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

Primary Purpose

Tuberculosis, Latent Tuberculosis, HIV/AIDS

Status
Active
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Streamlined weekly DOT visits
Weekly DOT visit reminders
Cost reimbursement DOT
99DOTS
Weekly SAT dosing reminders/check-ins
Cost reimbursement SAT
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tuberculosis focused on measuring latent tuberculosis, tuberculosis, HIV/AIDS, implementation science, Uganda, 3HP, shared decision making, rifapentine

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Mulago Immune Suppression Syndrome (ISS) Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Facilitated Directly Observed Therapy (DOT)

Facilitated Self-Administered Therapy (SAT)

Patient Choice between facilitated DOT and facilitated SAT

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Acceptance and completion of 3HP
The proportion of eligible participants who accept treatment and take at least 11 of 12 once weekly doses of RPT/INH within 16 weeks of treatment initiation.

Secondary Outcome Measures

Treatment acceptance
Proportion of eligible PLHIV offered 3HP who accept to initiate treatment (by age, gender, CD4 stratum, viral load suppression).
Treatment completion
Proportion of participants who take at least 11 of 12 doses within 16 weeks of treatment initiation of those who take at least one dose of 3HP.
3HP discontinuation due to adverse events/intolerance
Proportion of participants who initiate 3HP for whom treatment is discontinued due to adverse events or intolerance.
Cumulative incidence of TB
Cumulative 16-month incidence of active TB in each arm
Cumulative incidence of TB
Cumulative 28-month incidence of active TB in each arm
Cost effectiveness (patient perspective)
The incremental patient cost per DALY averted.
Cost effectiveness (health system perspective)
The incremental health system cost per disability-adjusted life year (DALY) averted.
Cost effectiveness (overall perspective)
Incremental cost of each delivery strategy per disability adjusted life year (DALY) averted.
Visit Cost Reimbursement - overall
Proportion reimbursed overall
Visit Cost Reimbursement
Proportion reimbursed on the same day as each 3HP clinic visit
Time to complete clinic visit - mean minutes
Mean number of minutes for each DOT/refill visit
Time to complete clinic visit - median minutes
Median number of minutes for each DOT/refill visit
SMS or IVR phone call reminders delivered - clinic visits
Proportion of SMS or IVR phone call reminders delivered to participants for clinic visits
Screening for active TB
Proportion of participants screened for active TB during DOT or refill visits
Screening for side effects
Proportion of participants screened for side effects during DOT or refill visits.
Dosing confirmation via 99DOTS (SAT only)
Proportion of doses confirmed using digital adherence technology. Doses directly observed (i.e., during initial or refill visits) will not be included in the denominator.
SMS or IVR phone call reminders delivered - medication dosing (SAT only)
Proportion of SMS or IVR phone call reminders delivered to participants for medication dosing
SMS or IVR phone calls delivered - weekly check-in (SAT only)
Proportion of weekly SMS or IVR phone call check-ins delivered to participants
SMS or IVR phone call reminders delivered - missed dose (SAT only)
Proportion of SMS or IVR phone call reminders delivered to participants following missed doses
SMS or IVR phone call missed appointment reminders delivered
Proportion of SMS or IVR phone call reminders delivered to participants following missed appointments
Follow up (phone calls or home visits) for negative response to weekly SMS or IVR phone call check-in (SAT only)
Proportion of participants who receive appropriate follow-up (phone call or home visit) for lack of response/negative response to weekly check-in SMS or IVR phone call
Costs of preventive services
Mean total participant costs related to TB preventive care services
Participant satisfaction
Mean score on participant satisfaction questionnaire
Barriers to 3HP delivery from the provider/clinic perspective
Thematic interpretation of provider- and clinic-level barriers to care from provider focus group discussions.
Barriers to 3HP completion from the patient perspective
Thematic interpretation of barriers to 3HP completion from patient interviews

