Clinical trial NCT02119390: Medication Adherence in Human Immunodeficiency Virus (HIV)
Official title: Targeting Enhanced Adherence to Medication: A Pilot Study in Adolescents and Young Adults With Human Immunodeficiency Virus (HIV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: adolescents
young adults
medication adherence
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 33
Sex: ALL
Minimum age (years): 13
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The proposed pilot study will utilize a randomized controlled trial to estimate the feasibility, acceptability, and preliminary efficacy of a novel intervention for AYAs diagnosed with behaviorally-acquired HIV initiating HAART.

Standard care for HIV at St. Jude Children's Research Hospital (SJCRH) includes a placebo pill trial to assess patient readiness for therapy prior to starting HAART. Participants on this study will be randomized to either: a control arm of standard therapy, or standard therapy plus an individualized behavioral, staff-delivered intervention (Pill Trial+).

Participants in the control arm will receive standard clinical care. Participants in the Pill Trial+ arm will receive standard therapy 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 to the Pill Trial+ arm following sessions 1 (in clinic) and 2 (by phone). In-person intervention sessions and all questionnaires will be completed in conjunction with scheduled clinical care visits. Sessions and measures will be completed by phone at designated time points if a participant becomes unavailable to return to clinic due to extenuating circumstances.

As recommended by Panel guidelines, discussion of placebo pill trial adherence during the first 25-minute session will provide a novel mechanism to discuss barriers to adherence and provide intervention prior to HAART initiation. Remaining sessions will promote adherence following HAART initiation using behavioral problem-solving and motivational interviewing strategies.

Primary Objective:

* To estimate a) rate of consent to the randomized trial and b) differences between the intervention and control conditions with respect to HAART adherence, as measured by pill count.

Secondary Objectives:

* To estimate differences between the intervention and control conditions with respect to other measures of adherence, including HAART self-reported adherence, HAART pharmacy refill, and clinic attendance.
* To examine disease and patient-reported outcomes during the first 6 months following HAART initiation and their relationship to participation in the Pill Trial+ intervention.

Eligibility criteria: Inclusion Criteria:

* 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.
* 13-24 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Rate of consent to trial participation
timeFrame: Day 1
measure: Pill count values compared between arms
timeFrame: 3 months post-HAART initiation
measure: Pill count values compared between arms
timeFrame: 6 months post-HAART initiation
Secondary outcomes:
measure: Adherence rates compared between groups
timeFrame: 3 months post-HAART initiation
measure: Patient outcome
timeFrame: 6 months following HAART initiation
measure: Adherence rates compared between groups
timeFrame: 6 months post-HAART initiation
measure: Change in adherence rates compared between groups
timeFrame: Baseline through 6 months post-HAART initiation
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Megan Wilkins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.