Closing -TB GAPs - for People Living with HIV: TB Guidance for Adaptable Patient-Centered Service

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Tuberculosis (TB) is the world's leading infectious cause of mortality and responsible for 1/3 of deaths in people living with human immunodeficiency virus (PLHIV). Children and adolescents living with HIV (CALHIV) are disproportionately affected due to inadequate preventive services, large case detection gaps, treatment and adherence challenges, and knowledge gaps. This project will generate evidence to inform interventions targeting several of these weaknesses in the TB/HIV cascade of care. Early detection and treatment of TB improve outcomes in people living with HIV (PLHIV). A key challenge in the detection of HIV-associated TB has been the implementation of screening that identifies the correct population for diagnostic testing. Increasing evidence demonstrates the poor performance of recommended symptom screens and diagnostic approaches. Hence, the investigators aim to define a more accurate TB screening and testing strategy among PLHIV (Objective 1 and Objective 2). TB preventive treatment (TPT) averts HIV-associated TB. Nevertheless, among PLHIV, TPT initiation and completion rates are sub-optimal and effective delivery strategies are not defined. As such, the investigators aim to identify the most effective TPT delivery strategy through shared decision making and by integrating approaches proven to be effective at improving HIV treatment adherence (Objective 3). Although evidence demonstrates that isoniazid preventive therapy (IPT) is cost-effective in young children living in TB/HIV high burden settings, the cost-effectiveness of newer short-course TPT has primarily been studied in the context of a TB low-burden, high-income setting. The investigators aim to generate evidence to fill this knowledge gap and inform policy for PLHIV living in TB/HIV high burden settings (Objective 4). This study is supported by the Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award totaling an anticipated $5,000,000 over five years with 100 percent funded by CDC/HHS.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• HIV positive or HIV exposed and presumptively positive while awaiting confirmatory testing in infants

• negative TB symptom screen OR for whom TB disease has been ruled out in accordance with WHO Guidelines in adults and according to consensus definitions for child TB

Locations
Other Locations
Lesotho
Baylor College of Medicine Children's Foundation
RECRUITING
Maseru
Malawi
Baylor College of Medicine Children's Foundation
RECRUITING
Lilongwe
Uganda
Baylor College of Medicine Children's Foundation
RECRUITING
Kampala
United Republic of Tanzania
Baylor College of Medicine Children's Foundation
RECRUITING
Mbeya
Contact Information
Primary
Anna Mandalakas, MD, PhD
anna.mandalakas@bcm.edu
832-822-6730
Backup
Alexander Kay, MD
alexander.kay@bcm.edu
Time Frame
Start Date: 2023-07-11
Estimated Completion Date: 2025-09
Participants
Target number of participants: 6500
Treatments
No_intervention: Standard of care
No intervention will be administered. Observational data regarding TPT uptake and adherence will be captured on all participants presenting for care
Experimental: TB screening and evaluation followed by TPT via a decentralized delivery system
The intervention phase includes i) enrolling participants who have had TB disease excluded and allowing participant selection of a preferred TPT regimen, and ii) randomizing participants to one of two participant adherence support modalities.
Related Therapeutic Areas
Sponsors
Collaborators: Centers for Disease Control and Prevention, University of Ottawa, London School of Hygiene and Tropical Medicine, University of Stellenbosch
Leads: Baylor College of Medicine

This content was sourced from clinicaltrials.gov