Tuberculosis (TB)TB PrEPNCT07119359
Integrating HIV Prevention With TB Household Contact Evaluation in Uganda
A study testing Home-based HIV self-testing and Home-based initiation of PrEP in people with Tuberculosis (TB) and Human Immunodeficiency Virus (HIV) Prophylaxis, run by University of Washington at 1 site in Uganda.
Trial summary
This household randomized implementation study assesses the implementation and effectiveness of home-based HIV self- testing and PrEP initiation versus standard clinic referral for PrEP initiation during modified standard-of-care (modified SOC) household TB contact investigation in Uganda. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis (TB), Human Immunodeficiency Virus (HIV) Prophylaxis
- What is being tested?
- Home-based HIV self-testing and Home-based initiation of PrEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,480 participants
- Where
- 1 siteUganda
- Study dates
- 10 Dec 2025to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda1 site, 1 recruiting
- Recruiting
Infectious Diseases Institute
Kampala
Andrew Mujugira, +256 392 265 887, amujugira@idi.co.ug
About this study
Official title: Integrating HIV Prevention With TB Household Contact Evaluation in Uganda (TB PrEP)
This household randomized implementation study assesses the implementation and effectiveness of home-based HIV self- testing and PrEP initiation versus standard clinic referral for PrEP initiation during modified standard-of-care (modified SOC) household TB contact investigation in Uganda. It uses qualitative methods to evaluate the process of implementing the intervention and a health economic evaluation to assess the financial sustainability of this strategy.
- Being tested
- Home-based HIV self-testing, Home-based initiation of PrEP
- Keywords
- Uganda, TB contact tracing, HIV, Tuberculosis, PrEP, Household
- Medical subject headings
- Tuberculosis, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based HIV self-testingOther
Integration of HIV self-testing into TB household contact investigation
Home-based initiation of PrEPOther
Integration of PrEP initiation into TB household contact investigation
| Study group | Role | What they receive |
|---|---|---|
| Home-based HIV self-testing and PrEP initiation | Experimental | Home-based HIV self-testing and PrEP initiation (for eligible participants) integrated into routine TB household contact investigation Receives: Other: Home-based HIV self-testing; Other: Home-based initiation of PrEP |
| Modified standard of care | No intervention | Referral to health facility for HIV testing and PrEP initiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP uptake
Uptake of PrEP among eligible household members, measured as the proportion initiating PrEP by 1 month and found to have detectable tenofovir use at the one-month visit
Measured: From enrollment to the one-month follow-up visit
Secondary outcomes (2)
PrEP continuation
Proportion of participants initiating PrEP with detectable tenofovir in urine samples at three- and six-month visits
Measured: From enrollment to six-month follow-up visit
HIV testing coverage
Proportion of participants known to be living with HIV or have tested HIV-negative among all participants
Measured: From enrollment to six-month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start10 Dec 2025
- Primary completion1 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis (TB)Studies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Household randomized implementation study
- Masking
- None (open label)
- Enrolment
- 2,480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Infectious Diseases Institute, Uganda, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jennifer Ross, University of Washington
- Investigators
- Jennifer M Ross, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119359
- Sponsor's protocol ID
- STUDY00020907
- Other IDs
- R01MH134685
- Acronym
- TB PrEP
- Status last verified
- Mar 2026
- First submitted
- 23 Jul 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Select IPD will be available through the NIMH data archive
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating HIV Prevention With TB Household Contact Evaluation in Uganda (TB PrEP)
- ClinicalTrials.gov ID
- NCT07119359
- Acronym / sponsor ID
- TB PrEP / STUDY00020907
- Keywords
- Uganda, TB contact tracing, HIV, Tuberculosis, PrEP, Household
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,480 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Infectious Diseases Institute, Uganda, National Institute of Mental Health (NIMH)
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This household randomized implementation study assesses the implementation and effectiveness of home-based HIV self- testing and PrEP initiation versus standard clinic referral for PrEP initiation during modified standard-of-care (modified SOC) household TB contact investigation in Uganda. It uses qualitative methods to evaluate the process of implementing the intervention and a health economic evaluation to assess the financial sustainability of this strategy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Household randomized implementation study
| Arm | Type | Receives |
|---|---|---|
| Home-based HIV self-testing and PrEP initiation | Experimental | Other: Home-based HIV self-testing, Other: Home-based initiation of PrEPHome-based HIV self-testing and PrEP initiation (for eligible participants) integrated into routine TB household contact investigation |
| Modified standard of care | No intervention | –Referral to health facility for HIV testing and PrEP initiation |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based HIV self-testingIntegration of HIV self-testing into TB household contact investigation | Other | Home-based HIV self-testing and PrEP initiation |
| Home-based initiation of PrEPIntegration of PrEP initiation into TB household contact investigation | Other | Home-based HIV self-testing and PrEP initiation |
Primary outcome
PrEP uptake
Time frame: From enrollment to the one-month follow-up visit
Uptake of PrEP among eligible household members, measured as the proportion initiating PrEP by 1 month and found to have detectable tenofovir use at the one-month visit
2 secondary outcomes
PrEP continuation
Time frame: From enrollment to six-month follow-up visit
HIV testing coverage
Time frame: From enrollment to six-month follow-up visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. Select IPD will be available through the NIMH data archive
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer M Ross, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based HIV self-testing and Home-based initiation of PrEP in people with Tuberculosis (TB) and Human Immunodeficiency Virus (HIV) Prophylaxis, run by University of Washington at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer M Ross, MD, MPH (206 543-9192, jross3@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP uptake (time frame: From enrollment to the one-month follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.