Medication AdherenceENLIGHTENNCT04232540
Establishing Novel Antiretroviral Imaging for Hair to Elucidate Non-Adherence (ENLIGHTEN)
A study testing MedViewer report in people with Medication Adherence, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This is a pilot study to assess the feasibility, acceptability and appropriateness of delivery of the investigational "MedViewer" intervention in adult patients living with HIV who have been prescribed antiretroviral (ARV) medications. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Medication Adherence
- What is being tested?
- MedViewer report
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2020to 15 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient participants:
- Documentation of HIV-1 infection by means of any one of the following:
- Documentation of HIV diagnosis in the medical record by a licensed health care provider;
- OR HIV-1 RNA detection by a licensed HIV-1 RNA test demonstrating >1000 RNA copies/mL;
- OR any licensed HIV screening antibody and/or HIV antibody/antigen combination test confirmed by a second licensed HIV test such as a HIV-1 Western blot confirmation or HIV rapid Multispot antibody differentiation test.
- At least 18 years of age on the day of consent.
Show all 21Show fewer
- Documentation of HIV viral loads over 2-year period prior to screening.
- Has been a patient at the UNC ID clinic for at least 90 consecutive days prior to the date of enrollment in the study (i.e. attended first appointment at the UNC ID Clinic at least 90 days prior to the date of enrollment in the study).
- Has attended at least one HIV appointment at the UNC ID clinic within the 365 days prior to the date of enrollment in the study.
- Has been prescribed one of the ARV medications eligible in this study (Dolutegravir, Emtricitabine) by a UNC provider for at least 90 days prior to the date of enrollment in the study.
- Has an HIV appointment scheduled at the UNC ID clinic during the enrollment period of the study with a medical provider enrolled in the study.
- Evidence of a personally signed and dated informed consent form indicating that the participant has been informed of all pertinent aspects of the study.
- Has stated willingness and availability to comply with all study procedures for the duration of the study.
- Literate in English.
- Has at least 1.0 cm of natural caput hair.
- As enrollment will occur in a stratified manner based on 2 viral load strata, (n = 25 for patients with undetectable viral loads, n = 25 for those with detectable viral loads), once a stratum quota is reached, patients whose viral loads fall within that stratum will not be eligible to participate in the study.
- Provider participants:
- Medical provider (including, but not limited to: attending physician, ID fellow, nurse practitioner, physician assistant, or a designated HIV Care pharmacist) for UNC ID clinic patients living with HIV.
- Provides medical care for patients at the UNC ID clinic at least one half-day per week (i.e. 4 hours per week).
- Evidence of a personally signed and dated informed consent form indicating that the participant has been informed of all pertinent aspects of the study.
- Has stated willingness and availability to comply with all study procedures for the duration of the study.
Who cannot join
- Patient participants:
- Previous participation in the study UNC 11530- Formative Sub-Study for Novel Mass Spectrometry Imaging Methods to Quantify Antiretroviral Adherence.
- Deemed, by medical provider in UNC ID clinic, too ill, or other relevant reason, to participate in the study.
- Prior history of clinically significant alteration of the gastrointestinal system or drug absorption capability, including but not limited to: gastrectomy, total colectomy
- Any chemical hair treatment with dye, bleach, or relaxers within the past 4 weeks prior to sampling
- Provider participants:
- Not willing or able to participate in any of the provider training sessions for this study or any form of make-up training session with research team.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
This is a pilot study to assess the feasibility, acceptability and appropriateness of delivery of the investigational "MedViewer" intervention in adult patients living with HIV who have been prescribed antiretroviral (ARV) medications. The Medviewer uses Infra-red (IR) matrix-assisted laser desorption electrospray ionization (MALDESI) technology for mass spectrometry imaging (MSI) to analyze patient hair samples to provide information on ARV adherence in real-time.
The study has two different groups of participants: the patients, and their clinician providers.
Read the detailed description
This study is part of a larger research program that is investigating a novel non-invasive approach to rapidly quantify ARV concentrations and provide evidence of drug ingestion. The ultimate goal is to provide clinicians and patients feedback on ARV adherence. Infra-red (IR) matrix-assisted laser desorption electrospray ionization (MALDESI) technology for mass spectrometry imaging (MSI) is used to visualize and quantify ARV concentrations in hair. The IR-MALDESI MSI has been labeled the "MedViewer".
