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CompletedNCT03934931Updated May 11, 2025Results posted

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

An interventional study of Streamlined weekly DOT visits and Weekly DOT visit reminders in Tuberculosis, Latent Tuberculosis and HIV/AIDS, sponsored by University of California, San Francisco. Completed at 1 site in Uganda. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-11.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,656
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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).
02

Conditions studied

  • Tuberculosis
  • Latent Tuberculosis
  • HIV/AIDS

Keywords

  • latent tuberculosis
  • tuberculosis
  • HIV/AIDS
  • implementation science
  • Uganda
  • 3HP
  • shared decision making
  • rifapentine
03

In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's enrollment of 1,656 is above the median of 150 across 952 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,133 studies on the registry; 376 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts 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

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.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
1,656 participants (actual)

Study arms

  • Experimental
    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.

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

  • Experimental
    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.

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

  • Experimental
    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.

    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

  • 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)

06

What researchers measure

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.

    Time frame: Within 16 weeks of treatment initiation

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Visit Cost Reimbursement - Overall

    Proportion reimbursed overall

    Time frame: Through study completion, an average of 16 weeks

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. Costs of Preventive Services

    Mean total participant costs related to TB preventive care services

    Time frame: Through study completion, an average of 16 weeks

  23. Participant Satisfaction

    Mean score on participant satisfaction questionnaire

    Time frame: Through study completion, an average of 16 weeks

  24. 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

  25. 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

07

Results

Posted Nov 7, 2023

Participant flow

Participant flow — Overall Study
MilestoneFacilitated Directly Observed Therapy (DOT)Facilitated Self-Administered Therapy (SAT)Patient Choice Between Facilitated DOT and Facilitated SAT
Started552552552
Completed551552552
Not completed100
Withdrew: Excluded as a duplicate enrollment100

Outcome measures

PrimaryProportion 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
Reported as:
Number · proportion of participants
Proportion of Participants Who Accepted and Completed 3HP
proportion of participantsFacilitated Directly Observed Therapy (DOT)Facilitated Self-Administered Therapy (SAT)Patient Choice Between Facilitated DOT and Facilitated SAT
Proportion of Participants Who Accepted and Completed 3HP0.9460.9220.944
SecondaryProportion 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
Reported as:
Number · proportion of participants
Proportion of Participants Who Accepted 3HP Treatment
proportion of participantsFacilitated Directly Observed Therapy (DOT)Facilitated Self-Administered Therapy (SAT)Patient Choice Between Facilitated DOT and Facilitated SAT
Proportion of Participants Who Accepted 3HP Treatment0.9981.000.995
SecondaryProportion 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
Reported as:
Number · proportion of participants
Proportion of Participants Who Completed 3HP Treatment
proportion of participantsFacilitated Directly Observed Therapy (DOT)Facilitated Self-Administered Therapy (SAT)Patient Choice Between Facilitated DOT and Facilitated SAT
Proportion of Participants Who Completed 3HP Treatment0.9470.9220.949
SecondaryProportion 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
Reported as:
Number · proportion of participants
Proportion of People Who Discontinued 3HP Treatment Due to Adverse Events/Intolerance
proportion of participantsFacilitated Directly Observed Therapy (DOT)Facilitated Self-Administered Therapy (SAT)Patient Choice Between Facilitated DOT and Facilitated SAT
Proportion of People Who Discontinued 3HP Treatment Due to Adverse Events/Intolerance0.00540.0130.0073
SecondaryCumulative 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

Results for this outcome have not been posted.

SecondaryCumulative 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

Results for this outcome have not been posted.

SecondaryCost 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

Results for this outcome have not been posted.

SecondaryCost 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

Results for this outcome have not been posted.

SecondaryCost 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

Results for this outcome have not been posted.

SecondaryVisit Cost Reimbursement - Overall

Proportion reimbursed overall

Time frame:
Through study completion, an average of 16 weeks

Results for this outcome have not been posted.

SecondaryVisit 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

Results for this outcome have not been posted.

SecondaryTime 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

Results for this outcome have not been posted.

SecondaryTime 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

Results for this outcome have not been posted.

SecondaryShort 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

Results for this outcome have not been posted.

SecondaryScreening 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

Results for this outcome have not been posted.

SecondaryScreening 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

Results for this outcome have not been posted.

SecondaryDosing 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

Results for this outcome have not been posted.

SecondarySMS 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

Results for this outcome have not been posted.

SecondarySMS 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

Results for this outcome have not been posted.

SecondarySMS 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

Results for this outcome have not been posted.

SecondarySMS 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

Results for this outcome have not been posted.

SecondaryFollow 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

Results for this outcome have not been posted.

SecondaryCosts of Preventive Services

Mean total participant costs related to TB preventive care services

Time frame:
Through study completion, an average of 16 weeks

Results for this outcome have not been posted.

