HIV/AIDSNCT01616940
Minority AIDS Initiative Retention and Re-Engagement Project
A study testing Enhanced Peer Intervention in people with HIV/AIDS, run by Boston University at 4 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether an enhanced peer intervention is effective in retaining and re-engaging at-risk people of color living with HIV/AIDS into care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Enhanced Peer Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Sep 2011to Mar 2014
- 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
Who may be able to join
- HIV-positive; AND
- Age 18 years or older; AND
- Identifies as belonging to one or more of the following racial/ethnic groups: American Indian or Alaskan Native, Asian, Black or African-American, Hispanic or Latino, native Hawaiian or other Pacific Islander; AND
- New patient to clinic (including newly-diagnosed) whose initial assessment or intake form indicates a need for substance abuse treatment, mental health or housing services, or a past history of substance abuse or mental health services; OR
- The individual has been out of medical care at your clinic for 4 months or more.
Who cannot join
None listed.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Center for Advancing Health Policy and Practice
Boston, Massachusetts, 02118
PATH Center, The Brooklyn Hospital
Brooklyn, New York, 11226
Care Resource
Miami, Florida, 33137
Puerto Rico1 site
Puerto Rico Community Network for Clinical Research on AIDS
San Juan, 00928-0850
About this study
Official title: Minority AIDS Initiative Retention and Re-Engagement Project: Peer Re-Engagement Project
The purpose of this study is to determine whether an enhanced peer intervention is effective in retaining and re-engaging at-risk people of color living with HIV/AIDS into care.
Read the detailed description
This is a multi-site longitudinal study of an enhanced peer intervention to re-engage and retain high-risk people of color living with HIV into HIV primary care and other needed medical or social services. Three demonstration sites are implementing programs in which peers are employed as part of the health care team. Peers are trained to conduct educational sessions, provide emotional support, help prepare for and accompany patients to appointments, and debrief after visits.
Study participants will be current or newly enrolled patients of three clinics: CARE Resources, in Miami FL, the PATH Program at Brooklyn Hospital in Brooklyn, NY, and PR CONCRA located in San Juan Puerto Rico who (1) have been out of care for 4 months or more or (2) present a need for substance abuse, mental health, or housing services.
Data will be collected at baseline and follow up (at six and twelve months) through client questionnaires, selected medical chart data (visit dates, laboratory tests and values) and intervention encounter forms on approximately 375 HIV positive adults. The data collected for this study will allow us to assess changes in: (a) retention in HIV primary care, (b) viral load suppression, (c) health-related quality of life, (d) self-efficacy, and (e) HIV knowledge that may be associated with an enhanced peer intervention.
- Conditions
- HIV/AIDS
- Being tested
- Enhanced Peer Intervention
- Keywords
- HIV/AIDS, Peer support
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Peer InterventionBehavioural
Also called Peer Re-Engagement Project (PREP)
Eight 30-60 minute educational sessions with peer will occur in-person bi-weekly once participant is randomized to intervention:
- Introduction and Assessment
- HIV Transmission \& Viral Life Cycle
- Effective Communication and Self-Advocacy
- Understanding Lab Values
- HIV Medications
- Drug Resistance \& Adherence, and Understanding \& Managing Side Effects
- Disclosure and Stigma
- Harm \& Risk Reduction
Weekly check-ins will be by phone or in-person over 12 months. Check-in questions/tasks:
- Are any services needed?
- Have referrals or appointments been made?
- Does patient need accompaniment to a visit?
- Connect patient with services as needed.
- Appointment reminders.
- Overall well-being?
- Schedule next peer contact.
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-care | No intervention | Standard-of-care at 3 demonstration sites includes: HIV medical care, medical case management, and referral to substance abuse, mental health, and housing services. |
| Enhanced Peer Intervention | Experimental | Provides emotional, informational, and instrumental peer support, in addition to Standard-of-Care. Receives: Behavioral: Enhanced Peer Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants retained continuously in quality HIV care
"In HIV care" is defined as having a medical visit with a provider with prescribing privileges in an HIV care setting two or more times at least 3 months apart during the measurement year (HAB Performance Measure and National AIDS Strategy).
Measured: 1 year
Number of participants who are virally suppressed
Measured: 1 year
Secondary outcomes (3)
Change from Baseline in Health-related Quality of Life
Health-related quality of life will be measured using the SF-8 Health Survey by QualityMetric Incorporated.
Measured: 1 year
Change from Baseline in Self-Efficacy
This will be measured using a scale that was developed and tested for the Chronic Disease Self-Management study*.
- Lorig, K., Stewart, A., Ritter, P., Gonzalez, V., Laurent, D. \& Lynch, J. (1996). Outcome Measures for Health Education and other Health Care Interventions. Thousand Oaks CA: Sage Publications, 24-25, 41-45.
Measured: 1 year
Change from Baseline in HIV knowledge
HIV Knowledge will be measured using The HIV Treatment Knowledge Scale*.
