Telephone Support to Improve Adherence to Anti-HIV Medications

HIV Infections Clinical Trial

Official title:

A Randomized Trial of Enhanced Nursing Telephone Support to Improve Medication Self-Management and Viral Outcomes of Antiretroviral Therapy-Experienced Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00988442
• Other study ID #: ACTG A5251
• Secondary ID: 1U01AI0686361063
• Status: Completed
• Phase: Phase 2
• First received: October 1, 2009
• Last updated: June 6, 2016
• Start date: October 2010
• Est. completion date: February 2013

Study information

• Verified date: June 2016
• Source: AIDS Clinical Trials Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will test a system of nursing telephone support to see if it improves adherence to antiretroviral therapy (ART) in at-risk, treatment-experienced people.

Description:

Antiretroviral therapy (ART) is only successful in treating HIV when people take all the medications prescribed to them when and how they are instructed. However, a third or more of patients on ART are not able to adhere to their medication regimens. Therefore, making sure that these patients stay healthy involves making sure they are motivated and informed about the importance of adhering to their ART. Nurses can deliver interventions to motivate and inform patients through regularly scheduled phone calls. These calls allow nurses to check in between clinic visits, are convenient to patients, and are cost efficient. This study will test an enhanced telephone support intervention provided by nurses that aims to improve ART adherence and treatment outcomes.

Participation in this study will last 48 weeks, with follow-up lasting 72 weeks. Participants will be randomly assigned to receive either care as usual or the enhanced telephone support intervention plus care as usual. The telephone support intervention will involve phone calls made weekly for the first 8 weeks of the study and then every 2 weeks for the next 40 weeks. Nurses will make these calls at a time and place participants choose. During the calls, nurses will provide information, motivational enhancement, and problem-solving skills.

Study assessments will take place at study entry and after 12, 24, 48, and 72 weeks. Assessments will measure CD4 cell count, HIV viral load, adherence, and illness events. Adherence will be measured through questionnaires and an electronic pill cap.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Enrollment in an AIDS Clinical Trials Group (ACTG) treatment study that is an approved A5251 parent or coenrolling partner study

• Virologic failure on combination antiretroviral therapy (ART), with an HIV-1 genotype conducted on or soon after the failure, within 16 weeks prior to entry. HIV-1 genotype results must be available at entry.

• History of prior nonadherence to ART during the past year documented either by patient self-report or recorded in the patient's medical record

• Most recent HIV-1 RNA value of at least 400 copies/mL, obtained within 90 days prior to study entry and measured using any FDA-approved test for quantifying HIV-1 RNA

• Initiating a new ART regimen within 3 days after randomization with two or more new antiretroviral (ARV) medications to which the participant is expected to be susceptible based on HIV-1 genotype, as specified in the parent or coenrolling partner study or determined by the site investigator. The regimen must be selected for the participant prior to the time of randomization for A5251.

• Ability to have CD4+ cell count and plasma HIV-1 RNA assays as a component of the parent or coenrolling partner study or per other mechanism. Only HIV-1 RNA at week 48 and confirmation of virologic failure will be collected by A5251, unless collected by the parent or coenrolling partner study per exact A5251 specifications.

Exclusion Criteria:

• No regular access to a phone. Candidates without phones may elect to participate by calling the HIV nurse specialists using an 800 number, rather than being called by the HIV nurse specialist.

• Coenrollment in another adherence trial, unless approved by the A5251 study chair

• Current incarceration

• Any condition that, in the opinion of the site investigator, would compromise the candidate's ability to participate in the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Enhanced nursing telephone support
Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses may schedule more frequent calls at their discretion. Calls will provide information, motivational enhancement, problem-solving skills, and affective support.
• Standard care
Care as usual for participants starting a new ART regimen; this may vary by study site.

