NCT00130273

Brief Summary

This study will determine whether a managed problem solving intervention can help patients with HIV better follow their anti-HIV drug regimen and can control HIV better than the standard of care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Jul 2005

Longer than P75 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2005

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

July 13, 2012

Status Verified

July 1, 2012

Enrollment Period

5.6 years

First QC Date

August 11, 2005

Last Update Submit

July 12, 2012

Conditions

HIV Infections

Keywords

HIVAIDSProblem SolvingAntiretroviral Therapy, Highly ActivePatient Compliance

Outcome Measures

Primary Outcomes (1)

  • Improved adherence

    Measured at Year 4

Secondary Outcomes (2)

  • Decrease in viral load

    Measured at Year 4

  • Increase in CD4 count

    Measured at Year 4

Study Arms (2)

1

EXPERIMENTAL

Participants will receive managed problem solving for 12 months

Behavioral: Managed problem solving

2

ACTIVE COMPARATOR

Participants will receive standard of care for 12 months

Behavioral: Standard care

Interventions

Managed problem solvingBEHAVIORAL

Participants in the managed problem solving group will have four study visits and will receive three phone calls for the first 3 months of the study, and one phone call every month for the following 9 months. At each study visit, participants will identify barriers to adherence. During the phone calls, participants will be asked about any steps they have taken to improve their adherence. A medication event monitoring system (MEMS) will be used to assess participants' treatment adherence. MEMS uses microelectronic monitors on the caps of medication bottles to record the timing and frequency of bottle openings. Participants whose adherence has decreased or remained the same at the end of 12 months will be evaluated for regimen changes. Blood collection at the beginning and end of the study will be used to measure viral load and CD4 count.

1
Standard careBEHAVIORAL

Participants will receive standard of care for 12 months.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV infected
  • Infection likely to be susceptible to a specific treatment regimen
  • Have access to a telephone
  • Willing and able to comply with all study requirements

You may not qualify if:

  • Live in a care facility that provides medications on schedule
  • Restarting HAART after a treatment interruption of at least 3 months OR after virologic failure with a viral load greater than 1,000 copies/ml
  • On a treatment regimen for less than 2 weeks prior to study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Gross R, Bellamy SL, Chapman J, Han X, O'Duor J, Palmer SC, Houts PS, Coyne JC, Strom BL. Managed problem solving for antiretroviral therapy adherence: a randomized trial. JAMA Intern Med. 2013 Feb 25;173(4):300-6. doi: 10.1001/jamainternmed.2013.2152.

    PMID: 23358784DERIVED

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromePatient Compliance

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Robert Gross, MD, MSCE

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine and Epidemiology

Study Record Dates

First Submitted

August 11, 2005

First Posted

August 15, 2005

Study Start

July 1, 2005

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

July 13, 2012

Record last verified: 2012-07

Locations

US(1)