Effectiveness of Enhanced Counseling and Observed Therapy on Antiretroviral Adherence in People With HIV

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kathy Goggin, University of Missouri, Kansas City
ClinicalTrials.gov Identifier:
NCT00602758
First received: January 4, 2008
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

This study will compare the effectiveness of enhanced counseling alone versus enhanced counseling combined with observed therapy at improving medication adherence in people with HIV.


Condition Intervention
HIV Infections
Acquired Immunodeficiency Syndrome
Behavioral: Motivational interviewing with cognitive behavioral therapy
Behavioral: Modified directly observed therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ART Adherence: Enhanced Counseling and Observed Therapy

Resource links provided by NLM:


Further study details as provided by University of Missouri, Kansas City:

Primary Outcome Measures:
  • Adherence with ART as measured by Micro-Electro-Mechanical Systems (MEMS) [ Time Frame: Measured at Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HIV RNA suppression [ Time Frame: Measured at Week 48 ] [ Designated as safety issue: No ]

Enrollment: 252
Study Start Date: December 2004
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enhanced Counseling
Participants meet with a counselor trained in motivational interviewing and cognitive behavioral techniques
Behavioral: Motivational interviewing with cognitive behavioral therapy
Counseling sessions are completed face-to-face or by telephone at baseline and Weeks 1, 2, 4, 6, 9, 11, 15, 19, and 23. Counselors are trained in motivational interview technique and focus on ART medication adherence.
Other Name: Enhanced counseling (EC)
No Intervention: Standard Care
Participants receive usual clinical care provided by health care providers and they participate only in evaluation components of the study
Experimental: Enhanced Counseling/Modified Directly Observed Therapy
Participants receive their ART medications delivered to them by study staff and they receive the enhanced counseling
Behavioral: Motivational interviewing with cognitive behavioral therapy
Counseling sessions are completed face-to-face or by telephone at baseline and Weeks 1, 2, 4, 6, 9, 11, 15, 19, and 23. Counselors are trained in motivational interview technique and focus on ART medication adherence.
Other Name: Enhanced counseling (EC)
Behavioral: Modified directly observed therapy
From baseline to Week 16, Monday through Friday, study staff meet the participants daily to observe one dose of their ART and to leave with the participants all other doses needed until the next observed dose. The frequency of observed doses begins to taper at Week 17 through to Week 24.
Other Names:
  • OT
  • Modified observed therapy (MDOT)

Detailed Description:

HIV is a virus that can lead to acquired immunodeficiency syndrome (AIDS), a disease that breaks down the immune system and allows for entry of life-threatening secondary infections. HIV is transmitted through the exchange of bodily fluids, primarily through sexual intercourse. Antiretroviral therapy (ART) has proven to be an effective treatment for inhibiting the replication of HIV, allowing for improved quality of life and survival. However, the long-term effectiveness of ART depends on strict adherence to a prescribed medication regimen. Previous studies have indicated that observing patients while they take their medications for a period of time can improve adherence to their prescribed drug regimens. This study will evaluate the effectiveness of enhanced counseling (EC) alone versus EC combined with modified directly observed therapy (mDOT) at improving medication adherence in people with HIV.

Participants in this 48-week study will be randomly placed into one of the following three treatment groups:

  • Group 1 participants will receive standard care, which will involve the care that the clinic staff normally provide to all patients on HIV therapy.
  • Group 2 participants will receive EC.
  • Group 3 participants will receive EC with mDOT.

All participants will continue to take the anti-HIV medication regimen prescribed by their health care provider. However, participants will be asked to keep one medication type in a bottle that has a special Micro-Electro-Mechanical System (MEMS) cap. This electronic cap will record each time the participant opens the bottle. Participants will meet with study staff for MEMS cap data collection once weekly for the first 4 weeks, every 2 weeks up to Week 12, and then every 4 weeks thereafter.

EC will consist of 30- to 45-minute counseling sessions about medication adherence. Participants will meet in person with a counselor for the first five sessions, occurring at baseline and Weeks, 1, 2, 6, and 11. An additional five counseling sessions will be conducted by phone during Weeks 4, 9, 15, 19, and 23. Participants receiving mDOT will have their doses of HIV medication delivered to them by an mDOT worker for the first 24 weeks of treatment. Participants will select a time and location to meet with an mDOT staff member, who will then provide the daily doses of drugs and observe participants taking those drugs. Participants will meet with an mDOT worker 5 times a week from baseline to Week 16. Starting at Week 17, the number of weekly meetings will gradually taper until Week 24 when there will be no meeting and participants will return to obtaining and taking their HIV medications as done prior to study enrollment.

Evaluation visits will occur for all participants at baseline and Weeks 12, 24, 36, and 48. Evaluation sessions will last 45 minutes to 1 hour and will include questionnaires about adherence, knowledge and attitudes about HIV and HIV therapy, quality of life, support systems, health status, medical history, drug and alcohol use, and satisfaction with HIV care. Blood samples will also be taken to measure CD4 cell count and amount of virus in the blood.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient at participating clinical site
  • English-speaking
  • Initiating new ART (new or change in therapy) or nonadherent to ART as documented by care provider's assessment, patient self-report, and consistent HIV RNA laboratory results
  • Lives within 45-mile radius of participating clinical site or able to participate in observed therapy procedures

Exclusion Criteria:

  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602758

Locations
United States, Kansas
Kansas University Medical Center ID Clinic
Kansas City, Kansas, United States, 66160
United States, Missouri
Truman Medical Center ID Clinic
Kansas City, Missouri, United States, 64108
Kansas City Free Health Clinic
Kansas City, Missouri, United States, 64110
Kansas City Veterans Administration Medical Center
Kansas City, Missouri, United States, 641128
Sponsors and Collaborators
University of Missouri, Kansas City
Investigators
Principal Investigator: Kathy Goggin, PhD University of Missouri, Kansas City
  More Information

Additional Information:
Publications:
Responsible Party: Kathy Goggin, Clinical Ph.D. Program Faculty, Curators Professor, University of Missouri, Kansas City
ClinicalTrials.gov Identifier: NCT00602758     History of Changes
Other Study ID Numbers: R01 MH068197, R01MH068197, PA 01 0173, DAHBR 9A-ASGA
Study First Received: January 4, 2008
Last Updated: April 25, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Missouri, Kansas City:
AIDS
Adherence
Antiretroviral Therapy
HIV

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 23, 2014