Comprehensive Assessment in a Longitudinal Study on Young Men Who Have Sex With Men Attracting to chemseX-2

Recruiting

• Conditions: ChemSex Users for YMSM

• Registration Number: NCT06741306
• Lead Sponsor: Institute of HIV Research and Innovation Foundation, Thailand

Brief Summary

CLYMAX is a two-phase observational study that assess multiple aspects of chemsex and young men who have sex with men (YMSM).

Phase I of the study (CLYMAX,IRB No. 0695/65) was a cross-sectional descriptive study using a mixed methods data collection (focusing on qualitative data collection) assessing multiple aspects of chemsex, including the patterns of chemsex use and the perspectives on factors influencing chemsex initiation/discontinuation, effects on physical health, mental health and social outcomes, and the necessary services for a comprehensive chemsex clinic among YMSM; and the acceptability and feasibility of developing a comprehensive chemsex clinic from the perspective of YMSM, their family members or peers, and clinic staff.

This phase II study (CLYMAX-2) will be a prospective cohort study using a quantitative data collection exploring the effectiveness of the implementation strategy of harm reduction models and consist of a larger number of YMSM, important baseline and follow-up information on multiple aspects of physical, psychological, and social harms.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-14
• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-16
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18
• Primary Completion: 2027-03-31
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 150

Inclusion Criteria

1. Men who have sex with men
2. Aged 16-35 years
3. Current chemsex users (defined as last chemsex used within 3 months)
4. Able to read and communicate in Thai
5. Provide informed consent

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The study outcomes of phase II can be broadly categorized into implementation outcomes include the prevalence and incidence of physical, psychological, and social harms which will be evaluated by laboratory or self-reported assessments as follows:	18 months	STIs testing including HIV (either HIV self-testing or facility-based HIV testing), HCV, HBV, gonorrhea, chlamydia, and syphilis will be offered at baseline and month 6. It will be optional for participants to decide whether to undergo the testing. Behavioral risk, substance use, mental health, quality of life, and criminality assessments will be conducted at every visit. Categorical data will be summarized as frequencies and percentages, while continuous data will be summarized as means and standard deviations or medians and interquartile ranges, as appropriate. In addition to describing the cohort, mixed-effects regression models will be used to assess temporal changes in each health outcome. Linear models will be applied for continuous outcomes (such as changes in depression, anxiety, and quality of life scores), and logistic models will be used for dichotomous outcomes.

Trial Locations

Locations (2)

Rainbow Sky Association of Thailand (RSAT); 🇹🇭 Bangkok, Bangkapi, Thailand

Foundation for Action on Inclusion Rights (FAIR); 🇹🇭 Bangkok, Minburi, Thailand