Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus

NCT01760759 | Completed DMC

• 2 other identifiers: 12-205O-2R01HD075630
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV

Keywords

HIV; Antiretroviral therapy adherence

Outcome Measures

Primary Outcomes (7)

• change in copies of human immunodeficiency virus per milliliter

  Week 48

• self-report of medication adherence

  baseline

• self-report of medication adherence

  Week 8

• self-report of medication adherence

  Week 16

• self-report of medication adherence

  Week 24

• self-report of medication adherence

  Week 36

• self-report of medication adherence

  Week 48

Study Arms (3)

Usual care

NO INTERVENTION

Patients receive usual care from their medical providers.

Usual care plus cell phone reminders

EXPERIMENTAL

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

Behavioral: cell phone reminders

Usual care, reminders & contingency management for adherence

EXPERIMENTAL

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

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

Interventions

cell phone reminders BEHAVIORAL

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

Usual care plus cell phone reminders; Usual care, reminders & contingency management for adherence

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.

Usual care, reminders & contingency management for adherence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UConn Health: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

University of Connecticut Health Center

Farmington, Connecticut, 06030-3944, United States

Location

Nathan Smith Clinic, Yale-New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

Study Officials

• Carla Rash, Ph.D.

  UConn Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: January 4, 2013
• Study Start: November 1, 2012
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: September 13, 2019

Record last verified: 2019-09

Locations

US (2)