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IMPAACT 2017

IMPAACT 2017.

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IMPAACT 2017

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  1. IMPAACT 2017 Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and AdolescentsMOCHAMore Options for Children and Adolescents

  2. MOCHA study-specific training Self-Review module: IMPAACT 2017 Adherence Assessment and Counseling

  3. Training Objectives To provide an overview and establish a common understanding of the following: Importance of conducting adherence assessments and counseling Timing and guidelines for conducting adherence assessments Timing and guidelines for conducting adherence counseling

  4. Protocol References

  5. Importance of Adherence • Adherence to medications, appointments and study related instructions is important for any study, including IMPAACT 2017 • Study data is only as good as the quality and completeness of the data points • The importance and types of adherence differs depending on the Cohort and Step of the participant: • All Cohort 1 participants: adherence to non-study provided cART • All Cohort 2 participants: adherence to study product regimen (oral and injectable) as participants are no longer receiving non-study provided cART • Cohort 1 Step 1 and Cohort 2 Step 3 participants: adherence to oral study product for safety, tolerability and PK evaluations of oral study product and determining eligibility for study product injections • Cohort 1 Step 2 and Cohort 2 Step 4 participants: adherence to study visit schedule and injectable dosing regimen to evaluate safety, tolerability and PK of injectable study product

  6. Adherence Assessment See MOP Section 5.2.4 for additional details and guidance on Adherence Assessments and Pill Counts

  7. Adherence Assessment: Cohort 1

  8. Adherence Assessment: Cohort 2

  9. Adherence Assessment Adherence assessments are conducted at specified study visits during the oral lead-in phase for Cohort 1 and Cohort 2 Prior to progressing to the injection phase, participants in Cohort 1 Step 1 and Cohort 2 Step 3 should be assessed for adherence to oral study product and whether sufficient evaluations of safety and tolerability were permitted to be conducted during the oral lead-in phase Adherence to the oral study product regimen during Cohort 1 Step 1 and Cohort 2 Step 3 will be assessed by pill count

  10. Adherence Assessment • Pill counts will not be the sole basis for determination of sufficient exposure to oral study product for progression from the oral lead-in to the injectable phase. • The IoR’s assessment should not attempt to reconcile discrepant information on study product use. Rather, thedata from the pill count should be combined with information learned from participant self-report and adherence counseling discussions for the broader assessment of participant eligibility to receive injectable study product.

  11. Adherence Assessment • The IoR, or designee, should source document all contributing information leading to the final determination with regards to this Step 2 or Step 4 eligibility criterion. In general, the following aspects are expected to be included in this source documentation: • Study visits and procedures contributing information (e.g., Week 2, Week 4a, Week 4b, and any interim visits), • Location of the information in the participant’s file (e.g., previous chart notes, site-specific tools/worksheets, eCRFs may be listed but not required), • Brief summary of the final assessment, • Statement of adequate or not adequate exposure (as assessed by the IoR or designee) to oral study product • IoR or designee initial/signature and date.

  12. Adherence Assessment Adherence assessment methods are the same for Cohort 1 and Cohort 2, however, for Cohort, 2 adherence to both oral CAB and oral RPV will be assessed, as participants are prescribed both study products. At the Entry Visit, the date and amount of oral CAB and/or oral RPV dispensed should be source documented and entered into Study/Step Treatment Initiation Form eCRF (ADM10002) and the Oral Study Treatment Log (TXW10004) Before the Week 2, Week 4a and Week 4b Visits participants should be instructed that they should bring in their remaining assigned oral study product (oral RPV and/or oral CAB) such that all unused oral study product should be returned to the site At each of these visits, site staff should count the amount of oral CAB and/or oral RPV remaining in the container. The amount of returned product should be source documented and recorded on the Drug Accountability Log eCRF (EVW10031)

  13. Adherence Assessment: Week 2 Visit • At a minimum, for the threedays prior to the Week 2 visit, participants should: • Take their oral study product at the same time of day as the scheduled per-dose PK collection time point, and • Be fully adherent to their assigned daily oral study product regimen • If either a missed dose is reported or the participant has not adjusted the timing of their oral study product dosing to align with the pre-dose PK collection time point, the Week 2 visit should be rescheduled. • In preparation for the Week 2 visit, sites may contact participants or parents and guardians, to reinforce these requirements.

