HIV
Conditions
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
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.
Interventions
BEHAVIORALPeer 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.
Sponsors
Merck Sharp & Dohme LLC
Jury Candelario
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Examine the Impact of Peer Mentoring on HIV viral load and CD4 lymphocyte cell counts | 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. |
| Examine the Impact of Peer Mentoring on HIV Medical Appointment Attendance | 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. |
Countries
United States
Outcome results
None listed