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

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02025322
• Other study ID #: MISP-51163
• Status: Unknown status
• Phase: N/A
• First received: December 13, 2013
• Last updated: January 16, 2015
• Start date: September 2013
• Est. completion date: September 2015

Study information

• Verified date: January 2015
• Source: Apait Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• HIV

Intervention

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.

Locations

Country	Name	City	State
United States	APAIT Health Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jury Candelario	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

References & Publications (7)

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

Outcome

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

External Links

•   Centers for Disease Control and Prevention (CDC). (2012). HIV Surveillance Report, vol. 22.
•   Los Angeles County, Department of Public Health. (2013). Five-Year Comprehensive HIV Plan (2013-2017). Los Angeles, CA: Los Angeles County, Department of Public Health
•   WHO. (2009). Track 2: Health literacy and health behavior. 7th Global Conference on Health Promotion. Nairobi, Kenya: WHO
•   World Health Organization (WHO). (2003). Adherence to Long-Term Therapies: Evidence for Action. Geneva, Switzerland: WHO