Status:
COMPLETED
SEARCH SAPPHIRE Phase A: A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Infectious Diseases Research Collaboration, Uganda
Makerere University
Conditions:
HIV
Hypertension
Eligibility:
All Genders
15+ years
Phase:
NA
Brief Summary
The randomized trials in this record will assess effectiveness, fidelity and cost of prevention and treatment interventions for HIV and hypertension with the objective of informing a population-based ...
Detailed Description
The study will conduct randomized trials to assess effectiveness, fidelity and cost of prevention and treatment interventions. The study will conduct two randomization trials to evaluate dynamic treat...
Eligibility Criteria
Inclusion
- INDIVIDUAL LEVEL INCLUSION CRITERIA FOR COMPONENT INTERVENTIONS
- PrEP/PEP at Outpatient Clinics
- Age ≥15 years
- HIV-negative
- Current or anticipated risk for HIV-infection
- PrEP/PEP at Antenatal Clinics
- Age ≥15 years
- HIV-negative
- Current or anticipated risk for HIV-infection
- PrEP/PEP at Community Households
- Age \> 15 years
- HIV-negative
- Current or anticipated risk for HIV-infection
- Mobility Dynamic Treatment Intervention
- Age ≥15 years
- HIV-positive
- 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
- Travel outside the community ≥2 times in past 12 months
- Enrolled or new to care in a study clinic
- Healthy Living Intervention for Heavy Alcohol Users
- Age ≥18 years
- HIV-positive
- 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
- Heavy alcohol use per AUDIT-C tool (scores of ≥4 for men, and ≥3 for women)
- Enrolled or new to care in a study clinic
- Hypertension Linkage Intervention
- Age ≥25 years
- Blood pressure ≥140/90 mmHg on three repeated measurements during community-based hypertension screening
- Resident (by self-report) within catchment area of referral health center
- Community Hypertension Intervention
- Age \>=40
- Blood pressure ≥160/100 on average of 2nd and 3rd measurements at initial screening
- Sustained blood pressure elevation to ≥140/90 at initial clinic enrollment visit
- INDIVIDUAL LEVEL EXCLUSION CRITERIA FOR COMPONENT INTERVENTIONS
- PrEP/PEP at Outpatient Clinics
- \<15 years of age
- Unable to provide consent or parental co-consent as per country guidelines
- Participation in another Phase A RCT intervention component
- PrEP/PEP at Antenatal Clinics
- \<15 years of age
- unable to provide consent or parental co-consent as per country guidelines
- Participation in another Phase A RCT intervention component
- PrEP/PEP at Community Households
- \<15 years of age
- unable to provide consent or parental co-consent as per country guidelines
- Participation in another Phase A RCT intervention component
- Mobility Dynamic Treatment intervention
- \<15 years of age
- Participation in another Phase A RCT intervention component
- Healthy Living Intervention for Heavy Alcohol Users
- \<18 years of age
- Participation in another Phase A RCT intervention component
- No access to mobile phone
- Hypertension Linkage Intervention
- \<25 years of age
- Plan to out-migrate from the catchment area of referral health center within 30 days of screening visit
- Already engaged in hypertensive care (by self-report)
- Blood pressure measure of ≥180/110 mmHg during screening symptoms of hypertensive emergency
- Community Hypertension Intervention
- Pregnancy
- Co-morbidities that preclude home monitoring
Exclusion
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2023
Estimated Enrollment :
2233 Patients enrolled
Trial Details
Trial ID
NCT04810650
Start Date
April 15 2021
End Date
October 16 2023
Last Update
February 6 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
GPRT / SEARCH Office
Kisumu, Kenya
2
IDRC Southwest Uganda
Mbarara, Uganda