Integrating HIV Prevention With TB Household Contact Evaluation in Uganda

NCT ID: NCT07119359

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

2480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2029-08-31

Brief Summary

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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

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Conditions

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Tuberculosis (TB) Human Immunodeficiency Virus (HIV) Prophylaxis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Household randomized implementation study
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Home-based HIV self-testing and PrEP initiation

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

Group Type EXPERIMENTAL

Home-based HIV self-testing

Intervention Type OTHER

Integration of HIV self-testing into TB household contact investigation

Home-based initiation of PrEP

Intervention Type OTHER

Integration of PrEP initation into TB household contact investigation

Modified standard of care

Referral to health facility for HIV testing and PrEP initiation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Home-based HIV self-testing

Integration of HIV self-testing into TB household contact investigation

Intervention Type OTHER

Home-based initiation of PrEP

Integration of PrEP initation into TB household contact investigation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Infectious Diseases Institute, Uganda

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Ross

Assistant Professor, Department of Medicine, Division of Allergy and Infectious Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer M Ross, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Infectious Diseases Institute

Kampala, , Uganda

Site Status

Countries

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Uganda

Central Contacts

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Jennifer M Ross, MD, MPH

Role: CONTACT

206 543-9192

Other Identifiers

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R01MH134685

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00020907

Identifier Type: -

Identifier Source: org_study_id

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