Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus

U

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)

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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