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Recruiting NCT07119359

Integrating HIV Prevention With TB Household Contact Evaluation in Uganda

No phase Interventional Tuberculosis (TB) Human Immunodeficiency Virus (HIV) Prophylaxis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Home-based HIV self-testing, Home-based initiation of PrEP.
Who it may be relevant to
Registry conditions: Tuberculosis (TB), Human Immunodeficiency Virus (HIV) Prophylaxis. Basic parameters: from 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Uganda
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • PrEP uptake [Time frame: From enrollment to the one-month follow-up visit]
Secondary outcome measures (2)
  • PrEP continuation [Time frame: From enrollment to six-month follow-up visit]
  • HIV testing coverage [Time frame: From enrollment to six-month follow-up visit]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Uganda · 1 center
  • Infectious Diseases Institute — Kampala

Identifiers

NCT: NCT07119359 · STUDY00020907 · R01MH134685

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