NCT00870792

Brief Summary

We hypothesized that providing physicians treating with HIV disease, at the time of a routine outpatient visit, with a detailed report describing patients' adherence with HIV antiretroviral medications, would improve the quality of the physician-patient interaction, and also patients' subsequent adherence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2002

Typical duration for not_applicable

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

November 1, 2002

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2009

Completed
Last Updated

January 11, 2017

Status Verified

March 1, 2009

Enrollment Period

2.2 years

First QC Date

March 26, 2009

Last Update Submit

January 10, 2017

Conditions

Keywords

HIVantiretroviral therapymedication adherenceTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • Antiretroviral medication adherence as assessed by electronic pill cap monitoring.

    6 months

Secondary Outcomes (1)

  • Self-reported medication adherence

    6 months

Study Arms (2)

Received report

ACTIVE COMPARATOR
Behavioral: Adherence report

Routine care

PLACEBO COMPARATOR

Patients receive usual, routine, care.

Behavioral: Adherence report

Interventions

During the intervention phase, the data collected at the study visit were summarized in a 3-page report that was given to the provider before each intervention visit. The report included data on self-reported adherence, MEMS adherence, reminder use, beliefs about ART, reasons for missed doses, alcohol and drug use, and depression.

Received reportRoutine care

Eligibility Criteria

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

You may qualify if:

  • on ART
  • willing to use MEMS cap
  • speaks and reads English
  • detectable viral loads

You may not qualify if:

  • uses a pill box

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (2)

  • Lu M, Safren SA, Skolnik PR, Rogers WH, Coady W, Hardy H, Wilson IB. Optimal recall period and response task for self-reported HIV medication adherence. AIDS Behav. 2008 Jan;12(1):86-94. doi: 10.1007/s10461-007-9261-4. Epub 2007 Jun 19.

    PMID: 17577653BACKGROUND
  • Vranceanu AM, Safren S, Cowan J, Ring D. The development of the negative pain thoughts questionnaire. Pain Pract. 2008 Sep-Oct;8(5):337-41. doi: 10.1111/j.1533-2500.2008.00213.x. Epub 2008 May 23.

    PMID: 18503620BACKGROUND

MeSH Terms

Conditions

HIV InfectionsMedication Adherence

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ira B. Wilson, MD

    Tufts Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

March 26, 2009

First Posted

March 27, 2009

Study Start

November 1, 2002

Primary Completion

January 1, 2005

Study Completion

February 1, 2005

Last Updated

January 11, 2017

Record last verified: 2009-03

Locations