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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04810650
Recruitment Status : Recruiting
First Posted : March 23, 2021
Last Update Posted : May 5, 2022
Sponsor:
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)
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
HIV Hypertension Alcohol Drinking Maternal Child Health Cost Effectiveness Other: Mobility Dynamic Treatment Intervention Other: Health Living Intervention for Heavy Alcohol Users Other: Hypertension Linkage Other: PrEP/PEP at Outpatient Clinics Other: PrEP/PEP at Antenatal Clinics Other: PrEP/PEP at Community Households Other: Standard of Care Other: Hypertension Community Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel randomized trials to assess effectiveness, fidelity and cost of prevention and treatment interventions.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa
Actual Study Start Date : April 15, 2021
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention Other: PrEP/PEP at Outpatient Clinics
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 Other: Standard of Care
Local country standard of care protocols

Experimental: PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention Other: PrEP/PEP at Antenatal Clinics
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 Other: Standard of Care
Local country standard of care protocols

Experimental: PREP/PEP at Community Households Dynamic Prevention Intervention Other: PrEP/PEP at Community Households
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 Other: Standard of Care
Local country standard of care protocols

Experimental: Mobility Dynamic Treatment Intervention Other: 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 Other: Standard of Care
Local country standard of care protocols

Experimental: Healthy Living for Heavy Alcohol Users Intervention Other: Health Living Intervention for Heavy Alcohol Users
1) Two in-person alcohol counseling sessions with support from a clinical psychologist; 2) Monthly booster phone calls

Active Comparator: Heavy Alcohol Users Control Other: Standard of Care
Local country standard of care protocols

Experimental: Hypertension Linkage Intervention Other: Hypertension Linkage
1) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits

Active Comparator: Hypertension Linkage Control Other: Standard of Care
Local country standard of care protocols

Experimental: Hypertension Community Intervention Other: Hypertension Community
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 Other: Standard of Care
Local country standard of care protocols




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04810650


Contacts
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Contact: Tamara Clark, MHS 628-206-8790 Tamara.Clark@ucsf.edu

Locations
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Kenya
GPRT / SEARCH Office Recruiting
Kisumu, Kenya
Contact: James Ayeiko, MBChB, MPH, PhD    +254-720-925262    jimayieko@gmail.com   
Principal Investigator: Elizabeth Bukusi, MBChB, PhD         
Uganda
IDRC Southwest Uganda Recruiting
Mbarara, Uganda
Contact: Jane Kabami, MPH    +256-706-315810    jkabami@idrc-uganda.org   
Principal Investigator: Moses R Kamya, MBChB, PhD         
Sponsors and Collaborators
University of California, San Francisco
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)
Investigators
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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
Additional Information:
SEARCH  This link exits the ClinicalTrials.gov site

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04810650    
Other Study ID Numbers: SAPPHIRE
U01AI150510 ( U.S. NIH Grant/Contract )
First Posted: March 23, 2021    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
PrEP
PEP
HIV Treatment and Prevention
Community Health
Mobile Populations
Youth and Adolescents
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior