N/A
Completed N=1,656
Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention (3HP Options Implementation Trial)
Tuberculosis · Latent Tuberculosis · HIV
Source: ClinicalTrials.gov NCT03934931 ↗
Enrolled (actual)
1,656
Serious AEs
0.9%
Results posted
Nov 2023
Primary outcomePrimary: Proportion of Participants Who Accepted and Completed 3HP — 0.946; 0.922; 0.944 proportion of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants Who Accepted and Completed 3HP |
0.946; 0.922; 0.944 | — |
| SECONDARY Proportion of Participants Who Accepted 3HP Treatment |
0.998; 1.00; 0.995 | — |
| SECONDARY Proportion of Participants Who Completed 3HP Treatment |
0.947; 0.922; 0.949 | — |
| SECONDARY Proportion of People Who Discontinued 3HP Treatment Due to Adverse Events/Intolerance |
0.0054; 0.013; 0.0073 | — |
| SECONDARY Cumulative Incidence of Tuberculosis (TB) |
— | — |
| SECONDARY Cumulative Incidence of TB |
— | — |
| SECONDARY Cost Effectiveness (Patient Perspective) |
— | — |
| SECONDARY Cost Effectiveness (Health System Perspective) |
— | — |
| SECONDARY Cost Effectiveness (Overall Perspective) |
— | — |
| SECONDARY Visit Cost Reimbursement - Overall |
— | — |
| SECONDARY Visit Cost Reimbursement |
— | — |
| SECONDARY Time to Complete Clinic Visit - Mean Minutes |
— | — |
| SECONDARY Time to Complete Clinic Visit - Median Minutes |
— | — |
| SECONDARY Short Messages Service (SMS) or Interactive Voice Response (IVR) Phone Call Reminders Delivered - Clinic Visits |
— | — |
| SECONDARY Screening for Active TB |
— | — |
| SECONDARY Screening for Side Effects |
— | — |
| SECONDARY Dosing Confirmation Via 99DOTS (SAT Only) |
— | — |
| SECONDARY SMS or IVR Phone Call Reminders Delivered - Medication Dosing (SAT Only) |
— | — |
| SECONDARY SMS or IVR Phone Calls Delivered - Weekly check-in (SAT Only) |
— | — |
| SECONDARY SMS or IVR Phone Call Reminders Delivered - Missed Dose (SAT Only) |
— | — |
| SECONDARY SMS or IVR Phone Call Missed Appointment Reminders Delivered |
— | — |
| SECONDARY Follow up (Phone Calls or Home Visits) for Negative Response to Weekly SMS or IVR Phone Call check-in (SAT Only) |
— | — |
| SECONDARY Costs of Preventive Services |
— | — |
| SECONDARY Participant Satisfaction |
— | — |
| SECONDARY Barriers to 3HP Delivery From the Provider/Clinic Perspective |
— | — |
| SECONDARY Barriers to 3HP Completion From the Patient Perspective |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT03934931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.