HIV Antiretroviral Therapy (ART) AdherencePhase 2NCT00247611

Improving Treatment Adherence in HIV-Infected Individuals

A Phase 2 study testing LifeWindows Intervention Sessions in people with HIV Antiretroviral Therapy (ART) Adherence and Health Behavior, run by University of Connecticut at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will develop and evaluate the efficacy of an individualized, interactive, computer software program delivered in conjunction with clinical care in increasing and supporting antiretroviral therapy adherence in HIV-infected individuals. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Antiretroviral Therapy (ART) Adherence, Health Behavior
What is being tested?: LifeWindows Intervention Sessions
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 594 participants
Where: 5 sitesUnited States
Study dates: Oct 2005to Mar 2008
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

HIV-infected
English-speaking
Currently receiving treatment at one of the participating sites
Currently receiving antiretroviral therapy

Who cannot join

Marked cognitive impairment

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

University of Connecticut Health Center
Farmington, Connecticut, 06030-3212
Hartford Hospital
Hartford, Connecticut, 06102
Yale-New Haven Hospital Nathan Smith Clinic
New Haven, Connecticut, 06510
Hospital of Saint Raphael
New Haven, Connecticut, 06511
Waterbury Hospital
Waterbury, Connecticut, 06708

Other trials in United States

About this study

Official title: Changing ART Adherence Behavior: The Lifewindows Project

Read the detailed description

When antiretroviral therapy (ART) is taken correctly, it can dramatically improve the health and well-being of HIV-infected individuals. However, when the treatment regimen is not followed carefully, the therapy can be ineffective in managing one's HIV, and also can allow for the development of strains of HIV that may be resistant to treatment. Effective ART adherence interventions can help patients to avoid potentially serious individual and public health consequences of suboptimal adherence, but such interventions are often expensive and too intensive for clinics to support offering over time to their patients. This study will develop and evaluate the effectiveness of an individualized, interactive, computer-software intervention program delivered in clinical care in increasing ART adherence in HIV-infected individuals. Because the intervention is a software program, clinic resources required for implementation and sustaining availability over time are minimized.

Participants in this ~18-month study were recruited from one of 5 participating clinics that provide HIV care and randomly assigned to control (an assessment only version of the software) or intervention (assessment and tailored intervention software) arm. Participants completed their assigned task in concert with their regularly scheduled HIV medical care visits (but no more frequently than once a month). Primary outcomes were measured at each medical visit. The effect of the adherence intervention was evaluated through comparison of treatment and control arm adherence reports over time and VL.

Conditions: HIV Antiretroviral Therapy (ART) Adherence, Health Behavior
Being tested: LifeWindows Intervention Sessions, Control
Keywords: HIV, AIDS, Antiretroviral Medication Adherence
Medical subject headings: Health Behavior, Acquired Immunodeficiency Syndrome

What participants receive

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

LifeWindows Intervention SessionsBehavioural
At each clinical care visit, intervention arm participants use the full LifeWindows program, which includes welcome and assessment surveys and also includes the active intervention modules. ART adherence promotion intervention activities are tailored to the participant's assessment responses. Participants select which activities he or she wishes to use which culminates in an adherence specific goal.
ControlOther
At each clinical care visit, control arm participants use the portion of the LifeWindows software program that provides a welcome from the avatar and collection of assessment items/surveys.

Study groups in NCT00247611
Study group	Role	What they receive
Control	Other	Participants will receive the control condition Receives: Other: Control
Intervention	Experimental	Participants will receive the LifeWindows Intervention sessions Receives: Behavioral: LifeWindows Intervention Sessions

What is being measured

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

AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken
This measure asks participants to report the number of doses taken on each of the past 3-days, relative to number he or she was prescribed to take, and produces a % adherence score. For this study, adherence over the past 3-days was established for each medication separately then averaged over the full regimen. For main outcomes, perfect vs imperfect adherence was evaluated. Significant findings on perfect/imperfect adherence were followed with sensitivity tests to determine if lowest threshold (eg., 90%, 80%, 70% adherence) effect was maintained.
See: Chesney MA, Ickovics JR, Chambers DB, et al. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient care committee \& adherence working group of the outcomes committee of the adult AIDS clinical trials group (AACTG). AIDS Care. 2000;12(3):255-266.
Measured: Measured at each clinical care visit over 18 months of participation
Visual Analog Scale Measure of Adherence to ART
This measure asks participants to rate their adherence over the past 3 to 4 weeks using a line that marks from 0 to 100% of doses taken. For this study, this item was asked for each antiretroviral in one's regimen and a total score was produced by averaging all reports. For main outcomes, perfect vs imperfect adherence was evaluated.
See: Walsh JC, Mandalia S, Gazzard BG. Responses to a 1 month self-report on adherence to antiretroviral therapy are consistent with electronic data and virological treatment outcome. AIDS.2002;16:269-77
Measured: Measured at each clinical visit over 18 months of participation

