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Supporting Treatment Adherence Readiness Through Training (START) (START)

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: NCT02329782
Recruitment Status : Completed
First Posted : January 1, 2015
Last Update Posted : October 6, 2020
Sponsor:
Collaborators:
University of California, Los Angeles
Long Beach Education and Research Consultants
Information provided by (Responsible Party):
RAND

Study Description
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Brief Summary:
Multi-site, randomized controlled trial of the Adherence Readiness Program (ARP) adherence intervention for HIV clients starting or restarting antiretroviral therapy (ART) for the purpose of achieving and sustaining optimal levels of ART adherence and virologic suppression. Eligible participants will be randomized to receive either the ARP intervention or usual care (no intervention) and followed for 24 months.

Condition or disease Intervention/treatment Phase
HIV Medication Adherence Behavioral: Adherence Readiness Program Not Applicable

Detailed Description:
This study will evaluate the effects of the Adherence Readiness Program (ARP) intervention on the primary outcomes of dose-taking HIV antiretroviral (ART) adherence and undetectable HIV viral load in a multi-site randomized controlled trial. The ARP is based on the Information Motivation Behavioral skills (IMB) model of behavior change and includes (1) brief pill taking practice trials for enhancing pre-treatment adherence counseling and providing a behavioral criterion for determining adherence readiness and the start of treatment, and (2) a performance driven dose regulation mechanism to tailor the amount of counseling (from pre-treatment through the full course of treatment) to the individual needs of the patient and conserve limited resources. Participants will be randomized to receive either the ARP (adherence counseling sessions) or usual care. Primary assessments will be administered at screening and every 6 months after ART initiation over a 24-month follow-up, making it one of the few studies to examine intervention effects longer than one year. Secondary outcomes include dose-timing adherence and CD4 count. If effective, the ARP will provide clinicians with an intervention that (1) informs providers and patients when the patient is ready to adhere well and start treatment, (2) enhances adherence readiness from the outset of treatment through the full course of therapy, and (3) tailors the amount of adherence support based on individual patient need and performance, thus more efficiently using clinic resources, fostering better acceptance from providers and patients, and increasing the likelihood of successful program adoption and dissemination. This emphasis on efficient use of resources will be complemented by a cost-effectiveness analysis to further inform policy decisions regarding the transportability of the intervention and its potential for more wide scale use and sustainability if effective.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Controlled Evaluation of the Adherence Readiness Program for ART Adherence
Actual Study Start Date : February 2015
Actual Primary Completion Date : March 30, 2020
Actual Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: ARP intervention
Adherence counseling intervention
 Behavioral: Adherence Readiness Program
The ARP consists of pre-treatment (including practice trials to determine readiness for and timing of ART initiation), early-treatment, and ongoing maintenance training (using a performance-based, dose regulation mechanism to tailor the amount and intensity) phases
No Intervention: usual care
no intervention, standard care practices regarding adherence support


Outcome Measures
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Primary Outcome Measures :
  1. HIV virologic suppression [ Time Frame: Month 24 ]
    undetectable HIV viral load at time of assessment

  2. log change in HIV viral load (log change in HIV RNA levels) [ Time Frame: Month 24 ]
    log change in HIV RNA levels from baseline to Month 24.

  3. optimal dose-taking adherence (whether at least 85% of prescribed doses were taken) [ Time Frame: Month 24 ]
    binary variable representing whether at least 85% of prescribed doses were taken between baseline and Month 24

  4. percent dose-taking adherence [ Time Frame: Month 24 ]
    percent of prescribed doses taken between baseline and Month 24

  5. HIV virologic suppression [ Time Frame: Month 6 ]
    undetectable HIV viral load at time of assessment

  6. log change in HIV viral load (log change in HIV RNA levels) [ Time Frame: Month 6 ]
    log change in HIV RNA levels from baseline to Month 6

  7. optimal dose-taking adherence (whether at least 85% of prescribed doses were taken) [ Time Frame: month 6 ]
    binary variable representing whether at least 85% of prescribed doses were taken between baseline and Month 6

  8. percent dose-taking adherence [ Time Frame: month 6 ]
    percent of prescribed doses taken between baseline and Month 6


Secondary Outcome Measures :
  1. dose-timing adherence [ Time Frame: Month 24 ]
    percent of prescribed doses taken within correct time-window between baseline and Month 24

  2. dose-timing adherence [ Time Frame: Month 6 ]
    percent of prescribed doses taken within correct time-window between baseline and Month 6

  3. optimal dose-timing adherence [ Time Frame: Month 24 ]
    binary variable representing whether at least 85% of prescribed doses were taken within correct time-window between baseline and Month 24

  4. optimal dose-timing adherence [ Time Frame: Month 6 ]
    binary variable representing whether at least 85% of prescribed doses were taken within correct time-window between baseline and Month 6

  5. change in CD4 count [ Time Frame: Month 24 ]
    change in CD4 count from baseline to Month 24

  6. change in CD4 count [ Time Frame: Month 6 ]
    change in CD4 count from baseline to Month 6

  7. clinic attendance (number of missed clinic appointments) [ Time Frame: Month 24 ]
    number of missed clinic appointments between baseline and Month 24

  8. clinic attendance (number of missed clinic appointments) [ Time Frame: Month 6 ]
    number of missed clinic appointments between baseline and Month 6


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient's provider views the patient as medically appropriate to begin (ART naïve) or restart ART (has been off ART for at least 2 months), and either

    • plans to start the patient on ART
    • would like to start the patient on ART but the provider or patient is uncertain about the patient's readiness to adhere well.

    Patients who are currently on ART are also eligible if they meet the following criteria, which are specific only to this type of patient:

    i) the patient has 2 or more HIV viral load tests in the past year > 1000 copies/ml ii) the patient has had no HIV viral load tests that were undetectable in the past year iii) the patient has a genotype in the past year that does not show resistance as a reason for virologic failure (detectable viral load) iv) primary care provider views the patient as a good candidate for the study, with the understanding that the patient will interrupt ART if assigned to the intervention.

    Criteria i to iii are intended to define a subgroup of nonadherent patients who are taking very little of their ART medications, as evidenced by the combination of consistently high viral load and no drug resistance. If the patient was taking at least a moderate level of drug and still had consistently high viral load, than they would have evidence of drug resistance. Providers are generally comfortable with this type of patient stopping their medication in order to facilitate the pre-treatment, adherence readiness assessment and training phase of the intervention prior to restarting the patient on treatment.

  2. The patient's health status is stable. There is no current acute OI or medical condition that calls for immediate ART, as determined by the patient's provider.
  3. Most recent HIV viral load is detectable.
  4. If CD4 < 200, the patient is on or will be prescribed prophylactic medication
  5. Patient is 18 or older.
  6. Patient is able and willing to give informed consent.
  7. English speaking.

Exclusion Criteria:

1. Patient just tested HIV+ and their provider suspects the patient may be acutely or recently infected (within past 6 months).

Contacts and Locations
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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): NCT02329782


Locations
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United States, California
CARE CLinic
Long Beach, California, United States
T.H.E. Clinic
Los Angeles, California, United States
UCLA Care Center
Los Angeles, California, United States
Sponsors and Collaborators
RAND
University of California, Los Angeles
Long Beach Education and Research Consultants
Investigators
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Principal Investigator: Glenn Wagner, PhD RAND
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT02329782    
Other Study ID Numbers: MH104086
First Posted: January 1, 2015    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No