Hypertension Clinical Trial
— SAPPHIREOfficial title:
A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa
Verified date | May 2023 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 study of multi-sectored, multi-disease interventions for HIV.
Status | Active, not recruiting |
Enrollment | 3000 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 15 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Kenya | GPRT / SEARCH Office | Kisumu | |
Uganda | IDRC Southwest Uganda | Mbarara |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Infectious Diseases Research Collaboration, Uganda, Kenya Medical Research Institute, Makerere University, National Heart, Lung, and Blood Institute (NHLBI), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), University College, London, University of California, Berkeley, University of Pennsylvania |
Kenya, Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevention coverage defined as proportion of follow-up weeks at risk that the participant is protected from HIV infection with either PrEP or PEP | Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at outpatient clinics vs. PrEP/PEP standard of care at outpatient clinics (not applicable to other arms). Primary definition of coverage will rely on self report. | 48 weeks | |
Primary | Prevention coverage defined as proportion of follow-up weeks at risk that the participant is protected from HIV infection with either PrEP or PEP | Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at antenatal clinics vs. PrEP/PEP standard of care at antenatal clinics (not applicable to other arms). Primary definition of coverage will rely on self report. | 48 weeks | |
Primary | Prevention coverage defined as proportion of follow-up weeks at risk that the participant is protected from HIV infection with either PrEP or PEP | Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at community households vs. PrEP/PEP standard of care at community households (not applicable to other arms). Primary definition of coverage will rely on self report. | 48 weeks | |
Primary | Number of participants with viral suppression defined by HIV RNA<400 cps/ml | Primary outcome for comparison of Mobility Dynamic Treatment intervention vs. standard of care control (not applicable to other arms). Data collected from medical records. | 48 weeks | |
Primary | Number of participants with viral suppression defined by HIV RNA<400 cps/ml | Primary outcome for comparison of Healthy Living Intervention for Heavy Alcohol Users vs. standard of care control (not applicable to other arms). Data collected from medical records. | 24 weeks | |
Primary | Number of participants to linked to hypertension care | Primary outcome for comparison of Hypertension linkage intervention vs. hypertension linkage control (not applicable for other arms). Linkage to hypertension care at the local government clinic within 30 days of screening positive for high blood pressure during community screening. The primary definition will rely on clinical records. | 30 days | |
Primary | Proportion of participants with hypertension control <140/90 mmHg | Primary outcome for hypertension community treatment intervention vs. hypertension community treatment control (not applicable for other arms). Blood pressure will be measured three times using standardized procedures in all trial participants at the 24-week study visit. Hypertension is considered controlled if the average of the 2nd and 3rd measures <140 mmHg systolic and <90 mmHg diastolic. | 24 weeks |
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