NCT03934931Completed
Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention (3HP Options Implementation Trial)
Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention: the 3HP Options Implementation Trial
Source: ClinicalTrials.gov · Last updated 11 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1656 (actual)
- First submitted
- 22 Apr 2019
- Start date
- 13 Jul 2020
- Primary completion date
- 29 Sept 2022
- Lead sponsor
- University of California, San Francisco
- Diseases
- Tuberculosis, HIV
- NCT number
- NCT03934931
What you commit to
- Study type: Interventional
- Participants enrolled: 1656
- From 13 Jul 2020 to the primary completion date, 29 Sept 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Actively taking an antiretroviral medication contraindicated for use with rifapentine under contemporary WHO or Ugandan policy
- Previously completed treatment for active TB or at least 6 months of isoniazid preventive therapy within past 2 years
- 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.
Other illness
- Pre-existing documentation of clinical liver disease.
- History of sensitivity or intolerance to isoniazid or rifamycins
Other
- 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
- 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
- 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
- Another household member already enrolled in the study (household members cannot be effectively randomized to different arms)
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mulago Immune Suppression Syndrome (ISS) Clinic Coordinator of this site? Confirm its status | Kampala | Uganda | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.