Telephone Support to Improve Adherence to Anti-HIV Medications

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00988442
First received: October 1, 2009
Last updated: December 5, 2013
Last verified: December 2013
  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 Phase
HIV Infections
Behavioral: Enhanced nursing telephone support
Behavioral: Standard care
Phase 2

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


Further study details as provided by AIDS Clinical Trials Group:

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 ]

Enrollment: 59
Study Start Date: October 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enhanced nursing telephone support with standard care
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.
Active Comparator: Standard care
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 26 Study Locations
Sponsors and Collaborators
AIDS Clinical Trials Group
Investigators
Study Chair: Nancy R. Reynolds, PhD, RN, NP Yale University School of Nursing
  More Information

Publications:
Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00988442     History of Changes
Other Study ID Numbers: ACTG A5251, 1U01AI068636, 10632
Study First Received: October 1, 2009
Last Updated: December 5, 2013
Health Authority: United States: Federal Government

Keywords provided by AIDS Clinical Trials Group:
Adherence
Treatment
Adherence Intervention
Telephone Intervention
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 18, 2014