Patient participants will be scheduled for the sampling visit to correspond with their next appointment at the University of North Carolina (UNC) Infectious Disease (ID) clinic. Patient participants will be asked to arrive to their clinic appointment at least two hours prior to the scheduled time to be consented and enrolled. If eligible and enrolled in the study, patient participants will have a small hair sample (5 strands) plucked from a discrete location on the back of their head. Patient participants will also have a small blood sample collected. The results from the MedViewer test will be provided to both the patient and their provider, in order to facilitate a discussion around medication adherence. After receiving the results, all participants will complete a brief questionnaire about their experience with the MedViewer.
As this is a feasibility study, results from the Medviewer test will not be used to make clinical decisions related to care.
Major changes after the start of enrollment:
- Removed the term "real-time" throughout the document-Pertinent feasibility endpoints now use "delivery of the report to the designated research staff member within 2 hours of initiation of hair processing" rather than "…within 2 hours of hair sample collection"
- Removed mitra sampling for the remaining 15 participants in cohort A. Now stated as "blood sample will be collected for 10 participants in Group A and a subset of participants in Group B." After Mitra is analyzed for the first 10 participants in Group B, we will reevaluate to determine if additional samples are needed to validate hair samples.
- V1 and V2 study activities will be conducted virtually (except hair collection and in-person patient provider clinic visits) to minimize in-person contact. Consent and screening will be conducted virtually using videoconferencing via zoom on computer, tablet or phone. All questionnaires (patient baseline, patient post-visit, patient endline, provider baseline, provider post-visit, and provider endline) will be conducted virtually through REDCap (emailed to participant or verbally administered via phone or videoconferencing). Hair collection will be conducted by research staff at remote locations to limit time in clinic. Implementation of the intervention will now be allowed in the setting of telehealth clinical visits between patient and provider in addition to in-person clinical visits. MedViewer reports will be sent to providers via secure email. All remaining V2s will be conducted virtually. Hair and blood samples will not be collected.
- Consenting will take place up to 3 days before scheduled clinic appointment with provider. Hair sample will be collected by research staff at a remote location in the 3 days between consent and the scheduled provider visit. MedViewer report will be discussed between patient and provider (or patient and pharmacist, if needed) within 4 weeks of hair sample collection.
- Interviewer-administered portions of the baseline questionnaire have been modified. Health Literacy measure (Newest Vital Sign) removed. ART adherence Visual Analog Scale modified to allow for remote self-administration.
- Maximum duration on study extended by 6 months for providers (increased from 10 to 16 months). Provider sample size range reduced (from 20-30 to 16-30)
These changes were implemented on November 5, 2020 in a Letter of Amendment (LOA) to ENLIGHTEN Protocol Version 2. The LOA detailed changes made to the protocol due to the COVID-19 Pandemic.
- Conditions
- Medication Adherence
- Being tested
- MedViewer report
- Keywords
- HIV infection, Medication Adherence, Hair, Dolutegravir, Emtricitabine, Antiretrovirals
- Medical subject headings
- Medication Adherence, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedViewer reportDevice
Results from the analysis of hair samples performed using the MedViewer
| Study group | Role | What they receive |
|---|---|---|
| Patient participants | Experimental | Patient and provider will view and discuss results of the MedViewer test. Receives: Device: MedViewer report |
| Provider participants | Experimental | Patient and provider will view and discuss results of the MedViewer test. Receives: Device: MedViewer report |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Patient Participants That Received a MedViewer Report as Planned
Patient participants received their MedViewer report as planned if: (1) they had results delivered to the research team member within 2 hours of initiation of hair sample processing; and (2) discussed results with a provider participant during their clinic visit. The percent of patient participants that received the MedViewer report as planned is reported.
Measured: Visit 1 (Day 1) after patient participant clinic visit
Percent of Contacted Patients That Were Eligible for a Screening Visit and Agreed to Participate in the Study
Contacted patients were deemed eligible for a screening visit using a pre-screening questionnaire and provided documented informed consent to participate in the study. The percent of all contacted eligible patients that agreed to participate in study is reported. Per study protocol, this outcome is not measured in providers.