Full Information

First Posted
April 22, 2019
Last Updated
September 21, 2023
Sponsor
University of California, San Francisco
Collaborators
Makerere University, Johns Hopkins Bloomberg School of Public Health, University of Colorado, Denver, National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03934931
Brief Title
Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention (3HP Options Implementation Trial)
Official Title
Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention: the 3HP Options Implementation Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 13, 2020 (Actual)
Primary Completion Date
September 29, 2022 (Actual)
Study Completion Date
November 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Makerere University, Johns Hopkins Bloomberg School of Public Health, University of Colorado, Denver, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The overall objective of this study is to identify a patient-centered strategy that will facilitate 3HP uptake by PLHIV in the context of routine HIV/AIDS care in a high HIV/TB burden country. The investigators' central hypothesis is that offering PLHIV an informed choice between directly observed therapy (DOT) and self-administered therapy (SAT) delivery strategies that are optimized to overcome key barriers to treatment adherence will result in greater acceptance and completion of 3HP. To test this hypothesis, the investigators will conduct a pragmatic randomized trial of three optimized strategies for delivering 3HP. Eligible participants will be randomized to one of three arms to receive latent tuberculosis infection (LTBI) treatment with once weekly INH and RPT for 12 weeks given by either facilitated DOT, facilitated SAT, or an informed choice between facilitated DOT and facilitated SAT (with the assistance of a decision aid tool). Primary Objective: To compare the uptake of 3HP under three delivery strategies: 1) Facilitated DOT; 2) Facilitated SAT; and 3) Informed patient choice (using a decision aid) between facilitated DOT and facilitated SAT. The primary outcome will be defined as the proportion of eligible participants who accept treatment and take at least 11 of 12 doses of RPT/INH within 16 weeks of treatment initiation. Study staff will assess medication dosing using clinic records for participants taking 3HP by DOT and using a combination of 99DOTS (Everwell Health Solutions, India) digital medication adherence technology records and pill counts at refill visits for participants taking 3HP by SAT. Secondary Objectives: To estimate the costs and compare the cost-effectiveness of the three strategies for delivering 3HP. To identify processes and contextual factors that influence patient acceptance and completion of 3HP under each delivery strategy. To identify clinic-level barriers to adoption and implementation of 3HP under each delivery strategy. To determine the proportion of patients for whom 3HP treatment is discontinued due to adverse events/intolerance. To determine the cumulative 16-month incidence of active TB in each arm, categorized as definite (positive sputum Xpert MTB/RIF or culture) or probable (TB medications started at the discretion of a clinician, with evidence of subsequent improvement). To determine the cumulative 28-month incidence of active TB in each arm, categorized as definite (positive sputum Xpert MTB/RIF or culture) or probable (TB medications started at the discretion of a clinician, with evidence of subsequent improvement).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, Latent Tuberculosis, HIV/AIDS
Keywords
latent tuberculosis, tuberculosis, HIV/AIDS, implementation science, Uganda, 3HP, shared decision making, rifapentine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1656 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Facilitated Directly Observed Therapy (DOT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Facilitated Self-Administered Therapy (SAT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Patient Choice between facilitated DOT and facilitated SAT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Streamlined weekly DOT visits
Intervention Description
Streamlined, weekly DOT clinic visits to have health worker observe medication ingestion and screen for side effects
Intervention Type
Other
Intervention Name(s)
Weekly DOT visit reminders
Intervention Description
Weekly SMS or interactive voice response (IVR) phone call reminder for DOT clinic visits
Intervention Type
Other
Intervention Name(s)
Cost reimbursement DOT
Intervention Description
Reimbursement of costs associated with weekly clinic visits (15,000 Ush/visit in Weeks 2-12)
Intervention Type
Other
Intervention Name(s)
99DOTS
Intervention Description
99DOTS-based digital adherence technology to monitor and promote adherence
Intervention Type
Other
Intervention Name(s)
Weekly SAT dosing reminders/check-ins
Intervention Description
Weekly SMS or IVR phone call dosing reminder/check-in for side effects
Intervention Type
Other
Intervention Name(s)
Cost reimbursement SAT
Intervention Description
Reimbursement of costs associated with streamlined refill and end-of treatment clinic visits (15,000 Ush/visit in Weeks 6 and 12)
Primary Outcome Measure Information:
Title
Acceptance and completion of 3HP
Description
The proportion of eligible participants who accept treatment and take at least 11 of 12 once weekly doses of RPT/INH within 16 weeks of treatment initiation.
Time Frame
Within 16 weeks of treatment initiation
Secondary Outcome Measure Information:
Title
Treatment acceptance
Description
Proportion of eligible PLHIV offered 3HP who accept to initiate treatment (by age, gender, CD4 stratum, viral load suppression).
Time Frame
Within 16 weeks of treatment initiation
Title
Treatment completion
Description
Proportion of participants who take at least 11 of 12 doses within 16 weeks of treatment initiation of those who take at least one dose of 3HP.
