Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: cell phone reminders; Behavioral: contingency management for adherence

• Registration Number: NCT01760759
• Lead Sponsor: UConn Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-21
• Study Start: 2012-11
• Study First Submitted QC: 2013-01-02
• Study First Posted: 2013-01-04
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-11
• Last Update Posted: 2019-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care, reminders & contingency management for adherence	cell phone reminders	Patients receive reminders and reinforcement in the form of vouchers for each video that they send in indicating adherence at the appropriate time.
Usual care, reminders & contingency management for adherence	contingency management for adherence	Patients receive reminders and reinforcement in the form of vouchers for each video that they send in indicating adherence at the appropriate time.
Usual care plus cell phone reminders	cell phone reminders	Patients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing.

Primary Outcome Measures

Name	Time	Method
self-report of medication adherence	Week 48
change in copies of human immunodeficiency virus per milliliter	Week 48

Trial Locations

Locations (2)

University of Connecticut Health Center; 🇺🇸 Farmington, Connecticut, United States

Nathan Smith Clinic, Yale-New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States