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NCT Number: NCT07119359

Integrating HIV Prevention With TB Household Contact Evaluation in Uganda

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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Key information

Conditions

Tuberculosis (TB) Acquired Immunodeficiency Syndrome Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases Gram-Positive Bacterial Infections HIV Infections Human Immunodeficiency Virus (HIV) Prophylaxis Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mycobacterium Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Tuberculosis Urogenital Diseases Virus Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. PrEP continuation

    Time frame: 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

  2. HIV testing coverage

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer M Ross, MD, MPH

CONTACT

[email protected]

206 543-9192

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Infectious Diseases Institute, Uganda
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: TB PrEP

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Aug 13, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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