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OpenTrials
Completed

NCT Number: NCT01760759

Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Connecticut Health Center, Farmington, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cell phone reminders

Behavioral

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

contingency management for adherence

Behavioral

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

Primary outcomes

  1. change in copies of human immunodeficiency virus per milliliter

    Time frame: Week 48

  2. self-report of medication adherence

    Time frame: baseline

  3. self-report of medication adherence

    Time frame: Week 8

  4. self-report of medication adherence

    Time frame: Week 16

  5. self-report of medication adherence

    Time frame: Week 24

  6. self-report of medication adherence

    Time frame: Week 36

  7. self-report of medication adherence

    Time frame: Week 48

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Jan 4, 2013
Registry last updated
Sep 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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