Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT06094634
Eligibility Criteria:
Inclusion Criteria:
* Newly initiating PrEP or re-initiating PrEP after at least 3 months from a missed PrEP appointment, based on local PrEP guidelines
* AUDIT-C score ≥ 4 or CRAFFT score ≥ 2 (for those ≤21 years old)
* 16 years of age or older
* Intention to receive PrEP care in Hanoi for 12 months
* Willingness to provide informed consent
Exclusion Criteria:
* Psychological disturbance, cognitive impairment, or threatening behavior
* Unwilling to provide locator information
* Current participation in alcohol programs or studies
* Current participation in other research studies (including HIV and PrEP studies)
* Ever enrolled in an HIV vaccine study
* Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA) ≥ 10, indicating risk for alcohol withdrawal
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT06094634
Study Brief:
Protocol Section:
NCT06094634