Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention (3HP Options Implementation Trial)

Summary

The Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention (3HP Options Implementation Trial) study will be a three-arm, open-label, parallel, randomized trial. This hybrid effectiveness-implementation trial will be conducted among people living with HIV infection (PLHIV) enrolled in HIV/AIDS care at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda. The overall objective of this study is to identify a patient-centered delivery strategy that will facilitate acceptance and completion of a three-month (12-dose) regimen of weekly rifapentine (RPT) and isoniazid (INH) by PLHIV enrolled in routine HIV/AIDS care in a high HIV/TB burden country. The primary outcome will be acceptance and completion of 3HP. Additional objectives will be to evaluate the implementation and cost-effectiveness of each delivery strategy.

Conditions

• Tuberculosis
• Latent Tuberculosis
• HIV/AIDS

Interventions

OTHER

Streamlined weekly DOT visits

Streamlined, weekly DOT clinic visits to have health worker observe medication ingestion and screen for side effects

OTHER

Weekly DOT visit reminders

Weekly SMS or interactive voice response (IVR) phone call reminder for DOT clinic visits

OTHER

Cost reimbursement DOT

Reimbursement of costs associated with weekly clinic visits (15,000 Ush/visit in Weeks 2-12)

OTHER

99DOTS

99DOTS-based digital adherence technology to monitor and promote adherence

OTHER

Weekly SAT dosing reminders/check-ins

Weekly SMS or IVR phone call dosing reminder/check-in for side effects

OTHER

Cost reimbursement SAT

Reimbursement of costs associated with streamlined refill and end-of treatment clinic visits (15,000 Ush/visit in Weeks 6 and 12)

Sponsors & Collaborators

• Makerere University

  collaborator OTHER

• Johns Hopkins Bloomberg School of Public Health

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

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

  collaborator NIH

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Adithya Cattamanchi, MD · University of California, San Francisco

• David W Dowdy, PhD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-07-13

Primary Completion

2022-09-29

Completion

2025-01-13

Countries

• Uganda

Study Locations