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

NCT ID: NCT02025322

Last Updated: 2015-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Peer Mentoring

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Peer-to-peer Community support worker

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Jury Candelario

OTHER

Sponsor Role lead

Responsible Party

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Jury Candelario

CEO

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jury Candelario

Role: PRINCIPAL_INVESTIGATOR

Apait Health Center

Jordan Lake, M.D., M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Apait Health Center

Locations

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APAIT Health Center

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15123440 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10770537 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15264978 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21518221 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10877736 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16448300 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16741877 (View on PubMed)

Related Links

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http://publichealth.lacounty.gov/aids/docs/LAC_FiveYear_ComprehensiveHIVPlan2013-2017.pdf

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

Other Identifiers

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MISP-51163

Identifier Type: -

Identifier Source: org_study_id

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