Secondary outcomes (1)

Viral Load Count
Viral load data extracted from medical records beginning 30 days prior to baseline.
Measured: Measured over 18 months

Timeline

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

Oct 2005Mar 2008

First posted2 Nov 2005 (estimated)
Study startOct 2005
Primary completionMar 2008
Study completionMar 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV Antiretroviral Therapy (ART) AdherenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 594 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00247611
Sponsor's protocol ID: R01MH066684
Other IDs: R01MH066684, DAHBR 9A-ASPG
Status last verified: Nov 2013
First submitted: 31 Oct 2005
Last updated: 20 Dec 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Fisher JD, Amico KR, Fisher WA, Cornman DH, Shuper PA, Trayling C, Redding C, Barta W, Lemieux AF, Altice FL, Dieckhaus K, Friedland G; LifeWindows Team. Computer-based intervention in HIV clinical care setting improves antiretroviral adherence: the LifeWindows Project. AIDS Behav. 2011 Nov;15(8):1635-46. doi: 10.1007/s10461-011-9926-x.
PubMed 21452051

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV Antiretroviral Therapy (ART) Adherence trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Changing ART Adherence Behavior: The Lifewindows Project
ClinicalTrials.gov ID: NCT00247611
Acronym / sponsor ID: R01MH066684
Conditions: HIV Antiretroviral Therapy (ART) Adherence, Health Behavior
Keywords: HIV, AIDS, Antiretroviral Medication Adherence
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 594 participants (actual)
Lead sponsor: University of ConnecticutUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Oct 2005
Primary completion: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 2 Nov 2005 (estimated)
Results: Posted 20 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control	Other	Other: ControlParticipants will receive the control condition
Intervention	Experimental	Behavioral: LifeWindows Intervention SessionsParticipants will receive the LifeWindows Intervention sessions

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

HIV-infected
English-speaking
Currently receiving treatment at one of the participating sites
Currently receiving antiretroviral therapy

Key exclusion criteria (1 listed)

Marked cognitive impairment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LifeWindows Intervention SessionsAt each clinical care visit, intervention arm participants use the full LifeWindows program, which includes welcome and assessment surveys and also includes the active intervention modules. ART adherence promotion intervention activities are tailored to the participant's assessment responses. Participants select which activities he or she wishes to use which culminates in an adherence specific goal.	Behavioural	Intervention
ControlAt each clinical care visit, control arm participants use the portion of the LifeWindows software program that provides a welcome from the avatar and collection of assessment items/surveys.	Other	Control

Primary outcome

AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken
Time frame: Measured at each clinical care visit over 18 months of participation
This measure asks participants to report the number of doses taken on each of the past 3-days, relative to number he or she was prescribed to take, and produces a % adherence score. For this study, adherence over the past 3-days was established for each medication separately then averaged over the full regimen. For main outcomes, perfect vs imperfect adherence was evaluated. Significant findings on perfect/imperfect adherence were followed with sensitivity tests to determine if lowest threshold (eg., 90%, 80%, 70% adherence) effect was maintained. See: Chesney MA, Ickovics JR, Chambers DB, et al. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient care committee \& adherence working group of the outcomes committee of the adult AIDS clinical trials group (AACTG). AIDS Care. 2000;12(3):255-266.
Visual Analog Scale Measure of Adherence to ART
Time frame: Measured at each clinical visit over 18 months of participation
This measure asks participants to rate their adherence over the past 3 to 4 weeks using a line that marks from 0 to 100% of doses taken. For this study, this item was asked for each antiretroviral in one's regimen and a total score was produced by averaging all reports. For main outcomes, perfect vs imperfect adherence was evaluated. See: Walsh JC, Mandalia S, Gazzard BG. Responses to a 1 month self-report on adherence to antiretroviral therapy are consistent with electronic data and virological treatment outcome. AIDS.2002;16:269-77

