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Vaccination against the most common oncogenic human papillomavirus (HPV) types, HPV-16 and HPV-18, could prevent development of up to 70% of cervical cancers worldwide. We did a randomised, double-blind, controlled trial to assess the efficacy, safety, and immunogenicity of a bivalent HPV-16/18 L1 virus-like particle vaccine for the prevention of incident and persistent infection with these two virus types, associated cervical cytological abnormalities, and precancerous lesions. We randomised 1113 women between 15–25 years of age to receive three doses of either the vaccine formulated with AS04 adjuvant or placebo on a 0 month, 1 month, and 6 month schedule in North America and Brazil. Women were assessed for HPV infection by cervical cytology and self-obtained cervicovaginal samples for up to 27 months, and for vaccine safety and immunogenicity. In the according-to-protocol analyses, vaccine efficacy was 91·6% (95% CI 64·5–98·0) against incident infection and 100% against persistent infection (47·0–100) with HPV-16/18. In the intention-to-treat analyses, vaccine efficacy was 95·1% (63·5–99·3) against persistent cervical infection with HPV-16/18 and 92·9% (70·0–98·3) against cytological abnormalities associated with HPV-16/18 infection. The vaccine was generally safe, well tolerated, and highly immunogenic. The bivalent HPV vaccine was efficacious in prevention of incident and persistent cervical infections with HPV-16 and HPV-18, and associated cytological abnormalities and lesions. Vaccination against such infections could substantially reduce incidence of cervical cancer.

Introduction and hypothesis We evaluated a pilot multi-component reintegration intervention to improve women’s physical and psychosocial quality of life after genital fistula surgery. Methods Twelve women undergoing fistula repair at Mulago Specialized Women and Neonatal Hospital (Kampala, Uganda) anticipated in a 2-week multi-component intervention including health education, psychosocial therapy, physiotherapy, and economic investment. We assessed feasibility through recruitment, retention, and adherence, acceptability through intervention satisfaction, and preliminary effectiveness through reintegration, mental health, physical health, and economic status. We collected quantitative data at enrollment, 6 weeks, 3 months, and 6 months. We conducted in-depth interviews with six participants. Quantitative data are presented descriptively, and qualitative data analyzed thematically. Results Participants had a median age of 34.5 years (25.5–38.0), 50% were married/partnered, 42% were separated, 50$ had completed less than primary education, and 67% were unemployed. Mean number of sessions received was 12 for health education (range 5–15), 8 for counseling (range 8–9), and 6 for physiotherapy (range 4–8). Feasibility was demonstrated by study acceptance among all those eligible (100%); comfort with study measures, data collection frequency and approach; and procedural fidelity. Acceptability was high; all participants reported being very satisfied with the intervention and each of the components. Participant narratives echoed quantitative findings and contributed nuanced perspectives to understanding approach and content. Conclusions Our results suggest that the intervention and associated research were both feasible and acceptable, and suggested certain modifications to the intervention protocol to reduce participant burden. Further research to determine the effectiveness of the intervention above and beyond surgery alone with regard to the health and well-being of women with fistulas is warranted.

Background: The majority of women with tubal damage do not have a history of acute pelvic inflammatory disease. The prevalence of upper genital tract inflammation was evaluated in women deemed not to have pelvic inflammatory disease by common diagnostic criteria. Goal of this Study: To compare clinical signs and laboratory tests used to diagnose pelvic inflammatory disease with endometrial biopsy histopathology. Study Design: Endometrial biopsy and commonly used physical and laboratory tests were performed on 52 women with pelvic tenderness, 51 with vaginosis or cervicitis, and 22 control subjects who had no evidence of infection with Neisseria gonorrhoeae or Chlamydia trachomatis and who tested negative for bacterial vaginosis using vaginal swab Gram's stain. Results: Thirty-six of 52 patients (69%) with pelvic tenderness, compared with 22 of 51 patients (43%) with vaginosis or cervicitis and two of 22 control subjects (9%), had plasma cell endometritis. The Centers for Disease Control and Prevention minimal diagnostic criteria for pelvic inflammatory disease had a sensitivity of 33% for plasma cell endometritis. Conclusions: The clinical diagnosis of pelvic inflammatory disease using published criteria correlates poorly with plasma cell endometritis.