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

NCT03934931 | Completed Results DMC

• 1 other identifier: R01HL144406
• Study Type: interventional
• Target: 1,656
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

latent tuberculosis; tuberculosis; HIV/AIDS; implementation science; Uganda; 3HP; shared decision making; rifapentine

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Who Accepted and Completed 3HP

  The count of eligible participants who accept treatment and take at least 11 of 12 once weekly doses of rifapentine (RPT)/isoniazid (INH) within 16 weeks of treatment initiation divided by the count of those randomized.

  Within 16 weeks of treatment initiation

Secondary Outcomes (25)

• Proportion of Participants Who Accepted 3HP Treatment

  Within 16 weeks of treatment initiation

• Proportion of Participants Who Completed 3HP Treatment

  Within 16 weeks of treatment initiation

• Proportion of People Who Discontinued 3HP Treatment Due to Adverse Events/Intolerance

  Within 16 weeks of treatment initiation

• Cumulative Incidence of Tuberculosis (TB)

  from date of 3HP treatment completion (11/12 doses) or once reached 16 weeks (regardless of number of doses taken) until time of active TB diagnosis or treatment initiation, death, loss to follow-up or end of the 12-month post-treatment follow-up period

• Cumulative Incidence of TB

  from date of 3HP treatment completion (11/12 doses) or once reached 16 weeks (regardless of number of doses taken) until time of active TB diagnosis or treatment initiation, death, loss to follow-up or end of the 24-month post-treatment follow-up period

Study Arms (3)

Facilitated Directly Observed Therapy (DOT)

EXPERIMENTAL

Facilitated DOT arm participants will attend the Mulago Immune Suppression Syndrome (ISS) clinic on a weekly basis to ingest 3HP medication under direct observation. DOT will be defined as a designated clinic staff member observing ingestion of each dose of 3HP. Additionally, participants randomized to facilitated DOT will receive: 1) DOT cards with instructions to present directly to the pharmacy for a pharmacy-only visit, without the need to wait in the general queue; 2) Automated short message service (SMS) or phone call reminders at no cost to participants the day before each appointment, 3) A fixed level of reimbursement (\~$5/visit) for each weekly visit, conditional on either directly observed therapy or evidence of an adverse event that would preclude further treatment.

Other: Streamlined weekly DOT visits; Other: Weekly DOT visit reminders; Other: Cost reimbursement DOT

Facilitated Self-Administered Therapy (SAT)

EXPERIMENTAL

Facilitated SAT participants will take their 1st dose of medication under direct observation and be given a 4-week 3HP supply to take weekly via self-administration. Participants will return to the Mulago ISS clinic after completing their 5th dose to review adherence data with the clinic pharmacy technician and receive 5 additional 3HP doses (doses 7-11). At the scheduled refill visit (dose 6) and end-of-treatment visit (dose 12) participants will ingest 3HP via direct observation. Participants will also receive: 1) Free automated SMS reminders or phone call reminders before each scheduled dose; 2) Weekly check-ins inquiring about side effects via two-way SMS with a follow-up phone call depending on participant response, 3) Fixed level of reimbursement (\~$5/visit) for the refill/end-of-treatment visit, conditional on either directly observed therapy or evidence of an adverse event that would preclude further treatment.

Other: 99DOTS; Other: Weekly SAT dosing reminders/check-ins; Other: Cost reimbursement SAT

Patient Choice between facilitated DOT and facilitated SAT

EXPERIMENTAL

Participants randomized to the Patient Choice between facilitated DOT and facilitated SAT arm will be offered a choice between arms 1 and 2. A research nurse will review each section of the decision aid with participants, discuss values and preferences, and, after addressing any questions, ask participants to select facilitated DOT or facilitated SAT. Participants will have the option to switch between DOT and SAT at any time. The reason for switching and time spent under each strategy will be recorded.

Other: Streamlined weekly DOT visits; Other: Weekly DOT visit reminders; Other: Cost reimbursement DOT; Other: 99DOTS; Other: Weekly SAT dosing reminders/check-ins; Other: Cost reimbursement SAT

Interventions

Streamlined weekly DOT visits OTHER

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

Facilitated Directly Observed Therapy (DOT); Patient Choice between facilitated DOT and facilitated SAT

Weekly DOT visit reminders OTHER

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

Facilitated Directly Observed Therapy (DOT); Patient Choice between facilitated DOT and facilitated SAT

Cost reimbursement DOT OTHER

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

Facilitated Directly Observed Therapy (DOT); Patient Choice between facilitated DOT and facilitated SAT

99DOTS OTHER

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

Facilitated Self-Administered Therapy (SAT); Patient Choice between facilitated DOT and facilitated SAT

Weekly SAT dosing reminders/check-ins OTHER

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

Facilitated Self-Administered Therapy (SAT); Patient Choice between facilitated DOT and facilitated SAT

Cost reimbursement SAT OTHER

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

Facilitated Self-Administered Therapy (SAT); Patient Choice between facilitated DOT and facilitated SAT

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-positive client engaged in care at the Mulago ISS clinic
• Weight ≥40kg
• Age 18 years or older
• Capacity to provide informed consent in English or Luganda

You may not qualify if:

• Suspicion of active TB based on positive World Health Organization (WHO) symptom screen AND elevated point-of-care (POC) C-reactive protein (CRP), or current or planned TB treatment
• Actively taking an antiretroviral medication contraindicated for use with rifapentine under contemporary WHO or Ugandan policy
• Contact of a TB patient with known resistance to isoniazid or rifamycins
• Women who are pregnant, breast feeding or intending to get pregnant in the next 120 days
• Prisoners
• Previously completed treatment for active TB or at least 6 months of isoniazid preventive therapy within past 2 years
• Not intending to remain within 25 km of the Mulago ISS clinic during the study period or to receive further care at the Mulago ISS clinic
• Lack of access to a mobile telephone or lack of willingness to receive SMS reminders
• Pre-existing documentation of clinical liver disease.
• History of sensitivity or intolerance to isoniazid or rifamycins
• Another household member already enrolled in the study (household members cannot be effectively randomized to different arms)
• Actively taking medication contraindicated for use with rifamycin (e.g., warfarin, phenytoin)
• Mixed methods and health economic sub-studies will include a subset of participants enrolled in the trial, as well as clinic administrators and clinicians (clinical officer, doctor, nurse or pharmacist) involved in 3HP delivery at the Mulago ISS clinic.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Makerere University: collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator
• University of Colorado, Denver: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Mulago Immune Suppression Syndrome (ISS) Clinic

Kampala, Uganda

Location

Related Publications (33)

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MeSH Terms

Conditions

Tuberculosis; Latent Tuberculosis; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Professor Adithya Cattamanchi
• Organization: University of California Irvine

adithya.cattamanchi@uci.edu

415-206-5489

Study Officials

• Adithya Cattamanchi, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• David W Dowdy, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: May 2, 2019
• Study Start: July 13, 2020
• Primary Completion: September 29, 2022
• Study Completion: January 13, 2025
• Last Updated: May 11, 2025
• Results First Posted: November 7, 2023

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

UG (1)