Integrating HIV Prevention With TB Household Contact Evaluation in Uganda

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07119359
• Lead Sponsor: University of Washington

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-23
• Study First Submitted QC: 2025-08-11
• Last Update Submitted: 2025-08-11
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Study Start: 2025-09-01
• Primary Completion: 2029-08-01
• Study Completion: 2029-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2480

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Infectious Diseases Institute; 🇺🇬 Kampala, Uganda