Clinical trial NCT00988442: Telephone Support to Improve Adherence to Anti-HIV Medications
Official title: A Randomized Trial of Enhanced Nursing Telephone Support to Improve Medication Self-Management and Viral Outcomes of Antiretroviral Therapy-Experienced Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Adherence
Treatment
Adherence Intervention
Telephone Intervention
treatment experienced
Lead sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2009-10-02
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study tested a system of nursing telephone support to determine if it improves adherence to antiretroviral therapy (ART) in at-risk, treatment-experienced people.

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 tested an enhanced telephone support intervention provided by nurses that aimed to improve ART adherence and treatment outcomes.

Follow-up for this study lasted 72 weeks. Participants were randomly assigned to receive either care as usual or the enhanced telephone support intervention plus care as usual. The telephone support intervention involved phone calls made weekly for the first 8 weeks of the study and then every 2 weeks for the next 40 weeks. Nurses made these calls at a time and place participants chose. During the calls, nurses provided information, motivational enhancement, and problem-solving skills.

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

This study was closed early to both accrual and follow-up due to low recruitment. The study aimed to enroll 296 participants. The actual study accrual at the time of early closing was 59 participants.

Eligibility criteria: Inclusion Criteria:

* Enrollment in an AIDS Clinical Trials Group (ACTG) treatment study that is an approved A5251 parent or coenrolling partner study ("ACTG parent study participant") or not enrolled in one of the ACTG parent studies, but receiving routine HIV patient care at an institution that was also an ACTG-funded site ("ACTG clinic patient participant").
* 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. Availability of HIV-1 genotype results 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 200 copies/mL, obtained within 90 days prior to study entry and measured using any FDA-approved test for quantifying HIV-1 RNA
* Initiating or restarting an ART regimen with 2 or more active ARV medications within 3 days after randomization. The regimen must have been selected for the participant prior to the time of randomization for A5251. An active ARV medication was defined as a medication to which the participant was expected to be susceptible based on HIV-1 resistance testing, as specified in the ACTG parent study, or determined by the participant's health care provider per standard of care.

Exclusion Criteria:

* No regular access to a phone. Candidates without phones may have elected 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 have compromised the candidate's ability to participate in the study

Primary outcomes:
measure: Number of Participants With Virologic Suppression
timeFrame: Week 48
Secondary outcomes:
measure: Number of Participants With Premature Antiretroviral Therapy (ART) Regimen Discontinuation
timeFrame: From study entry to Week 72
measure: Change in CD4 Cell Count at Week 12
timeFrame: Baseline and Week 12
measure: Change in CD4 Cell Count at Week 24
timeFrame: Baseline and Week 24
measure: Change in CD4 Cell Count at Week 48
timeFrame: Baseline and Week 48
measure: Confirmed Virologic Failure
timeFrame: Week 24 through Week 72
measure: Cost of the Adherence Telephone Interventions
timeFrame: Week 48
measure: Number of Participants With Illness Events or Mortality
timeFrame: Measured from entry to Week 72 or premature study discontinuation
measure: Number of Participants With Virological Suppression
timeFrame: Measured from entry to Week 72 or premature study discontinuation
measure: Number of Participants Who Received Last Telephone Call if Prior to the End of Defined Intervention Period
timeFrame: Measured from entry to Week 72 or premature study discontinuation
measure: Intervention Dosage Score for Enhanced Nursing Telephone Support (Total Percentage of Scheduled Calls Successfully Delivered)
timeFrame: Measured at Week 12
measure: Intervention Dosage Score for Enhanced Nursing Telephone Support (Total Amount of Time Spent in Calls)
timeFrame: Week 12
measure: Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 12
timeFrame: Week 12
measure: Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 24.
timeFrame: Week 24
measure: Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 12
timeFrame: Week 12
measure: Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 24
timeFrame: Week 24
measure: Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 48
timeFrame: Measured at Week 48
measure: Antiretroviral (ARV) Medication Adherence at Week 12 Using ACTG Adherence Questionnaire
timeFrame: Week 12
measure: Antiretroviral (ARV) Medication Adherence at Week 24 Using ACTG Adherence Questionnaire
timeFrame: Week 24
measure: Antiretroviral (ARV) Medication Adherence at Week 12 Using Four Day Recall
timeFrame: Week 12
measure: Antiretroviral (ARV) Medication Adherence at Week 24 Using Four Day Recall
timeFrame: Week 24
measure: Antiretroviral (ARV) Medication Adherence at Week 12 Using Visual Analog Scale
timeFrame: Week 12
measure: Antiretroviral (ARV) Medication Adherence at Week 24 Using Visual Analog Scale
timeFrame: Week 24
measure: Quality of Life Measured by Euro-QoL - Mobility
timeFrame: Week 24
measure: Quality of Life Measured by Euro-QoL - Self-Care
timeFrame: Week 24
measure: Quality of Life Measured by Euro-QoL - Usual Activities
timeFrame: Week 24
measure: Quality of Life Measured by Euro-QoL - Pain/Discomfort
timeFrame: Week 24
measure: Quality of Life Measured by Euro-QoL - Anxiety/Depression
timeFrame: Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Therapeutics CRS
state: Alabama
city: San Diego
country: United States
facility: Ucsd, Avrc Crs
state: California
city: Chicago
country: United States
facility: Northwestern University CRS (2701)
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center ACTG
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital ACTG CRS
state: Massachusetts
city: Boston
country: United States
facility: Bmc Actg Crs (104)
state: Massachusetts
city: Camden
country: United States
facility: Cooper Univ. Hosp. CRS (31476)
state: New Jersey
city: Newark
country: United States
facility: New Jersey Medical School-Adult Clinical Research Ctr. CRS
state: New Jersey
city: New York
country: United States
facility: Cornell CRS
state: New York
city: New York
country: United States
facility: HIV Prevention & Treatment CRS
state: New York
city: Chapel Hill
country: United States
facility: Unc Aids Crs
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center Adult CRS
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth CRS
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania CRS
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Therapeutics CRS
state: Tennessee
city: Dallas
country: United States
facility: 31443 Trinity Health and Wellness Center CRS
state: Texas
Study officials:
affiliation: Yale University School of Nursing
name: Nancy R. Reynolds, PhD, RN, NP
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1097/QAI.0b013e3181582d54.
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.
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.
citation: Robbins GK, Cohn SE, Harrison LJ, Smeaton L, Moran L, Rusin D, Dehlinger M, Flynn T, Lammert S, Wu AW, Safren SA, Reynolds NR. Characteristics associated with virologic failure in high-risk HIV-positive participants with prior failure: a post hoc analysis of ACTG 5251. HIV Clin Trials. 2016 Jul;17(4):165-72. doi: 10.1080/15284336.2016.1189754.