Medication Adherence in Human Immunodeficiency Virus (HIV)
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional

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.
    

Intervention name(s): Staff-delivered intervention sessions; Demographic Questionnaire; Questionnaires
Intervention type(s): Behavioral; Other; Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: adolescents; young adults; medication adherence