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Clinical Trials/NCT00509340
NCT00509340TerminatedPhase 1

Cognitive Behavioral Adherence Intervention for Depressed HIV Patients

RAND1 site in 1 country7 target enrollmentStarted: June 2007Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Terminated
Sponsor
RAND
Enrollment
7
Locations
1
Primary Endpoint
Microelectronic medication adherence

Study Overview

Brief Summary

This study will compare the effectiveness of a cognitive behavioral intervention versus usual clinic care in helping HIV infected adults with depression to take their HIV medications on schedule.

Detailed Description

Antiretroviral therapy (ART) is a type of medication treatment for HIV that impairs the virus's ability to multiply. When used properly, it has been shown to be successful in reducing HIV-related deaths. A high adherence rate to ART is required to adequately suppress the virus, limit drug resistance, and reduce transmission. HIV infected people who are depressed often experience increased difficulty with adhering to their ART regimen. This study will compare the effectiveness of a cognitive behavioral intervention that targets both depression and adherence versus usual care practices which may or may not include mental health intervention with the goal of improving ART adherence among HIV infected adults with depression who are experiencing difficulty with adhering to their medication regimen.

This study will last 24 weeks. Participants will be randomly assigned to receive the cognitive behavioral intervention or usual care. Study visits for all participants will occur at baseline and Weeks 4, 8, 16, and 24. Those receiving the intervention will also have visits at Weeks 1 and 2. Participants receiving the intervention will attend five individual treatment sessions followed by one to three booster treatment sessions; these sessions will coincide with the study visits.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • reports significant depressive symptoms as indicated by score of 10 or greater on PHQ-9
  • Currently taking ART for HIV infection
  • Less than 90% adherence rate to ART regimen
  • Capable of walking and in stable health
  • Speaks fluent English

Exclusion Criteria

  • Depression therapy is needed immediately
  • Meets criteria for current drug dependency
  • Current diagnosis of psychotic disorder or bipolar depression

Outcomes

Primary Outcomes

Microelectronic medication adherence

Time Frame: Measured at Weeks 16 and 24

Secondary Outcomes

  • Self-reported depression(Measured at Weeks 16 and 24)

Investigators

Sponsor
RAND
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Glenn Wagner

Senior Behavioral Scientist

RAND

Study Sites (1)

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