AzTrials
AzTrials

HIV InfectionsPhase 2NCT00988442

Telephone Support to Improve Adherence to Anti-HIV Medications

A Phase 2 study testing Enhanced nursing telephone support in people with HIV Infections, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 16 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Enhanced nursing telephone support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
16 sitesUnited States
Study dates
Oct 2010to Feb 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Alabama Therapeutics CRS

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital ACTG CRS

    Boston, Massachusetts, 02114

  • Bmc Actg Crs (104)

    Boston, Massachusetts, 02118

  • Cooper Univ. Hosp. CRS (31476)

    Camden, New Jersey, 08103

  • Unc Aids Crs

    Chapel Hill, North Carolina, 27514

  • Northwestern University CRS (2701)

    Chicago, Illinois, 60611

  • Rush University Medical Center ACTG

    Chicago, Illinois, 60612

  • MetroHealth CRS

    Cleveland, Ohio, 44109

  • 31443 Trinity Health and Wellness Center CRS

    Dallas, Texas, 75208

  • Duke University Medical Center Adult CRS

    Durham, North Carolina, 27710

  • Vanderbilt Therapeutics CRS

    Nashville, Tennessee, 37232

  • Cornell CRS

    New York, New York, 10011

  • HIV Prevention & Treatment CRS

    New York, New York, 10032

  • New Jersey Medical School-Adult Clinical Research Ctr. CRS

    Newark, New Jersey, 07103

  • Hospital of the University of Pennsylvania CRS

    Philadelphia, Pennsylvania, 19104

  • Ucsd, Avrc Crs

    San Diego, California, 92103

Other trials in United States

About this study

Official title: A Randomized Trial of Enhanced Nursing Telephone Support to Improve Medication Self-Management and Viral Outcomes of Antiretroviral Therapy-Experienced Patients

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.

Read the 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
Being tested
Enhanced nursing telephone support, Standard care
Keywords
Adherence, Treatment, Adherence Intervention, Telephone Intervention, treatment experienced
Medical subject headings
HIV Infections, Adherence Interventions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhanced nursing telephone supportBehavioural

    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 careBehavioural

    Usual ACTG site care.

Study groups in NCT00988442
Study groupRoleWhat they receive
Enhanced nursing telephone support with standard careExperimentalParticipants received enhanced nursing telephone support plus care as usual.
Receives: Behavioral: Enhanced nursing telephone support; Behavioral: Standard care
Standard careActive comparatorParticipants received care as usual.
Receives: Behavioral: Standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 48

Secondary outcomes (27)

  1. Number of Participants With Premature Antiretroviral Therapy (ART) Regimen Discontinuation

    Number of premature ART regimen discontinuations, defined as the first substitution, subtraction, or addition of one or more ARVs made to the initial study regimen.

    Measured: From study entry to Week 72

  2. Change in CD4 Cell Count at Week 12

    Change in CD4 cell count from baseline at week 12, calculated as Week 12 CD4 minus baseline CD4.

    Measured: Baseline and Week 12

  3. Change in CD4 Cell Count at Week 24

    Change in CD4 cell count from baseline at Week 24, calculated as Week 24 CD4 minus baseline CD4.

    Measured: Baseline and Week 24

  4. Change in CD4 Cell Count at Week 48

    Change in CD4 cell count from baseline at Week 48, calculated as Week 48 CD4 minus baseline CD4.

    Measured: Baseline and Week 48

  5. Confirmed Virologic Failure

    Number of participants with confirmed virologic failure. Virologic failure is defined as confirmed HIV-1 RNA ≥200 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 20 weeks after the date of randomization).

    Measured: Week 24 through Week 72

  6. Cost of the Adherence Telephone Interventions

    This outcome was planned to be analyzed if the intervention was found to be successful. However, the intervention was not determined to be successful.

    Measured: Week 48

  7. Number of Participants With Illness Events or Mortality

    Number of participants who had acute illnesses and mortality during follow-up. The categories of illness events and mortality are not mutually exclusive.

    Measured: Measured from entry to Week 72 or premature study discontinuation

  8. Number of Participants With Virological Suppression

    Number of participants with virological suppression, defined as HIV-1 RNA less than 200 copies/mL.

    Measured: Measured from entry to Week 72 or premature study discontinuation

  9. Number of Participants Who Received Last Telephone Call if Prior to the End of Defined Intervention Period

    Number of participants whose last telephone call received occurred prior to the end of the defined intervention period.

