NCT00051805

Brief Summary

One of the main causes of treatment failure in HIV infected individuals is lack of adherence to complicated drug regimens. The purpose of this study is to evaluate the effectiveness of a behavioral intervention program designed to improve adherence to anti-HIV drug regimens. Participants in this study will be recruited from the University of Alabama at Birmingham (UAB) Outpatient HIV Clinic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
119

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Timeline
Completed

Started Aug 2002

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 17, 2003

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

September 18, 2007

Status Verified

August 1, 2007

First QC Date

January 16, 2003

Last Update Submit

September 17, 2007

Conditions

HIV Infections

Keywords

Patient ComplianceAdherenceTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • Pill counts for ARV medications

Secondary Outcomes (4)

  • Viral load

  • disease progression measures (CD4 count, viral resistance)

  • self-reported adherence

  • self-reported psychosocial measures

Interventions

Promotion of adherence to ARV medicationsBEHAVIORAL

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV infected
  • Receiving services at UAB Outpatient HIV Clinic
  • Taking antiretroviral medication
  • Able to attend monthly assessment meetings at clinic for 6 months
  • Passing score on Mini Mental State Examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham Outpatient HIV Clinic

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

  • Stewart KE,Greene PG,Ross D,Kratt P, Balentine C, Lee P, Wang Y. Sex, drugs, and viral load: Associations in an HIV+ cohort. In: Society of Behavioral Medicine, 27th Annual Meeting & Scientific Sessions; 2006 Mar 23; San Francisco [CA]: Behavioral Medicine Across the Lifespan. Session Abstracts & Program Information Vol. 31, No. suppl. 1, Pages i-I.

    BACKGROUND

MeSH Terms

Conditions

HIV InfectionsPatient Compliance

Condition Hierarchy (Ancestors)

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

Study Officials

  • Polly Kratt, PhD, MSPH

    University of Alabama at Birmingham Outpatient HIV Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

January 16, 2003

First Posted

January 17, 2003

Study Start

August 1, 2002

Study Completion

July 1, 2006

Last Updated

September 18, 2007

Record last verified: 2007-08

Locations

US(1)