NCT05559658

Brief Summary

The study is a two-phase observational study that assess multiple aspects of study and young men who have sex with men (YMSM). Phase I of the study will be a cross-sectional descriptive study using a mixed methods data collection (focusing on qualitative data collection) to acquire information necessary for developing a more extensive study on the same matter. Phase II of the study will be a prospective cohort study using a quantitative data collection. Findings from phase I will guide the development of phase II which consist of a larger number of YMSM, important baseline and follow-up questionnaires and comorbidities assessments, sexually transmitted infections testing, and integration to care. This protocol exclusively addresses the phase I of the study. Once the phase I findings are finalized, the principal investigator will submit the phase II to the IRB of the Faculty of Medicine, Chulalongkorn University.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

February 20, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

April 2, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

September 26, 2022

Last Update Submit

April 1, 2026

Conditions

Keywords

ChemSex users

Outcome Measures

Primary Outcomes (1)

  • The study will be divided into two phases. The information on the procedures of the phase I single study visit is presented below.

    Qualitative data collection The qualitative study component will use semi-structured individual in-depth interviews (IDIs) in Thai conducted in-person at the team community health clinic facilities. All participants will be included in the qualitative data collection - 40 YMSM, all 10 family members or peers of chemsex users, and all 10 clinic staff. Quantitative data collection Demographic information of all participants, the proportion of all eligible participants who agree to participate in the study, and the relationship status between Group 2 and Group 1 participants will be collected.

    12 months

Study Arms (1)

Group 1

A: Current chemsex users Men who have sex with men, Aged 16-35 years, Able to communicate in Thai fluently, Current chemsex users. B: Former chemsex users (discontinued ≥90 days) Men who have sex with men, Aged 16-35 years, Able to communicate in Thai fluently, Former chemsex users (discontinued ≥90 days).

Eligibility Criteria

Age16 Years - 35 Years
Sexmale
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Current chemsex users

You may qualify if:

  • Group 1A: Current chemsex users
  • Men who have sex with men
  • Aged 16-35 years
  • Able to communicate in Thai fluently
  • Current chemsex users
  • Provide informed consent
  • Group 1B: Former chemsex users (discontinued ≥90 days)
  • Men who have sex with men
  • Aged 16-35 years
  • Able to communicate in Thai fluently
  • Former chemsex users (discontinued ≥90 days)
  • Provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of HIV Research and Innovation

Pathum Wan, Bangkok, 10330, Thailand

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2022

First Posted

September 29, 2022

Study Start

February 20, 2023

Primary Completion

March 20, 2026

Study Completion

March 30, 2026

Last Updated

April 2, 2026

Record last verified: 2026-04

Locations