Integrating HIV Prevention With TB Household Contact Evaluation in Uganda

N/ANot Yet RecruitingNCT07119359

University of Washington2,480 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

2,480

Conditions

Tuberculosis (TB)Human Immunodeficiency Virus (HIV) Prophylaxis

Interventions

Home-based HIV self-testingOTHER

Integration of HIV self-testing into TB household contact investigation

Home-based initiation of PrEPOTHER

Integration of PrEP initation into TB household contact investigation

Eligibility

Sex: ALLMin age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Infectious Diseases Institute

Kampala, Uganda

Outcomes

Primary Outcomes

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

Time frame: From enrollment to the one-month follow-up visit

Secondary Outcomes

PrEP continuation

Proportion of participants initiating PrEP with detectable tenofovir in urine samples at three- and six-month visits

Time frame: From enrollment to six-month follow-up visit

HIV testing coverage

Proportion of participants known to be living with HIV or have tested HIV-negative among all participants

Time frame: From enrollment to six-month follow-up visit

Central Contacts

Jennifer M Ross, MD, MPH

CONTACT

206 543-9192 jross3@uw.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.