Integrating HIV Prevention With TB Household Contact Evaluation in Uganda

NCT07119359 — Not applicable, Recruiting, 2480 participants, University of Washington

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Integrating HIV Prevention With TB Household Contact Evaluation in Uganda (TB PrEP)

Registry	NCT07119359, acronym TB PrEP
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	2480 (Estimated)
Sponsor	University of Washington (Other); collaborators: Infectious Diseases Institute, Uganda, National Institute of Mental Health (NIMH)
Conditions	Tuberculosis (TB), Human Immunodeficiency Virus (HIV) Prophylaxis
Interventions	Home-based HIV self-testing, Home-based initiation of PrEP (Other)
Dates	start 2025-12-10, primary completion 2029-08-01 (estimated), completion 2029-08-31 (estimated), first posted 2025-08-13, last updated 2026-05-05
Locations	1 site in Uganda

-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. 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.

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+Arms and interventions

Arm	Type	Interventions	Description
Home-based HIV self-testing and PrEP initiation	Experimental	Other: Home-based HIV self-testing; Other: Home-based initiation of PrEP	Home-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

Home-based HIV self-testing (Other): Integration of HIV self-testing into TB household contact investigation
Home-based initiation of PrEP (Other): Integration of PrEP initiation into TB household contact investigation

+Outcome measures

Primary outcomes

PrEP uptake [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

Secondary outcomes

PrEP continuation [From enrollment to six-month follow-up visit]: Proportion of participants initiating PrEP with detectable tenofovir in urine samples at three- and six-month visits
HIV testing coverage [From enrollment to six-month follow-up visit]: Proportion of participants known to be living with HIV or have tested HIV-negative among all participants

+Eligibility

Sex: All, ages: 15 Years to any, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Infectious Diseases Institute	Kampala	Uganda	Recruiting

+Investigators

Jennifer M Ross, MD, MPH, Principal investigator, University of Washington

+Funding

NIH grants: R01MH134685