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IMPAACT 2017 Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirinein Virologically Suppressed HIV-Infected Children and AdolescentsMOCHAMore Options for Children and Adolescents
MOCHA study-specific training Self-review module: Acceptability and tolerability questionnaires Overview
Training Objectives To provide an overview and establish a common understanding of the following: Importance and rationale of the acceptability and tolerability questionnaires Definitions of “acceptability” and “tolerability” Components of the acceptability and tolerability questionnaires Administration specifications for the acceptability and tolerability questionnaires. AE documentation Interviewing techniques
Manual of Procedures Refer to Section 6 of the IMPAACT 2017 MOP for detailed guidance on the acceptability and tolerability questionnaires
Importance and Rationale These intramuscular LA formulations will be the first injectable antiretroviral agents to be studied in adolescents since the early 2000’s trials of enfuvirtide, a twice daily subcutaneous injection fusion inhibitor Acceptability and tolerability are critical to understand from both the standpoint of the participantsand their caregivers, who facilitate their access to healthcare. Acceptability and tolerability will ultimately determine uptake and persistence (not stopping treatment) among adolescents prescribed these formulations. Protocol section 1.3.5
Importance and Rationale MOCHA will gather data on participant perceptions of the study product injections, reasons for switching from daily oral cART to long-acting study products, satisfaction with treatment, and quality of life at multiple time points throughout the study Protocol section 1.3.5
This study is the first opportunity to hear directly from adolescents receiving LAI ARVs – what do they like, what don’t they like, etc. With new treatment approaches, it’s critical to try to anticipate future implementation challenges…
Definitions ACCEPTABILITY – perception that a given intervention is agreeable, accessible, convenient. Measures of acceptability encompass feelings, perceptions, and behaviors that relate to use of the product. If an intervention is considered acceptable, patients are more likely to adhere to treatment recommendations and to benefit from improved clinical outcomes.
Definitions TOLERABILITY – the extent to which adverse effects & demands of a therapy are endured by the subject for a particular intervention (e.g. drug interactions, ease of use, burden and time involved in adhering to intervention)
Acceptability & Tolerability Measures What approaches will be used to collect this information? Two data collection methods: Staff-administered and self-administered questionnaires for all adolescent participants (quantitative data) In-depth phone interviews of selected adolescent participants and selected parents/caregivers (qualitative data)
Acceptability Questionnaires • Motivation for changing regimens • Cohort 1 • Reasons for Switch Questionnaire - Cohort 1 • Cohort 2 • Reasons for Switch Questionnaire - Cohort 2 • Post-Injection Phase Questionnaire • Quality of Life (Cohort 1 and Cohort 2) • Pediatric Quality of Life Inventory (PedsQL; separate Child and Adolescent Report versions) • Satisfaction with Treatment (Cohort 2 only) • Study Medication Satisfaction Questionnaire Status • Asks participants to rate their satisfaction with the injections administered at their previous injection visit • Study Medication Satisfaction Questionnaire Change (Week 24 visit only) • Asks participants to compare their current satisfaction with their satisfaction with the medicines they took prior to starting the study. • Preference for injectable versus oral regimen (Cohort 2 only) • Preferences Questionnaire – Adolescent Version
Tolerability Questionnaires Cohort 1 and 2: • Pain during and after injections • Pain During Injections (with the Wong-Baker FACES Pain Rating Scale; separate forms for Cohort 1 and Cohort 2) • Revised Perceptions of Injection Questionnaire • Injection site reactions • Revised Perception of Injections Questionnaire • Reasons for Early Study Termination (if applicable) • Reason for Early Study Medication and/or Study Termination Questionnaire
In-depth Interviews: Cohort 1 and 2 Overall experience with injections, drug delivery preferences • Semi-structured in-depth interviews of adolescents and parents with the goal of elucidating acceptability and tolerability concerns that may be unique to adolescent populations (If unanticipated acceptability/tolerability issues arise from interviews in Cohort 1, these may be incorporated into Cohort 2 assessments)
Special notes about AE documentation • The acceptability and tolerability assessments are NOT meant to track adverse events (AEs). • If participants note AEs (e.g. injection site pain) during completion of the acceptability and tolerability assessments these MUST ALSO BE DOCUMENTED and managed as AEs. Who at your site is designated to review the questionnaires prior to the participant leaving the clinic?
Consideration of Visit Procedures • The following questionnaires must be administered prior to administration of the injection: • Reason for Switch Questionnaire (Cohort 1 and Cohort 2) • Study Medication Satisfaction Questionnaire Status • Study Medication Satisfaction Questionnaire Change (this questionnaire is only at Week 24, and should be administered immediately after the SMSQs) • The following questionnaires must be administered afterthe participant has received an injection: • Revised Perceptions of Injection Questionnaire • Pain During Injections (Cohort 1 and Cohort 2) • All other questionnaires may be administered at the most convenient timepoint during the visit
Administering the Questionnaires • Some questionnaires require site staff to directly administer them (i.e. read aloud) to the participants • Preferences Questionnaire- Adolescent Version • Pain During Injections - Cohort 1 and Cohort 2 • All other questionnaires can be self-administered by participants after site staff read the instructions to the participant • Sites should be prepared to help facilitate understanding of all questionnaires • If the participant is more comfortable (e.g. if they have limited literacy) the site staff can read each question and record the participant’s responses
Administering the Questionnaires The following questionnaires should NOT be administered by the same staff that gave the injection: • Revised Perceptions of Injection Questionnaire • Study Medication Satisfaction Questionnaire (Status and Change) • Pain During Injections (Cohort 1 and Cohort 2) • The same staff who conduct the AE assessments can administer any of the questionnaires, as long as they are not also the staff who gave the injection Who at your site is administering the questionnaires to participants?
