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Medication Adherence in Human Immunodeficiency Virus (HIV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02119390
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : August 2, 2016
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

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.


Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Behavioral: Staff-delivered intervention sessions Other: Demographic Questionnaire Other: Questionnaires Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Targeting Enhanced Adherence to Medication: A Pilot Study in Adolescents and Young Adults With Human Immunodeficiency Virus (HIV)
Study Start Date : April 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.
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.

Experimental: 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).
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.




Primary Outcome Measures :
  1. Rate of consent to trial participation [ Time Frame: Day 1 ]
  2. Pill count values compared between arms [ Time Frame: 3 months post-HAART initiation ]
    Using Fisher Exact tests

  3. Pill count values compared between arms [ Time Frame: 6 months post-HAART initiation ]
    Using Fisher Exact tests


Secondary Outcome Measures :
  1. Adherence rates compared between groups [ Time Frame: 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.

  2. Patient outcome [ Time Frame: 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.

  3. Adherence rates compared between groups [ Time Frame: 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.

  4. Change in adherence rates compared between groups [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02119390


Locations
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United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
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Principal Investigator: Megan Wilkins, PhD St. Jude Children's Research Hospital
Additional Information:
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Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT02119390    
Other Study ID Numbers: P1TEAM
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: July 2016
Keywords provided by St. Jude Children's Research Hospital:
adolescents
young adults
medication adherence
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Virus Diseases
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases