Study Stopped
This study was closed to recruitment and follow-up early due to low recruitment.
Telephone Support to Improve Adherence to Anti-HIV Medications
A Randomized Trial of Enhanced Nursing Telephone Support to Improve Medication Self-Management and Viral Outcomes of Antiretroviral Therapy-Experienced Patients
3 other identifiers
interventional
59
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv-infections
Started Oct 2010
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2009
CompletedFirst Posted
Study publicly available on registry
October 2, 2009
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
July 17, 2017
CompletedJuly 17, 2017
April 1, 2017
2.3 years
October 1, 2009
February 13, 2017
April 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Virologic Suppression
Number of participants with virologic suppression, defined as HIV-1 RNA at less than 200 copies/mL at week 48.
Week 48
Secondary Outcomes (27)
Number of Participants With Premature Antiretroviral Therapy (ART) Regimen Discontinuation
From study entry to Week 72
Change in CD4 Cell Count at Week 12
Baseline and Week 12
Change in CD4 Cell Count at Week 24
Baseline and Week 24
Change in CD4 Cell Count at Week 48
Baseline and Week 48
Confirmed Virologic Failure
Week 24 through Week 72
- +22 more secondary outcomes
Study Arms (2)
Enhanced nursing telephone support with standard care
EXPERIMENTALParticipants received enhanced nursing telephone support plus care as usual.
Standard care
ACTIVE COMPARATORParticipants received care as usual.
Interventions
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.
Usual ACTG site care.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Alabama Therapeutics CRS
Birmingham, Alabama, 35294, United States
Ucsd, Avrc Crs
San Diego, California, 92103, United States
Northwestern University CRS (2701)
Chicago, Illinois, 60611, United States
Rush University Medical Center ACTG
Chicago, Illinois, 60612, United States
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, 02114, United States
Bmc Actg Crs (104)
Boston, Massachusetts, 02118, United States
Cooper Univ. Hosp. CRS (31476)
Camden, New Jersey, 08103, United States
New Jersey Medical School-Adult Clinical Research Ctr. CRS
Newark, New Jersey, 07103, United States
Cornell CRS
New York, New York, 10011, United States
HIV Prevention & Treatment CRS
New York, New York, 10032, United States
Unc Aids Crs
Chapel Hill, North Carolina, 27514, United States
Duke University Medical Center Adult CRS
Durham, North Carolina, 27710, United States
MetroHealth CRS
Cleveland, Ohio, 44109, United States
Hospital of the University of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt Therapeutics CRS
Nashville, Tennessee, 37232, United States
31443 Trinity Health and Wellness Center CRS
Dallas, Texas, 75208, United States
Related Publications (4)
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.
PMID: 17891043BACKGROUNDSitta 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.
PMID: 19668085BACKGROUNDZaric 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.
PMID: 18349433BACKGROUNDRobbins 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.
PMID: 27347650RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study was closed to recruitment and follow-up early due to slow enrollment.
Results Point of Contact
- Title
- ACTG Clinicaltrials.gov Coordinator
- Organization
- ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Study Officials
- STUDY CHAIR
Nancy R. Reynolds, PhD, RN, NP
Yale University School of Nursing
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2009
First Posted
October 2, 2009
Study Start
October 1, 2010
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
July 17, 2017
Results First Posted
July 17, 2017
Record last verified: 2017-04