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

January 16, 2015 updated by: Jury Candelario

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90015
        • APAIT Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
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.

Other Names:
  • Peer-to-peer
  • Community support worker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Peer Mentoring on Improving Medication Adherence
Time Frame: 4 months post-baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the Long-Term Impact of Peer Mentoring on Medication adherence
Time Frame: 6-months post-baseline
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Examine the Impact of Peer Mentoring on HIV viral load and CD4 lymphocyte cell counts
Time Frame: 6-months post-baseline
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
Examine the Impact of Peer Mentoring on HIV Medical Appointment Attendance
Time Frame: 6-months post-baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jury Candelario

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Jury Candelario, APAIT Health Center
  • Principal Investigator: Jordan Lake, M.D., M.Sc., APAIT Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

December 13, 2013

First Submitted That Met QC Criteria

December 30, 2013

First Posted (Estimate)

January 1, 2014

Study Record Updates

Last Update Posted (Estimate)

January 21, 2015

Last Update Submitted That Met QC Criteria

January 16, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MISP-51163

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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