Study Summary
This trial is examining the administration of CABENUVA, a long-acting medication for HIV, in infusion centers in the United States. The acceptability and feasibility of the infusion center to deliver CABENUVA injections will be assessed from the perspectives of the participants, HIV care providers and IC staff.
Treatment Effectiveness
Phase-Based Effectiveness
Phase 4
Study Objectives
1 Primary · 93 Secondary · Reporting Duration: Baseline (Month 1), at Months 3, 6 and 12
Month 3
Proportion of IC Staff who agree or completely agree (a score of 4 or higher) across all items on the FIM
Proportion of participants and IC staff respectively who agree or completely agree (a score of 4 or higher) across all items on the AIM
Month 6
Proportion of HIV care providers who agree or completely agree (a score of 4 or higher) across all items on the FIM
Month 3
Change from Baseline in AIM score for IC staff over time
Change from Baseline in AIM score for IC/ ASA staff over time
Month 8
Change in composite score of feasibility process indications
Change in each individual item of composite score of feasibility process indications
Month 3
Change in FIM score over time in IC Staff at Month 3 and 8
Change in FIM score over time in IC/ ASA Staff at Month 3 and 8
Change in FIM score over time in participants at Month 3 and 8
Month 3
Change from Baseline in AIM score for participants and IC staff respectively over time (scores on a scale)
Month 3
Change from Baseline in AIM score for participants over time
Month 4
Change from Baseline in AIM score for HIV care providers over time
Change in FIM score over time in HIV care providers at Month 4 and 8
Month 6
Change in feasibility composite score over time using FIM
Feasibility composite score using FIM
Month 6
Change in AIM scale of Expert Panel over time through Month 6
Change in FIM scale of Expert Panel over time through Month 6
Month 1
Acceptability of CABENUVA administration at infusion center assessed by Quantitative questionnaire in Participants at Month 1, 3 and 8
Acceptability of CABENUVA administration at infusion center/ ASA assessed by other Quantitative questionnaire in Participants at Month 1, 3 and 8
Acceptability of the process of receiving injections at ICs assessed by Quantitative questionnaires in participants
Acceptability of the process of receiving injections at ICs/ ASAs assessed by other Quantitative questionnaires in participants
Advantages of receiving CABENUVA at IC assessed by Quantitative questionnaires in participants
Advantages of receiving CABENUVA at IC/ ASA assessed by other Quantitative questionnaires in participants
Disadvantages of receiving CABENUVA at IC assessed by Quantitative questionnaires in participants
Disadvantages of receiving CABENUVA at IC/ ASA assessed by other Quantitative questionnaires in participants
Feasibility of Cabenuva administration assessed by other quantitative questionnaires in participants at Month 1, 3 and 8
Feasibility of Cabenuva administration assessed by quantitative questionnaires in participants at Month 1, 3 and 8
Overall opinion of receiving the injection at an IC assessed by Quantitative questionnaires in participants
Overall opinion of receiving the injection at an IC/ ASA assessed by other Quantitative questionnaires in participants
Perceptions, facilitators, and barriers/concerns of CABENUVA administration assessed with Quantitative questionnaires in Participants
Perceptions, facilitators, and barriers/concerns of CABENUVA administration assessed with other Quantitative questionnaires in Participants
Preference on the location to receive CABENUVA assessed with Quantitative questionnaires in participants
Preference on the location to receive CABENUVA assessed with other Quantitative questionnaires in participants
Proportion of IC/ ASA participants who agree or completely agree (a score of 4 or higher) across all items on the AIM
Proportion of participants who agree or completely agree (a score of 4 or higher) across all items on the AIM
Month 1
Acceptability of CABENUVA administration at infusion center assessed by Quantitative questionnaire in HIV care providers at Month 1, 4 and 8
Acceptability of CABENUVA administration at infusion center/ ASA assessed by other Quantitative questionnaire in HIV care providers at Month 1, 4 and 8
Acceptability of the process of referring participants to the IC for CABENUVA assessed by Quantitative questionnaires in HIV care providers
Acceptability of the process of referring participants to the IC/ ASA for CABENUVA assessed by other Quantitative questionnaires in HIV care providers
Advantages of referring participants to the IC to receive CABENUVA assessed by Quantitative questionnaires in HIV care providers
