HIVPtWNCT02932384
Reducing HIV Risk With High Risk HIV Negative Black MSM-Passport to Wellness
A study testing Intervention-Passport and Peer Mentor in people with HIV and Men, run by Charles Drew University of Medicine and Science at 2 sites in United States.
Trial summary
The proposed research study will focus on Black men who have sex with men (BMSM) who are HIV- or unknown status AND have not received HIV testing in over a year or who test irregularly (on 9/21/2016, the protocol was changed to modify the last to criteria and focus on those who have not used PrEP in the prior six… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- What is being tested?
- Intervention-Passport and Peer Mentor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2015to Apr 2018
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self identify as male
- self-identify as Black or African American
- sex with a male or male-to-female transgender in the last 6 months
- intercourse without a condom in the last 6 months
- Los Angeles County resident,
- either is unaware of HIV status and has not tested for HIV in the last 12 months or has recently tested (within 30 days), but had not received testing in the prior 12 months
- 6) Modified 9/21/2016 to has not taken PrEP in the prior 6 months
Who cannot join
- self-identify as female or transgender male or female
- does not self-identify as Black or African American
- no sex with a man or a male-to-female transgender in the last 6 months
- no sexual intercourse in the last 6 months
- resides outside of Los Angeles County
- is HIV-positive OR has tested between 1 and 13 months prior to enrollment.
- 6) Modified 9/21/2016 to has not taken PrEP in the prior 6 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Los Angeles Centers for Alcohol and Drug Abuse (LA CADA)
Los Angeles, California, 90013
Charles Drew University of Medicine and Science
Los Angeles, California, 90059
About this study
Official title: Passport to Wellness-Full Intervention Phase
The proposed research study will focus on Black men who have sex with men (BMSM) who
- are HIV- or unknown status AND
- have not received HIV testing in over a year or
- who test irregularly (on 9/21/2016, the protocol was changed to modify the last to criteria and focus on those who have not used PrEP in the prior six months). and implement an innovative, culturally-informed, peer-based, and client-centered approach that is designed to increase their awareness of their HIV status and their timely entry into prevention (including PrEP), testing, care, and treatment services. The research design compares the effect of an incentives-only approach to one that uses incentives, along with the involvement of peer mentors to support timely entry into prevention, testing, care and treatment. This phase of the study is designed to assess peer-supported intervention group versus a passport/incentive-only control group over an 18-month period using a randomized trial approach.
Read the detailed description
The proposed research study focuses on BMSM who have not received HIV testing in over a year, or who test irregularly, and implement an innovative, culturally-informed, peer-based, and client-centered approach that is designed to increase their awareness of their HIV status and their timely entry into prevention, care, and treatment services. On 9/21/2016, the protocol was changed to focus on those who have not used PrEP in the prior six months.
The research design compares the effect of an incentives-only approach to one that uses incentives, along with the involvement of peer mentors to support timely entry into prevention, testing, care and treatment. This phase of the study is designed to assess peer-supported intervention group versus a passport/incentive-only control group over an 18-month period using a randomized trial approach.
The Specific Aims of the full intervention phase are:
2 (Modified). To assess the effectiveness of a peer-supported, incentivized, and client-centered approach (PtW) compared to a non-peer supported, incentivized, and client-centered approach (Control) for linking at-risk BMSM to biomedical (PEP, STD testing), structural or behavioral services that support HIV prevention and care.
2a. Hypothesis: the peer-supported model (PtW) will lead to more frequent and earlier linkages to services than the non-peer supported model (Control).
2b. Hypothesis: the peer-supported model (PtW) will lead to greater reductions in HIV risk behaviors than the non-peer-supported model (Control).
3 (NEW). To assess the effectiveness of a peer-supported, incentivized, and client-centered approach (PtW) compared to a non-peer supported, incentivized, and client-centered approach (Control) for linking at-risk BMSM to PrEP services.