Measured: Visit 1 (Day 1) before patient participant clinic visit
Percent of Patient Participants That Were Satisfied With Their Discussion With a Provider Participant About Antiretroviral (ART) Adherence Using the MedViewer Report
Patient participants were asked to rate their satisfaction with the MedViewer report for promoting a productive discussion of ART adherence with a provider participant. Satisfaction was rated on a rated on a 5-point scale (1="very unsatisfied" to 5="very satisfied"), with higher scores being more favorable. The percent of patient participants reporting 4 or greater (4="somewhat satisfied" or 5="very satisfied") on this scale as was calculated.
Measured: Visit 1 (Day 1) after patient participant clinic visit
Percent of Patient Participants for Whom Provider Participants Reported the MedViewer Report as Being Useful for Promoting a Productive Antiretroviral (ART) Adherence Discussion
For each of patient participant, provider participants were asked to rate the usefulness of the MedViewer report in promoting a productive discussion with the patient participant about ART adherence using a 5-point scale (1="not at all useful" to 5="extremely useful"), with a higher score being more favorable. The percent of patient participants with provider participants reporting 4 or greater (4="very useful" or 5="extremely useful") on this scale as was calculated.
Measured: Visit 1 (Day 1) after patient participant clinic visit
Secondary outcomes (7)
Among Patient Participants That Did Dot Receive a MedViewer Report, Percent of Patient Participants That Did Not Receive the MedViewer for a Given Reason or Reasons
Reasons for patient participants' non-receipt of MedViewer report were only assessed for the subset of patient participants for whom non-receipt was reported. Reasons for non-receipt were assessed by provider participants for each patient participant after their scheduled visit using a single multiple-choice, multiple-answer question. The percent of patient participants for whom a reason or combination of reasons for non-receipt is reported.
Measured: Visit 1 (Day 1) after patient participant clinic visit
Mean Hours From Patient Participant Hair Sample Processing Initiation to MedViewer Report Delivery to Designated Research Staff Member
For each patient participant, the number of hours elapsed from the time of initiation of hair processing in the lab (Time 1) to the time of results delivery to designated research staff member (Time 2) was calculated, and a population mean was determined.
Measured: Time 1 to Time 2 prior to or on Visit 1 (Day 1)
Percent of Participants Reporting a High Likelihood of Future MedViewer Report Use
The 4-point scale measuring the likelihood of future MedViewer report use ranged from 1="definitely would not" to 4="definitely would", with a higher score being more favorable. The percent of participants that scored 3 or greater on the likelihood of future MedViewer use scale (3="probably would" or "4="definitely would") was calculated.
Measured: Visit 1 (Day 1) after patient participant clinic visit for patient participants, end line visit for provider participants
Percent of Patient Participants Reporting High Comprehension of the MedViewer Report
Patient participants were asked to rate their comprehension of the information presented in the MedViewer report using a 4-point scale (1="very difficult to understand" to 4="very easy to understand"), with a higher score being more favorable. The percent of patient participants reporting 3 or greater on this scale (3="somewhat easy to understand" or 4="very easy to understand") was calculated.
Measured: Visit 1 (Day 1) after patient participant clinic visit
Percent of Patient Participants Reported by Provider Participants as Having High Comprehension of the MedViewer Report
Provider participants were asked to rate each of patient participant's comprehension of the information presented in the MedViewer report using a 5-point scale (1="understood not at all well" to 5="understood excellently"), with a higher score being more favorable. The percent of patient participants with provider participants reporting 4 or greater (4="understood very well" or 5="understood excellently") on this scale as was calculated.
Measured: Visit 1 (Day 1) after patient participant clinic visit
Mean Usefulness Score for the MedViewer Report to Promote ART (Antiretroviral) Adherence
Participants were asked to rate their perceived usefulness of the MedViewer report for promoting ART adherence. Usefulness was rated on a rated on a 5-point scale (1="not at all useful" to 5="extremely useful"), with higher scores being more favorable. A mean usefulness score was calculated for each participant.
Measured: Visit 1 (Day 1) after patient participant clinic visit for patient participants, end line visit for provider participants
Percent of Participants That Reported a Positive Change in the Patient-provider Relationship After Using the MedViewer Report
Participants were asked to rate the comparative satisfaction with patient participant-provider participant discussions during the MedViewer visits as compared to typical visits. Patient participants were asked this question after Visit 1, while provider participants were asked this question at their end line visit. Change in relationship was rated on 5-point scale (1="much less satisfied than usual" to 5="much more satisfied than usual"), with a higher score being more favorable. The percent of participants reporting 4 or greater on this scale (4="somewhat more satisfied than usual" or 5="much more satisfied than usual") was calculated.
