Medication Adherence in Human Immunodeficiency Virus (HIV)
Targeting Enhanced Adherence to Medication: A Pilot Study in Adolescents and Young Adults With Human Immunodeficiency Virus (HIV)
1 other identifier
interventional
33
1 country
1
Brief Summary
Although effective treatments are currently available to treat human immunodeficiency virus (HIV), the retrovirus leading to acquired immune deficiency syndrome (AIDS), strict adherence to the treatment regimen is required. Nonadherence to highly active antiretroviral therapy (HAART) regimens is well documented in individuals with HIV. This is especially true for adolescents and young adults (AYA), where rates of adherence range from 20 to 100%. Nonadherence has significant implications for subsequent treatment response and health outcomes, including poor virologic response, development of drug resistance, and mortality. Of note, previous research has suggested that every 1% increase in nonadherence is related to a 2% increased likelihood of detectable viral load (VL) in youth with behaviorally acquired HIV. Furthermore, higher VL is the most salient variable related to increased risk of virus transmission. Thus, nonadherence to HAART is a significant public health issue. The objective of the proposed research plan is to systematically examine an individualized, behavioral intervention targeting HAART nonadherence in AYAs initiating HAART. The current intervention will support AYA participation in brief, staff-delivered instruction in adherence-promotion skills. Individualized behavioral analysis and motivational interviewing will be applied to provide effective solutions for current barriers to HAART adherence before and after HAART initiation, as recommended by the Panel on Antiretroviral Guidelines for Adults and Adolescents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 15, 2014
CompletedFirst Posted
Study publicly available on registry
April 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedAugust 2, 2016
July 1, 2016
2.3 years
April 15, 2014
August 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Rate of consent to trial participation
Day 1
Pill count values compared between arms
Using Fisher Exact tests
3 months post-HAART initiation
Pill count values compared between arms
Using Fisher Exact tests
6 months post-HAART initiation
Secondary Outcomes (4)
Adherence rates compared between groups
3 months post-HAART initiation
Patient outcome
6 months following HAART initiation
Adherence rates compared between groups
6 months post-HAART initiation
Change in adherence rates compared between groups
Baseline through 6 months post-HAART initiation
Study Arms (2)
Standard Care
OTHERParticipants in the Standard Care group will complete a demographic questionnaire at the time of consent as well as other questionnaires during the course of the study. They will receive standard clinical care.
Pill Trial+
EXPERIMENTALParticipants in the Pill Trial+ group will complete a demographic questionnaire at the time of consent as well as other questionnaires during the course of the study. They will receive standard clinical care plus three 25-minute individualized, behavioral, staff-delivered intervention sessions at HAART initiation, and 1-, and 3-month follow-up visits. Two brief booster sessions will also be provided following sessions 1 (in clinic) and 2 (by phone).
Interventions
In addition to standard clinical care, participants in the Pill Trial+ arm will receive staff-delivered intervention sessions individualized for each participant at HAART initiation, 1-month, and 3-month follow-up. Two booster sessions will also be provided at two weeks following intervention session 1 (in clinic) and intervention session 2 (by phone) to assess any difficulties using the created adherence plans.
Participants will complete a questionnaire developed for the purposes of the current study assessing basic background information.
Self-reported adherence, health-related quality of life and other questionnaire measures will be administered using a password protected laptop the same day as participants' regularly scheduled outpatient clinic appointments.
Eligibility Criteria
You may qualify if:
- Behaviorally acquired HIV diagnosis, confirmed via medical chart review.
- Currently followed in the St. Jude Children's Research Hospital (SJCRH) HIV clinic.
- Initiating HAART.
- Recommended a placebo trial.
- years of age at time of study entry.
- If 15 years of age or over, willing to give informed consent. If under the age of 15, willing to give assent and accompanied by legal guardian/representative to give informed consent.
- Fluent in English
You may not qualify if:
- Previous HAART exposure.
- Unable to understand English and/or not cognitively intact (known IQ \< 70) such that the study questionnaires cannot be understood and completed.
- Pregnant female.
- Enrolled on another protocol that excludes participation in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Publications (1)
Ingerski LM, Means B, Wang F, Zhang H, Patel N, Gaur AH, Wilkins ML. Preventing Medication Nonadherence of Youth (13-24 Years) With HIV Initiating Antiretroviral Therapy. J Adolesc Health. 2021 Oct;69(4):644-652. doi: 10.1016/j.jadohealth.2021.04.006. Epub 2021 May 28.
PMID: 34059425DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Megan Wilkins, PhD
St. Jude Children's Research Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2014
First Posted
April 21, 2014
Study Start
April 1, 2014
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
August 2, 2016
Record last verified: 2016-07