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

• ClinicalTrials.gov Identifier: NCT04810650
• Recruitment Status: Recruiting
• First Posted: March 23, 2021
• Last Update Posted: May 5, 2022
• 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)
• Information provided by (Responsible Party): University of California, San Francisco

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

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

• 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

More Information

Additional Information:

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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
• Last Update Posted: May 5, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Alcohol Drinking; Drinking Behavior