Measured: Visit 1 (Day 1) after patient participant clinic visit for patient participants, end line visit for provider participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start14 Jan 2020
- Primary completion15 Nov 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Dual Group Assignment
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Kashuba, PharmD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232540
- Sponsor's protocol ID
- 18-3360
- Other IDs
- R01AI122319, 122319
- Acronym
- ENLIGHTEN
- Status last verified
- Sep 2022
- First submitted
- 14 Jan 2020
- Last updated
- 12 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Response to individual request for raw data. Any resulting publication from this proposal will include the principle investigator or a co-investigator listed on the application as corresponding author. Raw de-identified datasets will be shared with requesting scientists at the discretion of principle investigator to foster scientific openness in an ethical and responsible manner.
Publications
Golin CE, Rosen EP, Ferguson EG, Perry NR, Poliseno AJ, Munson AJ, Davis A, Hill LM, Keys J, White NR, Farel CE, Kashuba A. Feasibility, Acceptability and Appropriateness of MedViewer: A Novel Hair-Based Antiretroviral Real-Time Clinical Monitoring Tool Providing Adherence Feedback to Patients and Their Providers. AIDS Behav. 2023 Dec;27(12):3886-3904. doi: 10.1007/s10461-023-04104-1. Epub 2023 Jul 26.
PubMed 37493932Poliseno A, Ferguson E, Perry R, Munson A, Davis A, Hill L, Keys J, White N, Farel C, Gay C, Golin C, Rosen E, Kashuba A. Establishing Novel Antiretroviral Imaging for Hair to Elucidate Nonadherence: Protocol for a Single-Arm Cross-sectional Study. JMIR Res Protoc. 2023 Apr 21;12:e41188. doi: 10.2196/41188.
PubMed 37083754
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Novel Antiretroviral Imaging for Hair to Elucidate Non-Adherence (ENLIGHTEN)
- ClinicalTrials.gov ID
- NCT04232540
- Acronym / sponsor ID
- ENLIGHTEN / 18-3360
- Conditions
- Medication Adherence
- Keywords
- HIV infection, Medication Adherence, Hair, Dolutegravir, Emtricitabine, Antiretrovirals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Posted 12 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to assess the feasibility, acceptability and appropriateness of delivery of the investigational "MedViewer" intervention in adult patients living with HIV who have been prescribed antiretroviral (ARV) medications. The Medviewer uses Infra-red (IR) matrix-assisted laser desorption electrospray ionization (MALDESI) technology for mass spectrometry imaging (MSI) to analyze patient hair samples to provide information on ARV adherence in real-time.
The study has two different groups of participants: the patients, and their clinician providers.
Detailed description
This study is part of a larger research program that is investigating a novel non-invasive approach to rapidly quantify ARV concentrations and provide evidence of drug ingestion. The ultimate goal is to provide clinicians and patients feedback on ARV adherence. Infra-red (IR) matrix-assisted laser desorption electrospray ionization (MALDESI) technology for mass spectrometry imaging (MSI) is used to visualize and quantify ARV concentrations in hair. The IR-MALDESI MSI has been labeled the "MedViewer".
Patient participants will be scheduled for the sampling visit to correspond with their next appointment at the University of North Carolina (UNC) Infectious Disease (ID) clinic. Patient participants will be asked to arrive to their clinic appointment at least two hours prior to the scheduled time to be consented and enrolled. If eligible and enrolled in the study, patient participants will have a small hair sample (5 strands) plucked from a discrete location on the back of their head. Patient participants will also have a small blood sample collected. The results from the MedViewer test will be provided to both the patient and their provider, in order to facilitate a discussion around medication adherence. After receiving the results, all participants will complete a brief questionnaire about their experience with the MedViewer.
As this is a feasibility study, results from the Medviewer test will not be used to make clinical decisions related to care.
