Comprehensive Assessment in a Longitudinal Study on Young Men Who Have Sex With Men Attracting to chemseX (CLYMAX)

A Cross-sectional Descriptive Study Using Mixed Method (Qualitative and Quantitative) Data Collection

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.

Study Overview

• Status: Recruiting
• Conditions: ChemSex Users for YMSM; ChemSex Users

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Nittaya Phanuphak, MD,PhD.; Phone Number: 6681 825 3544; Email: nittaya.p@ihri.org
• Study Contact Backup: Name: Siriporn Nonenoy, RN.MPH.; Phone Number: 661 818 4143; Email: siriporn.n@ihri.org

Study Locations

• Thailand
  • Bangkok
    • Pathum wan, Bangkok, Thailand, 10330
      • Recruiting
      • Institute of HIV Research and Innovation
      • Contact: Nittaya Phanuphak, MD.,Ph.D.; Phone Number: +66 2 1605371; Email: nittaya.p@ihri.org
      • Contact: Napasawan Chinlaertworasiri; Phone Number: +66 2 1605371; Email: napasawan@ihir.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Current chemsex users

Description

Inclusion Criteria:

Group 1A: Current chemsex users

1. Men who have sex with men
2. Aged 16-35 years
3. Able to communicate in Thai fluently
4. Current chemsex users
5. Provide informed consent

Inclusion Criteria:

Group 1B: Former chemsex users (discontinued ≥90 days)

1. Men who have sex with men
2. Aged 16-35 years
3. Able to communicate in Thai fluently
4. Former chemsex users (discontinued ≥90 days)
5. Provide informed consent

Exclusion Criteria:

No exclusion criteria for all groups of participants

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Institute of HIV Research and Innovation Foundation, Thailand
• Collaborators: amfAR, The Foundation for AIDS Research

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Estimated): November 20, 2025
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: ChemSex users
• Other Study ID Numbers: IHRI021