Advantages of referring participants to the IC/ ASA to receive CABENUVA assessed by other Quantitative questionnaires in HIV care providers
Disadvantages of referring participants to the IC to receive CABENUVA assessed by Quantitative questionnaires in HIV care providers
Disadvantages of referring participants to the IC/ ASA to receive CABENUVA assessed by other Quantitative questionnaires in HIV care providers
Feasibility of Cabenuva administration assessed by Quantitative questionnaires in HIV care providers at Month 1, 4 and 8
Feasibility of Cabenuva administration assessed by other Quantitative questionnaires in HIV care providers at Month 1, 4 and 8
Overall opinion of referring the participant to an IC/ ASA assessed by other Quantitative questionnaires in HIV care provider
Overall opinion of referring the patient to an IC assessed by Quantitative questionnaires in HIV care provider
Perceptions, facilitators, and barriers/concerns of CABENUVA administration assessed with Quantitative questionnaires in HIV care provider
Month 4 and 8
Usefulness of Plan of Treatment (POT) assessed by Quantitative questionnaires in HIV care providers
Usefulness of Plan of Treatment (POT) assessed by other Quantitative questionnaires in HIV care providers
Month 8
Acceptability of CABENUVA administration at infusion center assessed by Qualitative interviews in participants, HIV care providers and IC staff at Month 8
Acceptability of CABENUVA administration at infusion center/ ASA assessed by Qualitative interviews in participants, HIV care providers and IC/ ASA staff at Month 8
Acceptability of the process of receiving injections at ICs assessed by Qualitative interviews in participants and HIV care providers
Acceptability of the process of receiving injections at ICs/ ASAs assessed by Qualitative interviews in participants and HIV care providers
Advantages of receiving CABENUVA at IC assessed by Qualitative interviews with HIV care providers and Participants
Advantages of receiving CABENUVA at IC/ ASA assessed by Qualitative interviews with HIV care providers and Participants
Disadvantages of receiving CABENUVA at IC assessed by Qualitative interviews with HIV care providers and Participants
Disadvantages of receiving CABENUVA at IC/ ASA assessed by Qualitative interviews with HIV care providers and Participants
Feasibility of Cabenuva administration assessed by Qualitative interviews in participants, HIV care providers and IC staff at Month 8
Feasibility of Cabenuva administration assessed by Qualitative interviews in participants, HIV care providers and IC/ ASA staff at Month 8
Overall opinion of receiving and administering the injection at an IC assessed by Qualitative interview in participants, HIV care providers and IC staff
Overall opinion of receiving and administering the injection at an IC/ ASA assessed by Qualitative interview in participants, HIV care providers and IC/ ASA staff
Perceptions, facilitators, and barriers/concerns of CABENUVA administration assessed by Qualitative interviews in participants, HIV care providers and IC staff
Perceptions, facilitators, and barriers/concerns of CABENUVA administration assessed by Qualitative interviews in participants, HIV care providers and IC/ ASA staff
Preference on the location to receive CABENUVA assessed by Qualitative interviews in participants
Proportion of participants who agree or completely agree (a score of 4 or higher) across all items on the Feasibility of Intervention Measure (FIM)
Usefulness of the blueprint intervention and POT assessed by Qualitative interviews in IC Staff and HIV care providers
Usefulness of the blueprint intervention and POT assessed by Qualitative interviews in IC/ ASA Staff and HIV care providers
Months 1 and 3
Proportion of participants who agree or completely agree (a score of 4 or higher) across all items on the FIM at Month 1 and 3
Month 1
Proportion of HIV care providers who agree or completely agree (a score of 4 or higher) across all items on the Acceptability of Intervention Measure (AIM)
Proportion of HIV care providers who agree or completely agree (a score of 4 or higher) across all items on the FIM at Month 1, 4 and 8
Month 3
Overall opinion of administering the injection at an IC assessed by Quantitative questionnaires in IC Staff
Overall opinion of administering the injection at an IC/ ASA assessed by other Quantitative questionnaires in IC/ ASA Staff
Usefulness of the blueprint intervention in IC Staff assessed with Quantitative questionnaires
Usefulness of the blueprint intervention in IC/ ASA Staff assessed with other Quantitative questionnaires
Month 3
Feasibility and acceptability of the process of CABENUVA administration assessed by Quantitative questionnaires in Expert Panel
Month 3
