HIV/AIDS, Latent Tuberculosis, Tuberculosis
Conditions
Keywords
latent tuberculosis, tuberculosis, HIV/AIDS, implementation science, Uganda, 3HP, shared decision making, rifapentine
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: 1. To estimate the costs and compare the cost-effectiveness of the three strategies for delivering 3HP. 2. To identify processes and contextual factors that influence patient acceptance and completion of 3HP under each delivery strategy. 3. To identify clinic-level barriers to adoption and implementation of 3HP under each delivery strategy. 4. To determine the proportion of patients for whom 3HP treatment is discontinued due to adverse events/intolerance. 5. 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). 6. 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).
Interventions
OTHERStreamlined weekly DOT visits
Streamlined, weekly DOT clinic visits to have health worker observe medication ingestion and screen for side effects
OTHERWeekly DOT visit reminders
Weekly SMS or interactive voice response (IVR) phone call reminder for DOT clinic visits
OTHERCost reimbursement DOT
Reimbursement of costs associated with weekly clinic visits (15,000 Ush/visit in Weeks 2-12)
OTHER99DOTS
99DOTS-based digital adherence technology to monitor and promote adherence
OTHERWeekly SAT dosing reminders/check-ins
Weekly SMS or IVR phone call dosing reminder/check-in for side effects
OTHERCost 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
Makerere University
Johns Hopkins Bloomberg School of Public Health
University of Colorado, Denver
National Heart, Lung, and Blood Institute (NHLBI)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Who Accepted and Completed 3HP | Within 16 weeks of treatment initiation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Who Accepted 3HP Treatment | Within 16 weeks of treatment initiation | The count of eligible people living with HIV (PLHIV) offered 3HP who accept to initiate treatment (by age, gender, CD4 stratum, viral load suppression) divided by the count of those randomized. |
| Proportion of Participants Who Completed 3HP Treatment | Within 16 weeks of treatment initiation | Count of participants who take at least 11 of 12 doses within 16 weeks of treatment initiation divided by the count those who take at least one dose of 3HP. |
| Proportion of People Who Discontinued 3HP Treatment Due to Adverse Events/Intolerance | Within 16 weeks of treatment initiation | Count of participants for whom treatment is discontinued due to adverse events or intolerance divided by the count of those who initiated 3HP. |
| 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 16-month incidence of active TB in each arm |
| 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 | Cumulative 28-month incidence of active TB in each arm |
| Cost Effectiveness (Patient Perspective) | At the conclusion of the study period, estimated 3 years | The incremental patient cost per disability-adjusted life year (DALY) averted. |
| Cost Effectiveness (Health System Perspective) | At the conclusion of the study period, estimated 3 years | The incremental health system cost per disability-adjusted life year (DALY) averted. |
| Cost Effectiveness (Overall Perspective) | At the conclusion of the study period, estimated 3 years | Incremental cost of each delivery strategy per disability adjusted life year (DALY) averted. |
| Visit Cost Reimbursement - Overall | Through study completion, an average of 16 weeks | Proportion reimbursed overall |
| Visit Cost Reimbursement | On the same day as each 3HP clinic visit throughout study completion, an average of 16 weeks | Proportion reimbursed on the same day as each 3HP clinic visit |
| Time to Complete Clinic Visit - Mean Minutes | On the same day as each 3HP clinic visit throughout study completion, an average of 16 weeks | Mean number of minutes for each DOT/refill visit |
| Time to Complete Clinic Visit - Median Minutes | On the same day as each 3HP clinic visit throughout study completion, an average of 16 weeks | Median number of minutes for each DOT/refill visit |
| SMS or IVR Phone Call Reminders Delivered - Medication Dosing (SAT Only) | The day before each scheduled dose throughout study completion, an average of 16 weeks | Proportion of SMS or IVR phone call reminders delivered to participants for medication dosing |
| Screening for Active TB | On the same day as each 3HP clinic visit throughout study completion, an average of 16 weeks | Proportion of participants screened for active TB during DOT or refill visits |
| Screening for Side Effects | On the same day as each 3HP clinic visit throughout study completion, an average of 16 weeks | Proportion of participants screened for side effects during DOT or refill visits. |
| Dosing Confirmation Via 99DOTS (SAT Only) | On the same day as each scheduled dose throughout study completion, an average of 16 weeks | 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 Calls Delivered - Weekly check-in (SAT Only) | On the same day as each scheduled dose throughout study completion, an average of 16 weeks | Proportion of weekly SMS or IVR phone call check-ins delivered to participants |
| SMS or IVR Phone Call Reminders Delivered - Missed Dose (SAT Only) | 24 hours after missed scheduled dose throughout study completion, an average of 16 weeks | Proportion of SMS or IVR phone call reminders delivered to participants following missed doses |
| SMS or IVR Phone Call Missed Appointment Reminders Delivered | 24 hours after missed scheduled appointment throughout study completion, an average of 16 weeks | 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) | 24 hours after negative response throughout study completion, an average of 16 weeks | 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 | Through study completion, an average of 16 weeks | Mean total participant costs related to TB preventive care services |
| Participant Satisfaction | Through study completion, an average of 16 weeks | Mean score on participant satisfaction questionnaire |
| Barriers to 3HP Delivery From the Provider/Clinic Perspective | At the conclusion of the study period, estimated 3 years | Thematic interpretation of provider- and clinic-level barriers to care from provider focus group discussions. |
| Barriers to 3HP Completion From the Patient Perspective | Through study completion, an average of 16 weeks | Thematic interpretation of barriers to 3HP completion from patient interviews |
| Short Messages Service (SMS) or Interactive Voice Response (IVR) Phone Call Reminders Delivered - Clinic Visits | The day before each 3HP clinic visit throughout study completion, an average of 16 weeks | Proportion of SMS or IVR phone call reminders delivered to participants for clinic visits |
Countries
Uganda
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Facilitated Directly Observed Therapy (DOT) 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.
