HIV-1-infectionNCT05096949
Implementing Cabenuva in Arkansas HIV Programs
A study testing Home visit delivery strategy in people with HIV-1-infection and Medication Adherence, run by University of Arkansas at 1 site in United States.
Trial summary
This study seeks to address this gap by studying two Cabenuva delivery strategies conducted at six outpatient HIV clinics in Arkansas, a Southern state with a large population of rural, poor, and African-American residents. The two delivery strategies are clinic delivery and home delivery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection, Medication Adherence, Satisfaction, Patient
- What is being tested?
- Home visit delivery strategy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons, 18-years old and older
- Receiving Cabenuva injections (following registered USPI) at one of the six clinics in this study
- Ability to provide informed consent
- Patients who would receive Cabenuva at home: Living within 40-miles from the three clinics randomized to the at-home arm of the study
Who cannot join
- Pregnant or breastfeeding women, or women who plan to become pregnant during the study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Implementing Long-Acting Cabotegravir + Rilpivirine in Arkansas Programs Utilizing Out-patient Clinics Versus In-home Visits
This study seeks to address this gap by studying two Cabenuva delivery strategies conducted at six outpatient HIV clinics in Arkansas, a Southern state with a large population of rural, poor, and African-American residents. The two delivery strategies are clinic delivery and home delivery. In the clinic delivery study arm patients will receive Cabenuva injections at the clinic (50 patients), and in the home delivery study arm patients will receive the injections at home (50 patients). The study team will follow the patients in both study arms for 10 months. After 5 months, the patients will complete a treatment satisfaction survey, and after 10 months the study team will examine clinic records to assess their medication adherence.
Secondary outcomes will include clinician perceptions of acceptability, feasibility, and appropriateness of Cabenuva delivery strategies. The study team will also collect qualitative data from patients and clinic employees to learn more in depth about their perceptions of Cabenuva, the delivery strategies, their implementation, and barriers and facilitators. Finally, the study team will estimate the costs associated with the two delivery strategies from the clinic and patient perspectives.
The data from this study provide information on what delivery strategies for long acting HIV medications offer best results, how these strategies are perceived by patients and clinicians, and how costly and feasible the strategies are to implement in practice.
Read the detailed description
Good medication adherence in patients living with HIV (PLHIV) is one of the key determinants of their treatment success. Most current HIV medications are taken daily, which represents a big burden and leads to many challenges for maintaining medication adherence. These challenges are exacerbated by socio-economic factors, such as poverty, rurality, race/ethnicity, and stigma, leading to disparities in treatment and outcomes. Long acting injectable medications offer promise of reducing medication adherence burden and barriers, potentially improving the health and well-being of PLHIV, and helping limit the spread of HIV. In January 2021, FDA approved Cabenuva, the first long acting HIV medication, administered as monthly or every-2-month injections. Injectable treatment holds promise to improve treatment adherence and facilitate access to treatment for rural residents. However, it is currently not known what delivery strategies would optimize delivery of long acting HIV medications for best patient adherence and satisfaction.
This study seeks to address this gap by studying two Cabenuva delivery strategies conducted at six outpatient HIV clinics in Arkansas, a Southern state with a large population of rural, poor, and African-American residents. The two delivery strategies are clinic delivery and home delivery. In the clinic delivery study arm patients will receive Cabenuva injections at the clinic (50 patients), and in the home delivery study arm patients will receive the injection at home (50 patients). The study team will follow the patients in both study arms for 10 months. After 5 months, the patients will complete a treatment satisfaction survey, and after 10 months the study team will examine clinic records to assess their medication adherence.
Secondary outcomes will include clinician perceptions of acceptability, feasibility, and appropriateness of Cabenuva delivery strategies. The study team will also collect qualitative data from patients and clinic employees to learn more in depth about their perceptions of Cabenuva, the delivery strategies, their implementation, and barriers and facilitators. Finally, the study team will estimate the costs associated with the two delivery strategies from the clinic and patient perspectives.
The data from this study provide information on what delivery strategies for long acting HIV medications offer best results, how these strategies are perceived by patients and clinicians, and how costly and feasible the strategies are to implement in practice.
- Conditions
- HIV-1-infection, Medication Adherence, Satisfaction, Patient
- Being tested
- Home visit delivery strategy
- Keywords
- Delivery, Implementation, Long acting medication
- Medical subject headings
- Medication Adherence, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home visit delivery strategyOther
A nurse will deliver and administer Cabenuva injection at patient's home
| Study group | Role | What they receive |
|---|---|---|
| Clinic visit arm | No intervention | Patient will receive Cabenuva injection at the clinic |
| Home visit arm | Experimental | Patient will receive Cabenuva injection at home Receives: Other: Home visit delivery strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
Medication adherence will be quantified as a binary variable, based on whether the patient received all scheduled injections as planned or not. (As of January 2022, Cabenuva is approved for monthly and every-2-month injection schedule, and the study does not dictate which schedule the participants follow.)
Measured: 10 months
Secondary outcomes (1)
Patient treatment satisfaction
Modified version of the Satisfaction with HIV/AIDS Treatment Interview Scale (SATIS) instrument (Tran \& Nguyen, 2012), with values ranging from 0 to 10 (higher scores are better).
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start7 Mar 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Why it stopped: Insufficient enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomized parallel design
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare
- Responsible party
- Sponsor
- Investigators
- Jure Baloh, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096949
- Sponsor's protocol ID
- 261250
- Status last verified
- Jan 2024
- First submitted
- 18 Oct 2021
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication, anonymized patient level data from the study may be shared with other researchers on reasonable request.