Time Frame
Within 16 weeks of treatment initiation
Title
3HP discontinuation due to adverse events/intolerance
Description
Proportion of participants who initiate 3HP for whom treatment is discontinued due to adverse events or intolerance.
Time Frame
Within 16 weeks of treatment initiation
Title
Cumulative incidence of TB
Description
Cumulative 16-month incidence of active TB in each arm
Time Frame
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
Title
Cumulative incidence of TB
Description
Cumulative 28-month incidence of active TB in each arm
Time Frame
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
Title
Cost effectiveness (patient perspective)
Description
The incremental patient cost per DALY averted.
Time Frame
At the conclusion of the study period, estimated 3 years
Title
Cost effectiveness (health system perspective)
Description
The incremental health system cost per disability-adjusted life year (DALY) averted.
Time Frame
At the conclusion of the study period, estimated 3 years
Title
Cost effectiveness (overall perspective)
Description
Incremental cost of each delivery strategy per disability adjusted life year (DALY) averted.
Time Frame
At the conclusion of the study period, estimated 3 years
Title
Visit Cost Reimbursement - overall
Description
Proportion reimbursed overall
Time Frame
Through study completion, an average of 16 weeks
Title
Visit Cost Reimbursement
Description
Proportion reimbursed on the same day as each 3HP clinic visit
Time Frame
On the same day as each 3HP clinic visit throughout study completion, an average of 16 weeks
Title
Time to complete clinic visit - mean minutes
Description
Mean number of minutes for each DOT/refill visit
Time Frame
On the same day as each 3HP clinic visit throughout study completion, an average of 16 weeks
Title
Time to complete clinic visit - median minutes
Description
Median number of minutes for each DOT/refill visit
Time Frame
On the same day as each 3HP clinic visit throughout study completion, an average of 16 weeks
Title
SMS or IVR phone call reminders delivered - clinic visits
Description
Proportion of SMS or IVR phone call reminders delivered to participants for clinic visits
Time Frame
The day before each 3HP clinic visit throughout study completion, an average of 16 weeks
Title
Screening for active TB
Description
Proportion of participants screened for active TB during DOT or refill visits
Time Frame
On the same day as each 3HP clinic visit throughout study completion, an average of 16 weeks
Title
Screening for side effects
Description
Proportion of participants screened for side effects during DOT or refill visits.
Time Frame
On the same day as each 3HP clinic visit throughout study completion, an average of 16 weeks
Title
Dosing confirmation via 99DOTS (SAT only)
Description
Proportion of doses confirmed using digital adherence technology. Doses directly observed (i.e., during initial or refill visits) will not be included in the denominator.
Time Frame
On the same day as each scheduled dose throughout study completion, an average of 16 weeks
Title
SMS or IVR phone call reminders delivered - medication dosing (SAT only)
Description
Proportion of SMS or IVR phone call reminders delivered to participants for medication dosing
Time Frame
The day before each scheduled dose throughout study completion, an average of 16 weeks
Title
SMS or IVR phone calls delivered - weekly check-in (SAT only)
Description
Proportion of weekly SMS or IVR phone call check-ins delivered to participants
Time Frame
On the same day as each scheduled dose throughout study completion, an average of 16 weeks
Title
SMS or IVR phone call reminders delivered - missed dose (SAT only)
Description
Proportion of SMS or IVR phone call reminders delivered to participants following missed doses
Time Frame
24 hours after missed scheduled dose throughout study completion, an average of 16 weeks
Title
SMS or IVR phone call missed appointment reminders delivered
Description
Proportion of SMS or IVR phone call reminders delivered to participants following missed appointments
Time Frame
24 hours after missed scheduled appointment throughout study completion, an average of 16 weeks
Title
Follow up (phone calls or home visits) for negative response to weekly SMS or IVR phone call check-in (SAT only)
Description
Proportion of participants who receive appropriate follow-up (phone call or home visit) for lack of response/negative response to weekly check-in SMS or IVR phone call
Time Frame
24 hours after negative response throughout study completion, an average of 16 weeks
Title
Costs of preventive services
Description
Mean total participant costs related to TB preventive care services
Time Frame
Through study completion, an average of 16 weeks
Title
Participant satisfaction
Description
Mean score on participant satisfaction questionnaire
Time Frame
Through study completion, an average of 16 weeks
Title
Barriers to 3HP delivery from the provider/clinic perspective
Description
Thematic interpretation of provider- and clinic-level barriers to care from provider focus group discussions.
Time Frame
At the conclusion of the study period, estimated 3 years
Title
Barriers to 3HP completion from the patient perspective
Description
Thematic interpretation of barriers to 3HP completion from patient interviews
Time Frame
Through study completion, an average of 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adithya Cattamanchi, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David W Dowdy, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mulago Immune Suppression Syndrome (ISS) Clinic
City
Kampala
Country
Uganda

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Provided upon request
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Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention (3HP Options Implementation Trial)

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