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Completed

NCT Number: NCT04810650

SEARCH SAPPHIRE Phase A: A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa

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.

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Key information

Conditions

HIV Alcohol Drinking Behavior Cardiovascular Diseases Cost Effectiveness Drinking Behavior Hypertension Maternal Child Health Vascular Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GPRT / SEARCH Office, Kisumu, Kenya

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobility Dynamic Treatment Intervention

Other
  • 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

Health Living Intervention for Heavy Alcohol Users

Other
  • Two in-person alcohol counseling sessions with support from a clinical psychologist; 2) Monthly booster phone calls

Hypertension Linkage

Other
  • Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits

PrEP/PEP at Outpatient Clinics

Other

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

PrEP/PEP at Antenatal Clinics

Other

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

PrEP/PEP at Community Households

Other

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

Standard of care

Other

Local country standard of care protocols

Hypertension Community

Other

Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications

Primary outcomes

  1. Prevention Coverage Defined as Percentage of Follow-up Months That the Participant Used 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 Percentage of Follow-up Months 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 Months 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. Percentage 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 Who 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. Percentage 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Infectious Diseases Research Collaboration, Uganda
  • Kenya Medical Research Institute
  • Makerere University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute of Mental Health (NIMH)
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • University College, London
  • University of California, Berkeley
  • University of Pennsylvania

Registry information

Official study title

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

Acronym: SAPPHIRE PhA

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 23, 2021
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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