Integrating HIV Prevention With TB Household Contact Evaluation in Uganda

NCT07119359 | Recruiting DMC

• 2 other identifiers: STUDY00020907R01MH134685
• Study Type: interventional
• Target: 2,480
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Uganda; TB contact tracing; HIV; Tuberculosis; PrEP; Household

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment to the one-month follow-up visit

Secondary Outcomes (2)

• PrEP continuation

  From enrollment to six-month follow-up visit

• HIV testing coverage

  From enrollment to six-month follow-up visit

Study Arms (2)

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

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

Interventions

Home-based HIV self-testing OTHER

Integration of HIV self-testing into TB household contact investigation

Home-based HIV self-testing and PrEP initiation

Home-based initiation of PrEP OTHER

Integration of PrEP initiation into TB household contact investigation

Home-based HIV self-testing and PrEP initiation

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Infectious Diseases Institute, Uganda: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Infectious Diseases Institute

Kampala, Uganda

RECRUITING

MeSH Terms

Conditions

Tuberculosis; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jennifer M Ross, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer M Ross, MD, MPH

CONTACT

206 543-9192; jross3@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Medicine, Division of Allergy and Infectious Diseases

Model Details: Household randomized implementation study

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: August 13, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Data will be shared through the NIMH Data Archive

Locations

UG (1)