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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT03098693
Eligibility Criteria:
Inclusion Criteria:
To be eligible for participation in the self-testing cohort, each individual has to be:
1. age 18 years or older (and at least one member of the couple has to be aged 55 years or below),
2. live in the household regularly,
3. have no plans for moving from the area before the follow up period.
To be eligible for the prevention and care portion of the study, couples must be:
1. in an HIV sero-discordant relationship,
2. pregnant or breastfeeding women will be allowed to enroll in the study after counseling on the risks and benefits is provided,
3. HIV-negative women who are pregnant or breastfeeding will be allowed to take PrEP after counseling on the risks and benefits is provided.
Exclusion Criteria:
Couples will not be eligible for enrolled in the sero-discordant sub-cohort if:
1. the HIV-negative member has signs of advanced kidney disease (measured by serum creatinine),
2. the HIV-negative partner has Hepatitis B and markers of poor liver functioning (measured by alanine aminotransferase).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03098693
Study Brief:
Protocol Section:
NCT03098693