About this trial
The goal of this observational study is to learn how common headache and migraine are and to describe headache patterns among transgender adults in Thailand. The main questions it aims to answer are:
* How common are headache and migraine among transgender adults in Thailand? * What headache patterns and levels of headache-related disability do participants report? * Are gender-affirming hormone therapy, gender-affirming surgery, or HIV pre-exposure prophylaxis (PrEP) use related to headache or migraine?
About 500 transgender adults aged 18 years or older who currently attend or previously attended the Tangerine Clinic in Bangkok, Thailand, will take part.
Participants will:
* Provide consent online * Complete an online questionnaire about their general health and headache symptoms * Answer questions about gender-affirming hormone therapy, gender-affirming surgery, and PrEP use * Complete questionnaires that screen for migraine and measure how headaches affect daily activities
This study will not assign any treatment or change the participants' usual medical care.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 years or older
Self-identifies as transgender
Currently attends or has previously attended the Tangerine Clinic in Bangkok, Thailand
Able to understand the study information and provide electronic informed consent
Disqualifiers
Alcohol or drug use, or a medical condition that, in the investigator's judgment, could interfere with completion of the study procedures or the ability to provide informed consent
A medical condition known to cause a secondary headache disorder unrelated to migraine, such as head trauma, a structural brain lesion, or an infection
Trial population
The study population will consist of self-identified transgender adults in Thailand who currently attend or have previously attended the Tangerine Clinic at the Institute of HIV Research and Innovation in Bangkok, Thailand. Potential participants will be invited through online communication using contact information previously provided to the clinic or approached during a clinic visit. Interested individuals will access the study information, provide electronic informed consent, and complete the online questionnaire.
Trial design
Other
Cross-sectional
Treatments tested in this trial
gender-affirming hormone therapy
DrugCurrent or previous use of gender-affirming hormone therapy as part of the participant's usual care. Information about medication name, dose, route, frequency, duration, and adherence will be collected through an online questionnaire. The researchers will not assign or modify hormone therapy.
Gender-Affirming Surgery
Procedure/SurgeryHistory of gender-affirming surgery received as part of the participant's usual care. The type and date of surgery will be collected through an online questionnaire. No surgical procedure will be assigned or performed as part of this study.
HIV Pre-Exposure Prophylaxis
DrugCurrent or previous use of HIV pre-exposure prophylaxis as part of the participant's usual care. Information about PrEP use will be collected through an online questionnaire. The researchers will not prescribe or modify PrEP as part of this study.
Treatment groups
Trial outcomes
Primary outcomes
Prevalence of Headache
Number and percentage of participants who report headache in 1 year based on the structured online headache questionnaire.
Clinical Characteristics of Headache
Number and percentage of participants reporting headache characteristics, including headache location, pain quality, aggravation by physical activity, nausea or vomiting, sensitivity to light, sensitivity to sound, aura symptoms, and reported headache triggers.
Secondary outcomes
Prevalence of Migraine
Number and percentage of participants who screen positive for migraine based on the ID Migraine and American Migraine Prevalence and Prevention/American Migraine Study questionnaires.
Headache-Related Disability Assessed Using the Migraine Disability Assessment Questionnaire
Headache-related disability measured using the total Migraine Disability Assessment (MIDAS) score. Higher scores indicate greater headache-related disability.
Association Between Gender-Affirming Hormone Therapy Use and Headache
Association between current or previous gender-affirming hormone therapy (GAHT) use and the presence of headache, as assessed by a self-reported headache item in the study questionnaire. The association will be estimated using logistic regression and reported as an odds ratio with a 95% confidence interval. Unit of Measure: Odds ratio
Association Between Gender-Affirming Surgery and Headache
Association between a history of gender-affirming surgery and the presence of headache, as assessed by a self-reported headache item in the study questionnaire. The association will be estimated using logistic regression and reported as an odds ratio with a 95% confidence interval. Unit of Measure: Odds ratio
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Chulalongkorn University
Lead sponsor
Institute of HIV Research and Innovation Foundation, Thailand
Collaborator
International Headache Society
Collaborator
This trial is not recruiting at the moment. You can still explore other options: