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 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT07199634
Eligibility Criteria:
Inclusion Criteria-
Clinic inclusion criteria:
* Public sector facility
* Primary care, outpatient clinic
* Follows national guidelines for HIV counseling
* Has dedicated HIV counselors
* At least 10 patients receiving HIV counseling per week (based on pre-study data)
* Follows national guidelines for lab monitoring (CD4 at diagnosis; VLs at 3 and 10 months on ART)
* Is interested in participating, as indicated by "sign-off" from the head nurse / facility director
Individual participant inclusion criteria:
* Adult (at least 18 years)
* Received HIV post-test counselling or adherence counseling
* Able to consent
* Provides informed consent
* Speaks one of the primary study languages: English, Zulu, Sotho, Tsonga
* Receives care at the facility as evidence by having a clinical record there
Individual participant exclusion Criteria:
* Require acute medical care that would be hindered by participation in the study
* Determined by clinical staff not to be physically or emotionally able to initiate ART
* Children (under 18 years).
* Prisoners or other institutionalized persons.
* Do not speak one of the primary study languages: English, Zulu, Sotho
* Are not able to consent (e.g. intoxicated or of limited mental capacity)
* Do not consent to participate in the study, including linkage to clinical records for follow-up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07199634
Study Brief:
Protocol Section:
NCT07199634