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

Not Applicable

• Conditions: HIV
• Interventions: Behavioral: Peer Mentoring

• Registration Number: NCT02025322
• Lead Sponsor: Jury Candelario

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-12-13
• Study First Submitted QC: 2013-12-30
• Study First Posted: 2014-01-01
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-16
• Last Update Posted: 2015-01-21
• Primary Completion: 2015-09
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peer Mentoring	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.

Primary Outcome Measures

Name	Time	Method
Efficacy of Peer Mentoring on Improving Medication Adherence	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.

Secondary Outcome Measures

Name	Time	Method
Assess the Long-Term Impact of Peer Mentoring on Medication adherence	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.

Trial Locations

Locations (1)

APAIT Health Center; 🇺🇸 Los Angeles, California, United States