Telephone Support to Improve Adherence to Anti-HIV Medications - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00988442

Purpose

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.

Condition	Intervention
HIV Infections	Behavioral: Enhanced nursing telephone support Behavioral: Standard care

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Efficacy Study
Official Title:	A Randomized Trial of Enhanced Nursing Telephone Support to Improve Medication Self-Management and Viral Outcomes of Antiretroviral Therapy-Experienced Patients

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Virologic suppression, defined as HIV-1 RNA at less than 200 copies/mL [ Time Frame: Measured at Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Estimated Enrollment:

296

Arms	Assigned Interventions
Enhanced nursing telephone support with standard care: Experimental Participants will receive enhanced nursing telephone support plus care as usual.	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. Behavioral: Standard care Care as usual for participants starting a new ART regimen; this may vary by study site.
Standard care: Active Comparator Participants will receive care as usual.	Behavioral: Standard care Care as usual for participants starting a new ART regimen; this may vary by study site.

Arms

Assigned Interventions

Enhanced nursing telephone support with standard care: Experimental

Participants will receive enhanced nursing telephone support plus care as usual.

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.

Behavioral: Standard care

Care as usual for participants starting a new ART regimen; this may vary by study site.

Standard care: Active Comparator

Participants will receive care as usual.

Behavioral: Standard care

Care as usual for participants starting a new ART regimen; this may vary by study site.

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988442

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:

Nancy R. Reynolds, PhD, RN, NP

Yale University School of Nursing

More Information

Publications:

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.

Sitta R, Lert F, Gueguen A, Spire B, Dray-Spira R; and the 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 Aug 7; [Epub ahead of print]

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. Epub 2008 Mar 18.

Responsible Party:	DAIDS ( Rona Siskind )
Study ID Numbers:	ACTG A5251, 10632
Study First Received:	October 1, 2009
Last Updated:	October 8, 2009
ClinicalTrials.gov Identifier:	NCT00988442 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Adherence
Treatment
Adherence Intervention
Telephone Intervention
treatment experienced

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on February 08, 2010