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

Jury Candelario

Status: Unknown

Conditions: HIV

Treatments: Behavioral: Peer Mentoring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02025322

MISP-51163

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

36 participants in 2 patient groups

Standard of Care

No Intervention group

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.

Peer Mentoring

Experimental group

Description:

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.

Treatment:

Behavioral: Peer Mentoring