Exploring long-acting HIV treatment for rural patients
IMplementation of CAB+RPV LA for People With HIV in Non-Metropolitan Areas: Addressing Adherence Barriers Through Learning and Evidence-Informed Strategies (IM-CAPABLE)
This study looks at how well long-acting HIV injections work for people living in rural areas and what challenges they face in getting this treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 55 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of Nebraska Academic / other |
| Locations | 2 sites (Grand Island, Nebraska and 1 other locations) |
| Trial ID | NCT06451341 on ClinicalTrials.gov |
What this trial studies
This observational study aims to understand the experiences of patients and healthcare providers regarding the administration of cabotegravir and rilpivirine long-acting injections for HIV treatment in non-metropolitan areas. It will assess the feasibility and acceptability of this treatment, identify barriers and supports affecting access, and evaluate its impact on HIV stigma, treatment satisfaction, medication adherence, and viral suppression. Participants will complete questionnaires and interviews over a 15-month period, providing valuable insights into the challenges faced by rural patients receiving HIV care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with documented HIV infection who reside outside the Omaha metropolitan area and are eligible for cabotegravir and rilpivirine treatment.
Not a fit: Patients who are currently receiving cabotegravir and rilpivirine, incarcerated, or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve access to effective HIV treatment for patients living in rural areas.
How similar studies have performed: While this approach is novel in the context of rural HIV care, similar studies have shown promise in improving access to treatment in underserved populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Patient Inclusion Criteria: * Age ≥ 19 years old (as per Nebraska's adult age definition) with documented HIV infection * Receiving care for the management of HIV disease by a provider at the Nebraska Medicine/UNMC Specialty Care Center ( UNMC SCC) * Deemed a clinically eligible candidate for CAB+RPV LA per HIV treatment guidelines and through shared medical decision-making by provider and patient * Resides outside of the Omaha, Nebraska metropolitan area Patient Exclusion Criteria: * Does not meet the clinical guidelines eligibility criteria for CAB+RPV LA * Currently receiving CAB+RPV LA * Currently incarcerated * Unable to give informed consent for participation * Pregnant or planning to become pregnant during the study period * 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 Staff Inclusion Criteria: * Age ≥ 19 years old (as per Nebraska's adult age definition) * Staff member of the UNMC SCC or the Grand Island clinic who is providing HIV-related care to patients and has a dedicated role in the IM-CAPABLE study * Able to provide written and/or oral feedback as outlined in the implementation method
Where this trial is running
Grand Island, Nebraska and 1 other locations
- Nebraska Medicine Grand Island Clinic — Grand Island, Nebraska, United States (Recruiting)
- University of Nebraska Specialty Care Center — Omaha, Nebraska, United States (Recruiting)
Study contacts
- Principal investigator: Nada Fadul, MD — University of Nebraska
- Study coordinator: Maureen Kubat, BSN, RN
- Email: mo.kubat@unmc.edu
- Phone: 402-559-4408
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.