*Balfour, L., MacPherson, P., Garber, G., Beique, L. \& Cameron, D. (2007). Development and psychometric validation of the HIV Treatment Knowledge Scale. AIDS Care, 19, 1141-1148.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startSep 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Care Resource, The Brooklyn Hospital Center, Puerto Rico Community Network for Clinical Research on AIDS, Justice Resource Institute, Kansas City Free Health Clinic
- Responsible party
- Sponsor
- Investigators
- Jane Fox, MPH, Principal investigator, Center for Advancing Health Policy and Practice, Boston University School of Public HealthSerena Rajabiun, MA, MPH, Principal investigator, Center for Advancing Health Policy and Practice, Boston University School of Public HealthHoward Cabral, MPH, PhD, Principal investigator, Department of Biostatistics, Boston University School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616940
- Sponsor's protocol ID
- U69HA23262
- Status last verified
- Mar 2017
- First submitted
- 7 Jun 2012
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Cabral HJ, Davis-Plourde K, Sarango M, Fox J, Palmisano J, Rajabiun S. Peer Support and the HIV Continuum of Care: Results from a Multi-Site Randomized Clinical Trial in Three Urban Clinics in the United States. AIDS Behav. 2018 Aug;22(8):2627-2639. doi: 10.1007/s10461-017-1999-8.
PubMed 29306990
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minority AIDS Initiative Retention and Re-Engagement Project: Peer Re-Engagement Project
- ClinicalTrials.gov ID
- NCT01616940
- Acronym / sponsor ID
- U69HA23262
- Conditions
- HIV/AIDS
- Keywords
- HIV/AIDS, Peer support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Care Resource, The Brooklyn Hospital Center, Puerto Rico Community Network for Clinical Research on AIDS, Justice Resource Institute, Kansas City Free Health Clinic
- Study start
- Sep 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 12 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether an enhanced peer intervention is effective in retaining and re-engaging at-risk people of color living with HIV/AIDS into care.
Detailed description
This is a multi-site longitudinal study of an enhanced peer intervention to re-engage and retain high-risk people of color living with HIV into HIV primary care and other needed medical or social services. Three demonstration sites are implementing programs in which peers are employed as part of the health care team. Peers are trained to conduct educational sessions, provide emotional support, help prepare for and accompany patients to appointments, and debrief after visits.
Study participants will be current or newly enrolled patients of three clinics: CARE Resources, in Miami FL, the PATH Program at Brooklyn Hospital in Brooklyn, NY, and PR CONCRA located in San Juan Puerto Rico who (1) have been out of care for 4 months or more or (2) present a need for substance abuse, mental health, or housing services.
Data will be collected at baseline and follow up (at six and twelve months) through client questionnaires, selected medical chart data (visit dates, laboratory tests and values) and intervention encounter forms on approximately 375 HIV positive adults. The data collected for this study will allow us to assess changes in: (a) retention in HIV primary care, (b) viral load suppression, (c) health-related quality of life, (d) self-efficacy, and (e) HIV knowledge that may be associated with an enhanced peer intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard-of-care | No intervention | –Standard-of-care at 3 demonstration sites includes: HIV medical care, medical case management, and referral to substance abuse, mental health, and housing services. |
| Enhanced Peer Intervention | Experimental | Behavioral: Enhanced Peer InterventionProvides emotional, informational, and instrumental peer support, in addition to Standard-of-Care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV-positive; AND
- Age 18 years or older; AND
- Identifies as belonging to one or more of the following racial/ethnic groups: American Indian or Alaskan Native, Asian, Black or African-American, Hispanic or Latino, native Hawaiian or other Pacific Islander; AND
- New patient to clinic (including newly-diagnosed) whose initial assessment or intake form indicates a need for substance abuse treatment, mental health or housing services, or a past history of substance abuse or mental health services; OR
- The individual has been out of medical care at your clinic for 4 months or more.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Peer InterventionAlso: Peer Re-Engagement Project (PREP)Eight 30-60 minute educational sessions with peer will occur in-person bi-weekly once participant is randomized to intervention: * Introduction and Assessment * HIV Transmission \& Viral Life Cycle * Effective Communication and Self-Advocacy * Understanding Lab Values * HIV Medications * Drug Resistance \& Adherence, and Understanding \& Managing Side Effects * Disclosure and Stigma * Harm \& Risk Reduction Weekly check-ins will be by phone or in-person over 12 months. Check-in questions/tasks: * Are any services needed? * Have referrals or appointments been made? * Does patient need accompaniment to a visit? * Connect patient with services as needed. * Appointment reminders. * Overall well-being? * Schedule next peer contact. | Behavioural | Enhanced Peer Intervention |
Primary outcome
Number of participants retained continuously in quality HIV care
Time frame: 1 year
"In HIV care" is defined as having a medical visit with a provider with prescribing privileges in an HIV care setting two or more times at least 3 months apart during the measurement year (HAB Performance Measure and National AIDS Strategy).
Number of participants who are virally suppressed
Time frame: 1 year
3 secondary outcomes
Change from Baseline in Health-related Quality of Life
Time frame: 1 year
Change from Baseline in Self-Efficacy
Time frame: 1 year
Change from Baseline in HIV knowledge
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- Derived from this study: PubMed 29306990Cabral HJ, Davis-Plourde K, Sarango M, Fox J, Palmisano J, Rajabiun S. Peer Support and the HIV Continuum of Care: Results from a Multi-Site Randomized Clinical Trial in Three Urban Clinics in the United States. AIDS Behav. 2018 Aug;22(8):2627-2639. doi: 10.1007/s10461-017-1999-8.
Related trials for HIV/AIDS
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Fox, MPH principal investigator
Center for Advancing Health Policy and Practice, Boston University School of Public Health
Serena Rajabiun, MA, MPH principal investigator
Center for Advancing Health Policy and Practice, Boston University School of Public Health
Howard Cabral, MPH, PhD principal investigator
Department of Biostatistics, Boston University School of Public Health
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Peer Intervention in people with HIV/AIDS, run by Boston University at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. 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: finished, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Puerto Rico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants retained continuously in quality HIV care (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT01616940, which also lists 1 linked publication.
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 22 Mar 2017.