Locations

Country	Name	City	State
Puerto Rico	Puerto Rico AIDS CRS	San Juan
United States	University of Colorado Hospital CRS	Aurora	Colorado
United States	Alabama Therapeutics CRS	Birmingham	Alabama
United States	Bmc Actg Crs (104)	Boston	Massachusetts
United States	Brigham and Women's Hospital ACTG CRS	Boston	Massachusetts
United States	Massachusetts General Hospital ACTG CRS	Boston	Massachusetts
United States	Cooper Univ. Hosp. CRS (31476)	Camden	New Jersey
United States	Unc Aids Crs	Chapel Hill	North Carolina
United States	Northwestern University CRS (2701)	Chicago	Illinois
United States	Rush University Medical Center ACTG	Chicago	Illinois
United States	University of Cincinnati CRS	Cincinnati	Ohio
United States	Case CRS	Cleveland	Ohio
United States	MetroHealth CRS	Cleveland	Ohio
United States	The Ohio State University AIDS CRS	Columbus	Ohio
United States	Duke University Medical Center Adult CRS	Durham	North Carolina
United States	Moses H. Cone Memorial Hospital CRS	Greensboro	North Carolina
United States	Vanderbilt Therapeutics CRS	Nashville	Tennessee
United States	Cornell CRS	New York	New York
United States	HIV Prevention & Treatment CRS	New York	New York
United States	New Jersey Medical School-Adult Clinical Research Ctr. CRS	Newark	New Jersey
United States	Hospital of the University of Pennsylvania CRS	Philadelphia	Pennsylvania
United States	Pitt CRS	Pittsburgh	Pennsylvania
United States	The Miriam Hospital ACTG CRS	Providence	Rhode Island
United States	Ucsd, Avrc Crs	San Diego	California
United States	Washington University CRS	St. Louis	Missouri
United States	Georgetown University CRS	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
AIDS Clinical Trials Group	National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (3)

Reynolds NR, Testa MA, Su M, Chesney MA, Neidig JL, Frank I, Smith S, Ickovics J, Robbins GK; AIDS Clinical Trials Group 731 and 384 Teams. Telephone support to improve antiretroviral medication adherence: a multisite, randomized controlled trial. J Acquir Immune Defic Syndr. 2008 Jan 1;47(1):62-8. — View Citation

Sitta R, Lert F, Gueguen A, Spire B, Dray-Spira R; VESPA group. No variability across centers in adherence and response to HAART in French hospitals: results from the ANRS-EN12-VESPA study. J Acquir Immune Defic Syndr. 2009 Dec;52(5):643-7. doi: 10.1097/QAI.0b013e3181b26eb9. — View Citation

Zaric GS, Bayoumi AM, Brandeau ML, Owens DK. The cost-effectiveness of counseling strategies to improve adherence to highly active antiretroviral therapy among men who have sex with men. Med Decis Making. 2008 May-Jun;28(3):359-76. doi: 10.1177/0272989X07312714. Epub 2008 Mar 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virologic suppression, defined as HIV-1 RNA at less than 200 copies/mL		Measured at Week 48	No
Secondary	Antiretroviral (ARV) medication adherence		Measured at Weeks 12, 24, 48, and 72	No
Secondary	Time to antiretroviral therapy (ART) regimen discontinuation		Measured throughout	No
Secondary	Quality of life		Measured at Weeks 24, 48, and 72	No
Secondary	CD4 cell count		Measured at Weeks 12, 24, 48, and 72	No
Secondary	Cost of the adherence telephone interventions, if the intervention is successful		Measured at Week 48	No
Secondary	Symptom distress, illness events, or mortality		Measured throughout the study	Yes
Secondary	Virologic suppression, defined as HIV-1 RNA less than 1,000 copies/mL		Measured at Week 48	No
Secondary	Virological suppression, measured as both HIV-1 RNA less than 200 and less than 1,000 copies/mL		Measured at Weeks 12, 24, and 72	No
Secondary	Time to virologic failure, with virologic failure defined as confirmed HIV-1 RNA of at least 200 copies/mL at or after 24 weeks		Measured at Weeks 24, 48, and 72	No
Secondary	Time to first virological suppression, defined as HIV-1 RNA less than 200 copies/mL		Measured at Weeks 12, 24, 48, and 72	No
Secondary	Time to discontinuation of enhanced nursing telephone adherence intervention		Measured throughout	No
Secondary	Intervention dosage score for enhanced nursing telephone support, including total percentage of scheduled calls successfully delivered and total amount of time spent in calls		Measured at Week 72	No