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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT06904456
Eligibility Criteria:
Cohort 1
Inclusion
* ≥18 years old
* Presenting at a study site clinic for HIV diagnosis or care
* Not currently on ART (or on ART for up to 1 month if enrolled at next visit after AHD screening)
* Screened for AHD by clinic, prior to or within 1 month of ART initiation
* Written informed consent to participate
Exclusion
* Pregnant and/or presenting for antenatal care
* Too ill at the time of AHD screening and at the next clinic visit to participate in the study
* Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant
Cohort 2
Inclusion
* ≥18 years old
* Living with HIV and screened for AHD at a study site within 12 months of the start of study prospective data collection at that site
* All inclusion criteria for the full cohort
* Initiated/re-initiated ART within the past 6 months
* Returns to the study site for a clinic visit during the study enrollment period
* Written informed consent to participate
Exclusion
* Pregnant and/or presenting for antenatal care as reported in records
* All exclusion criteria for the full cohort
* Too ill at the time of study enrollment visit to participate in the study
* Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant
* Been on ART \>6 months
Cohort 3
Inclusion
* ≥18 years old
* Living with HIV
* Admitted for inpatient care related to AHD
* Initiated or re-initiated ART within the last 6 months
* Written informed consent to participate
Exclusion
* Pregnant and/or presenting for antenatal care
* Not physically, mentally, or emotionally able to participate in the study prior to discharge, in the opinion of facility or study staff
* Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant
* Confined to tuberculosis isolation ward; intensive care unit; or other ward specifically for clients with acute infectious disease.
Cohort 4
Inclusion
* Employed by or at the study site for at least 6 months
* Directly interact with clients presenting with AHD
* Written informed consent to participate
Exclusion
* None
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06904456
Study Brief:
Protocol Section:
NCT06904456