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 @ 5:18 AM
Ignite Modification Date:
2025-12-25 @ 5:18 AM
NCT ID:
NCT05901727
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria for the time and motion study are:
* Patient-facing or patient-supporting service provider at the study site (patient-supporting providers include data clerks, pharmacists, etc.)
* Directly or indirectly involved in the site's implementation of ART and DSD models
* Employed in current role at the study site for at least six months
* Provides written informed consent to participate
Inclusion criteria for provider interviews are:
* Direct or indirect service provider at the study site (indirect providers include supervisors, technical advisors, etc.)
* Directly or indirectly involved in the site's implementation of ART and DSD models
* Employed in current role at the study site for at least six months
* Provides written informed consent to participate.
Inclusion criteria for the patient survey are:
* Living with HIV and on ART for at least six months at the study site
* ≥ 16 years old (16 and older considered adult for research purposes in Malawi)
* Enrolled in a specified model of care (including conventional care) up to the target number of participants for that model and have received at least one medication refill under this model
* Provide written informed consent to participate.
Inclusion criteria for the testing survey are:
* Undergoing HIV testing at the study site or other testing site within the catchment area
* ≥ 16 years old (16 and older considered adult for research purposes in Malawi)
* Provide written informed consent to participate.
Exclusion Criteria:
Exclusion criteria for the time and motion study are:
● None.
Exclusion criteria for provider interviews are:
● None.
Exclusion criteria for the patient survey are:
* Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant
* Not physically, mentally, or emotionally able to participate in the study, in the opinion of the investigators or study staff.
* Unwilling to take the time required to complete the questionnaire on the day of consent.
Exclusion criteria for the testing survey are:
* Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant
* Not physically, mentally, or emotionally able to participate in the study, in the opinion of the investigators or study staff.
* Unwilling to take the time required to complete the questionnaire on the day of consent.
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT05901727
Study Brief:
Protocol Section:
NCT05901727