3a. Hypothesis: the peer-supported model (PtW) will lead to more frequent receipt of PrEP education and consultations than the non-peer-supported model (Control) 3b. Hypothesis: the peer-supported model (PtW) will lead to more frequent uptake of PrEP (defined as taking PrEP at six month follow-up) than the non-peer-supported model (Control).
- Being tested
- Intervention-Passport and Peer Mentor, Control-Passport Only
- Keywords
- HIV, Black/African American, Men, Gay/bisexual, Los Angeles
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention-Passport and Peer MentorBehavioural
Also called Passport To Wellness
In addition to the passport and incentives described below for the control condition, participants assigned to the intervention will select a peer mentor trained in motivational interviewing. The mentor will help guide the participant to complete passport items and address priorities. Participants will also be incentivized for regular meetings with his peer mentor.
Control-Passport OnlyBehavioural
Also called Control
A trained staff member will use a needs assessment and the participant's own priorities to develop a 'Passport to Wellness,' a personalized set of services whose access may encourage HIV prevention or address barriers to HIV testing.
Example passport items include: getting an HIV test, attending an informational session about PEP/PrEP, meeting with a PrEP provider, attending 12-step meetings, yoga classes, a massage or Reiki session, or reviewing specific HIV prevention information online. Participants will be incentivized for each passport item they complete.
| Study group | Role | What they receive |
|---|---|---|
| Control-Passport Only | Active comparator | Complete a needs assessment and develop a written "Passport to Wellness," an itemized set of health promoting behaviors and services aligned with lifestyle and goals. Participants are compensated based on the items they complete, services they attend. Receives: Behavioral: Control-Passport Only |
| Intervention-Passport and Peer Mentor | Experimental | In addition to the "Passport to Wellness" developed with project staff, study participants will select a peer mentor trained in motivational interviewing. The peer mentor will help guide the participant to complete passport items. Part of passport development will include compensation for meeting with peer mentors to form strategies for meeting goals and addressing barriers/challenges that arise. Receives: Behavioral: Intervention-Passport and Peer Mentor; Behavioral: Control-Passport Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number self-reporting specific HIV/STD (sexually transmitted disease) Testing outcomes
--Number of participants 1) human immunodeficiency virus (HIV) tested within one and six months of their baseline; 2) newly diagnosed with HIV, and 3) obtaining testing for other STDs within six months of their baseline.
Measured: 6 Months
Number with specific PrEP outcomes
--Number of participants who attend a PrEP information session, meet with a PrEP provider, or obtain a new PrEP prescription.
Measured: 6 Months
Number self-reporting specific Social and Behavioral Outcomes
--Number of participants who obtain social and behavioral services that support HIV prevention and care.
Measured: 6 Months
Percentage self-reporting specific HIV/STD (sexually transmitted disease) Testing outcomes
--Percentage of participants 1) human immunodeficiency virus (HIV) tested within one and six months of their baseline; 2) newly diagnosed with HIV, and 3) obtaining testing for other STDs within six months of their baseline. Summary data may include the percentage who report HIV or STD testing.
Measured: 6 Months
Percentage with specific PrEP outcomes
--Percentage of participants who attend a PrEP information session, meet with a PrEP provider, or obtain a new PrEP prescription. Summary items may include the percentage who report doing any of these three PrEP activities.
Measured: 6 Months
Percentage of self-reporting specific Social and Behavioral Outcomes
--Percentage of participants who obtain social and behavioral services that support HIV prevention and care.
