Background
Methods & design
Design
Setting
Characteristics of participants
Note on HPV vaccination
Note on enrolling individuals who are up-to-date on cervical cancer screening
Study procedures
Recruitment
Screening for eligibility
Clinical visit procedures
Section Topic Area | Specific Content |
---|---|
Socio-demographics | Age; Race/Ethnicity; Education; Employment status; Income; Relationship status; Children; Housing stability; Zip code; Cross streets |
Transgender History & Gender Affirmation | Sex assigned at birth; Gender identity; Pronouns; Childhood gender behavior/feelings; Ages of transgender first awareness, gender affirmation, disclosure; Legal gender affirmation status (i.e., legal documents); Internalized stigma; Physical gender affirmation status (i.e., binding, testosterone, surgery); Access to gender-affirming care |
General Healthcare Access (for routine care not related to transition) | Insurance; Barriers to accessing care; Healthcare satisfaction; Healthcare avoidance; Experiences of discrimination in healthcare; Anticipated stigma in healthcare |
General Sexual Health | Age of menarche; Gender(s) of sexual partners (lifetime); Age at first intercourse; History of contraception, pregnancy, and childbirth; Parenting desires; Beliefs about cervical Pap tests; Pap testing history; HPV vaccine and testing history; HPV risk beliefs; HIV testing history; PrEP knowledge and use; STI testing, diagnosis, treatment, and partner notification history; Libido and sexual satisfaction; STI knowledge and beliefs; Anticipated acceptability of and comfort with self- and provider-collection methods |
Sexual Risk Activity | Sexual orientation; Gender(s) of sexual partners (past 36 months); Unprotected sexual contact (past 36 months); Partner-level sexual activity (3 most recent partners in past 12 months) ➔ Gender of partner; Relationship type; Sexual activities (e.g., oral-genital performed/received, receptive and/or insertive vaginal or anal sex) and barrier use frequency; Partner HIV/STI status |
Trauma, Victimization & Resilience | Childhood abuse/trauma (prior to 18 years of age); Adult abuse/trauma; Intimate Partner Violence (lifetime and past 12 months); Victimization and attribution; Physical symptoms due to victimization; Stress recovery/Resilience; Social support |
Mental Health & Substance Use | Mental health treatment (lifetime and current); Depression (CESD-10); Anxiety (BSI-18); Self- and community-acceptance; Suicide attempts (lifetime and past 12 months); Non-lethal self-injury (lifetime and past 12 months); Alcohol, tobacco, and other drug use (past 6 months) |
Other | Cancer history (self and family); BMI; Weight description; Weight management; Body consciousness; Nutrition; Exercise |
Self-Collected | (2) Vaginal swabs | 1. Vaginal HPV 2. Vaginal GC/CT |
(1) Rectal swab | 1. Rectal GC/CT | |
Provider Collected | (1) Pharyngeal swab | 1. Pharyngeal GC/CT |
(4) Vaginal swabs | 1. Vaginal HPV 2. Vaginal GC/CT 3. Trichomonas Vaginalis (Analyzed via Rapid Test) 4. Vaginal Bacterial Vaginosis (Analyzed via Rapid Test) | |
(1) Cervical swab | 1. Cervical cytology and HPV specimen (Pap) |
Specimen | Collection Materials | Lab Analysis (Quest Diagnostics) |
---|---|---|
Vaginal HPV DNA | Polyester Swab (Puritan) ThinPrep Solution (Cytyc®) | DNA Hybridization Assay via Digene probe (HPV Types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68) |
Vaginal GC/CT | Aptima Unisex Swab Specimen Collection Kit for Female Endocervical and Male Urethral Swab Specimens | |
Rectal GC/CT | Aptima Unisex Swab Specimen Collection Kit for Female Endocervical and Male Urethral Swab Specimens |
Specimen | Collection Materials | Lab Analysis (Quest Diagnostics) |
---|---|---|
Pharyngeal GC | Aptima Unisex Swab Specimen Collection Kit for Female Endocervical and Male Urethral Swab Specimens | |
Vaginal GC/CT | Aptima Unisex Swab Specimen Collection Kit for Female Endocervical and Male Urethral Swab Specimens | |
Vaginal Trichomonisas | OSOM Trichomonas Rapid Test Kit, Sterile Swab | |
Vaginal BV | OSOM Bvblue Rapid Test Kit, Sterile Swab | |
Vaginal HPV DNA | Polyester Swab (Puritan) Thinprep Solution (Cytyc®) | DNA Hybridization Assay via Digene probe (HPV Types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68) |
Cervical HPV DNA/mRNA & Cytology | Medscand® Pap-Perfect® Spatula and Cytobrush Plus (Cooper Surgical) Cytyc® ThinPrep® solution |