Interviewing Techniques Refer to MOP Section 6.2 for additional guidance
Overall Approach To standardize interviewer-administered data collection from site to site and to maximize data quality, it is critical that participant questionnaires be administered in a non-biased, non-judgmentalmanner. Study staff should help a participant feel comfortable sharing their personal information and opinions while asking study questions in a consistent manner from participant to participant.
Welcoming the participant • When a participant decides to take part in a study, everything about the study is new. Help make them feel comfortable. • Considering offering the participant some refreshment. • Introduce yourself and try to create rapport (connection) between yourself and the participant to help them feel comfortable during administration of the questionnaire.
Welcoming the participant • Speak with the participant and administer questionnaires in the participant’s preferred language. • Choose the local language questionnaire that corresponds to the participant’s preferred language and read directly from that form. Do not use another language form and translate in real-time. • Some questionnaires include introductory statements to help prepare the participant for sensitive questions. Read these introductions as they appear on the forms.
Asking sensitive questions • Your level of comfort with asking sensitive questions will affect the participant's comfort and answers to the questions • If you ask the questions in a confident and supportive manner, the participant will feel more confident and comfortable answering the questions
Asking sensitive questions • Make eye contact with the participant to let them know that you are listening to them and aware that they are being asked difficult questions. • Avoid apologizing for questions or making facial gestures that might show you feel any way but neutral about a question or the participant's response. • If the participant feels judged, they will be less likely to share honestly with you.
Pacing the questions • Every participant is different; some will answer questions quickly whereas others may take longer to answer or change their answers after giving more thought to the question. • Always account for this variety when administering questionnaires. • Read questions slowly and let the participant finish thinking before you record their answer and go on to the next question.
Reading items aloud • Read all items to the participant word-for-word and speak clearly. • Avoid re-phrasing questions because this can change the meaning of the question, making it inconsistent with questions administered to other participants. • Provide explanation or interpretation if necessary only after reading the item word-for-word.
Reading items aloud • Avoid counseling or educating the participant during data collection. • When applicable, acknowledge questions and concerns raised by the participant during the questionnaire and state that these can be discussed after the questionnaire is completed.
Reading items aloud • Read the questions with interest and variability, so you don't sound automated. • Emphasize the important words in a question, so that the meaning of the question comes through. • For questions with multiple sub-parts, read all sub-parts to the participant and mark the appropriate response for each, based on the participant’s answers.
Recording responses verbatim • Often, questions will have a list of response categories to capture the participant’s response. • Sometimes, an “other, specify” option is included for responses that do not fit into one of the categories already listed. • When “other, specify” must be used, record the participant’s verbatim response, word-for-word, in the language spoken by the participant. • Once the questionnaire is completed, go back and translate the local language text into English, for entry into eCRF screens. Do not translate in real-time during administration of the questionnaire.
Probing • Silent probe • Non-verbal probe • Specification probe • Repeat probe • Echo probe • Historical probe Effective probing helps a participant think more about a question or refine an answer that is too general. However, probing must not bias or otherwise direct participant answers. As the interviewer, you cannot offer an answer to the participant. Therefore, all probes must be neutral. Techniques for helping a participant remember an answer, clarify an answer, decide between two similar but different answers, or answer more precisely
Watching for non-verbal cues • A participant may give you one answer verbally, but express something else using body language or facial expressions. • Although you should not question a participant so as to make them feel like you don't trust their answers, be aware of whether they are giving you non-verbal cues that indicate they are not feeling comfortable, not taking the questionnaire seriously, or not answering honestly.
Checking your work • While administering the questionnaire, follow any written form instructions and guidance. • Also, make sure the participant is understanding and responding to you, and that you record all reported information on the form. • After the questionnaire is completed, and while the participant is still there, review the form for accuracy and completeness so you can complete an item that might have been missed or mis-marked. • This review step is not intended as an active review with the participant to confirm all of his/her responses; rather, it is a check to help ensure that any items that might have accidentally been missed or miss-marked can be completed or corrected before the participant leaves the study site. • Once the participant has left, review the forms more thoroughly, following standard site procedures for QC/QA review.
Questions? Liz Lowenthal, MD MSCE Protocol Investigator lowenthale@email.chop.edu Jennifer Chapman, MPH Qualitative Project Manager ChapmanJ1@email.chop.edu IMPAACT 2017 Protocol Team IMPAACT.TEAM2017@fstrf.org
Thank you for viewing this self-review module! Please remember to document your completion of this training component Per the DAIDS policy on Requirements for Manual of Operational Procedures, all sites must establish and follow a standard operation procedure (SOP) for personnel training and certification documentation Each site is responsible for preparing attendance documentation for this self-review module in accordance with this SOP.
