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Medication Adherence in Human Immunodeficiency Virus (HIV)

1 augusti 2016 uppdaterad av: St. Jude Children's Research Hospital

Targeting Enhanced Adherence to Medication: A Pilot Study in Adolescents and Young Adults With Human Immunodeficiency Virus (HIV)

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

33

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Tennessee
      • Memphis, Tennessee, Förenta staterna, 38105
        • St. Jude Children's Research Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

13 år till 24 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: Standard Care
Participants 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.
Övrig: Demographic Questionnaire
Participants will complete a questionnaire developed for the purposes of the current study assessing basic background information.
Övrig: 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.
Experimentell: Pill Trial+
Participants 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).
Övrig: Demographic Questionnaire
Participants will complete a questionnaire developed for the purposes of the current study assessing basic background information.
Övrig: 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.
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Rate of consent to trial participation
Tidsram: Day 1
Day 1
Pill count values compared between arms
Tidsram: 3 months post-HAART initiation
Using Fisher Exact tests
3 months post-HAART initiation
Pill count values compared between arms
Tidsram: 6 months post-HAART initiation
Using Fisher Exact tests
6 months post-HAART initiation

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Adherence rates compared between groups
Tidsram: 3 months post-HAART initiation
Self-reported adherence rates, pharmacy refill, and clinic attendance will be included in this analysis. Fisher exact tests will be performed to compare adherence rates between groups.
3 months post-HAART initiation
Patient outcome
Tidsram: 6 months following HAART initiation
Disease and patient-reported outcomes will be examined as well as their relationship to participation in the Pill Trial+ intervention. Viral load (VL), CD4 count/%, health-related quality of life (HRQOL) scores, and beliefs about medication (BAM) scores will be analyzed. Mixed effects models will be employed to explore the efficacy of the intervention on virologic response, HRQOL, and medical beliefs. VL, CD4 count/%, HRQOL, and beliefs will be used as the response variables, respectively, while time since treatment, intervention, and their interaction will be included as covariates.
6 months following HAART initiation
Adherence rates compared between groups
Tidsram: 6 months post-HAART initiation
Self-reported adherence rates, pharmacy refill, and clinic attendance will be included in this analysis. Fisher exact tests will be performed to compare adherence rates between groups.
6 months post-HAART initiation
Change in adherence rates compared between groups
Tidsram: Baseline through 6 months post-HAART initiation
Self-reported adherence rates, pharmacy refill, and clinic attendance will be included in this analysis. Mixed effects models and logistic link will be used to examine differences between groups adherence data and within-subject changes in adherence over time.
Baseline through 6 months post-HAART initiation

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

St. Jude Children's Research Hospital

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2014

Primärt slutförande (Faktisk)

1 juli 2016

Avslutad studie (Faktisk)

1 juli 2016

Studieregistreringsdatum

Först inskickad

15 april 2014

Först inskickad som uppfyllde QC-kriterierna

17 april 2014

Första postat (Uppskatta)

21 april 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

2 augusti 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 augusti 2016

Senast verifierad

1 juli 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • P1TEAM

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