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

University of Washington

Status: Not yet enrolling

Conditions: Tuberculosis (TB); Human Immunodeficiency Virus (HIV) Prophylaxis

Treatments: Other: Home-based initiation of PrEP; Other: Home-based HIV self-testing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07119359

STUDY00020907

R01MH134685 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 2,480 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,480 participants in 2 patient groups

Home-based HIV self-testing and PrEP initiation

Experimental group

Description:

Home-based HIV self-testing and PrEP initiation (for eligible participants) integrated into routine TB household contact investigation

Treatment:

Other: Home-based HIV self-testing

Other: Home-based initiation of PrEP

Modified standard of care

No Intervention group

Description:

Referral to health facility for HIV testing and PrEP initiation