Home-based HIV self-testing and PrEP start for household contacts of people with pulmonary TB in Uganda
Integrating HIV Prevention With TB Household Contact Evaluation in Uganda (TB PrEP)
NA · University of Washington · NCT07119359
This project will try giving home HIV self-tests and starting PrEP for people aged 15 and older who live with someone treated for pulmonary TB, and compare that to referring them to clinics.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 2480 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | University of Washington (other) |
| Locations | 1 site (Kampala) |
| Trial ID | NCT07119359 on ClinicalTrials.gov |
What this trial studies
This household-randomized implementation trial in Uganda compares home-based HIV self-testing with on-the-spot PrEP initiation to modified standard-of-care clinic referral during TB household contact investigation. Households that include at least two people and an index pulmonary TB case are randomized to receive either the home-based intervention or the modified SOC. The study enrolls individuals aged 15 years and older and uses qualitative interviews with participants and staff to document implementation processes and barriers. A health economic evaluation will estimate the financial sustainability of delivering HIV prevention integrated into TB contact investigation while outcomes include HIV testing uptake, PrEP initiation, and linkage to care.
Who should consider this trial
Good fit: Ideal candidates are people aged 15 or older who live in the same household (at least two people) as someone being treated for pulmonary TB, live in the study catchment area, and are willing to participate in study procedures.
Not a fit: People living in congregate settings, residing outside the study area, unable to provide informed consent, or already stably on PrEP may not receive added benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could substantially increase HIV testing and PrEP uptake among TB household contacts and help prevent new HIV infections.
How similar studies have performed: Integrated TB/HIV contact investigations have previously improved HIV case-finding and linkage, but immediate home-based PrEP initiation is relatively novel and has limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Person with pulmonary TB OR live in a household with someone with pulmonary TB being treated at one of the participating health facilities * Household includes ≥2 persons * Age 15 years and older * Willingness to participate in study procedures Exclusion Criteria: * Lives in a congregate setting (e.g., dormitory or jail) * Lives outside the study area * Any other condition that, in the opinion of the Investigator/designee, could preclude informed consent, make study participation unsafe, or otherwise interfere with achieving study objectives
Where this trial is running
Kampala
- Infectious Diseases Institute — Kampala, Uganda (RECRUITING)
Study contacts
- Principal investigator: Jennifer M Ross, MD, MPH — University of Washington
- Study coordinator: Jennifer M Ross, MD, MPH
- Email: jross3@uw.edu
- Phone: 206 543-9192
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tuberculosis, Human Immunodeficiency Virus Prophylaxis, Uganda, TB contact tracing, HIV, PrEP, Household