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:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-24 @ 4:47 PM
NCT ID:
NCT01686750
Eligibility Criteria:
Inclusion Criteria:
Key Informant Interviews:
Persons may be included in the key informant interviews if they meet all of the following criteria:
1. 18 years of age or older
2. Knowledge of the local HIV risk group of interest (IDU or MSM)
3. Psychologically fit to participate in the study and to understand the consent
4. Ability to comprehend one of the consent translation languages
5. Provide informed consent
Focus groups:
Persons may be included in the focus groups if they meet all of the following criteria:
1. 18 years of age or older
2. Member of a target HIV risk group, meeting criterion 2a or 2b
1. IDU: self-reported injection drug use in prior 12 months
2. MSM: self-identify as male and report oral/anal sex with another male in prior 12 months
3. Psychologically fit to participate in the study and to understand the consent
4. Ability to comprehend one of the consent translation languages
5. Provide informed consent
Baseline or evaluation respondent-driven sampling (RDS) survey
Persons may be included in the baseline or evaluation RDS survey if they meet all of the following criteria:
1. 18 years of age or older
2. Member of a target HIV risk group, meeting criterion 2a or 2b
1. IDU: self-reported injection drug use in prior 24 months
2. MSM: self-identify as male and report oral/anal sex with another male in prior 12 months
3. Psychologically fit to participate in the study and to understand the consent
4. Ability to comprehend one of the consent translation languages
5. Present a valid RDS referral coupon (unless a seed)
6. Provide informed consent
Exclusion Criteria:
Key Informant Interviews:
Persons will be excluded from the key informant interviews if they meet any of the following criteria:
1. Younger than 18 years
2. Do not have knowledge of the local HIV risk group of interest (IDU or MSM)
3. Are not psychologically fit to participate in the study or to understand the consent
4. Do not have ability to comprehend one of the consent translation languages
5. Do not provide informed consent
Focus groups:
Persons will be excluded from the focus groups if they meet any of the following criteria:
1. Younger than 18 years
2. Are not a member of a target HIV risk group, meeting neither criterion 2a nor 2b
1. IDU: self-reported injection drug use in prior 12 months
2. MSM: self-identify as male and report oral/anal sex with another male in prior 12 months
3. Are not psychologically fit to participate in the study or to understand the consent
4. Do not have ability to comprehend one of the consent translation languages
5. Do not provide informed consent
Baseline or evaluation RDS survey
Persons will be excluded in the baseline or evaluation RDS survey if they meet any of the following criteria:
1. Younger than 18 years
2. Are not a member of a target HIV risk group, meeting neither criterion 2a nor 2b
1. IDU: self-reported injection drug use in prior 24 months
2. MSM: self-identify as male and report oral/anal sex with another male in prior 12 months
3. Are not psychologically fit to participate in the study or to understand the consent
4. Do not have ability to comprehend one of the consent translation languages
5. Do not present a valid RDS referral coupon and are not a seed
6. Do not provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01686750
Study Brief:
Protocol Section:
NCT01686750