N/A
Completed N=2,233
SEARCH SAPPHIRE Phase A: A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa
HIV · Hypertension · Alcohol Drinking · Maternal Child Health
Source: ClinicalTrials.gov NCT04810650 ↗
Enrolled (actual)
2,233
Serious AEs
2.3%
Results posted
Feb 2025
Primary outcomePrimary: Prevention Coverage Defined as Percentage of Follow-up Months That the Participant Used Either PrEP or PEP — 47.5; 18.3 Percentage of months
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 study of multi-sectored, multi-disease interventions for HIV.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prevention Coverage Defined as Percentage of Follow-up Months That the Participant Used Either PrEP or PEP |
47.5; 18.3 | — |
| PRIMARY Prevention Coverage Defined as Percentage of Follow-up Months at Risk That the Participant is Protected From HIV Infection With Either PrEP or PEP |
70; 29 | — |
| PRIMARY Prevention Coverage Defined as Proportion of Follow-up Months at Risk That the Participant is Protected From HIV Infection With Either PrEP or PEP |
28.0; 0.5 | — |
| PRIMARY Number of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml |
85; 83 | — |
| PRIMARY Percentage of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml |
83; 82 | — |
| PRIMARY Number of Participants Who Linked to Hypertension Care |
96; 65 | — |
| PRIMARY Percentage of Participants With Hypertension Control <140/90 mmHg |
77; 51 | — |
Eligibility Criteria
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
- 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
Data sourced from ClinicalTrials.gov (NCT04810650). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.