Acceptability of CABENUVA administration at infusion center assessed by Quantitative questionnaire in IC Staff prior to Month 1 and Months 3 and 8
Acceptability of CABENUVA administration at infusion center/ ASA assessed by other Quantitative questionnaire in IC/ ASA Staff prior to Month 1 and Months 3 and 8
Feasibility of Cabenuva administration assessed by Quantitative questionnaires in IC Staff prior to Month 1, Month 3 and 8
Feasibility of Cabenuva administration assessed by other Quantitative questionnaires in IC/ ASA Staff prior to Month 1, Month 3 and 8
Perceptions, facilitators, and barriers/concerns of CABENUVA administration assessed with Quantitative questionnaires in IC Staff
Perceptions, facilitators, and barriers/concerns of CABENUVA administration assessed with other Quantitative questionnaires in IC/ ASA Staff
Month 6
Feasibility and acceptability of the process of CABENUVA administration assessed by Qualitative interviews in Expert Panel
Month 3
Proportion of IC Staff who agree or completely agree (a score of 4 or higher) across all items on the FIM Prior to Month 1 and at Months 3 and 8
Proportion of IC/ ASA Staff who agree or completely agree (a score of 4 or higher) across all items on the FIM Prior to Month 1 and at Months 3 and 8
Month 3
Proportion of Expert Panel that agree or completely agree (a score of 4 or higher) across all items on the AIM Scale
Proportion of Expert Panel that agree or completely agree (a score of 4 or higher) across all items on the FIM Scale
Month 3
Proportion of IC staff who agree or completely agree (a score of 4 or higher) across all items on the AIM
Proportion of IC/ ASA staff who agree or completely agree (a score of 4 or higher) across all items on the AIM
Up to Month 12
Proportion of clinics contacted by the infusion center to initiate referrals for the injections
Proportion of participants receiving injections at the infusion center
Month 8
Composite score of feasibility process indications
Proportion of injections occurring within target window from target date
Trial Safety
Phase-Based Safety
This is further along than 85% of similar trials
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
1 Treatment Group
Participants receiving CABENUVA
1 of 1
Experimental Treatment
120 Total Participants · 1 Treatment Group
Primary Treatment: CABENUVA · No Placebo Group · Phase 4
Participants receiving CABENUVA
Drug
Experimental Group · 1 Intervention: CABENUVA · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (month 1), at months 3, 6 and 12
Who is running the clinical trial?
ViiV HealthcareLead Sponsor
338 Previous Clinical Trials
462,297 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorViiV Healthcare
3,573 Previous Clinical Trials
6,136,970 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
What potential hazards come with taking CABENUVA?
"Given its approval as a Phase 4 treatment, CABENUVA was rated 3 for safety by our Power team." - Anonymous Online Contributor
Unverified Answer
How many medical centers are running this clinical experiment?
"Currently, 21 different medical sites are opening their doors to participate in this clinical trial. Options include centres located in Charlotte, Charleston and Columbia as well as 18 other locations across the country. To reduce travel demands associated with participation, we suggest selecting the clinic closest to you." - Anonymous Online Contributor
Unverified Answer
Has CABENUVA been explored in any other scientific investigations?
"Currently, CABENUVA has 20 active clinical trials with 7 having reached Phase 3. Primarily centered in Pathum Wan, Bangkok, there are 639 sites conducting studies on this drug's efficacy." - Anonymous Online Contributor
Unverified Answer
What conditions is CABENUVA typically employed to treat?
"CABENUVA is commonly prescribed to individuals who are HIV test negative. Additionally, this drug may be beneficial in treating cases of treatment failure, viral resistance, and when the HIV-1 RNA count is less than or equal to 100,000 copies/ml." - Anonymous Online Contributor
Unverified Answer
Are there any vacancies left for participants in this investigation?
"As per clinicaltrials.gov, this research project is presently enlisting participants. It was initially announced on November 18th 2021 and the latest update came out on November 21st 2022." - Anonymous Online Contributor
Unverified Answer
How many participants in this research project are currently being monitored?
"Correct. According to the information on clinicaltrials.gov, this study was originally posted in November 2021 and is presently recruiting participants for a total of 120 patients from 21 different sites. The listing was last modified on 11/21/2022." - Anonymous Online Contributor
Unverified Answer