Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus

HIV Clinical Trial

Official title:

Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01760759
• Other study ID #: 12-205O-2
• Secondary ID: R01HD075630
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: April 2019

Study information

• Verified date: September 2019
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV
• HIV Infections

Intervention

Behavioral:
• cell phone reminders
Patients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing.
• contingency management for adherence
Patients will receive reinforcement in the form of vouchers for each video that they send in indicating adherence at the appropriate time.

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	Nathan Smith Clinic, Yale-New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in copies of human immunodeficiency virus per milliliter		Week 48
Primary	self-report of medication adherence		baseline
Primary	self-report of medication adherence		Week 8
Primary	self-report of medication adherence		Week 16
Primary	self-report of medication adherence		Week 24
Primary	self-report of medication adherence		Week 36
Primary	self-report of medication adherence		Week 48