Streamlined weekly DOT visits: Streamlined, weekly DOT clinic visits to have health worker observe medication ingestion and screen for side effects
Weekly DOT visit reminders: Weekly SMS or interactive voice response (IVR) phone call reminder for DOT clinic visits
Cost reimbursement DOT: Reimbursement of costs associated with weekly clinic visits (15,000 Ush/visit in Weeks 2-12) | 551 |
| Facilitated Self-Administered Therapy (SAT) 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.
99DOTS: 99DOTS-based digital adherence technology to monitor and promote adherence
Weekly SAT dosing reminders/check-ins: Weekly SMS or IVR phone call dosing reminder/check-in for side effects
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) | 552 |
| Patient Choice Between Facilitated DOT and Facilitated SAT 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.
Streamlined weekly DOT visits: Streamlined, weekly DOT clinic visits to have health worker observe medication ingestion and screen for side effects
Weekly DOT visit reminders: Weekly SMS or interactive voice response (IVR) phone call reminder for DOT clinic visits
Cost reimbursement DOT: Reimbursement of costs associated with weekly clinic visits (15,000 Ush/visit in Weeks 2-12)
99DOTS: 99DOTS-based digital adherence technology to monitor and promote adherence
Weekly SAT dosing reminders/check-ins: Weekly SMS or IVR phone call dosing reminder/check-in for side effects
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) | 552 |
| Total | 1,655 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Excluded as a duplicate enrollment | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Facilitated Directly Observed Therapy (DOT) | Total | Patient Choice Between Facilitated DOT and Facilitated SAT | Facilitated Self-Administered Therapy (SAT) |
|---|---|---|---|---|
| Age, Continuous | 42 years | 42 years | 42 years | 42 years |
| Prior Tuberculosis | 104 Participants | 301 Participants | 89 Participants | 108 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 551 Participants | 1655 Participants | 552 Participants | 552 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Uganda | 551 participants | 1655 participants | 552 participants | 552 participants |
| Sex: Female, Male Female | 378 Participants | 1122 Participants | 369 Participants | 375 Participants |
| Sex: Female, Male Male | 173 Participants | 533 Participants | 183 Participants | 177 Participants |
| Time on Antiretroviral therapy (ART) | 9.0 years | 9.0 years | 9.1 years | 9.1 years |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 551 | 0 / 552 | 0 / 552 |
| other Total, other adverse events | 83 / 551 | 86 / 552 | 76 / 552 |
| serious Total, serious adverse events | 3 / 551 | 7 / 552 | 4 / 552 |
Outcome results
Primary
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.
Time frame: Within 16 weeks of treatment initiation
Population: 1,656 people were eligible and randomized. One participant was erroneously re-randomized (facilitated DOT arm) after an initial enrollment; data from their second randomization was excluded. 1,655 were included in the primary outcome analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Facilitated Directly Observed Therapy (DOT) | Proportion of Participants Who Accepted and Completed 3HP | 0.946 proportion of participants |
| Facilitated Self-Administered Therapy (SAT) | Proportion of Participants Who Accepted and Completed 3HP | 0.922 proportion of participants |
| Patient Choice Between Facilitated DOT and Facilitated SAT | Proportion of Participants Who Accepted and Completed 3HP | 0.944 proportion of participants |
Secondary
Barriers to 3HP Completion From the Patient Perspective
Thematic interpretation of barriers to 3HP completion from patient interviews
Time frame: Through study completion, an average of 16 weeks
Secondary
Barriers to 3HP Delivery From the Provider/Clinic Perspective
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
Secondary
Cost Effectiveness (Health System Perspective)
The incremental health system cost per disability-adjusted life year (DALY) averted.
