A Pilot Study to Examine Efficacy of Peer Mentoring in Promoting Medication Adherence Among People Living With HIV/AIDS

This study is currently recruiting participants.
Verified December 2013 by Apait Health Center
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Jury Candelario, Apait Health Center
ClinicalTrials.gov Identifier:
NCT02025322
First received: December 13, 2013
Last updated: December 30, 2013
Last verified: December 2013
  Purpose

This study aims to investigate the effectiveness of an in-person peer mentoring and health literacy intervention on improving medication adherence, HIV-1 viral load, CD4+ T lymphocyte counts, and HIV medical appointment attendance among newly-diagnosed and/or medication non-adherent HIV-positive individuals, compared to standard of care provider/staff-delivered education.


Condition Intervention
HIV
Behavioral: Peer Mentoring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study Using Randomized, Parallel Design to Compare the Efficacy of Peer Mentoring Versus Standard of Care in Promoting Medication Adherence Among Newly Diagnosed and Medication Non-adherent People Living With HIV/AIDS

Resource links provided by NLM:


Further study details as provided by Apait Health Center:

Primary Outcome Measures:
  • Efficacy of Peer Mentoring on Improving Medication Adherence [ Time Frame: 4 months post-baseline ] [ Designated as safety issue: No ]
    Test the efficacy of a peer mentoring intervention on improving medication adherence among newly diagnosed and/or medication non-adherent HIV-positive individuals, compared to standard of care.


Secondary Outcome Measures:
  • Assess the Long-Term Impact of Peer Mentoring on Medication adherence [ Time Frame: 6-months post-baseline ] [ Designated as safety issue: No ]
    Assess the long-term impact of peer mentoring on medication adherence among newly diagnosed and/or medication non-adherent HIV-positive individuals, compared to standard of care.


Other Outcome Measures:
  • Examine the Impact of Peer Mentoring on HIV viral load and CD4 lymphocyte cell counts [ Time Frame: 6-months post-baseline ] [ Designated as safety issue: No ]
    Compared to standard of care, participants receiving peer mentoring will have significantly lower HIV viral loads and significantly higher CD4 lymphocyte cell counts between baseline and six months post-baseline.

  • Examine the Impact of Peer Mentoring on HIV Medical Appointment Attendance [ Time Frame: 6-months post-baseline ] [ Designated as safety issue: No ]
    Examine the impact of peer mentoring on HIV medical appointment attendance among newly diagnosed and/or medication non-adherent HIV-positive individuals, compared to standard of care.


Estimated Enrollment: 36
Study Start Date: September 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard of Care
Between baseline and 4-month follow-up, control group patients will receive current standard of care which includes: (a) two or more HIV basics education and medication adherence counseling sessions with their HIV specialty care provider and Patient Navigator; (b) resource referrals from a Patient Navigator based on the participant's needs (e.g., mental health, substance abuse, social support groups, etc.); and (c) automated medical appointment reminders via phone.
Experimental: Peer Mentoring
Between baseline and 4-month follow-up, experiment group patients will be receiving (a) Weekly contacts with their Peer Mentor, with the option of receiving more frequent contact, if needed; and (b) 4 monthly, 1-hour workshops on HIV/AIDS, medication adherence, health literacy, and health and wellness. In addition, experiment group participants will also be provided with all standard practice services given to control group participants, including: (c) Two more or HIV basics education and medication adherence counseling sessions with their HIV specialty care provider and Patient Navigator; (d) resource referrals from a Patient Navigator based on the participant's needs; and (e) automated medical appointment reminders via phone.
Behavioral: Peer Mentoring

Participants in the Peer Mentoring arm will be paired with a Peer Mentor for the duration of the 4-month intervention. Peer Mentors are HIV-positive patients who demonstrate high levels of medication and treatment adherence and are knowledgeable about HIV/AIDS and barriers to care. During the 4-month intervention, Peer Mentors will contact participants weekly via in-person, phone, or email, with the option to provide more frequent contact, if needed. Peer Mentors will provide social support and remind participants to take their medications and attend upcoming medical appointments.

Study participants will also attend four monthly, one hour workshops on HIV/AIDS, medication adherence, health literacy, and health and wellness, which will be developed and co-facilitated by Peer Mentors.

Other Names:
  • Peer-to-peer
  • Community support worker

  Eligibility

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

Inclusion Criteria: All of the following criteria must be met for a participant to be eligible for the study:

  • Confirmed diagnosis of HIV-1
  • Newly diagnosed and initiating treatment (e.g., treatment naive) OR off medications for more than fourteen consecutive days (2 weeks) and re-initiating treatment OR currently on antiretroviral therapy with demonstrated ongoing adherence problems (missing more than 3 doses per month)
  • Has a detectable (greater than 50 copies/ml) HIV-1 viral load
  • Is able to obtain HIV medications during the entire study period (e.g., if uninsured, is enrolled in AIDS Drug Assistance Program).

Exclusion Criteria: Subject is ineligible for this study if:

  • He/She suffers from cognitive impairment, active psychosis, or has a known history of harming others, OR
  • He/She has a severe mental health and/or substance abuse condition that requires residential or inpatient treatment, OR
  • The medical provider believes participation would not be in the best interest of the subject for other reasons.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02025322

Contacts
Contact: Jordan Lake, M.D., M.Sc. 310-557-9679 jlake@mednet.ucla.edu
Contact: Jury Candelario 213-553-1832 jcandelario@apaitonline.org

Locations
United States, California
APAIT Health Center Recruiting
Los Angeles, California, United States, 90015
Contact: Jordan Lake, M.D., M.Sc.    310-557-9679    jlake@mednet.ucla.edu   
Contact: Jury Candelario    213-553-1832    jcandelario@apaitonline.org   
Principal Investigator: Jordan Lake, M.D., M.Sc         
Principal Investigator: Jury Candelario         
Sponsors and Collaborators
Jury Candelario
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Jury Candelario Apait Health Center
Principal Investigator: Jordan Lake, M.D., M.Sc. Apait Health Center
  More Information

Additional Information:
Publications:

Responsible Party: Jury Candelario, CEO, Apait Health Center
ClinicalTrials.gov Identifier: NCT02025322     History of Changes
Other Study ID Numbers: MISP-51163
Study First Received: December 13, 2013
Last Updated: December 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Apait Health Center:
HIV/AIDS
Peer Mentoring
Medication Adherence
Medication Non-adherent
Newly diagnosed
HIV-positive individuals
HIV viral load
CD4 lymphocyte cell counts
Treatment adherence
Health literacy
Self-efficacy

ClinicalTrials.gov processed this record on April 17, 2014