Major changes after the start of enrollment:
- Removed the term "real-time" throughout the document-Pertinent feasibility endpoints now use "delivery of the report to the designated research staff member within 2 hours of initiation of hair processing" rather than "…within 2 hours of hair sample collection"
- Removed mitra sampling for the remaining 15 participants in cohort A. Now stated as "blood sample will be collected for 10 participants in Group A and a subset of participants in Group B." After Mitra is analyzed for the first 10 participants in Group B, we will reevaluate to determine if additional samples are needed to validate hair samples.
- V1 and V2 study activities will be conducted virtually (except hair collection and in-person patient provider clinic visits) to minimize in-person contact. Consent and screening will be conducted virtually using videoconferencing via zoom on computer, tablet or phone. All questionnaires (patient baseline, patient post-visit, patient endline, provider baseline, provider post-visit, and provider endline) will be conducted virtually through REDCap (emailed to participant or verbally administered via phone or videoconferencing). Hair collection will be conducted by research staff at remote locations to limit time in clinic. Implementation of the intervention will now be allowed in the setting of telehealth clinical visits between patient and provider in addition to in-person clinical visits. MedViewer reports will be sent to providers via secure email. All remaining V2s will be conducted virtually. Hair and blood samples will not be collected.
- Consenting will take place up to 3 days before scheduled clinic appointment with provider. Hair sample will be collected by research staff at a remote location in the 3 days between consent and the scheduled provider visit. MedViewer report will be discussed between patient and provider (or patient and pharmacist, if needed) within 4 weeks of hair sample collection.
- Interviewer-administered portions of the baseline questionnaire have been modified. Health Literacy measure (Newest Vital Sign) removed. ART adherence Visual Analog Scale modified to allow for remote self-administration.
- Maximum duration on study extended by 6 months for providers (increased from 10 to 16 months). Provider sample size range reduced (from 20-30 to 16-30)
These changes were implemented on November 5, 2020 in a Letter of Amendment (LOA) to ENLIGHTEN Protocol Version 2. The LOA detailed changes made to the protocol due to the COVID-19 Pandemic.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dual Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Patient participants | Experimental | Device: MedViewer reportPatient and provider will view and discuss results of the MedViewer test. |
| Provider participants | Experimental | Device: MedViewer reportPatient and provider will view and discuss results of the MedViewer test. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Documentation of HIV-1 infection by means of any one of the following:
- At least 18 years of age on the day of consent.
- Documentation of HIV viral loads over 2-year period prior to screening.
- Has been a patient at the UNC ID clinic for at least 90 consecutive days prior to the date of enrollment in the study (i.e. attended first appointment at the UNC ID Clinic at least 90 days prior to the date of enrollment in the study).
- Has attended at least one HIV appointment at the UNC ID clinic within the 365 days prior to the date of enrollment in the study.
Key exclusion criteria (7 listed)
- Previous participation in the study UNC 11530- Formative Sub-Study for Novel Mass Spectrometry Imaging Methods to Quantify Antiretroviral Adherence.
- Deemed, by medical provider in UNC ID clinic, too ill, or other relevant reason, to participate in the study.
- Prior history of clinically significant alteration of the gastrointestinal system or drug absorption capability, including but not limited to: gastrectomy, total colectomy
- Any chemical hair treatment with dye, bleach, or relaxers within the past 4 weeks prior to sampling
- Not willing or able to participate in any of the provider training sessions for this study or any form of make-up training session with research team.
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 |
|---|---|---|
| MedViewer reportResults from the analysis of hair samples performed using the MedViewer | Device | Patient participants, Provider participants |
Primary outcome
Percent of Patient Participants That Received a MedViewer Report as Planned
Time frame: Visit 1 (Day 1) after patient participant clinic visit
Patient participants received their MedViewer report as planned if: (1) they had results delivered to the research team member within 2 hours of initiation of hair sample processing; and (2) discussed results with a provider participant during their clinic visit. The percent of patient participants that received the MedViewer report as planned is reported.
Percent of Contacted Patients That Were Eligible for a Screening Visit and Agreed to Participate in the Study
Time frame: Visit 1 (Day 1) before patient participant clinic visit
Contacted patients were deemed eligible for a screening visit using a pre-screening questionnaire and provided documented informed consent to participate in the study. The percent of all contacted eligible patients that agreed to participate in study is reported. Per study protocol, this outcome is not measured in providers.