Measured: 6 Months
Secondary outcomes (1)
Number of referrals HIV tested
The investigators will compare between the two arms, the number of HIV tested referrals from study participants in each arm who were 1) BMSM, 2) BMSM newly diagnosed with HIV, and 3) people from other race/gender/sexual orientation groups
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startAug 2015
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, University of Southern California, Los Angeles Centers for Alcohol and Drug Addiction (L.A. CADA)
- Responsible party
- Sponsor
- Investigators
- Nina T. Harawa, PhD; MPH, Principal investigator, UCLA; Charles R. Drew University of ScienceRicky Bluthenthal, PhD, Principal investigator, University of Southern CaliforniaCharles McWells, Principal investigator, Los Angeles Centers for Alcohol and Drug Addiction (LA CADA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932384
- Sponsor's protocol ID
- TL13-LACA-576
- Acronym
- PtW
- Status last verified
- Aug 2018
- First submitted
- 30 Aug 2016
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passport to Wellness-Full Intervention Phase
- ClinicalTrials.gov ID
- NCT02932384
- Acronym / sponsor ID
- PtW / TL13-LACA-576
- Keywords
- HIV, Black/African American, Men, Gay/bisexual, Los Angeles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, University of Southern California, Los Angeles Centers for Alcohol and Drug Addiction (L.A. CADA)
- Study start
- Aug 2015 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 13 Oct 2016 (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 proposed research study will focus on Black men who have sex with men (BMSM) who
- are HIV- or unknown status AND
- have not received HIV testing in over a year or
- who test irregularly (on 9/21/2016, the protocol was changed to modify the last to criteria and focus on those who have not used PrEP in the prior six months). and implement an innovative, culturally-informed, peer-based, and client-centered approach that is designed to increase their awareness of their HIV status and their timely entry into prevention (including PrEP), testing, care, and treatment services. The research design compares the effect of an incentives-only approach to one that uses incentives, along with the involvement of peer mentors to support timely entry into prevention, testing, care and treatment. This phase of the study is designed to assess peer-supported intervention group versus a passport/incentive-only control group over an 18-month period using a randomized trial approach.
Detailed description
The proposed research study focuses on BMSM who have not received HIV testing in over a year, or who test irregularly, and implement an innovative, culturally-informed, peer-based, and client-centered approach that is designed to increase their awareness of their HIV status and their timely entry into prevention, care, and treatment services. On 9/21/2016, the protocol was changed to focus on those who have not used PrEP in the prior six months.
The research design compares the effect of an incentives-only approach to one that uses incentives, along with the involvement of peer mentors to support timely entry into prevention, testing, care and treatment. This phase of the study is designed to assess peer-supported intervention group versus a passport/incentive-only control group over an 18-month period using a randomized trial approach.
The Specific Aims of the full intervention phase are:
2 (Modified). To assess the effectiveness of a peer-supported, incentivized, and client-centered approach (PtW) compared to a non-peer supported, incentivized, and client-centered approach (Control) for linking at-risk BMSM to biomedical (PEP, STD testing), structural or behavioral services that support HIV prevention and care.
2a. Hypothesis: the peer-supported model (PtW) will lead to more frequent and earlier linkages to services than the non-peer supported model (Control).
2b. Hypothesis: the peer-supported model (PtW) will lead to greater reductions in HIV risk behaviors than the non-peer-supported model (Control).
3 (NEW). To assess the effectiveness of a peer-supported, incentivized, and client-centered approach (PtW) compared to a non-peer supported, incentivized, and client-centered approach (Control) for linking at-risk BMSM to PrEP services.
