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Comparing self- and provider-collected swabbing for HPV DNA testing in female-to-male transgender adult patients: a mixed-methods biobehavioral study protocol.

ABSTRACT: Cervical cancer, nearly all cases of which are caused by one of several high-risk strains of the human papillomavirus (hr-HPV), leads to significant morbidity and mortality in individuals with a cervix. Trans masculine (TM) individuals were born with female reproductive organs and identify as male, man, transgender man, or another diverse gender identity different from their female assigned sex at birth. Routine preventive sexual health screening of TM patients is recommended, including screening for cervical cancer and other sexually transmitted infections (STIs); however, as many as one in three TM patients are not up-to-date per recommended U.S.Among cisgender (non-transgender) women, self-swab hr.-HPV DNA testing as a primary cervical cancer screening method and self-swab specimen collection for other STIs have high levels of acceptability. No study has yet been conducted to compare the performance and acceptability of self- and provider-collected swabs for hr.-HPV DNA testing and other STIs in TM patients.This article describes the study protocol for a mixed-methods biobehavioral investigation enrolling 150 sexually active TM to (1) assess the clinical performance and acceptability of a vaginal self-swab for hr.-HPV DNA testing compared to provider cervical swab and cervical cytology, and (2) gather acceptability data on self-collected specimens for other STIs. Study participation entails a one-time clinical visit at Fenway Health in Boston, MA comprised of informed consent, quantitative assessment, venipuncture for syphilis testing and HIV (Rapid OraQuick) testing, randomization, collection of biological specimens/biomarkers, participant and provider satisfaction survey, and qualitative exit interview. Participants are compensated $100. The primary study outcomes are concordance (kappa statistic) and performance (sensitivity and specificity) of self-collected vaginal HPV DNA specimens vs provider-collected cervical HPV swabs as a gold standard.This study addresses critical gaps in current clinical knowledge of sexual health in TM patients, including comparing alternative strategies for screening and diagnosis of cervical cancer, hr.-HPV, and other STIs. Findings have implications for improving the delivery of sexual health screening to this often overlooked and underserved patient population. Less-invasive patient-centered strategies may also generalize to other at-risk cisgender female populations that face barriers to timely and needed STI and cervical cancer screening.ClinicalTrials.gov ID: NCT02401867.

SUBMITTER: Reisner SL

PROVIDER: S-EPMC5481878 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Comparing self- and provider-collected swabbing for HPV DNA testing in female-to-male transgender adult patients: a mixed-methods biobehavioral study protocol.

Reisner Sari L SL Deutsch Madeline B MB Peitzmeier Sarah M SM White Hughto Jaclyn M JM Cavanaugh Timothy T Pardee Dana J DJ McLean Sarah S Marrow Elliot J EJ Mimiaga Matthew J MJ Panther Lori L Gelman Marcy M Green Jamison J Potter Jennifer J

BMC infectious diseases 20170623 1

<h4>Background</h4>Cervical cancer, nearly all cases of which are caused by one of several high-risk strains of the human papillomavirus (hr-HPV), leads to significant morbidity and mortality in individuals with a cervix. Trans masculine (TM) individuals were born with female reproductive organs and identify as male, man, transgender man, or another diverse gender identity different from their female assigned sex at birth. Routine preventive sexual health screening of TM patients is recommended, ...[more]

PMID: 28645254

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Project description:BackgroundGender-affirming surgeries in female-to-male (FtM) transgender patients include mostly hysterectomy, bilateral salpingo-oophorectomy and mastectomy. Sometimes further surgery is performed, such as phalloplasty. Colpectomy may be performed to overcome gender dysphoria and disturbing vaginal discharge; furthermore, it may be important in reducing the risk of fistulas due to the phalloplasty procedure with urethral elongation. Colpectomy prior to the reconstruction of the neourethra seems to reduce fistula rates on the very first anastomosis. Therefore, at our center, colpectomy has become a standard procedure prior to phalloplasty and metoidioplasty with urethral elongation. Colpectomy is known as a procedure with potentially serious complications, e.g., extensive bloodloss, vesicovaginal fistula or rectovaginal fistula. Colpectomy performed via the vaginal route can be a challenging procedure due to lack of exposure of the surgical field, as many patients are virginal. Therefore, we investigated whether robot-assisted laparoscopic hysterectomy with bilateral salpingo-oophorectomy (TLH-BSO) followed by robot-assisted laparoscopic colpectomy (RaLC) is an alternative for the vaginal approach.MethodsRobot TLH/BSO and RaLC as a single-step procedure was performed in 36 FtM patients in a prospective cohort study.ResultsMedian length of the procedure was 230 min (197-278), which reduced in the second half of the patients, median blood loss was 75 mL (30-200), and median discharge was 3 days (2-3) postoperatively. One patient with a major complication (postoperative bleeding with readmission and transfusion) was reported.ConclusionTo our knowledge, this is the first report of RaLC. Our results show that RaLC combined with robot TLH-BSO is feasible as a single-step surgical procedure in FtM transgender surgery. Future studies are needed to compare this technique to the two-step surgical approach and on its outcome and complication rates of subsequent phalloplasty.

Project description:ObjectivesIdentifying factors associated with human papillomavirus (HPV) vaccine uptake is essential for designing successful vaccination programmes. We aimed to examine the association between vaccine hesitancy (VH) and HPV vaccine uptake among male and female youth in Switzerland.DesignWith a cross-sectional study, an interview-based questionnaire was used to collect information on sociodemographic factors, vaccination records and to measure the prevalence of VH using the Youth Attitudes about Vaccines scale (YAV-5), a modified version of the Parent Attitudes about Childhood Vaccinations survey instrument.Setting and participantsEligible male and female participants, 15-26 years of age, were recruited through physicians' offices and military enlistment in all three language regions of Switzerland. Of 1001 participants, we included 674 participants with a vaccination record available (415 males and 259 females) in this study.Primary and secondary outcome measuresThe outcome was uptake for HPV vaccine (having received ≥1 dose of HPV vaccine). Covariates were VH, sex, age and other sociodemographics.Results151 (58%) female and 64 (15%) male participants received ≥1 dose of HPV vaccine. 81 (31%) female and 92 (22%) male participants were VH (YAV-5-Score >50). The odds for being unvaccinated were higher for VH women than non-VH women, adjusted OR=4.90 (95% CI 2.53 to 9.50), but similar among VH and non-VH men, OR=1.90 (95% CI 0.84 to 4.31). The odds for being unvaccinated were lower for younger men (born on or after 1 July 2002) than older men (born before 1 July 2002), OR=0.34 (95% CI 0.14 to 0.81), but we found no association between age and vaccine uptake for female youth, OR=0.97 (95% CI 0.48 to 1.97).ConclusionsVH was associated with lower HPV vaccine uptake in female youth but not male youth in our study population in Switzerland. Our findings suggest that issues other than VH contribute to HPV underimmunisation in male youth in Switzerland.

Dataset Information

Comparing self- and provider-collected swabbing for HPV DNA testing in female-to-male transgender adult patients: a mixed-methods biobehavioral study protocol.

Publications

Comparing self- and provider-collected swabbing for HPV DNA testing in female-to-male transgender adult patients: a mixed-methods biobehavioral study protocol.

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