Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus

UConn Health

Status: Completed

Conditions: HIV

Treatments: Behavioral: contingency management for adherence; Behavioral: cell phone reminders

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01760759

12-205O-2

R01HD075630 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

In this study, investigators propose to randomize 165 human immunodeficiency virus positive patients to one of three 16-week treatment conditions: (1) standard care; (2) standard care + cell phone-based adherence reminders; or (3) standard care + cell phone-based adherence reminders and contingency management. In this latter condition, patients will earn reinforcement for sending in time- and date-stamped self videos of antiretroviral therapy medication ingestion. Primary outcomes will include viral loads and self-report measures of adherence, and effects will be evaluated both during the treatment period and throughout a one-year follow-up. Investigators hypothesize that the cell phone reminder condition will improve adherence relative to standard care, and the cell phone reminder plus contingency management condition will have the best outcomes. Results from this study may have widespread implications for the use of cell phones as a novel technology to improve initial adherence to antiretroviral therapy, thereby reducing the spread of drug resistant human immunodeficiency virus strains to the community.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age > 18 years
• initiating or on an antiretroviral therapy regimen and have a viral load >200 copies/mL in the past 6 months
• one or more risk factors for poor adherence
• English speaking
• willing to use a cell phone to receive reminders and record medication ingestion for up to 16 weeks
• able to read at 5th grade level and pass a brief quiz related to understanding the informed consent form

Exclusion criteria

• living in an environment or has a visiting nurse that dispenses antiretroviral therapy medication
• participating in another antiretroviral therapy adherence study
• uncontrolled psychiatric disorders
• significant cognitive impairment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 3 patient groups

Usual care

No Intervention group

Description:

Patients receive usual care from their medical providers.

Usual care plus cell phone reminders

Experimental group

Description:

Patients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing.

Treatment:

Behavioral: cell phone reminders

Usual care, reminders & contingency management for adherence

Experimental group

Description:

Patients receive reminders and reinforcement in the form of vouchers for each video that they send in indicating adherence at the appropriate time.

Treatment:

Behavioral: cell phone reminders

Behavioral: contingency management for adherence