An Educational and Supportive Counseling Program for Increasing Antiretroviral Use and Adherence in People With HIV

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00611429
First received: February 6, 2008
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

This study will develop and test the effectiveness of an educational and supportive counseling program called Preparing Patients to Start Antiretroviral Therapy in helping people with HIV make informed decisions about their health care.


Condition Intervention
HIV
Behavioral: Counseling sessions
Behavioral: Group workshop

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Preparing Patients to Start Antiretroviral Therapy: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Treatment uptake [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment adherence [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Enrollment: 219
Study Start Date: May 2008
Estimated Study Completion Date: April 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Participants will receive treatment consisting of at least three individual counseling sessions and one group workshop over 12 months
Behavioral: Counseling sessions
The individual counseling sessions will last 60 minutes and will involve discussion about health care options and information on the latest advances in HIV treatment.
Behavioral: Group workshop
During the 3-hour group workshop, doctors, nurses, and case managers will talk to participants about HIV treatments and what it is like to undergo treatment. Participants will also hear from other people with HIV and their experiences with treatment.
Active Comparator: Group B
Participants will receive treatment consisting of one individual counseling session and one group workshop during the last month of the study
Behavioral: Counseling sessions
The individual counseling sessions will last 60 minutes and will involve discussion about health care options and information on the latest advances in HIV treatment.
Behavioral: Group workshop
During the 3-hour group workshop, doctors, nurses, and case managers will talk to participants about HIV treatments and what it is like to undergo treatment. Participants will also hear from other people with HIV and their experiences with treatment.

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.

Despite the widespread availability and effectiveness of ART, a large number of people with advanced AIDS are not on the therapy, and a number of HIV-infected people die because they are unable to access ART. The Preparing Patients to Start Antiretroviral Therapy (PATH) program is designed to inform patients about HIV treatment and to provide motivation, information, and skills to enhance treatment decision-making. The PATH program may help increase ART use and adherence. This study will develop and test the effectiveness of PATH in helping people with HIV make informed decisions about their healthcare.

This study will be divided into two phases. Phase 1 will last a total of 60 to 90 minutes and will consist of an interview about participants' relationships with friends and family and a medical history. Participants will also provide a blood sample for CD4 count and viral load measurements, returning 1 week later for the lab results. Eligible participants will then be invited to partake in Phase II of the study, which will last 12 months.

Over the 12-month study, participants in Phase 2 will be randomly assigned to Group A or Group B. Group A will be asked to attend at least three individual sessions with a counselor and one group workshop meeting with HIV experts and other people with HIV who have previously been treated with ART. The individual sessions will last 60 minutes and will involve discussion about health care options and information on the latest advances in HIV treatment. The group workshop meeting will last 3 hours and will involve teaching participants about HIV treatment and what it is like to undergo treatment. Participants assigned to Group B will attend one individual counseling session and one group workshop, both of which will cover much of the same information as the Group A sessions. Treatment for Group B will not occur until the last month of the study. Any participants in either group who decide to start taking medications for HIV during the study will be visited monthly by a research assistant who will ask about medications and check medication adherence. Participants will also be expected to check in monthly with the research team.

All participants will complete four 90-minute interviews, occurring at baseline and Months 3, 6, and 12. Interviews will include questions about relationships with friends and family, healthcare and drug-using behaviors, mental state, personal background, and education. All participants will also provide blood samples to measure CD4 count and viral load at Months 6 and 12. Selected participants may be asked to complete an additional exit interview about their opinions surrounding participation in the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HIV infected
  • Not taking antiretroviral medications
  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: NCT00611429

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Mallory O. Johnson, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00611429     History of Changes
Other Study ID Numbers: R01 MH079700, R01MH079700, DAHBR 9A-ASGA
Study First Received: February 6, 2008
Last Updated: October 15, 2013
Health Authority: United States: Federal Government

Keywords provided by University of California, San Francisco:
Treatment
Adherence
Intervention
Quality of Life

ClinicalTrials.gov processed this record on October 01, 2014