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

RecruitingOBSERVATIONAL
Enrollment

55

Participants

Timeline

Start Date

July 1, 2024

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2026

Conditions
HIV
Interventions
BEHAVIORAL

Acceptability of Intervention Measure (AIM)

"The Acceptability of Intervention Measure (AIM) questionnaire will be administered at Baseline, Month 7 and Month 15 to patient and staff participants. This is a four-item validated measure of implementation outcomes that is often considered a leading indicator of implementation success.~The AIM will measure the extent to which participants believe CAB+RPV LA implementation is acceptable."

BEHAVIORAL

Intervention Appropriateness Measure (IAM)

"The Intervention Appropriateness Measure (IAM) questionnaire will be administered at Baseline to patient and staff participants. This is a four-item validated measure of implementation outcomes that is often considered a leading indicator of implementation success.~The IAM will measure the extent to which participants believe CAB+RPV LA implementation is appropriate."

BEHAVIORAL

Feasibility of Intervention Measure (FIM)

"The Feasibility of Intervention Measure (FIM) questionnaire will be administered at Baseline, Month 7 and Month 15 to patient and staff participants. This is a four-item validated measure of implementation outcomes that is often considered a leading indicator of implementation success.~The FIM will measure the extent to which participants believe CAB+RPV LA implementation is feasible."

BEHAVIORAL

HIV Stigma Scale Questionnaire

"The HIV Stigma Scale Questionnaire used in this study is a shortened version of the validated 40-item HIV stigma scale. This 12-item questionnaire measures the same four stigma subscales measured in the original version, for a streamlined approach to collecting this data on personalized stigma, disclosure concerns, concerns with public attitudes and negative self-image.~This will be administered at Baseline, Month 7 and Month 15."

BEHAVIORAL

HIV Treatment Satisfaction Questionnaire status version (HIVTSQs12)

"The HIV Treatment Satisfaction Questionnaire was developed to evaluate treatments for HIV and patient satisfaction. The original 10 item HIVTSQ, which underwent two stages of psychometric validation, has been adapted to include questions regarding injectable treatment for HIV.~Two versions of the HIVTSQ are being used. The status version (HIVTSQs12) will assess change in treatment satisfaction over time, and the change version (HIVTSQc12) will assess the change in treatment satisfaction between a patient participant's previous and current treatment.~The status version will be administered at Baseline, Month 7 and Month 15."

BEHAVIORAL

HIV Treatment Satisfaction Questionnaire change version (HIVTSQc12)

"The HIV Treatment Satisfaction Questionnaire was developed to evaluate treatments for HIV and patient satisfaction. The original 10 item HIVTSQ, which underwent two stages of psychometric validation, has been adapted to include questions regarding injectable treatment for HIV.~Two versions of the HIVTSQ are being used. The status version (HIVTSQs12) will assess change in treatment satisfaction over time, and the change version (HIVTSQc12) will assess the change in treatment satisfaction between a patient participant's previous and current treatment.~The change version will be administered at Month 15."

BEHAVIORAL

Needs and Barriers Assessment

"The Needs and Barriers Assessment is a questionnaire designed to assess patient participant barriers and social determinants of health, emotional challenges related to antiretroviral therapy, and the impact of switching to CAB+RPV LA treatment.~This will be administered at Baseline, Month 7 and Month 15."

BEHAVIORAL

Pre-visit Outreach

Patient participants will be contacted prior to each clinical injection visit for an appointment reminder and a needs assessment.

BEHAVIORAL

Qualitative interview

Qualitative interviews will be conducted within thirty days after study completion at Month 15 to further evaluate the participant's experience with the implementation of CAB+RPV LA treatment.

BEHAVIORAL

Staff education

Staff participants will participate in Extension for Community Healthcare Outcomes (Project ECHO) educational sessions with topics such as fundamentals of HIV treatment and care, HIV outcomes, delivery of antiretroviral therapies (ART) including long-acting ART, cultural sensitivity, and social determinants of health in rural areas.

Trial Locations (2)

68106

RECRUITING

University of Nebraska Specialty Care Center, Omaha

68803

RECRUITING

Nebraska Medicine Grand Island Clinic, Grand Island

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

ViiV Healthcare

INDUSTRY

lead

University of Nebraska

OTHER