Ql5004.doc

PEDIATRIC ADHERENCE QUESTIONNAIRE MODULE 2- REVISED
GENERAL REASONS FOR NON-ADHERENCE
NIAID PEDIATRIC AIDS CLINICAL TRIALS GROUP Page 1 of 3
Protocol Number 0 0 0 0 0
* Enter a “1” if this is the first of this form for this date. Designate subsequent forms on the same date with a 2, 3, etc. **Enter the subject’s current study step number. Enter '1' if the study does not have multiple steps. This module captures the general reasons for non-adherence linked to each drug taken. In this step, the interviewer will collect information on reasons why the study participant may be having difficulty taking each agent. This form should be completed for study participants < 13 years of age. For study participants ≥ 13 years of age, complete the ADOLESCENT ADHERENCE QUESTIONNAIRE MODULE
QUESTIONS 1 - 3 ARE TO BE COMPLETED BY THE STUDY NURSE:

1. Was the questionnaire completed at this visit? ……………………………………… (1-Yes, 2-No)
If Yes, go to question 2.
If No, complete ‘a’ and STOP.
a. Indicate the reason the questionnaire was not completed: … 1-Study participant refused If Other, specify [30]:
2. Who responded to the questions?…………………………………………… 1-Study participant If “4, 5, 6 or 9”, specify [30]:
3. Does the study participant know his/her HIV status?………………………… 1-Yes
INSTRUCTIONS FOR COMPLETION OF DRUG SPECIFIC TABLE:

• Enter the name of each antiretroviral drug that the study participant is receiving in the space provided

Identification of Reasons for Non-Adherence:

READ the following paragraph to the study participant or primary caregiver:
“Many people at one time or another have trouble with these medications. We would like to better understand the things that make giving medications hard for families. These are some of the reasons others have identified which have made it difficult to take [give] all of the HIV medicines.”
Show and read the list of reasons to the study participant or primary caregiver.

After the list is read, ask the following question for each drug (question 4 on page 2):
“Have any of the following been problems for you with (drug name or characteristics)
If “Yes,” enter the frequency code for each reason (a-n).
If “No,” go to the next drug.
For data entry, use the tab key after the last entry on the page.
PEDIATRIC ADHERENCE QUESTIONNAIRE MODULE 2- REVISED
Page 2 of 3
GENERAL REASONS FOR NON-ADHERENCE

DRUG SPECIFIC ADHERENCE DIFFICULTIES:
Frequency Codes
Use these codes to indicate the frequency with which each listed reason for non-adherence occurs. 1-Hardly ever a problem (1-2 times per month) This needs to be done for each antiretroviral drug 3-Almost always a problem (≥ 3 times per week) Drug Code [8]: Drug Code [8]: Drug Code [8]: Drug Code [8]: Drug Code [8]: Reasons for Non-adherence:
a. Can’t get drug (drug
Date Form Keyed (DO NOT KEY): ______ /______ / ______ PEDIATRIC ADHERENCE QUESTIONNAIRE MODULE 2- REVISED
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GENERAL REASONS FOR NON-ADHERENCE
DRUG CODE REFERENCE
Drug Codes and Names for Commonly Used Drugs. Refer to Appendix 3 or the Drug Code Lookup Program at the DMC Web Site (http://www.fstrf.org) for drugs not listed below. Anti-HIV Drugs for Protocol
08181205 Amprenavir/APV/Agenerase/141W94/VX-479 08180006 Azidouridine/AzdU/azido-2’,3’-dideoxyuridine 08181208 Lopinavir/Ritonavir (LPV/RTV)/Kaletra/ 08181209 Saquinavir soft gel/FTV/Fortovase 08180030 Saquinavir/SQV/Invirase/R031-8959 08188804 T-20/pentafuside/Enfuvirtide/ENF 08182002 TDF/Tenofovir/Tenofovir disoproxil 08180031 DLV/delavirdine mesylate/Rescriptor 08180804 Efavirenz/EFV/Sustiva/DMP266/Stocrin® 08180421 Truvada(tenofovir disoproxil/emtricitabine) Date Form Keyed (DO NOT KEY): ______ /______ / ______

Source: https://www.fstrf.org/apps/cfmx/apps/common/QOLAdherenceForms/resources/impaact/forms/english/ql5004.pdf