Medication Adherence in Human Immunodeficiency Virus (HIV)

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.

Conditions

• Human Immunodeficiency Virus

Interventions

BEHAVIORAL

Staff-delivered intervention sessions

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.

OTHER

Demographic Questionnaire

Participants will complete a questionnaire developed for the purposes of the current study assessing basic background information.

OTHER

Questionnaires

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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital

  lead OTHER

Principal Investigators

• Megan Wilkins, PhD · St. Jude Children's Research Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

13 Years

Max Age

24 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-04-30

Primary Completion

2016-07-31

Completion

2016-07-31

Countries

• United States

Study Locations