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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00870792
Other study ID # ibwadhrct88$
Secondary ID
Status Completed
Phase N/A
First received March 26, 2009
Last updated January 10, 2017
Start date November 2002
Est. completion date February 2005

Study information

Verified date March 2009
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 156
Est. completion date February 2005
Est. primary completion date January 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- on ART

- willing to use MEMS cap

- speaks and reads English

- detectable viral loads

Exclusion Criteria:

- uses a pill box

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
Adherence report
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.

Locations

Country Name City State
United States Tufts Medical Center Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Antiretroviral medication adherence as assessed by electronic pill cap monitoring. 6 months No
Secondary Self-reported medication adherence 6 months No
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