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. 2023 Apr 21;12:e41188. doi: 10.2196/41188

Table 1.

Objectives and end points for the study.

Objectives End points Justification for end points
Primary

  • Investigate the feasibility of delivering the MedViewer intervention as planned, the acceptability to patients of participation in the MedViewer intervention, and the appropriateness of MedViewer use for adherence counseling

  • Feasibility: proportion of participants receiving the MedViewer report during their provider visit as planned (ie, the results are delivered to the designated research staff member within 2 hours of initiation of hair processing and the results are discussed with the provider or pharmacist within 4 weeks of hair collection)

  • Acceptability: proportion of contacted patients who are eligible for a screening visit (not including inclusion criterion 9) who agree to participate in the MedViewer intervention pilot study

  • Appropriateness: perceived usefulness of the MedViewer intervention for adherence counseling

  • Evaluation of these implementation domains will indicate the potential for future application of MedViewer in routine care and help identify needed modifications to the MedViewer intervention to improve delivery. The framework by Proctor et al [13] for outcomes in implementation research indicates the importance of assessing feasibility, acceptability, and appropriateness.
Secondary

  • Investigate additional dimensions of feasibility, acceptability, and appropriateness of using hair IRa-MALDESIb MSIc (MedViewer) to provide patients living with HIV with feedback regarding longitudinal patterns of medication adherence

  • Feasibility:

    • Reasons for patients’ nonreceipt of the MedViewer report during a visit with the provider or pharmacist within 4 weeks of hair collection (if applicable)

    • Reasons for nondiscussion of the MedViewer report with the provider or pharmacist (if applicable)

    • Length of time (in minutes) from initiation of hair processing to MedViewer report delivery to the designated research staff member

  • Acceptability:

    • Provider-reported likelihood of recommending MedViewer to future patients

    • Patient-reported likelihood of agreeing to future MedViewer use

    • Patient comprehension of the MedViewer report

  • Appropriateness:

    • Perceived usefulness of MedViewer to promote ARTd adherence

    • Perceived impact of MedViewer use on patient-provider communication and relationship

  • Evaluation of these implementation domains will indicate the potential for future application of MedViewer in routine care and help identify needed modifications to the MedViewer procedure to improve delivery. The framework by Proctor et al [13] for outcomes in implementation research indicates the importance of assessing feasibility, acceptability, and appropriateness.
Exploratory

  • Assess exploratory aspects of MedViewer feasibility and acceptability and patient and provider views of and experiences with the MedViewer test



  • Explore the impact of adherence counseling using MedViewer on ART adherence and hypothesized mechanisms of change (adherence information, motivation, and behavioral skills)

  • Feasibility:

    • Patient-reported maximum out-of-pocket cost willing to pay for MedViewer

    • Cost of MedViewer delivery per person

    • Compatibility of MedViewer with current clinic practices

  • Acceptability:

    • Patient-reported reasons for declining participation in the MedViewer intervention pilot study

    • Reasons why participants would or would not agree to (patient-reported) or recommend (provider-reported) future MedViewer use

    • Acceptability of specific components of the MedViewer procedure:

      • Sufficiency of provider training and materials

      • Sufficiency of patient education (video)

      • Provider satisfaction with results delivery (discussion format and content)

      • Patient satisfaction with results delivery (person, discussion format, and content)

  • Adherence-related:

    • ART adherence measured via self-reported assessment of 3-, 7-, and 30-day adherence

    • Adherence information (qualitative assessment of information and understanding gained of patient adherence resulting from use of MedViewer)

    • Adherence motivation (quantitative and qualitative assessment of adherence motivation resulting from use of MedViewer)

    • Adherence behavioral skills (quantitative and qualitative assessment of adherence behavioral skills and self-efficacy resulting from use of MedViewer)

  • Preliminary assessment of MedViewer’s impact on the intended behavioral outcome (ART adherence) and hypothesized mechanisms of influence (based on the Information–Motivation–Behavioral Skills model) will be used to inform the design of a future randomized trial to evaluate the effect of MedViewer on these end points [14].

  • Further explore the accuracy of the MedViewer test as an adherence measure

  • ARVe concentrations in blood collected for first patient study visit and follow-up patient study visit when applicable

  • Patient viral load assessed with a clinical care visit linked to a patient-provider MedViewer visit and abstracted from the medical record by study staff

  • log10 ARV drug response in hair via IR-MALDESI collected for first patient study visit and follow-up patient study visit when applicable

  • These end points will allow for comparison of reported concentrations of medication in hair with recent ART adherence, as measured via Mitra and current viral load. These comparisons will provide further evidence to assess MedViewer accuracy (in addition to that gathered in aims 1 and 2) among a larger group of patients.

aIR: infrared.

bMALDESI: matrix-assisted laser desorption electrospray ionization.

cMSI: mass spectrometry imaging.

dART: antiretroviral therapy.

eARV: antiretroviral.