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 @ 3:37 PM
Ignite Modification Date:
2025-12-24 @ 3:37 PM
NCT ID:
NCT05502692
Eligibility Criteria:
Inclusion Criteria:
Adults of at least 18 years of age with HIV-1 infection who are currently on the TLD state programme who satisfy the below eligibility criteria.
The following eligibility criteria will be used to select study participants for the main study (baseline visit only):
* Inclusion criteria (baseline visit/main study):
1. Able and willing to provide written or electronic informed consent for the baseline visit prior to any study-specific assessment or procedure.
2. Age at least 18 years at the time of signing the informed consent form.
3. Previously enrolled in the ADVANCE trial and have been on the TLD state programme for more than one year \[Cohort 1\] or, part of an existing cohort of patients initiating TLE (and switched to TEE) more than 9 years ago, who have been transitioned to TLD within the state programme for more than one year \[Cohort 2\].
4. Access to a reliable telephone or other device permitting information transfer.
Exclusion Criteria:
* Exclusion criteria (baseline visit/main study):
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1. Personnel (e.g., investigator, sub-investigator, research assistant, pharmacist, study coordinator or anyone mentioned in the delegation log) directly involved in the conduct of the study.
2. Any physical, mental, or social condition, that, in the Investigator's judgment, might interfere with the completion of the baseline assessments and evaluations. The Investigator should make this determination in consideration of the volunteer's medical history.
3. Participant is judged by the Investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results.
Additional eligibility criteria will be used to identify study participants who are eligible for random selection for any of the sub-studies:
* Inclusion criteria (sub-studies):
1. Enrolled into main study and completed baseline visit.
2. Able and willing to provide written or electronic informed consent for the relevant sub-study.
3. Identified as high risk for development of OSA based on the Berlin Questionnaire responses \[Sleep sub study only\].
Exclusion criteria (sub-studies):
1. Self-reported diabetic or on treatment for diabetes mellitus (Type 1 or 2) \[Glucose metabolism sub-study only\].
2. Serum glucose and/or HbA1C assessment at baseline consistent with a diagnosis of diabetes mellitus \[Glucose metabolism sub-study only\].
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05502692
Study Brief:
Protocol Section:
NCT05502692