Telephone Support to Improve Adherence to Anti-HIV Medications

NCT ID: NCT00988442

Last Updated: 2017-07-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-02-28

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Enhanced nursing telephone support with standard care

Participants received enhanced nursing telephone support plus care as usual.

Group Type: EXPERIMENTAL

Enhanced nursing telephone support

Intervention Type: BEHAVIORAL

Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.

Standard care

Intervention Type: BEHAVIORAL

Usual ACTG site care.

Standard care

Participants received care as usual.

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: BEHAVIORAL

Usual ACTG site care.

Interventions

Enhanced nursing telephone support

Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.

Intervention Type: BEHAVIORAL

Standard care

Usual ACTG site care.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nancy R. Reynolds, PhD, RN, NP

Role: STUDY_CHAIR

Yale University School of Nursing

Locations

Alabama Therapeutics CRS

Birmingham, Alabama, United States

Ucsd, Avrc Crs

San Diego, California, United States

Northwestern University CRS (2701)

Chicago, Illinois, United States

Rush University Medical Center ACTG

Chicago, Illinois, United States

Massachusetts General Hospital ACTG CRS

Boston, Massachusetts, United States

Bmc Actg Crs (104)

Boston, Massachusetts, United States

Cooper Univ. Hosp. CRS (31476)

Camden, New Jersey, United States

New Jersey Medical School-Adult Clinical Research Ctr. CRS

Newark, New Jersey, United States

Cornell CRS

New York, New York, United States

HIV Prevention & Treatment CRS

New York, New York, United States

Unc Aids Crs

Chapel Hill, North Carolina, United States

Duke University Medical Center Adult CRS

Durham, North Carolina, United States

MetroHealth CRS

Cleveland, Ohio, United States

Hospital of the University of Pennsylvania CRS

Philadelphia, Pennsylvania, United States

Vanderbilt Therapeutics CRS

Nashville, Tennessee, United States

31443 Trinity Health and Wellness Center CRS

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 17891043 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19668085 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18349433 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27347650 (View on PubMed)

Other Identifiers

1U01AI068636

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10632

Identifier Type: -

Identifier Source: secondary_id

ACTG A5251

Identifier Type: -

Identifier Source: org_study_id