    Measured: Measured from entry to Week 72 or premature study discontinuation

  10. Intervention Dosage Score for Enhanced Nursing Telephone Support (Total Percentage of Scheduled Calls Successfully Delivered)

    Intervention dosage score for enhanced nursing telephone support. This is the total percentage of scheduled calls successfully delivered.

    Measured: Measured at Week 12

  11. Intervention Dosage Score for Enhanced Nursing Telephone Support (Total Amount of Time Spent in Calls)

    Intervention dosage score for enhanced nursing telephone support. This is the total amount of time spent in calls overall.

    Measured: Week 12

  12. Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 12

    Number of participants with virologic suppression, defined as HIV-1 RNA less than 200 copies/mL, at week 12.

    Measured: Week 12

  13. Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 24.

    Number of participants with virologic suppression, defined as HIV-1 RNA less than 200 copies/mL, at week 24.

    Measured: Week 24

  14. Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 12

    Number of participants with virologic suppression, defined as HIV-1 RNA less than 1,000 copies/mL, at week 12.

    Measured: Week 12

  15. Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 24

    Number of participants with virologic suppression, defined as HIV-1 RNA less than 1,000 copies/mL, at week 24.

    Measured: Week 24

  16. Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 48

    Number of participants with virologic suppression, defined as HIV-1 RNA less than 1,000 copies/mL, at week 48.

    Measured: Measured at Week 48

  17. Antiretroviral (ARV) Medication Adherence at Week 12 Using ACTG Adherence Questionnaire

    ARV medication adherence at week 12, as measured by the ACTG adherence questionnaire index. This questionnaire index is on a 0-100 scale, with higher scores indicating higher adherence.

    Measured: Week 12

  18. Antiretroviral (ARV) Medication Adherence at Week 24 Using ACTG Adherence Questionnaire

    ARV medication adherence at week 24, as measured by the ACTG adherence questionnaire index. The ACTG adherence questionnaire index is on a 0-100 scale where higher scores indicate better adherence.

    Measured: Week 24

  19. Antiretroviral (ARV) Medication Adherence at Week 12 Using Four Day Recall

    ARV medication adherence at week 12, as measured by four day recall, i.e. "Missed doses in last 4 days".

    Measured: Week 12

  20. Antiretroviral (ARV) Medication Adherence at Week 24 Using Four Day Recall

    ARV medication adherence, as measured by four day recall, i.e. "Missed doses in last 4 days".

    Measured: Week 24

  21. Antiretroviral (ARV) Medication Adherence at Week 12 Using Visual Analog Scale

    ARV medication adherence at week 12, as measured by the visual analog scale. The visual analog scale is a 0-100% scale that measures the percentage of HIV medication taken in the past month.

    Measured: Week 12

  22. Antiretroviral (ARV) Medication Adherence at Week 24 Using Visual Analog Scale

    ARV medication adherence at Week 24, as measured by the visual analog scale. The visual analog scale is a 0-100% scale that measures the percentage of HIV medication taken in the past month.

    Measured: Week 24

  23. Quality of Life Measured by Euro-QoL - Mobility

    Quality of life measured by Euro-QoL - Question 1: Mobility.

    Measured: Week 24

  24. Quality of Life Measured by Euro-QoL - Self-Care

    Quality of Life Measured by Euro-QoL - Question 2: Self-Care.

    Measured: Week 24

  25. Quality of Life Measured by Euro-QoL - Usual Activities

    Quality of Life Measured by Euro-QoL - Question 3: Usual activities.

    Measured: Week 24

  26. Quality of Life Measured by Euro-QoL - Pain/Discomfort

    Quality of Life Measured by Euro-QoL - Question 4: Pain/Discomfort.

    Measured: Week 24

  27. Quality of Life Measured by Euro-QoL - Anxiety/Depression

    Quality of Life Measured by Euro-QoL - Question 5: Anxiety/Depression.

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2009 (estimated)
  2. Study startOct 2010
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Why it stopped: This study was closed to recruitment and follow-up early due to low recruitment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00988442
Sponsor's protocol ID
ACTG A5251
Other IDs
1U01AI068636, 10632
Status last verified
Apr 2017
First submitted
1 Oct 2009
Last updated
17 Jul 2017
Data monitoring committee
Yes

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. doi: 10.1097/QAI.0b013e3181582d54.

    PubMed 17891043

  • 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.

    PubMed 19668085

  • 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.

    PubMed 18349433

  • 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.

    PubMed 27347650

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enhanced nursing telephone support in people with HIV Infections, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Virologic Suppression (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00988442, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in