search
Back to results

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

Primary Purpose

HIV, Hypertension, Alcohol Drinking

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Mobility Dynamic Treatment Intervention
Health Living Intervention for Heavy Alcohol Users
Hypertension Linkage
PrEP/PEP at Outpatient Clinics
PrEP/PEP at Antenatal Clinics
PrEP/PEP at Community Households
Standard of Care
Hypertension Community
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HIV focused on measuring PrEP, PEP, HIV Treatment and Prevention, Community Health, Mobile Populations, Youth and Adolescents

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • GPRT / SEARCH Office
  • IDRC Southwest Uganda

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention

PREP/PEP at Outpatient Clinics Control

PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention

PREP/PEP at Antenatal Clinics Control

PREP/PEP at Community Households Dynamic Prevention Intervention

PREP/PEP at Community Households Control

Mobility Dynamic Treatment Intervention

Mobility Control

Healthy Living for Heavy Alcohol Users Intervention

Heavy Alcohol Users Control

Hypertension Linkage Intervention

Hypertension Linkage Control

Hypertension Community Intervention

Hypertension Community Control

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 18, 2021
Last Updated
May 17, 2023
Sponsor
University of California, San Francisco
Collaborators
Infectious Diseases Research Collaboration, Uganda, Makerere University, Kenya Medical Research Institute, University of California, Berkeley, University College, London, University of Pennsylvania, National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Mental Health (NIMH), National Heart, Lung, and Blood Institute (NHLBI)
search

1. Study Identification

Unique Protocol Identification Number
NCT04810650
Brief Title
A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa
Acronym
SAPPHIRE
Official Title
A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Infectious Diseases Research Collaboration, Uganda, Makerere University, Kenya Medical Research Institute, University of California, Berkeley, University College, London, University of Pennsylvania, National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Mental Health (NIMH), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 study of multi-sectored, multi-disease interventions for HIV.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Hypertension, Alcohol Drinking, Maternal Child Health, Cost Effectiveness
Keywords
PrEP, PEP, HIV Treatment and Prevention, Community Health, Mobile Populations, Youth and Adolescents

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel randomized trials to assess effectiveness, fidelity and cost of prevention and treatment interventions.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention
Arm Type
Experimental
Arm Title
PREP/PEP at Outpatient Clinics Control
Arm Type
Active Comparator
Arm Title
PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention
Arm Type
Experimental
Arm Title
PREP/PEP at Antenatal Clinics Control
Arm Type
Active Comparator
Arm Title
PREP/PEP at Community Households Dynamic Prevention Intervention
Arm Type
Experimental
Arm Title
PREP/PEP at Community Households Control
Arm Type
Active Comparator
Arm Title
Mobility Dynamic Treatment Intervention
Arm Type
Experimental
Arm Title
Mobility Control
Arm Type
Active Comparator
Arm Title
Healthy Living for Heavy Alcohol Users Intervention
Arm Type
Experimental
Arm Title
Heavy Alcohol Users Control
Arm Type
Active Comparator
Arm Title
Hypertension Linkage Intervention
Arm Type
Experimental
Arm Title
Hypertension Linkage Control
Arm Type
Active Comparator
Arm Title
Hypertension Community Intervention
Arm Type
Experimental
Arm Title
Hypertension Community Control
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Mobility Dynamic Treatment Intervention
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Health Living Intervention for Heavy Alcohol Users
Intervention Description
1) Two in-person alcohol counseling sessions with support from a clinical psychologist; 2) Monthly booster phone calls
Intervention Type
Other
Intervention Name(s)
Hypertension Linkage
Intervention Description
1) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits
Intervention Type
Other
Intervention Name(s)
PrEP/PEP at Outpatient Clinics
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
PrEP/PEP at Antenatal Clinics
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
PrEP/PEP at Community Households
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Local country standard of care protocols
Intervention Type
Other
Intervention Name(s)
Hypertension Community
Intervention Description
Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications
Primary Outcome Measure Information:
Title
Prevention coverage defined as proportion of follow-up weeks at risk that the participant is protected from HIV infection with either PrEP or PEP
Description
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.
Time Frame
48 weeks
Title
Prevention coverage defined as proportion of follow-up weeks at risk that the participant is protected from HIV infection with either PrEP or PEP
Description
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.
Time Frame
48 weeks
Title
Prevention coverage defined as proportion of follow-up weeks at risk that the participant is protected from HIV infection with either PrEP or PEP
Description
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.
Time Frame
48 weeks
Title
Number of participants with viral suppression defined by HIV RNA<400 cps/ml
Description
Primary outcome for comparison of Mobility Dynamic Treatment intervention vs. standard of care control (not applicable to other arms). Data collected from medical records.
Time Frame
48 weeks
Title
Number of participants with viral suppression defined by HIV RNA<400 cps/ml
Description
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.
Time Frame
24 weeks
Title
Number of participants to linked to hypertension care
Description
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.
Time Frame
30 days
Title
Proportion of participants with hypertension control <140/90 mmHg
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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, 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane Havlir, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Moses Kamya, MBChB, PhD
Organizational Affiliation
Makerere University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maya Petersen, PhD
Organizational Affiliation
University of California, Berkeley
Official's Role
Principal Investigator
Facility Information:
Facility Name
GPRT / SEARCH Office
City
Kisumu
Country
Kenya
Facility Name
IDRC Southwest Uganda
City
Mbarara
Country
Uganda

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.searchendaids.com/
Description
SEARCH

Learn more about this trial

A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa

We'll reach out to this number within 24 hrs