A Pilot Study to Examine Efficacy of Peer Mentoring in Promoting Medication Adherence Among People Living With HIV/AIDS
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|ClinicalTrials.gov Identifier: NCT02025322|
Recruitment Status : Unknown
Verified January 2015 by Jury Candelario, Apait Health Center.
Recruitment status was: Active, not recruiting
First Posted : January 1, 2014
Last Update Posted : January 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: Peer Mentoring||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||September 2015|
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.
- Efficacy of Peer Mentoring on Improving Medication Adherence [ Time Frame: 4 months post-baseline ]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.
- Assess the Long-Term Impact of Peer Mentoring on Medication adherence [ Time Frame: 6-months post-baseline ]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.
- Examine the Impact of Peer Mentoring on HIV viral load and CD4 lymphocyte cell counts [ Time Frame: 6-months post-baseline ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025322
|United States, California|
|APAIT Health Center|
|Los Angeles, California, United States, 90015|
|Principal Investigator:||Jury Candelario||Apait Health Center|
|Principal Investigator:||Jordan Lake, M.D., M.Sc.||Apait Health Center|