HIV Clinical Trial
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
Verified date | January 2015 |
Source | Apait Health Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Unknown status |
Enrollment | 36 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | APAIT Health Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Jury Candelario | Merck Sharp & Dohme Corp. |
United States,
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. — View 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. — View Citation
Gonzalez JS, Penedo FJ, Antoni MH, Durán 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):413-8. — View 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. Review. — View 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. Erratum in: Ann Intern Med 2002 Feb 5;136(3):253. — View 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. — View 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. Epub 2006 Jun 1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Examine the Impact of Peer Mentoring on HIV viral load and CD4 lymphocyte cell counts | 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. | 6-months post-baseline | |
Other | Examine the Impact of Peer Mentoring on HIV Medical Appointment Attendance | 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. | 6-months post-baseline | |
Primary | Efficacy of Peer Mentoring on Improving Medication Adherence | 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. | 4 months post-baseline | |
Secondary | Assess the Long-Term Impact of Peer Mentoring on Medication adherence | 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. | 6-months post-baseline |
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