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

Primary Purpose

HIV

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Peer Mentoring

About this trial

This is an interventional treatment trial for HIV focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

APAIT Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

Peer Mentoring

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02025322

First Posted

December 13, 2013

Last Updated

January 16, 2015

Sponsor

Jury Candelario

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT02025322

Brief Title

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

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2013 (undefined)

Primary Completion Date

September 2015 (Anticipated)

Study Completion Date

September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jury Candelario

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care

Arm Type

No Intervention

Arm Description

Arm Title

Peer Mentoring

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Peer Mentoring

Other Intervention Name(s)

Peer-to-peer, Community support worker

Intervention Description

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.

Primary Outcome Measure Information:

Title

Efficacy of Peer Mentoring on Improving Medication Adherence

Description

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.

Time Frame

4 months post-baseline

Secondary Outcome Measure Information:

Title

Assess the Long-Term Impact of Peer Mentoring on Medication adherence

Description

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.

Time Frame

6-months post-baseline

Other Pre-specified Outcome Measures:

Title

Examine the Impact of Peer Mentoring on HIV viral load and CD4 lymphocyte cell counts

Description

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.

Time Frame

6-months post-baseline

Title

Examine the Impact of Peer Mentoring on HIV Medical Appointment Attendance

Description

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.

Time Frame

6-months post-baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jury Candelario

Organizational Affiliation

Apait Health Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Apait Health Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

APAIT Health Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90015

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

15123440

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.

Results Reference

background

PubMed Identifier

10770537

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.

Results Reference

background

PubMed Identifier

15264978

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.

Results Reference

background

PubMed Identifier

21518221

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.

Results Reference

background

PubMed Identifier

10877736

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. Erratum In: Ann Intern Med 2002 Feb 5;136(3):253.

Results Reference

background

PubMed Identifier

16448300

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.

Results Reference

background

PubMed Identifier

16741877

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.

Results Reference

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Links:

URL

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

Description

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

URL

https://careacttarget.org/library/integrating-peers-hiv-care-and-treatment

Description

Peer Education and Evaluation Resource (PEER) Center. (HRSA HIV/AIDS Bureau). (2010). Models for Integrating Peers into HIV Care and Treatment [Webinar].

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

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