type of injectable or OCP used to increase understanding of biological pathways; more research is needed on implants and hormonal intrauterine devices.

Are hormonal contraceptive users more likely to misreport unprotected sex? Evidence from a biomarker validation study in Zimbabwe.

We analyzed biomarker validation data of unprotected sex from women in Zimbabwe to determine whether condom and sexual behavior misreporting differs between users of different contraceptive methods. Self-reported sexual behavior was compared with the presence of prostate-specific antigen (PSA) in vaginal fluid, a biomarker of semen exposure. Of the 195 women who were PSA positive, 94 (48 %) reported no sex or only condom-protected sex. Hormonal contraceptive users misreported sexual behavior less than women using non-hormonal methods (45 vs. 67 %, P = 0.03). This misclassification pattern could have implications on the elevated risk of HIV infection associated with hormonal contraception in some studies.