About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men who have sex with men
Aged 16-35 years
Current chemsex users (defined as last chemsex used within 3 months)
Able to read and communicate in Thai
Disqualifiers
None
Trial population
Current chemsex users
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Group1
BehavioralCurrent chemsex users Men who have sex with men, Aged 16-35 years (defined as last chemsex used within 3 months), Able to communicate in Thai fluently.
Treatment groups
Trial outcomes
Primary outcomes
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:
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.
Sponsors and contacts
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Institute of HIV Research and Innovation Foundation, Thailand
Lead sponsor
The US NIH through the International Epidemiology Databases to Evaluate AIDS (IeDEA) IeDEA Asia-Pacific
Collaborator
amfAR, The Foundation for AIDS Research
Collaborator