3a. Hypothesis: the peer-supported model (PtW) will lead to more frequent receipt of PrEP education and consultations than the non-peer-supported model (Control) 3b. Hypothesis: the peer-supported model (PtW) will lead to more frequent uptake of PrEP (defined as taking PrEP at six month follow-up) than the non-peer-supported model (Control).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control-Passport Only | Active comparator | Behavioral: Control-Passport OnlyComplete a needs assessment and develop a written "Passport to Wellness," an itemized set of health promoting behaviors and services aligned with lifestyle and goals. Participants are compensated based on the items they complete, services they attend. |
| Intervention-Passport and Peer Mentor | Experimental | Behavioral: Intervention-Passport and Peer Mentor, Behavioral: Control-Passport OnlyIn addition to the "Passport to Wellness" developed with project staff, study participants will select a peer mentor trained in motivational interviewing. The peer mentor will help guide the participant to complete passport items. Part of passport development will include compensation for meeting with peer mentors to form strategies for meeting goals and addressing barriers/challenges that arise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- self identify as male
- self-identify as Black or African American
- sex with a male or male-to-female transgender in the last 6 months
- intercourse without a condom in the last 6 months
- Los Angeles County resident,
Key exclusion criteria (7 listed)
- self-identify as female or transgender male or female
- does not self-identify as Black or African American
- no sex with a man or a male-to-female transgender in the last 6 months
- no sexual intercourse in the last 6 months
- resides outside of Los Angeles County
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 |
|---|---|---|
| Intervention-Passport and Peer MentorAlso: Passport To WellnessIn addition to the passport and incentives described below for the control condition, participants assigned to the intervention will select a peer mentor trained in motivational interviewing. The mentor will help guide the participant to complete passport items and address priorities. Participants will also be incentivized for regular meetings with his peer mentor. | Behavioural | Intervention-Passport and Peer Mentor |
| Control-Passport OnlyAlso: ControlA trained staff member will use a needs assessment and the participant's own priorities to develop a 'Passport to Wellness,' a personalized set of services whose access may encourage HIV prevention or address barriers to HIV testing. Example passport items include: getting an HIV test, attending an informational session about PEP/PrEP, meeting with a PrEP provider, attending 12-step meetings, yoga classes, a massage or Reiki session, or reviewing specific HIV prevention information online. Participants will be incentivized for each passport item they complete. | Behavioural | Control-Passport Only, Intervention-Passport and Peer Mentor |
Primary outcome
Number self-reporting specific HIV/STD (sexually transmitted disease) Testing outcomes
Time frame: 6 Months
--Number of participants 1) human immunodeficiency virus (HIV) tested within one and six months of their baseline; 2) newly diagnosed with HIV, and 3) obtaining testing for other STDs within six months of their baseline.
Number with specific PrEP outcomes
Time frame: 6 Months
--Number of participants who attend a PrEP information session, meet with a PrEP provider, or obtain a new PrEP prescription.
Number self-reporting specific Social and Behavioral Outcomes
Time frame: 6 Months
--Number of participants who obtain social and behavioral services that support HIV prevention and care.
Percentage self-reporting specific HIV/STD (sexually transmitted disease) Testing outcomes
Time frame: 6 Months
--Percentage of participants 1) human immunodeficiency virus (HIV) tested within one and six months of their baseline; 2) newly diagnosed with HIV, and 3) obtaining testing for other STDs within six months of their baseline. Summary data may include the percentage who report HIV or STD testing.
Percentage with specific PrEP outcomes
Time frame: 6 Months
--Percentage of participants who attend a PrEP information session, meet with a PrEP provider, or obtain a new PrEP prescription. Summary items may include the percentage who report doing any of these three PrEP activities.
Percentage of self-reporting specific Social and Behavioral Outcomes
Time frame: 6 Months
--Percentage of participants who obtain social and behavioral services that support HIV prevention and care.
1 secondary outcome
Number of referrals HIV tested
Time frame: 6 Months
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 2 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for HIV
Recruiting
A Chatbot to Reduce Chemsex and HIV-related Risk Behaviors Among Men Who Have Sex With Men
Behavior
Not yet recruiting
VR Mindfulness for People With HIV and Substance Use
HIV, Substance Use (Drugs, Alcohol)
Not yet recruiting
Adapting the "Do More, Feel Better" Intervention for Older People Living With HIV
Depression, HIV
Recruiting
AYAHIV Role-based Responsibilities for Oncology-focused Workforce (ARROW)
Cervical Cancer, Kaposi Sarcoma
Recruiting
A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test
HIV1 Infection, HIV 2 Infection
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.
Nina T. Harawa, PhD; MPH principal investigator
UCLA; Charles R. Drew University of Science
Ricky Bluthenthal, PhD principal investigator
University of Southern California
Charles McWells principal investigator
Los Angeles Centers for Alcohol and Drug Addiction (LA CADA)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention-Passport and Peer Mentor in people with HIV and Men, run by Charles Drew University of Medicine and Science at 2 sites 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?
The sponsor lists 7 inclusion and 7 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 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 self-reporting specific HIV/STD (sexually transmitted disease) Testing outcomes (time frame: 6 Months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2018.