Percent of Patient Participants That Were Satisfied With Their Discussion With a Provider Participant About Antiretroviral (ART) Adherence Using the MedViewer Report
Time frame: Visit 1 (Day 1) after patient participant clinic visit
Patient participants were asked to rate their satisfaction with the MedViewer report for promoting a productive discussion of ART adherence with a provider participant. Satisfaction was rated on a rated on a 5-point scale (1="very unsatisfied" to 5="very satisfied"), with higher scores being more favorable. The percent of patient participants reporting 4 or greater (4="somewhat satisfied" or 5="very satisfied") on this scale as was calculated.
Percent of Patient Participants for Whom Provider Participants Reported the MedViewer Report as Being Useful for Promoting a Productive Antiretroviral (ART) Adherence Discussion
Time frame: Visit 1 (Day 1) after patient participant clinic visit
For each of patient participant, provider participants were asked to rate the usefulness of the MedViewer report in promoting a productive discussion with the patient participant about ART adherence using a 5-point scale (1="not at all useful" to 5="extremely useful"), with a higher score being more favorable. The percent of patient participants with provider participants reporting 4 or greater (4="very useful" or 5="extremely useful") on this scale as was calculated.
7 secondary outcomes
Among Patient Participants That Did Dot Receive a MedViewer Report, Percent of Patient Participants That Did Not Receive the MedViewer for a Given Reason or Reasons
Time frame: Visit 1 (Day 1) after patient participant clinic visit
Mean Hours From Patient Participant Hair Sample Processing Initiation to MedViewer Report Delivery to Designated Research Staff Member
Time frame: Time 1 to Time 2 prior to or on Visit 1 (Day 1)
Percent of Participants Reporting a High Likelihood of Future MedViewer Report Use
Time frame: Visit 1 (Day 1) after patient participant clinic visit for patient participants, end line visit for provider participants
Percent of Patient Participants Reporting High Comprehension of the MedViewer Report
Time frame: Visit 1 (Day 1) after patient participant clinic visit
Percent of Patient Participants Reported by Provider Participants as Having High Comprehension of the MedViewer Report
Time frame: Visit 1 (Day 1) after patient participant clinic visit
Mean Usefulness Score for the MedViewer Report to Promote ART (Antiretroviral) Adherence
Time frame: Visit 1 (Day 1) after patient participant clinic visit for patient participants, end line visit for provider participants
Percent of Participants That Reported a Positive Change in the Patient-provider Relationship After Using the MedViewer Report
Time frame: Visit 1 (Day 1) after patient participant clinic visit for patient participants, end line visit for provider participants
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37493932Golin CE, Rosen EP, Ferguson EG, Perry NR, Poliseno AJ, Munson AJ, Davis A, Hill LM, Keys J, White NR, Farel CE, Kashuba A. Feasibility, Acceptability and Appropriateness of MedViewer: A Novel Hair-Based Antiretroviral Real-Time Clinical Monitoring Tool Providing Adherence Feedback to Patients and Their Providers. AIDS Behav. 2023 Dec;27(12):3886-3904. doi: 10.1007/s10461-023-04104-1. Epub 2023 Jul 26.
- Derived from this study: PubMed 37083754Poliseno A, Ferguson E, Perry R, Munson A, Davis A, Hill L, Keys J, White N, Farel C, Gay C, Golin C, Rosen E, Kashuba A. Establishing Novel Antiretroviral Imaging for Hair to Elucidate Nonadherence: Protocol for a Single-Arm Cross-sectional Study. JMIR Res Protoc. 2023 Apr 21;12:e41188. doi: 10.2196/41188.
- Individual participant dataSharing planned: Yes. Response to individual request for raw data. Any resulting publication from this proposal will include the principle investigator or a co-investigator listed on the application as corresponding author. Raw de-identified datasets will be shared with requesting scientists at the discretion of principle investigator to foster scientific openness in an ethical and responsible manner.
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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.
Angela Kashuba, PharmD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MedViewer report in people with Medication Adherence, run by University of North Carolina, Chapel Hill 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 21 inclusion and 7 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: finished, as of the sponsor's last update on 12 Oct 2022. 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?
Yes. Results are posted in the registry (first posted 12 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Patient Participants That Received a MedViewer Report as Planned (time frame: Visit 1 (Day 1) after patient participant clinic visit). The study lists 4 primary outcomes in all. 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 NCT04232540, 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 12 Oct 2022.