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

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.

Conditions

• HIV
• Hypertension
• Alcohol Drinking
• Maternal Child Health
• Cost Effectiveness

Interventions

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

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

OTHER

Hypertension Linkage

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

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

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

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

OTHER

Standard of Care

Local country standard of care protocols

OTHER

Hypertension Community

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

Sponsors & Collaborators

• Infectious Diseases Research Collaboration, Uganda

  collaborator OTHER

• Makerere University

  collaborator OTHER

• Kenya Medical Research Institute

  collaborator OTHER

• University of California, Berkeley

  collaborator OTHER

• University College, London

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• National Institute of Mental Health (NIMH)

  collaborator NIH

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Diane Havlir, MD · University of California, San Francisco

• Moses Kamya, MBChB, PhD · Makerere University

• Maya Petersen, PhD · University of California, Berkeley

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-04-15

Primary Completion

2023-10-16

Completion

2023-10-16

Countries

• Kenya
• Uganda

Study Locations