RECRUITING

IMplementation of CAB+RPV LA for People With HIV in Non-Metropolitan Areas

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this implementation science study is to learn about the experience of receiving and providing cabotegravir + rilpivirine long-acting (CAB+RPV LA) injections as treatment for human immunodeficiency virus (HIV) for people who live a significant distance from an HIV provider. The main questions it aims to answer are: * Is CAB+RPV LA feasible and acceptable to patients and staff? * What barriers and supports exist and have the most impact on receiving and providing CAB+RPV LA? * How does CAB+RPV LA affect HIV stigma, treatment satisfaction, medication adherence and viral suppression? People living with HIV who reside outside of the Omaha, Nebraska metro area and are starting CAB+RPV LA as part of regular medical care for HIV will be invited to participate in this study which involves completing questionnaires and an interview over 15 months. Clinic staff who are involved in providing HIV care and CAB+RPV LA will also provide input through questionnaires and an interview.

Official Title

IMplementation of CAB+RPV LA for People With HIV in Non-Metropolitan Areas: Addressing Adherence Barriers Through Learning and Evidence-Informed Strategies (IM-CAPABLE)

Quick Facts

Study Start:2024-07-01
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06451341

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 19 years old (as per Nebraska's adult age definition) with documented HIV infection
  2. * Receiving care for the management of HIV disease by a provider at the Nebraska Medicine/UNMC Specialty Care Center ( UNMC SCC)
  3. * Deemed a clinically eligible candidate for CAB+RPV LA per HIV treatment guidelines and through shared medical decision-making by provider and patient
  4. * Resides outside of the Omaha, Nebraska metropolitan area
  1. * Does not meet the clinical guidelines eligibility criteria for CAB+RPV LA
  2. * Currently receiving CAB+RPV LA
  3. * Currently incarcerated
  4. * Unable to give informed consent for participation
  5. * Pregnant or planning to become pregnant during the study period
  6. * Intends to move from their current residence to the Omaha metropolitan area or intend to move out of the Specialty Care Center service area within 12 months after enrollment

Contacts and Locations

Study Contact

Maureen Kubat, BSN, RN
CONTACT
402-559-4408
mo.kubat@unmc.edu
Jennifer O'Neill, BSN, RN
CONTACT
402-559-4312
jloneill@unmc.edu

Principal Investigator

Nada Fadul, MD
PRINCIPAL_INVESTIGATOR
University of Nebraska

Study Locations (Sites)

Nebraska Medicine Grand Island Clinic
Grand Island, Nebraska, 68803
United States
University of Nebraska Specialty Care Center
Omaha, Nebraska, 68106
United States

Collaborators and Investigators

Sponsor: University of Nebraska

  • Nada Fadul, MD, PRINCIPAL_INVESTIGATOR, University of Nebraska

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01
Study Completion Date2026-04

Study Record Updates

Study Start Date2024-07-01
Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

  • CAB
  • RPV
  • Cabotegravir
  • Rilpivirine
  • Long acting injections
  • Rural
  • Antiretroviral therapy
  • HIV-1
  • Implementation science

Additional Relevant MeSH Terms

  • HIV