SEARCH SAPPHIRE Phase A: A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa (SAPPHIRE PhA)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Hypertension; HIV; Maternal Child Health; Cost Effectiveness; Alcohol Drinking

Treatments: Other: PrEP/PEP at Outpatient Clinics; Other: Health Living Intervention for Heavy Alcohol Users; Other: Hypertension Linkage; Other: PrEP/PEP at Community Households; Other: Standard of Care; Other: Hypertension Community; Other: PrEP/PEP at Antenatal Clinics; Other: Mobility Dynamic Treatment Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04810650

U01AI150510 (U.S. NIH Grant/Contract)

SEARCH SAPPHIRE Phase A

Details and patient eligibility

About

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.

Full 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 treatment interventions tailored to the needs of heavy alcohol users and mobile populations. The study will conduct three randomized trials to evaluate dynamic choice prevention interventions delivered in the context of antenatal clinics, the outpatient department, and in the community delivered by village health teams. The trial will conduct a randomized trial to evaluate a linkage intervention for patients with hypertension and a randomized trial to evaluate a clinic vs. community based intervention for hypertension.

Enrollment: 2,233 patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,233 participants in 14 patient groups

PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention

Experimental group

Treatment:

Other: PrEP/PEP at Outpatient Clinics

PREP/PEP at Outpatient Clinics Control

Active Comparator group

Treatment:

Other: Standard of Care

PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention

Experimental group

Treatment:

Other: PrEP/PEP at Antenatal Clinics

PREP/PEP at Antenatal Clinics Control

Active Comparator group

Treatment:

Other: Standard of Care

PREP/PEP at Community Households Dynamic Prevention Intervention

Experimental group

Treatment:

Other: PrEP/PEP at Community Households

PREP/PEP at Community Households Control

Active Comparator group

Treatment:

Other: Standard of Care

Mobility Dynamic Treatment Intervention

Experimental group

Treatment:

Other: Mobility Dynamic Treatment Intervention

Mobility Control

Active Comparator group

Treatment:

Other: Standard of Care

Healthy Living for Heavy Alcohol Users Intervention

Experimental group

Treatment:

Other: Health Living Intervention for Heavy Alcohol Users

Heavy Alcohol Users Control

Active Comparator group

Treatment:

Other: Standard of Care

Hypertension Linkage Intervention

Experimental group

Treatment:

Other: Hypertension Linkage

Hypertension Linkage Control

Active Comparator group

Treatment:

Other: Standard of Care

Hypertension Community Intervention

Experimental group

Treatment:

Other: Hypertension Community

Hypertension Community Control

Active Comparator group

Treatment:

Other: Standard of Care