- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04810650
A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa (SAPPHIRE)
Study Overview
Status
Intervention / Treatment
- Other: PrEP/PEP at Outpatient Clinics
- Other: Standard of Care
- Other: PrEP/PEP at Antenatal Clinics
- Other: PrEP/PEP at Community Households
- Other: Mobility Dynamic Treatment Intervention
- Other: Health Living Intervention for Heavy Alcohol Users
- Other: Hypertension Linkage
- Other: Hypertension Community
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention
|
Intervention delivered at Outpatient Clinics: Counseling and education on and choice between prevention modalities (e.g.
PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services
|
Active Comparator: PREP/PEP at Outpatient Clinics Control
|
Local country standard of care protocols
|
Experimental: PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention
|
Intervention delivered at Antenatal Clinics: Counseling and education on and choice between prevention modalities (e.g.
PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services
|
Active Comparator: PREP/PEP at Antenatal Clinics Control
|
Local country standard of care protocols
|
Experimental: PREP/PEP at Community Households Dynamic Prevention Intervention
|
Intervention delivered in community by village health team: Counseling and education on and choice between prevention modalities (e.g.
PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services
|
Active Comparator: PREP/PEP at Community Households Control
|
Local country standard of care protocols
|
Experimental: Mobility Dynamic Treatment Intervention
|
1) Access to a mobility coordinator who will assist with transfers, rescheduling, and out-of-facility refills; 2) Provision of a "travel pack" with alternative ART packaging options (e.g.
ziplock bags, envelopes, pill boxes), a packing list and mobility coordinator phone contact for unplanned travel; 3) Screening at every clinic visit for planned mobility; 4) Mobile number and mobile minutes for unexpected travel; 5) Provision of longer refills (up to 6-months) for planned travel
|
Active Comparator: Mobility Control
|
Local country standard of care protocols
|
Experimental: Healthy Living for Heavy Alcohol Users Intervention
|
1) Two in-person alcohol counseling sessions with support from a clinical psychologist; 2) Monthly booster phone calls
|
Active Comparator: Heavy Alcohol Users Control
|
Local country standard of care protocols
|
Experimental: Hypertension Linkage Intervention
|
1) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits
|
Active Comparator: Hypertension Linkage Control
|
Local country standard of care protocols
|
Experimental: Hypertension Community Intervention
|
Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications
|
Active Comparator: Hypertension Community Control
|
Local country standard of care protocols
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevention coverage defined as proportion of follow-up weeks at risk that the participant is protected from HIV infection with either PrEP or PEP
Time Frame: 48 weeks
|
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
|
Prevention coverage defined as proportion of follow-up weeks at risk that the participant is protected from HIV infection with either PrEP or PEP
Time Frame: 48 weeks
|
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
|
Prevention coverage defined as proportion of follow-up weeks at risk that the participant is protected from HIV infection with either PrEP or PEP
Time Frame: 48 weeks
|
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
|
Number of participants with viral suppression defined by HIV RNA<400 cps/ml
Time Frame: 48 weeks
|
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
|
Number of participants with viral suppression defined by HIV RNA<400 cps/ml
Time Frame: 24 weeks
|
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
|
Number of participants to linked to hypertension care
Time Frame: 30 days
|
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
|
Proportion of participants with hypertension control <140/90 mmHg
Time Frame: 24 weeks
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Diane Havlir, MD, University of California, San Francisco
- Principal Investigator: Moses Kamya, MBChB, PhD, Makerere University
- Principal Investigator: Maya Petersen, PhD, University of California, Berkeley
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAPPHIRE
- U01AI150510 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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