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

Jury Candelario1 site in 1 country36 target enrollmentSeptember 2013

ConditionsHIV

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: HIV
Sponsor: Jury Candelario
Enrollment: 36
Locations: 1
Primary Endpoint: Efficacy of Peer Mentoring on Improving Medication Adherence
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2013

End Date

September 2015

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jury Candelario

Responsible Party

Sponsor Investigator

Principal Investigator

Jury Candelario

CEO

Apait Health Center

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.

Outcomes

Primary Outcomes

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.