AzTrials
AzTrials

HIV Medication AdherenceSTARTNCT02329782

Supporting Treatment Adherence Readiness Through Training (START)

A study testing Adherence Readiness Program in people with HIV Medication Adherence, run by RAND at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Medication Adherence
What is being tested?
Adherence Readiness Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
3 sitesUnited States
Study dates
Feb 2015to 30 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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.
Show all 12Show fewer
  • 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.
  • Most recent HIV viral load is detectable.
  • If CD4 < 200, the patient is on or will be prescribed prophylactic medication
  • Patient is 18 or older.
  • Patient is able and willing to give informed consent.
  • English speaking.

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • CARE CLinic

    Long Beach, California

  • T.H.E. Clinic

    Los Angeles, California

  • UCLA Care Center

    Los Angeles, California

Other trials in United States

About this study

Official title: Controlled Evaluation of the Adherence Readiness Program for ART Adherence

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.

Read the 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.

Being tested
Adherence Readiness Program

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adherence Readiness ProgramBehavioural

    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

Study groups in NCT02329782
Study groupRoleWhat they receive
ARP interventionExperimentalAdherence counseling intervention
Receives: Behavioral: Adherence Readiness Program
usual careNo interventionno intervention, standard care practices regarding adherence support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HIV virologic suppression

    undetectable HIV viral load at time of assessment

    Measured: Month 24

  2. log change in HIV viral load (log change in HIV RNA levels)

    log change in HIV RNA levels from baseline to Month 24.

    Measured: Month 24

  3. optimal dose-taking adherence (whether at least 85% of prescribed doses were taken)

    binary variable representing whether at least 85% of prescribed doses were taken between baseline and Month 24

    Measured: Month 24

  4. percent dose-taking adherence

    percent of prescribed doses taken between baseline and Month 24

    Measured: Month 24

  5. HIV virologic suppression

    undetectable HIV viral load at time of assessment

    Measured: Month 6

  6. log change in HIV viral load (log change in HIV RNA levels)

    log change in HIV RNA levels from baseline to Month 6

    Measured: Month 6

  7. optimal dose-taking adherence (whether at least 85% of prescribed doses were taken)

    binary variable representing whether at least 85% of prescribed doses were taken between baseline and Month 6

    Measured: month 6

  8. percent dose-taking adherence

    percent of prescribed doses taken between baseline and Month 6

    Measured: month 6

Secondary outcomes (8)

  1. dose-timing adherence

    percent of prescribed doses taken within correct time-window between baseline and Month 24

    Measured: Month 24

  2. dose-timing adherence

    percent of prescribed doses taken within correct time-window between baseline and Month 6

    Measured: Month 6

  3. optimal dose-timing adherence

    binary variable representing whether at least 85% of prescribed doses were taken within correct time-window between baseline and Month 24

    Measured: Month 24

  4. optimal dose-timing adherence

    binary variable representing whether at least 85% of prescribed doses were taken within correct time-window between baseline and Month 6

    Measured: Month 6

  5. change in CD4 count

    change in CD4 count from baseline to Month 24

    Measured: Month 24

  6. change in CD4 count

    change in CD4 count from baseline to Month 6

    Measured: Month 6

  7. clinic attendance (number of missed clinic appointments)

    number of missed clinic appointments between baseline and Month 24

    Measured: Month 24

  8. clinic attendance (number of missed clinic appointments)

    number of missed clinic appointments between baseline and Month 6

    Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completion30 Mar 2020
  4. Study completion30 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02329782
Sponsor's protocol ID
MH104086
Acronym
START
Status last verified
Oct 2020
First submitted
22 Dec 2014
Last updated
6 Oct 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Wagner GJ, Seelam R, Hoffman R, Ghosh-Dastidar B. Mediators and moderators of ART adherence effects of supporting treatment adherence readiness through training (START): evidence that START helps vulnerable clients achieve better adherence. AIDS Care. 2022 Oct;34(10):1249-1256. doi: 10.1080/09540121.2021.2006133. Epub 2021 Nov 21.

    PubMed 34802352

  • Wagner GJ, Hoffman R, Linnemayr S, Schneider S, Ramirez D, Gordon K, Seelam R, Ghosh-Dastidar B. START (Supporting Treatment Adherence Readiness through Training) Improves Both HIV Antiretroviral Adherence and Viral Reduction, and is Cost Effective: Results of a Multi-site Randomized Controlled Trial. AIDS Behav. 2021 Oct;25(10):3159-3171. doi: 10.1007/s10461-021-03188-x. Epub 2021 Apr 2.

    PubMed 33811266

  • Wagner GJ, Linnemayr S, Ghosh-Dastidar B, Currier JS, Hoffman R, Schneider S. Supporting Treatment Adherence Readiness through Training (START) for patients with HIV on antiretroviral therapy: study protocol for a randomized controlled trial. Trials. 2016 Mar 24;17:162. doi: 10.1186/s13063-016-1287-3.

    PubMed 27009061

Questions about this trial

What is this clinical trial studying?

A study testing Adherence Readiness Program in people with HIV Medication Adherence, run by RAND at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIV virologic suppression (time frame: Month 24). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02329782, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020; AzTrials last refreshed its copy on 29 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in