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Clinical Trials/NCT05559658
NCT05559658RecruitingNot Applicable

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

Institute of HIV Research and Innovation Foundation, Thailand1 site in 1 country60 target enrollmentStarted: February 20, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
The study will be divided into two phases. The information on the procedures of the phase I single study visit is presented below.

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
16 Years to 35 Years (Child, Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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
  • Inclusion Criteria:
  • 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

Exclusion Criteria

  • No exclusion criteria for all groups of participants

Outcomes

Primary Outcomes

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

Time Frame: 12 months

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Institute of HIV Research and Innovation Foundation, Thailand
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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