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 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
NCT ID:
NCT02419066
Eligibility Criteria:
Inclusion Criteria:
* • Participants will be ART naïve and initiating within one month of enrollment date
* Participants will be at least 18 years of age
* Participants will be able to provide informed consent
* Participants will live within 60 km of the clinic; intention to stay in the area for the next year
* Participants will either be 1) in early-stage disease (CD4\>350) with WHO stage I (i.e., asymptomatic), or 2) in advanced-stage disease (CD4\<200).
* Pregnant participants will be 34 weeks or less in pregnancy (per best available estimates
Exclusion Criteria:
* • Live \>60 km from the clinic (due to logistics of following participants) or intention to move outside 60km area within the next year
* \<18 years old (adherence patterns and determinants likely differ significantly from those \>18 years)
* Currently in an intermediate stages of disease (i.e., CD4 200-349; the intent of the proposed research is to examine differences in adherence between HIV-infected people initiating ART at early versus advanced-staged disease)
* Women who have a CD4\<200 and who report current pregnancy at the time of consent
* Unable to provide informed consent (e.g., due to mental limitations or intoxication)
* Anyone who does not initiate on ART within 1 month of the enrollment date
* Any pregnant participant greater than 34 weeks in pregnancy (per best available estimate)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02419066
Study Brief:
Protocol Section:
NCT02419066