  14. Adherence Counseling See MOP Section 8.4 for additional details and guidance on Adherence Counseling

  15. Adherence Counseling: Timing • Adherence counseling will be provided to all study participants and parents/guardians, and as needed based on IoR discretion, at the following study visits: • Cohort 1: Entry (Step 1), Week 2, Week 4a, Week 4b (Step 2 Entry), Week 8, Week 16 • Cohort 2: Entry (Step 3), Week 2, Week 4a, Week 4b (Step 4 Entry), Week 8, Week 24, Week 48, Week 72, Week 96 • LSFU: Week 4 Post-Last Injection, Week 48 Post-Last Injection • All Participants: Early Termination

  16. Adherence Counseling: General Considerations Adherence related counseling should be provided by clinic and/or pharmacy staff consistent with local standards of care and site SOPs Counseling should be provided in a client-centered manner, tailored as needed to the information, skills building, and support needs of each participant. Counseling should acknowledge challenges to consistent use of oral study product or attending injectable study visits over time and should encourage participants to openly discuss challenges, with the aim of supporting participants in identifying strategies to address any such challenges

  17. Adherence Counseling Considerations for Cohort 1 Participants:Non-study cART Cohort 1 participants will continue taking their non-study oral cART throughout participation in Cohort 1 Remind participants that the study drug (whether oral or injectable) is in addition to and not a replacement for their oral non-study drugs The importance of continuing non-study daily cART will also be discussed prior to participants transitioning to the LSFU visit schedule (if permanently discontinuing injectable study product), during specified LSFU visits, and at Early Termination visits

  18. Adherence Counseling: Cohort 1 Step 1 and Cohort 2 Step 3 • Counseling will focus on adhering to the oral study product • Explain to participants and guardians that: • Adherence to the oral study product is important to be able to fully evaluate the safety and tolerability of the study products and assess for possible side effects before determining if the participant is eligible to receive injections of study product • These evaluations are important because the oral study drug clears the from the body within days but traces of the injectable study drug can be detected even for a year • Remind Cohort 2 participants/guardians that adherence to oral study product is especially important for controlling their HIV, as they are no longer taking their non-study provided cART

  19. Adherence Counseling: Cohort 1 Step 2 and Cohort 2 Step 4 • Counseling will focus on adhering to the injectable study product dosing regimen and the study visit schedule and addressing potential challenges • Explain to participants that: • Adherence to the dosing regimen is needed to sufficiently evaluate safety and tolerability of the study products • The allowable visit windows for the study product injections are small, so adhering to the visit schedule is important to ensure injections can be given as intended • Remind Cohort 2 participants/guardians that adherence to injectable product regimen is especially important for controlling their HIV, as they are no longer taking their non-study provided cART

  20. Adherence Counseling: After Cohort 2 Week 96 For participants continuing injectable study product (external to the protocol) after Cohort 2 Week 96, counseling should include the importance of adhering to the injectable dosing regimen and schedule

  21. Issues of Non-Adherence • Sustained non-adherence may result in study product discontinuation and early study termination (See Section 8.7) • In Cohort 1 Step 1 and Cohort 2 Step 3, sustained non-adherence to oral regimen (study product, and/or non-study provided cART for Cohort 1 Step 1 participants) • In Cohort 1 Step 2 and Cohort 2 Step 3, sustained non-adherence to injectable study product dosing regimen • The CMC should be consulted before terminating participants • Procedures for early study termination and study product discontinuation will differ based on Cohort and Step • Refer to protocol Section 6.5.5 Early Study Termination and 6.7 Study Exit for additional information and considerations

  22. 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.

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