Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention (3HP Options Implementation Trial)
Tuberculosis, Latent Tuberculosis, HIV/AIDS
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
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
Experimental
Experimental
Experimental
Facilitated Directly Observed Therapy (DOT)
Facilitated Self-Administered Therapy (SAT)
Patient Choice between facilitated DOT and facilitated SAT
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.