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

HIV Infections Clinical Trial

Official title:

ART Adherence: Enhanced Counseling and Observed Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00602758
• Other study ID #: R01MH068197
• Secondary ID: R01MH068197PA 01
• Status: Completed
• Phase: N/A
• First received: January 4, 2008
• Last updated: May 19, 2016
• Start date: December 2004
• Est. completion date: August 2009

Study information

• Verified date: May 2016
• Source: University of Missouri, Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Kansas City Free Health Clinic	Kansas City	Missouri
United States	Kansas City Veterans Administration Medical Center	Kansas City	Missouri
United States	Kansas University Medical Center ID Clinic	Kansas City	Kansas
United States	Truman Medical Center ID Clinic	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri, Kansas City	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Goggin K, Liston RJ, Mitty JA. Modified directly observed therapy for antiretroviral therapy: a primer from the field. Public Health Rep. 2007 Jul-Aug;122(4):472-81. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence with ART as measured by Micro-Electro-Mechanical Systems (MEMS)		Measured at Week 48	No
Secondary	HIV RNA suppression		Measured at Week 48	No

External Links

•   Click here for more information on the Kansas City Adherence Study (MOTIV8)