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

February 6, 2008
October 15, 2013
May 2008
May 2013   (final data collection date for primary outcome measure)
Treatment uptake [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00611429 on ClinicalTrials.gov Archive Site
Treatment adherence [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Educational and Supportive Counseling Program for Increasing Antiretroviral Use and Adherence in People With HIV
Preparing Patients to Start Antiretroviral Therapy: A Randomized Controlled Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
HIV
  • 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.
  • Experimental: Group A
    Participants will receive treatment consisting of at least three individual counseling sessions and one group workshop over 12 months
    Interventions:
    • Behavioral: Counseling sessions
    • Behavioral: Group workshop
  • 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
    Interventions:
    • Behavioral: Counseling sessions
    • Behavioral: Group workshop
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
219
April 2014
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV infected
  • Not taking antiretroviral medications
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00611429
R01 MH079700, R01MH079700, DAHBR 9A-ASGA
No
University of California, San Francisco
University of California, San Francisco
National Institute of Mental Health (NIMH)
Principal Investigator: Mallory O. Johnson, PhD University of California, San Francisco
University of California, San Francisco
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP