HIV CDC Category A1B-MENCT01722838
Black Men Evolving Behavioral HIV Prevention Intervention for Black MSM
A study testing B-ME Intervention in people with HIV CDC Category A1, run by Loyola University Chicago at 1 site in United States.
Trial summary
B-ME is a research intervention study designed to address the needs of African American men who have sex with men (AAMSM) who are at high risk for HIV. The intent of the intervention is to decrease HIV risk behaviors among African American MSM using an intervention developed by and for African American MSM. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV CDC Category A1
- What is being tested?
- B-ME Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 438 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Apr 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 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- a) Be 18 to 55 years old b) Self identify as African American (Black national) c) Self identify as a male (because this is a study of an intervention to impact change among Black MSM, only self identified males will be included, therefore no females or transgendered identified persons will be included).
- Report being sexually active in the past 30 days (ie., one or more instances of vaginal or anal sex with a male or female) e) Report at least one instance of unprotected anal or oral sex with a male identified partner in the past year f) Have not previously participated in the CTCA intervention. g) Have not received an evidence-based HIV prevention intervention in the past 180 days
Who cannot join
- Men are ineligible to participate in the trial if they:
- Identify as a transgender woman; OR
- Plan to move before the end of the study; OR
- Have participated in any HIV or substance use prevention studies in the last 180 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of a Locally Developed Homegrown HIV Prevention Intervention
B-ME is a research intervention study designed to address the needs of African American men who have sex with men (AAMSM) who are at high risk for HIV. The intent of the intervention is to decrease HIV risk behaviors among African American MSM using an intervention developed by and for African American MSM.
The hypothesis guiding this study is: that participants who complete B-ME intervention will report greater reductions in sexual risk behaviors than the standard of care comparison group.
Read the detailed description
The Specific Aims of this study are 1) to further explicate and develop the intervention, 2) to evaluate its efficacy in reducing HIV risk behaviors and 3) to expand the limited body of research on HIV prevention/risk reduction practices for African American men who have sex with men(AAMSM). The study will use a randomized-controlled trial design to compare receiving B-ME intervention to receiving basic men's health and wellness messaging (standard of care), hypothesizing: hypothesizing: that participants who complete B-ME intervention will report greater reductions in sexual risk behaviors than the standard of care comparison group. The study will utilize a pre-test/post-test design with participants randomized to intervention and comparison groups; have a strategy to retain at least 80% of participants through study completion; collect data at baseline, at 3 months post-intervention, and at 6 months post-intervention; and rigorously measure outcomes that directly impact HIV risk. Data will be collected at each assessment point to assess B-ME's ability to improve behavioral outcomes that directly impact Black MSM HIV risk: (1) number of unprotected anal and vaginal sex events; (2) number of unprotected sex events with persons of unknown HIV status; (3) frequency of HIV testing, and (4) increased communication between partners about sex and strategies for reducing the risk of HIV infection.
- Conditions
- HIV CDC Category A1
- Being tested
- B-ME Intervention
- Keywords
- Black MSM, HIV Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-ME InterventionBehavioural
B-ME is a behavioral intervention of HIV prevention risk reduction administered in a group format during a 2.5 day retreat (19 hours) format.
| Study group | Role | What they receive |
|---|---|---|
| B-ME intervention | Experimental | Men will receive behavioral HIV prevention intervention, B-ME. Receives: Behavioral: B-ME Intervention |
| Control Arm | No intervention | Men in this arm will receive monthly text or telephone voice messages relaying general health messages. |
What is being measured
The primary outcome is the main question the study is designed to answer.
reductions in sexual risk behaviors
Unprotected anal or vaginal sex and condom use during
Measured: baseline, 3-month, 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV CDC Category A1Studies 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
- Model description
- Assignment to behavioral intervention or comparison group
- Masking
- None (open label)
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Darrell P Wheeler, PHD MPH, Principal investigator, Loyola University Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722838
- Sponsor's protocol ID
- 5U01PS001574
- Other IDs
- PS09-007
- Acronym
- B-ME
- Status last verified
- Feb 2019
- First submitted
- 5 Nov 2012
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of a Locally Developed Homegrown HIV Prevention Intervention
- ClinicalTrials.gov ID
- NCT01722838
- Acronym / sponsor ID
- B-ME / 5U01PS001574
- Conditions
- HIV CDC Category A1
- Keywords
- Black MSM, HIV Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Loyola University ChicagoUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 7 Nov 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.
B-ME is a research intervention study designed to address the needs of African American men who have sex with men (AAMSM) who are at high risk for HIV. The intent of the intervention is to decrease HIV risk behaviors among African American MSM using an intervention developed by and for African American MSM.
The hypothesis guiding this study is: that participants who complete B-ME intervention will report greater reductions in sexual risk behaviors than the standard of care comparison group.
Detailed description
The Specific Aims of this study are 1) to further explicate and develop the intervention, 2) to evaluate its efficacy in reducing HIV risk behaviors and 3) to expand the limited body of research on HIV prevention/risk reduction practices for African American men who have sex with men(AAMSM). The study will use a randomized-controlled trial design to compare receiving B-ME intervention to receiving basic men's health and wellness messaging (standard of care), hypothesizing: hypothesizing: that participants who complete B-ME intervention will report greater reductions in sexual risk behaviors than the standard of care comparison group. The study will utilize a pre-test/post-test design with participants randomized to intervention and comparison groups; have a strategy to retain at least 80% of participants through study completion; collect data at baseline, at 3 months post-intervention, and at 6 months post-intervention; and rigorously measure outcomes that directly impact HIV risk. Data will be collected at each assessment point to assess B-ME's ability to improve behavioral outcomes that directly impact Black MSM HIV risk: (1) number of unprotected anal and vaginal sex events; (2) number of unprotected sex events with persons of unknown HIV status; (3) frequency of HIV testing, and (4) increased communication between partners about sex and strategies for reducing the risk of HIV infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Assignment to behavioral intervention or comparison group
| Arm | Type | Receives |
|---|---|---|
| B-ME intervention | Experimental | Behavioral: B-ME InterventionMen will receive behavioral HIV prevention intervention, B-ME. |
| Control Arm | No intervention | –Men in this arm will receive monthly text or telephone voice messages relaying general health messages. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- a) Be 18 to 55 years old b) Self identify as African American (Black national) c) Self identify as a male (because this is a study of an intervention to impact change among Black MSM, only self identified males will be included, therefore no females or transgendered identified persons will be included).
Key exclusion criteria (4 listed)
- Men are ineligible to participate in the trial if they:
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 |
|---|---|---|
| B-ME InterventionB-ME is a behavioral intervention of HIV prevention risk reduction administered in a group format during a 2.5 day retreat (19 hours) format. | Behavioural | B-ME intervention |
Primary outcome
reductions in sexual risk behaviors
Time frame: baseline, 3-month, 6-month
Unprotected anal or vaginal sex and condom use during
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 28 Feb 2019.
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.
Darrell P Wheeler, PHD MPH principal investigator
Loyola University Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-ME Intervention in people with HIV CDC Category A1, run by Loyola University Chicago 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?
The sponsor lists 2 inclusion and 4 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 28 Feb 2019. 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?
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?
reductions in sexual risk behaviors (time frame: baseline, 3-month, 6-month). 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 28 Feb 2019.