Here is the design of a clinical trial:

Official Title: Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention: the 3HP Options Implementation Trial

Included conditions:
- Tuberculosis
- Latent Tuberculosis
- HIV/AIDS

Study Armgroups:
- {'label': 'Facilitated Directly Observed Therapy (DOT)', 'type': 'EXPERIMENTAL', '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.', 'interventionNames': ['Other: Streamlined weekly DOT visits', 'Other: Weekly DOT visit reminders', 'Other: Cost reimbursement DOT']}
- {'label': 'Facilitated Self-Administered Therapy (SAT)', 'type': 'EXPERIMENTAL', '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.', 'interventionNames': ['Other: 99DOTS', 'Other: Weekly SAT dosing reminders/check-ins', 'Other: Cost reimbursement SAT']}
- {'label': 'Patient Choice between facilitated DOT and facilitated SAT', 'type': 'EXPERIMENTAL', '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.', 'interventionNames': ['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:
- {'type': 'OTHER', 'name': 'Streamlined weekly DOT visits', 'description': 'Streamlined, weekly DOT clinic visits to have health worker observe medication ingestion and screen for side effects', 'armGroupLabels': ['Facilitated Directly Observed Therapy (DOT)', 'Patient Choice between facilitated DOT and facilitated SAT']}
- {'type': 'OTHER', 'name': 'Weekly DOT visit reminders', 'description': 'Weekly SMS or interactive voice response (IVR) phone call reminder for DOT clinic visits', 'armGroupLabels': ['Facilitated Directly Observed Therapy (DOT)', 'Patient Choice between facilitated DOT and facilitated SAT']}
- {'type': 'OTHER', 'name': 'Cost reimbursement DOT', 'description': 'Reimbursement of costs associated with weekly clinic visits (15,000 Ush/visit in Weeks 2-12)', 'armGroupLabels': ['Facilitated Directly Observed Therapy (DOT)', 'Patient Choice between facilitated DOT and facilitated SAT']}
- {'type': 'OTHER', 'name': '99DOTS', 'description': '99DOTS-based digital adherence technology to monitor and promote adherence', 'armGroupLabels': ['Facilitated Self-Administered Therapy (SAT)', 'Patient Choice between facilitated DOT and facilitated SAT']}
- {'type': 'OTHER', 'name': 'Weekly SAT dosing reminders/check-ins', 'description': 'Weekly SMS or IVR phone call dosing reminder/check-in for side effects', 'armGroupLabels': ['Facilitated Self-Administered Therapy (SAT)', 'Patient Choice between facilitated DOT and facilitated SAT']}
- {'type': 'OTHER', 'name': 'Cost reimbursement SAT', 'description': 'Reimbursement of costs associated with streamlined refill and end-of treatment clinic visits (15,000 Ush/visit in Weeks 6 and 12)', 'armGroupLabels': ['Facilitated Self-Administered Therapy (SAT)', 'Patient Choice between facilitated DOT and facilitated SAT']}

Primary Outcomes:
- {'measure': 'Proportion of Participants Who Accepted and Completed 3HP', 'description': '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.', 'timeFrame': 'Within 16 weeks of treatment initiation'}

Please estimate the sample size based on the assumption: 
Two-sided alpha of 0.025, 5% loss between consent and allocation, power of 0.90 to detect the difference, and Bonferroni correction applied for two independent comparisons.
Sample size and power
        We estimated our sample size based on a minimum clinically important difference of 10% in 3HP completion, comparing patient choice vs. DOT arms. Of note, a similar study of 3HP delivery strategies chose a 15% non-inferiority margin between DOT and SAT based on cost-effectiveness modeling in the USA [15]. We chose 10% to be more conservative because similar modeling studies have not been done in low-income settings and because ours is not a non-inferiority design. To be maximally conservative, we applied a Bonferroni correction based on two independent comparisons (choice vs. DOT and choice vs. SAT). Assuming a two-sided alpha of 0.025 and 5% loss between consent and allocation, a sample size of 552 participants per arm (1656 total) is required to provide power of 0.90 to detect this difference. This sample size will also give us power of 0.85 to detect a point estimate of at least 80% effectiveness in the patient choice arm, assuming a true effectiveness of 85%. If the true effectiveness rises to 86%, our power to show effectiveness > 80% increases to 0.96.