Supporting Treatment Adherence Readiness Through Training (START)

Completed · Not applicable

Conditions studied: HIV Medication Adherence

In brief

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.

Key facts

Study ID

NCT02329782

Run by

RAND

People needed

240

Starts

2015-02-01

Expected to finish

2020-03-30

Last updated by the study team

2020-10-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• CARE CLinic — Long Beach, California, United States
• T.H.E. Clinic — Los Angeles, California, United States
• UCLA Care Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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