Clinical trial NCT02025322: A Pilot Study to Examine Efficacy of Peer Mentoring in Promoting Medication Adherence Among People Living With HIV/AIDS
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Keywords: 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
Lead sponsor: Apait Health Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2014-01-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Efficacy of Peer Mentoring on Improving Medication Adherence
timeFrame: 4 months post-baseline
Secondary outcomes:
measure: Assess the Long-Term Impact of Peer Mentoring on Medication adherence
timeFrame: 6-months post-baseline
Other outcomes:
measure: Examine the Impact of Peer Mentoring on HIV viral load and CD4 lymphocyte cell counts
timeFrame: 6-months post-baseline
measure: Examine the Impact of Peer Mentoring on HIV Medical Appointment Attendance
timeFrame: 6-months post-baseline
Locations:
city: Los Angeles
country: United States
facility: APAIT Health Center
state: California
Study officials:
affiliation: Apait Health Center
name: Jury Candelario
role: PRINCIPAL_INVESTIGATOR
affiliation: Apait Health Center
name: Jordan Lake, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bontempi JM, Burleson L, Lopez MH. HIV medication adherence programs: the importance of social support. J Community Health Nurs. 2004 Summer;21(2):111-22. doi: 10.1207/s15327655jchn2102_05.
citation: Bangsberg DR, Hecht FM, Charlebois ED, Zolopa AR, Holodniy M, Sheiner L, Bamberger JD, Chesney MA, Moss A. Adherence to protease inhibitors, HIV-1 viral load, and development of drug resistance in an indigent population. AIDS. 2000 Mar 10;14(4):357-66. doi: 10.1097/00002030-200003100-00008.
citation: Gonzalez JS, Penedo FJ, Antoni MH, Duran RE, McPherson-Baker S, Ironson G, Isabel Fernandez M, Klimas NG, Fletcher MA, Schneiderman N. Social support, positive states of mind, and HIV treatment adherence in men and women living with HIV/AIDS. Health Psychol. 2004 Jul;23(4):413-418. doi: 10.1037/0278-6133.23.4.413.
citation: Kenya S, Chida N, Symes S, Shor-Posner G. Can community health workers improve adherence to highly active antiretroviral therapy in the USA? A review of the literature. HIV Med. 2011 Oct;12(9):525-34. doi: 10.1111/j.1468-1293.2011.00921.x. Epub 2011 Apr 24.
citation: Paterson DL, Swindells S, Mohr J, Brester M, Vergis EN, Squier C, Wagener MM, Singh N. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med. 2000 Jul 4;133(1):21-30. doi: 10.7326/0003-4819-133-1-200007040-00004.
citation: Simoni JM, Frick PA, Huang B. A longitudinal evaluation of a social support model of medication adherence among HIV-positive men and women on antiretroviral therapy. Health Psychol. 2006 Jan;25(1):74-81. doi: 10.1037/0278-6133.25.1.74.
citation: Walensky RP, Paltiel AD, Losina E, Mercincavage LM, Schackman BR, Sax PE, Weinstein MC, Freedberg KA. The survival benefits of AIDS treatment in the United States. J Infect Dis. 2006 Jul 1;194(1):11-9. doi: 10.1086/505147. Epub 2006 Jun 1.