Promoting Adherence to Anti-HIV Drug Regimens | NCT00051805

Studies
Promoting Adherence to Anti-HIV Drug Regimens

NCT00051805

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Status

Completed

Last Update Posted

Sep 18, 2007Estimated

Enrollment

119

Phase

Not Applicable

Conditions

HIV Infections

Interventions

Promotion of adherence to ARV medications

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
3R01AI045403-02S1	U.S. NIH Grant/Contract		View source
5R01AI045403-03	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2002

Primary Completion Date

Not provided

Completion Date

Jul 2006Actual

First Submitted Date

Jan 16, 2003

First Submission Date that Met QC Criteria

Jan 16, 2003

First Posted Date

Jan 17, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2007

Last Update Posted Date

Sep 18, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)NIH

Collaborators

Not provided

Description Module

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.

Detailed Description

Poor adherence to complicated antiretroviral (ARV) drug regimens is one of the most pressing behavioral problems in the clinical management of HIV infected persons. Recent medical advances have made it possible to maintain tighter control of viral replication, allowing people with HIV to live longer, healthier lives. However, the complexity of ARV drug regimens and drug side effects make medication adherence problematic. Deviations from the prescribed regimen may allow the virus to resume rapid replication and develop drug resistant mutations that could render the prescribed drugs useless. This study will evaluate the efficacy of a 6-month, theory-based behavioral intervention to enhance adherence to antiretroviral treatment regimens. HIV-related attitudes, depressive symptoms, coping strategies, and social support will also be assessed to examine theoretical assumptions regarding the causal relationship between psychosocial constructs and medication adherence.

Participants in this study will be recruited from UAB Outpatient HIV Clinic patients who are taking ARV medication. Participants will be randomized to a Standard Adherence Promotion Group or an Enhanced Adherence Promotion Group. The Enhanced Adherence Promotion will systematically address specific psychosocial issues associated with medication adherence. Participants will be followed for 6 months, and adherence will be evaluated at monthly study visits. Pill counts, viral loads, self-reported adherence to ARV medication, CD4 count, and genotypic viral resistance will be assessed.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

119

Name	Type	Description	Arm Group Labels	Other Names
Promotion of adherence to ARV medications	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pill counts for ARV medications

Secondary Outcomes

Measure	Description	Time Frame
Viral load
disease progression measures (CD4 count, viral resistance)
self-reported adherence

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Polly Kratt, PhD, MSPH	University of Alabama at Birmingham Outpatient HIV Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham Outpatient HIV Clinic		Birmingham	Alabama	35294	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	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.

ID	Term
D015658	HIV Infections
D010349	Patient Compliance

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral