Headache and Hormone Use Among Transgender Population in Thailand: A Cross-Sectional Online Study (H-TRANS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Migraine; Headache
• Intervention / Treatment: Drug: gender-affirming hormone therapy; Procedure: Gender-Affirming Surgery; Drug: HIV Pre-Exposure Prophylaxis

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Prakit Anukoolwittaya, M.D.; Phone Number: 0629141942; Email: Prakit.A@chula.ac.th
• Study Contact Backup: Name: Sirawit Roongrojwittayakul, M.D.

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Location Back to Contacts and Locations On this page, enter a location where the study is taking place.
    • Contact: Jakkrapatara Boonruang, MD; Phone Number: +66 2 160 5372; Email: tangerineclinic@ihri.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

• 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
• Able to complete the online study questionnaire

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Transgender Adults; Adults in Thailand who self-identify as transgender and currently attend or have previously attended the Tangerine Clinic in Bangkok. Participants will complete an online questionnaire about headache symptoms, migraine, gender-affirming care, and HIV pre-exposure prophylaxis use.

Drug: gender-affirming hormone therapy; Current 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.; Procedure: Gender-Affirming Surgery; History 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.; Drug: HIV Pre-Exposure Prophylaxis; Current 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Headache	Number and percentage of participants who report headache in 1 year based on the structured online headache questionnaire.	At enrollment during the one-time online 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.	At enrollment during the one-time online questionnaire

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At enrollment during the one-time online questionnaire
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.	During the 3 months before enrollment
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	At enrollment during the one-time online questionnaire
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	At enrollment during the one-time online questionnaire
Association Between HIV Pre-Exposure Prophylaxis Use and Headache	Association between current or previous HIV pre-exposure prophylaxis (PrEP) 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	At enrollment during the one-time online questionnaire
Association Between Gender-Affirming Hormone Therapy Use and Migraine	Association between current or previous gender-affirming hormone therapy (GAHT) use and the presence of migraine, assessed using the ID Migraine and American Migraine Prevalence and Prevention/American Migraine Study questionnaires.. The association will be estimated using logistic regression and reported as an odds ratio with a 95% confidence interval. Unit of Measure: Odds ratio	At enrollment during the one-time online questionnaire
Association Between Gender-Affirming Surgery and Migraine	Association between a history of gender-affirming surgery and the presence of migraine, as assessed by the ID Migraine and American Migraine Prevalence and Prevention/American Migraine Study questionnaires. The association will be estimated using logistic regression and reported as an odds ratio with a 95% confidence interval. Unit of Measure: Odds ratio	At enrollment during the one-time online questionnaire
Association Between HIV Pre-Exposure Prophylaxis Use and Migraine	Association between current or previous HIV pre-exposure prophylaxis (PrEP) use and the presence of migraine, as assessed by the ID Migraine and American Migraine Prevalence and Prevention/American Migraine Study questionnaires. The association will be estimated using logistic regression and reported as an odds ratio with a 95% confidence interval. Unit of Measure: Odds ratio	Time Frame: At enrollment during the one-time online questionnaire

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Collaborators: Institute of HIV Research and Innovation Foundation, Thailand; International Headache Society
• Investigators: Principal Investigator: Prakit Anukoolwittaya, M.D., Chulalongkorn University; Principal Investigator: Sirawit Roongrojwittayakul, M.D., Ratchaburi Hospital; Study Director: Akarin Hiransuthikul, M.D., M.Sc., Chulalongkorn University; Study Director: Sekh Thanprasertsuk, M.D., Chulalongkorn University; Study Director: Jakkrapatara Boonruang, M.D., Institute of HIV Research and Innovation

Publications and helpful links

General Publications

• Trovao Diniz E, Rocha Leite JB, Ribeiro Coutinho Madruga C, Maia Arca V, Macedo Cavalcanti Albuquerque JA, Sampaio Rocha-Filho PA. Headache in transgender men using gender-affirming hormone therapy: A case-control study. Headache. 2025 Sep;65(8):1449-1456. doi: 10.1111/head.14944. Epub 2025 Apr 18.
• Zavala LJ, Gil Ramirez A, Vetvik KG, Jensen RH, Hougaard A. Headache in individuals undergoing hormone therapy for gender transition: A cross-sectional, observational study. Headache. 2026 Mar;66(3):725-732. doi: 10.1111/head.15076. Epub 2025 Oct 16.
• Yalinay Dikmen P, Ertas M, Kosak S, Cimentepe C, Kocoglu M, Oztosun G, Direk Tecirli N, Onur Aysevener E. Primary headaches among gender dysphoric female-to-male individuals: A cross-sectional survey on gender transition experience. Headache. 2021 Sep;61(8):1194-1206. doi: 10.1111/head.14203. Epub 2021 Aug 31.
• Hranilovich JA, Kaiser EA, Pace A, Barber M, Ziplow J. Headache in transgender and gender-diverse patients: A narrative review. Headache. 2021 Jul;61(7):1040-1050. doi: 10.1111/head.14171.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 7, 2026
• First Submitted That Met QC Criteria: September 10, 2026
• First Posted (Actual): September 14, 2026

Study Record Updates

• Last Update Posted (Actual): September 14, 2026
• Last Update Submitted That Met QC Criteria: September 10, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: HIV Pre-Exposure Prophylaxis; Transgender Persons; Gender-Affirming Surgery; Gender-Affirming Hormone Therapy; Gender Diverse Persons; Headache Prevalence; Migraine Prevalence
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Migraine Disorders; Headache; Health Services Administration; Delivery of Health Care; Health Care Quality, Access, and Evaluation; Therapeutics; Surgical Procedures, Operative; Urogenital Surgical Procedures; Patient Care Management; Plastic Surgery Procedures; Gender-Affirming Procedures; Gender-Affirming Care; Gender-Affirming Surgery
• Other Study ID Numbers: Med Chula IRB 0840/69

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No