Publications
Tran BX, Nguyen NP. Patient satisfaction with HIV/AIDS care and treatment in the decentralization of services delivery in Vietnam. PLoS One. 2012;7(10):e46680. doi: 10.1371/journal.pone.0046680. Epub 2012 Oct 5.
PubMed 23071611Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Long-Acting Cabotegravir + Rilpivirine in Arkansas Programs Utilizing Out-patient Clinics Versus In-home Visits
- ClinicalTrials.gov ID
- NCT05096949
- Acronym / sponsor ID
- 261250
- Conditions
- HIV-1-infection, Medication Adherence, Satisfaction, Patient
- Keywords
- Delivery, Implementation, Long acting medication
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- ViiV Healthcare
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to address this gap by studying two Cabenuva delivery strategies conducted at six outpatient HIV clinics in Arkansas, a Southern state with a large population of rural, poor, and African-American residents. The two delivery strategies are clinic delivery and home delivery. In the clinic delivery study arm patients will receive Cabenuva injections at the clinic (50 patients), and in the home delivery study arm patients will receive the injections at home (50 patients). The study team will follow the patients in both study arms for 10 months. After 5 months, the patients will complete a treatment satisfaction survey, and after 10 months the study team will examine clinic records to assess their medication adherence.
Secondary outcomes will include clinician perceptions of acceptability, feasibility, and appropriateness of Cabenuva delivery strategies. The study team will also collect qualitative data from patients and clinic employees to learn more in depth about their perceptions of Cabenuva, the delivery strategies, their implementation, and barriers and facilitators. Finally, the study team will estimate the costs associated with the two delivery strategies from the clinic and patient perspectives.
The data from this study provide information on what delivery strategies for long acting HIV medications offer best results, how these strategies are perceived by patients and clinicians, and how costly and feasible the strategies are to implement in practice.
Detailed description
Good medication adherence in patients living with HIV (PLHIV) is one of the key determinants of their treatment success. Most current HIV medications are taken daily, which represents a big burden and leads to many challenges for maintaining medication adherence. These challenges are exacerbated by socio-economic factors, such as poverty, rurality, race/ethnicity, and stigma, leading to disparities in treatment and outcomes. Long acting injectable medications offer promise of reducing medication adherence burden and barriers, potentially improving the health and well-being of PLHIV, and helping limit the spread of HIV. In January 2021, FDA approved Cabenuva, the first long acting HIV medication, administered as monthly or every-2-month injections. Injectable treatment holds promise to improve treatment adherence and facilitate access to treatment for rural residents. However, it is currently not known what delivery strategies would optimize delivery of long acting HIV medications for best patient adherence and satisfaction.
This study seeks to address this gap by studying two Cabenuva delivery strategies conducted at six outpatient HIV clinics in Arkansas, a Southern state with a large population of rural, poor, and African-American residents. The two delivery strategies are clinic delivery and home delivery. In the clinic delivery study arm patients will receive Cabenuva injections at the clinic (50 patients), and in the home delivery study arm patients will receive the injection at home (50 patients). The study team will follow the patients in both study arms for 10 months. After 5 months, the patients will complete a treatment satisfaction survey, and after 10 months the study team will examine clinic records to assess their medication adherence.
Secondary outcomes will include clinician perceptions of acceptability, feasibility, and appropriateness of Cabenuva delivery strategies. The study team will also collect qualitative data from patients and clinic employees to learn more in depth about their perceptions of Cabenuva, the delivery strategies, their implementation, and barriers and facilitators. Finally, the study team will estimate the costs associated with the two delivery strategies from the clinic and patient perspectives.
The data from this study provide information on what delivery strategies for long acting HIV medications offer best results, how these strategies are perceived by patients and clinicians, and how costly and feasible the strategies are to implement in practice.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomized parallel design
| Arm | Type | Receives |
|---|---|---|
| Clinic visit arm | No intervention | –Patient will receive Cabenuva injection at the clinic |
| Home visit arm | Experimental | Other: Home visit delivery strategyPatient will receive Cabenuva injection at home |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Persons, 18-years old and older
- Receiving Cabenuva injections (following registered USPI) at one of the six clinics in this study
- Ability to provide informed consent
- Patients who would receive Cabenuva at home: Living within 40-miles from the three clinics randomized to the at-home arm of the study
Key exclusion criteria (1 listed)
- Pregnant or breastfeeding women, or women who plan to become pregnant during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home visit delivery strategyA nurse will deliver and administer Cabenuva injection at patient's home | Other | Home visit arm |
Primary outcome
Medication adherence
Time frame: 10 months
Medication adherence will be quantified as a binary variable, based on whether the patient received all scheduled injections as planned or not. (As of January 2022, Cabenuva is approved for monthly and every-2-month injection schedule, and the study does not dictate which schedule the participants follow.)
1 secondary outcome
Patient treatment satisfaction
Time frame: 5 months
Results and safety
The study was stopped early (reason given: Insufficient enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Background: PubMed 23071611Tran BX, Nguyen NP. Patient satisfaction with HIV/AIDS care and treatment in the decentralization of services delivery in Vietnam. PLoS One. 2012;7(10):e46680. doi: 10.1371/journal.pone.0046680. Epub 2012 Oct 5.
- Background: PubMed 28851459Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Individual participant dataSharing planned: Yes. After publication, anonymized patient level data from the study may be shared with other researchers on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jure Baloh, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home visit delivery strategy in people with HIV-1-infection and Medication Adherence, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05096949, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.