Time frame: At the conclusion of the study period, estimated 3 years
Secondary
Cost Effectiveness (Overall Perspective)
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
Secondary
Cost Effectiveness (Patient Perspective)
The incremental patient cost per disability-adjusted life year (DALY) averted.
Time frame: At the conclusion of the study period, estimated 3 years
Secondary
Costs of Preventive Services
Mean total participant costs related to TB preventive care services
Time frame: Through study completion, an average of 16 weeks
Secondary
Cumulative Incidence of TB
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
Secondary
Cumulative Incidence of Tuberculosis (TB)
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
Secondary
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.
Time frame: On the same day as each scheduled dose throughout study completion, an average of 16 weeks
Secondary
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
Time frame: 24 hours after negative response throughout study completion, an average of 16 weeks
Secondary
Participant Satisfaction
Mean score on participant satisfaction questionnaire
Time frame: Through study completion, an average of 16 weeks
Secondary
Proportion of Participants Who Accepted 3HP Treatment
The count of eligible people living with HIV (PLHIV) offered 3HP who accept to initiate treatment (by age, gender, CD4 stratum, viral load suppression) divided by the count of those randomized.
Time frame: Within 16 weeks of treatment initiation
Population: 1,656 people were eligible and randomized. One participant was erroneously re-randomized (facilitated DOT arm) after an initial enrollment; data from their second randomization was excluded. 1,655 were included in this secondary outcome analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Facilitated Directly Observed Therapy (DOT) | Proportion of Participants Who Accepted 3HP Treatment | 0.998 proportion of participants |
| Facilitated Self-Administered Therapy (SAT) | Proportion of Participants Who Accepted 3HP Treatment | 1.00 proportion of participants |
| Patient Choice Between Facilitated DOT and Facilitated SAT | Proportion of Participants Who Accepted 3HP Treatment | 0.995 proportion of participants |
Secondary
Proportion of Participants Who Completed 3HP Treatment
Count of participants who take at least 11 of 12 doses within 16 weeks of treatment initiation divided by the count those who take at least one dose of 3HP.
Time frame: Within 16 weeks of treatment initiation
Population: Those analyzed included the number of participants who took at least one dose of 3HP.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Facilitated Directly Observed Therapy (DOT) | Proportion of Participants Who Completed 3HP Treatment | 0.947 proportion of participants |
| Facilitated Self-Administered Therapy (SAT) | Proportion of Participants Who Completed 3HP Treatment | 0.922 proportion of participants |
| Patient Choice Between Facilitated DOT and Facilitated SAT | Proportion of Participants Who Completed 3HP Treatment | 0.949 proportion of participants |
Secondary
Proportion of People Who Discontinued 3HP Treatment Due to Adverse Events/Intolerance
Count of participants for whom treatment is discontinued due to adverse events or intolerance divided by the count of those who initiated 3HP.
Time frame: Within 16 weeks of treatment initiation
Population: Those analyzed included the number of participants who took at least one dose of 3HP.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Facilitated Directly Observed Therapy (DOT) | Proportion of People Who Discontinued 3HP Treatment Due to Adverse Events/Intolerance | 0.0054 proportion of participants |
| Facilitated Self-Administered Therapy (SAT) | Proportion of People Who Discontinued 3HP Treatment Due to Adverse Events/Intolerance | 0.013 proportion of participants |
| Patient Choice Between Facilitated DOT and Facilitated SAT | Proportion of People Who Discontinued 3HP Treatment Due to Adverse Events/Intolerance | 0.0073 proportion of participants |
Secondary
Screening for Active TB
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
Secondary
Screening for Side Effects
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
Secondary
Short Messages Service (SMS) or Interactive Voice Response (IVR) Phone Call Reminders Delivered - Clinic Visits
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
Secondary
SMS or IVR Phone Call Missed Appointment Reminders Delivered
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
Secondary
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
Time frame: The day before each scheduled dose throughout study completion, an average of 16 weeks
Secondary
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
Time frame: 24 hours after missed scheduled dose throughout study completion, an average of 16 weeks
Secondary
SMS or IVR Phone Calls Delivered - Weekly check-in (SAT Only)
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
Secondary
Time to Complete Clinic Visit - Mean Minutes
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
Secondary
Time to Complete Clinic Visit - Median Minutes
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
Secondary
Visit Cost Reimbursement
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
Secondary
Visit Cost Reimbursement - Overall
Proportion reimbursed overall
Time frame: Through study completion, an average of 16 weeks