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 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT04810650
Eligibility Criteria:
INDIVIDUAL LEVEL INCLUSION CRITERIA FOR COMPONENT INTERVENTIONS
PrEP/PEP at Outpatient Clinics
1. Age ≥15 years
2. HIV-negative
3. Current or anticipated risk for HIV-infection
PrEP/PEP at Antenatal Clinics
1. Age ≥15 years
2. HIV-negative
3. Current or anticipated risk for HIV-infection
PrEP/PEP at Community Households
1. Age \> 15 years
2. HIV-negative
3. Current or anticipated risk for HIV-infection
Mobility Dynamic Treatment Intervention
1. Age ≥15 years
2. HIV-positive
3. HIV RNA non-suppression (\>400 c/mL in the prior 12 months) or missed 2 visits in past 12 months or missed 2 visits in past 12 months or no VL measured in past 12 months
4. Travel outside the community ≥2 times in past 12 months
5. Enrolled or new to care in a study clinic
Healthy Living Intervention for Heavy Alcohol Users
1. Age ≥18 years
2. HIV-positive
3. HIV RNA non-suppression (\>400 c/mL in the prior 12 months) or missed clinic visits (\>2 weeks or \<=90 days from last scheduled clinic visit) within past 6 months, or out of care without return to care (\>90 days from last scheduled clinic visit) within past 6 months
4. Heavy alcohol use per AUDIT-C tool (scores of ≥4 for men, and ≥3 for women)
5. Enrolled or new to care in a study clinic
Hypertension Linkage Intervention
1. Age ≥25 years
2. Blood pressure ≥140/90 mmHg on three repeated measurements during community-based hypertension screening
3. Resident (by self-report) within catchment area of referral health center
Community Hypertension Intervention
1. Age \>=40
2. Blood pressure ≥160/100 on average of 2nd and 3rd measurements at initial screening
3. Sustained blood pressure elevation to ≥140/90 at initial clinic enrollment visit
INDIVIDUAL LEVEL EXCLUSION CRITERIA FOR COMPONENT INTERVENTIONS
PrEP/PEP at Outpatient Clinics
1. \<15 years of age
2. Unable to provide consent or parental co-consent as per country guidelines
3. Participation in another Phase A RCT intervention component
PrEP/PEP at Antenatal Clinics
1. \<15 years of age
2. unable to provide consent or parental co-consent as per country guidelines
3. Participation in another Phase A RCT intervention component
PrEP/PEP at Community Households
1. \<15 years of age
2. unable to provide consent or parental co-consent as per country guidelines
3. Participation in another Phase A RCT intervention component
Mobility Dynamic Treatment intervention
1. \<15 years of age
2. Participation in another Phase A RCT intervention component
Healthy Living Intervention for Heavy Alcohol Users
1. \<18 years of age
2. Participation in another Phase A RCT intervention component
3. No access to mobile phone
Hypertension Linkage Intervention
1. \<25 years of age
2. Plan to out-migrate from the catchment area of referral health center within 30 days of screening visit
3. Already engaged in hypertensive care (by self-report)
4. Blood pressure measure of ≥180/110 mmHg during screening symptoms of hypertensive emergency
Community Hypertension Intervention
1. Pregnancy
2. Co-morbidities that preclude home monitoring
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT04810650
Study Brief:
Protocol Section:
NCT04810650