1 secondary outcome

Viral Load Count
Time frame: Measured over 18 months

Results and safety

Results posted to the registry on 20 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	304	287
Intervention	290	277

Primary outcome: AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken

Time frame: Measured at each clinical care visit over 18 months of participation. Number. Unit: percent with 100% adherence

Measure	Control (ITT Sample %) n = 287	Intervention (ITT Sample) n = 277	Control (On Protocol Sample) n = 176	Intervention (On Protocol) n = 152
1 LifeWindows Visit (%)	72.89	75.46	74.86	77.33
2 LifeWindows Visits (%)	80.36	82.48	81.50	85.53
3 LifeWindows Visits (%)	81.15	80.16	84.09	84.11
4 LifeWindows Visits (%)	79.92	81.78	80.11	81.58
5 LifeWindows Visits (%)	83.41	87.13	82.86	88.74
6 LifeWindows Visits (%)	81.25	82.46	81.61	83.55
7 LifeWindows Visits (%)	79.73	85.61	79.70	87.18
8 LifeWindows Visits (%)	79.82	88.54	79.00	91.76

Control (ITT Sample %) vs Intervention (ITT Sample): p = 0.12, HLM
Control (On Protocol Sample) vs Intervention (On Protocol): p = 0.024, HLM

Population analysed: Intent to treat included all participants with \>=2 adherence assessments; OP sample further restricted this sample to those with \>=6 assessments and no treatment interruptions over 18-months of participation. Multiple pairwise comparison replaced missing values. HLM was used for over-time analyses on proportion reporting perfect adherence.

Primary outcome: Visual Analog Scale Measure of Adherence to ART

Time frame: Measured at each clinical visit over 18 months of participation. Number. Unit: percent with 100% adherence

Measure	Control (ITT Sample) n = 287	Intervention (ITT Sample) n = 277	Control (On Protocol Sample) n = 176	Intervention (On Protocol Sample) n = 152
1 LifeWindows Visit (%)	42.61	46.15	45.71	45.33
2 LifeWindows Visits (%)	43.27	47.81	43.35	47.37
3 LifeWindows Visits (%)	42.69	47.77	42.05	49.67
4 LifeWindows Visits (%)	42.21	48.44	40.34	44.74
5 LifeWindows Visits (%)	42.79	50.99	41.14	50.99
6 LifeWindows Visits (%)	45.83	49.12	45.98	51.32
7 LifeWindows Visits (%)	41.89	41.67	40.60	46.15
8 LifeWindows Visits (%)	35.09	40.63	34.00	42.35

Control (ITT Sample) vs Intervention (ITT Sample): p = 0.12, HLM
Control (On Protocol Sample) vs Intervention (On Protocol Sample): p = 0.12, HLM

Population analysed: Intent to treat included all participants with \>=2 adherence assessments; OP sample further restricted this sample to those with \>=6 assessments and no treatment interruptions over 18-months of participation. Multiple pairwise comparisons replaced missing values. HLM was used for over-time analyses on proportion reporting perfect adherence.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Patient enrollment to end of IRB annual renewals. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 304 (0%)	0 of 304 (0%)	Not reported
Intervention	0 of 290 (0%)	0 of 290 (0%)	Not reported

Limitations and caveats (from the sponsor): * The only empirical demonstration of LifeWindows outcomes to date * OP sample was defined a posteriori * Under-powered to detect changes in Viral Load

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21452051Fisher JD, Amico KR, Fisher WA, Cornman DH, Shuper PA, Trayling C, Redding C, Barta W, Lemieux AF, Altice FL, Dieckhaus K, Friedland G; LifeWindows Team. Computer-based intervention in HIV clinical care setting improves antiretroviral adherence: the LifeWindows Project. AIDS Behav. 2011 Nov;15(8):1635-46. doi: 10.1007/s10461-011-9926-x.
PubMed record of results articleLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeffrey D. Fisher, PhD principal investigator

University of Connecticut

K. Rivet Amico*, PhD principal investigator

University of Connecticut (*co-PI)

Deborah H. Cornman*, PhD principal investigator

University of Connecticut (*co-PI)

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LifeWindows Intervention Sessions in people with HIV Antiretroviral Therapy (ART) Adherence and Health Behavior, run by University of Connecticut at 5 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 20 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 20 Dec 2013). 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?

AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken (time frame: Measured at each clinical care visit over 18 months of participation). The study lists 2 primary outcomes in all. 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 NCT00247611, which also lists 1 linked publication.

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 20 Dec 2013.