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HIVNCT02025322

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

A study testing Peer Mentoring in people with HIV, run by Jury Candelario at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV
What is being tested?
Peer Mentoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
Sep 2013to Sep 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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 locations and contacts

1 site in 1 country.

United States1 site

  • APAIT Health Center

    Los Angeles, California, 90015

Other trials in United States

About this study

Official title: 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.

Conditions
HIV
Being tested
Peer Mentoring
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
Medical subject headings
Acquired Immunodeficiency Syndrome, Medication Adherence, Treatment Adherence and Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peer MentoringBehavioural

    Also called Peer-to-peer, Community support worker

    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.

Study groups in NCT02025322
Study groupRoleWhat they receive
Standard of CareNo interventionBetween 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 MentoringExperimentalBetween 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.
Receives: Behavioral: Peer Mentoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of Peer Mentoring on Improving Medication Adherence

    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.

    Measured: 4 months post-baseline

Secondary outcomes (1)

  1. Assess the Long-Term Impact of Peer Mentoring on Medication adherence

    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.

    Measured: 6-months post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2014 (estimated)
  2. Study startSep 2013
  3. Primary completionSep 2015 (estimated)
  4. Study completionSep 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02025322
Sponsor's protocol ID
MISP-51163
Status last verified
Jan 2015
First submitted
13 Dec 2013
Last updated
21 Jan 2015
Results posted
No
Data monitoring committee
No

Publications

  • Bontempi JM, Burleson L, Lopez MH. HIV medication adherence programs: the importance of social support. J Community Health Nurs. 2004 Summer;21(2):111-22. doi: 10.1207/s15327655jchn2102_05.

    PubMed 15123440

  • Bangsberg DR, Hecht FM, Charlebois ED, Zolopa AR, Holodniy M, Sheiner L, Bamberger JD, Chesney MA, Moss A. Adherence to protease inhibitors, HIV-1 viral load, and development of drug resistance in an indigent population. AIDS. 2000 Mar 10;14(4):357-66. doi: 10.1097/00002030-200003100-00008.

    PubMed 10770537

  • Gonzalez JS, Penedo FJ, Antoni MH, Duran RE, McPherson-Baker S, Ironson G, Isabel Fernandez M, Klimas NG, Fletcher MA, Schneiderman N. Social support, positive states of mind, and HIV treatment adherence in men and women living with HIV/AIDS. Health Psychol. 2004 Jul;23(4):413-418. doi: 10.1037/0278-6133.23.4.413.

    PubMed 15264978

  • Kenya S, Chida N, Symes S, Shor-Posner G. Can community health workers improve adherence to highly active antiretroviral therapy in the USA? A review of the literature. HIV Med. 2011 Oct;12(9):525-34. doi: 10.1111/j.1468-1293.2011.00921.x. Epub 2011 Apr 24.

    PubMed 21518221

  • Paterson DL, Swindells S, Mohr J, Brester M, Vergis EN, Squier C, Wagener MM, Singh N. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med. 2000 Jul 4;133(1):21-30. doi: 10.7326/0003-4819-133-1-200007040-00004.

    PubMed 10877736

  • Simoni JM, Frick PA, Huang B. A longitudinal evaluation of a social support model of medication adherence among HIV-positive men and women on antiretroviral therapy. Health Psychol. 2006 Jan;25(1):74-81. doi: 10.1037/0278-6133.25.1.74.

    PubMed 16448300

  • Walensky RP, Paltiel AD, Losina E, Mercincavage LM, Schackman BR, Sax PE, Weinstein MC, Freedberg KA. The survival benefits of AIDS treatment in the United States. J Infect Dis. 2006 Jul 1;194(1):11-9. doi: 10.1086/505147. Epub 2006 Jun 1.

    PubMed 16741877

Questions about this trial

What is this clinical trial studying?

A study testing Peer Mentoring in people with HIV, run by Jury Candelario at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of Peer Mentoring on Improving Medication Adherence (time frame: 4 months post-baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02025322, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2015.

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