NCT02329782

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 1, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

5.2 years

First QC Date

December 22, 2014

Last Update Submit

October 5, 2020

Conditions

HIV Medication Adherence

Outcome Measures

Primary Outcomes (8)

  • HIV virologic suppression

    undetectable HIV viral load at time of assessment

    Month 24

  • log change in HIV viral load (log change in HIV RNA levels)

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

    Month 24

  • 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

    Month 24

  • percent dose-taking adherence

    percent of prescribed doses taken between baseline and Month 24

    Month 24

  • HIV virologic suppression

    undetectable HIV viral load at time of assessment

    Month 6

  • log change in HIV viral load (log change in HIV RNA levels)

    log change in HIV RNA levels from baseline to Month 6

    Month 6

  • 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

    month 6

  • percent dose-taking adherence

    percent of prescribed doses taken between baseline and Month 6

    month 6

Secondary Outcomes (8)

  • dose-timing adherence

    Month 24

  • dose-timing adherence

    Month 6

  • optimal dose-timing adherence

    Month 24

  • optimal dose-timing adherence

    Month 6

  • change in CD4 count

    Month 24

  • +3 more secondary outcomes

Study Arms (2)

ARP intervention

EXPERIMENTAL

Adherence counseling intervention

Behavioral: Adherence Readiness Program

usual care

NO INTERVENTION

no intervention, standard care practices regarding adherence support

Interventions

Adherence Readiness ProgramBEHAVIORAL

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

ARP intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CARE CLinic

Long Beach, California, United States

Location

T.H.E. Clinic

Los Angeles, California, United States

Location

UCLA Care Center

Los Angeles, California, United States

Location

Related Publications (3)

  • 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.

    PMID: 34802352DERIVED

  • 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.

    PMID: 33811266DERIVED

  • 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.

    PMID: 27009061DERIVED

Study Officials

  • Glenn Wagner, PhD

    RAND

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2014

First Posted

January 1, 2015

Study Start

February 1, 2015

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

October 6, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(3)