QOL/Adherence Forms

IMPAACT Adherence to Therapy Subcommittee
IMPAACT Complications of HIV Disease RAC

Drug adherence is critical to the success of any treatment regimen. Mastering the skills involved in adopting complex treatment regimens involves a learning process for most people. Furthermore, most drugs taken for chronic conditions demonstrate acceptable efficacy even when a considerable number of doses are missed making occasional lapses harmless. Antiretroviral regimens, on the other hand, are far less forgiving since poor adherence to an HAART regimen can lead to incomplete suppression of viral replication, resulting in the emergence of drug-resistant virus. The new and unique challenges associated with combination therapies for HIV/AIDS require that health care providers address the issues created by adherence to complex regimens for infants, children, adolescents, pregnant women and family members living with HIV disease.

History and Membership

The IMPAACT Adherence to HIV Therapy Subcommittee was constituted in 1998 as a working group of the IMPAACT Opportunistic Infection Committee and is now a subcommittee of the Complications of HIV Disease Research Agenda Committee. The IMPAACT Pediatric Executive Committee (PEC) endorsed the agenda of this subcommittee as a priority within the IMPAACT. The subcommittee consists of IMPAACT members from the Complications of HIV RAC, Primary Therapy RAC, Perinatal RAC, the Pediatric Site Resource, Patient Care, Adolescent, and Pharmacology Committees, the Community Constituency Group, DMC, NICHD and NIAID Investigators and the IMPAACT Operations Center.

Objectives and Goals

The objectives of the Adherence Subcommittee are:

The goals of the Adherence Subcommittee are:

The Adherence Modules

What is the IMPAACT study drug adherence strategy?

The committee reviewed all currently employed adherence measures and concluded that the simplest strategy for use across all IMPAACT studies would be based on self-report. Although traditionally researchers have viewed self-report with skepticism based on demonstrated lack of validity, recent experience has shown that when study participants are queried within an atmosphere of a therapeutic alliance self reported information can be valid.

A protocol team should determine if additional measures of drug adherence would serve the objectives of a particular study protocol (e.g., serum drug levels, drug markers, physiologic parameters, pill counts, computerized dispensers, pharmacy records, subject diaries, etc.) Protocol teams should consult with the IMPAACT Adherence Subcommittee and the Pharmacology Committee for assistance in development of these measures.

How is the self-report implemented?

Each module has a specific objective. To view these files, a PDF reader such as Adobe Reader is required.

Module One:

Purpose: to measure reported adherence in a standardized manner across all IMPAACT protocols

QL5002 Pediatric Adherence Questionnaire - Module 1 - Revised
QL5002 Scripts
QL5002 Scripts in Spanish
QL5003 Pediatric Adherence Questionnaire Module 1- III Behavior/Identification
QL5030 Pediatric International Adherence Questionnaire Behavior/Identification

Module Two:

Purpose: to investigate the causes of non-adherence relative to the impact of different treatment regimens on quality of life

QL5001 Pediatric Adherence Questionnaire - Module 2
QL5001 Pediatric Adherence Questionnaire - Module 2 in Spanish
QL5004 Pediatric Adherence Questionnaire Module 2 - Revised General Reasons For Non-Adherence

QL5010 Perinatal Adherence Questionnaire - Module 2
QL5010 Perinatal Adherence Questionnaire - Module 2 in Spanish
QL5011 Perinatal Adherence Questionnaire Module 2 - Revised General Reasons For Non-Adherence

QL5020 Adolescent Adherence Questionnaire - Module 2
QL5020 Adolescent Adherence Questionnaire - Module 2 in Spanish
QL5021 Adolescent Adherence Questionnaire Module 2 - Revised General Reasons For Non-Adherence

Does the self-reporting work at IMPAACT sites?

An important committee goal is to pilot test and continually evaluate the performance of the Modules in relation to other measures of adherence and drug effect. Both Module One and Module Two were pilot tested in IMPAACT Protocol 377. Analysis of the 125 patients in IMPAACT 377 indicated that adherence as measured by module one predicted the virologic response to HAART therapy (Van Dyke, 2000). They were also incorporated into IMPAACT Protocol 403 and have been implemented into several other IMPAACT Protocols. John Farley and colleagues at the University of Maryland conducted a test of the modules in a non-IMPAACT venue. His results, reported at the July 1999 IMPAACT Poster Session (Farley, 1999) suggested that Module One may underestimate missed doses while subjects or caretakers were more likely to report difficulties with medications using Module Two.

How can the IMPAACT have a "standard" measure particularly in Module Two when IMPAACT studies enroll infants, children, adolescents, and pregnant women- all with quite different issues?

The initial Modules were created as measures of pediatric adherence in study subjects. The committee has developed "perinatal" adherence modules for use with pregnant women in Perinatal IMPAACT protocols. Likewise, an "adolescent" module has been developed for adolescents enrolled in IMPAACT protocols. The adolescent module can be utilized by participants 13 years of age and older. IMPAACT 219C (Late Pediatric Outcomes-Long Term follow Up Protocol) will contain a customized adherence module for use in the 219C Protocol.

How are the modules administered?

The instrument consists of two parts: Adherence Module One and Adherence Module Two. The IMPAACT site Study Coordinator or research staff administers the modules by interviewing the patient or their primary care taker. Each Module contains instructions and a script that should be read exactly as written during administration. The patient is interviewed if he/she is responsible for his/her own medications. If the caretaker is responsible for giving the medications at home, then they are interviewed.

Adherence Module One

Module One will be incorporated into all IMPAACT Protocols.

What is a subject asked in Module One?

A subject is asked to identify the medications, their frequency of administration, and the number of doses of each medication missed within the three days prior to the clinic visit. It contains a comprehensive script that is necessary to follow for at least the first three sessions of the Module with the subject. The condensed script can be used after that time.

How often is Module One administered?

The Adherence Subcommittee recommends that Module One be administered no more than every eight weeks. It should not be administered until the subject has been on medications for at least 4 weeks. Protocol teams may choose to alter the frequency depending upon the study objectives and the schedule of study visits. For example, a protocol team may chose to administer the adherence modules to coincide with protocol pharmacokinetic schedules. In general, it should not be administered more often than every 8 weeks.

Adherence Module Two

Module Two is used at the discretion of the protocol team.

What is a subject asked in Module Two?

In Module Two, reasons for non-adherence are explored and sought as well as sources of difficulty in fitting drug-taking into their daily lives.

How often is Module Two administered?

For most IMPAACT Protocols, neither Module should be administered at baseline since the subjects will be starting new medications and they will need to experience time on the therapy in order to be able to respond to the Modules. However, if the subject is already receiving the medication of interest at entry, then it could be appropriate to administer the Modules at that time. It is recommended that Module Two not be administered more frequently than every 16 weeks. Some Protocol teams may choose to administer Module Two every 8 weeks. When Module Two is administered, it is recommended that Module One always be given at that same time. (Module One may be given without Module Two).

The Adherence to Therapy Committee has created Medication Labels for medicine bottles. IMPAACT sites have the choice of using these labels, which may assist some children and families in identifying their medications in situations where there may be confusion regarding medication names and schedules.

The Adherence to Therapy Modules are available in PDF on the Quality of Life/Adherence Forms page located on the FSTRF home page.

Please direct any questions or comments on this material to the data manager for the study.