SecondaryParticipant Satisfaction

Mean score on participant satisfaction questionnaire

Time frame:
Through study completion, an average of 16 weeks

Results for this outcome have not been posted.

SecondaryBarriers 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

Results for this outcome have not been posted.

SecondaryBarriers 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

Results for this outcome have not been posted.

Adverse events

Collected over Adverse events were collected weekly over the course of 3HP treatment duration (up to 16 weeks after treatment initiation). Non-serious events are listed at a 4% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Facilitated Directly Observed Therapy (DOT)1/551 (0.2%)3/551 (0.5%)83/551 (15.1%)
Facilitated Self-Administered Therapy (SAT)0/552 (0%)7/552 (1.3%)86/552 (15.6%)
Patient Choice Between Facilitated DOT and Facilitated SAT0/552 (0%)4/552 (0.7%)76/552 (13.8%)
Most frequent serious events
Most frequent serious events
EventFacilitated Directly Observed Therapy (DOT)Facilitated Self-Administered Therapy (SAT)Patient Choice Between Facilitated DOT and Facilitated SAT
Generalized pruritus/skin rashSkin and subcutaneous tissue disorders2/5511/5521/552
3HP-related hypersensitivityGeneral disorders0/5512/5520/552
GastritisGastrointestinal disorders1/5510/5520/552
Hearing impairmentEar and labyrinth disorders0/5511/5520/552
Liver injuryHepatobiliary disorders0/5511/5520/552
Pulmonary embolismVascular disorders0/5510/5521/552
Flu-like syndromeGeneral disorders0/5511/5521/552
Toxic ConjunctivitisEye disorders0/5511/5520/552
Venous thromboembolismBlood and lymphatic system disorders0/5510/5521/552
Most frequent other events
Most frequent other events
EventFacilitated Directly Observed Therapy (DOT)Facilitated Self-Administered Therapy (SAT)Patient Choice Between Facilitated DOT and Facilitated SAT
Joint painMusculoskeletal and connective tissue disorders21/55121/55229/552
HeadacheNervous system disorders23/55124/55216/552
FeverGeneral disorders19/55121/55217/552
WeaknessGeneral disorders20/55120/55214/552

Baseline characteristics

1 participant in the DOT arm was excluded as a duplicate enrollment

Age, Continuous
Age, Continuous(years)Facilitated Directly Observed Therapy (DOT)Facilitated Self-Administered Therapy (SAT)Patient Choice Between Facilitated DOT and Facilitated SATTotal
Median42 (36 to 48)42 (36 to 48)42 (36 to 48)42 (36 to 48)
Sex: Female, Male
Sex: Female, Male(Participants)Facilitated Directly Observed Therapy (DOT)Facilitated Self-Administered Therapy (SAT)Patient Choice Between Facilitated DOT and Facilitated SATTotal
Female3783753691122
Male173177183533
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Facilitated Directly Observed Therapy (DOT)Facilitated Self-Administered Therapy (SAT)Patient Choice Between Facilitated DOT and Facilitated SATTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American5515525521655
White0000
More than one race0000
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(participants)Facilitated Directly Observed Therapy (DOT)Facilitated Self-Administered Therapy (SAT)Patient Choice Between Facilitated DOT and Facilitated SATTotal
Uganda5515525521655
Prior Tuberculosis
Prior Tuberculosis(Participants)Facilitated Directly Observed Therapy (DOT)Facilitated Self-Administered Therapy (SAT)Patient Choice Between Facilitated DOT and Facilitated SATTotal
Count of participants10410889301
Time on Antiretroviral therapy (ART)
Time on Antiretroviral therapy (ART)(years)Facilitated Directly Observed Therapy (DOT)Facilitated Self-Administered Therapy (SAT)Patient Choice Between Facilitated DOT and Facilitated SATTotal
Median9.0 (5.8 to 12.4)9.1 (5.6 to 12.5)9.1 (5.5 to 12.7)9.0 (5.6 to 12.5)
08

Study locations

1 site
  • Mulago Immune Suppression Syndrome (ISS) Clinic
    Kampala, Uganda
09

References and documents

Publications

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Study documents

  • Study protocol · Mar 20, 2023
  • Statistical analysis plan · Apr 26, 2022
  • Informed consent form · Sep 7, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Provided upon request

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03934931
Lead 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)
Responsible party
Sponsor
First posted
May 2, 2019
Start date
Jul 13, 2020
Primary completion
Sep 29, 2022
Completion
Jan 13, 2025
Results posted
Nov 7, 2023
Last update
May 11, 2025

Study contacts

Adithya Cattamanchi, MD
principal investigator · University of California, San Francisco
David W Dowdy, PhD
principal investigator · Johns Hopkins Bloomberg School of Public Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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