Unsafe SexMLMSNCT01640392
MyLife MyStyle Evaluation Project
A study testing MyLife MyStyle group-level intervention in people with Unsafe Sex, run by Los Angeles County Department of Public Health at 1 site in United States.
Trial summary
The purpose of the MyLife MyStyle Evaluation Project is to determine whether the MyLife MyStyle group-level intervention reduces HIV sexual-risk behaviors among 18- to 29-year-old African American men who have sex with men (MSM). Read more about this study
- Who is it for?
- Ages 18 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Unsafe Sex
- What is being tested?
- MyLife MyStyle group-level intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 528 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 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 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Identify as African American or Black
- Identify as male
- Age 18 to 29 years
- Reside within Los Angeles County
- Self-reported anal sex with a male partner in the past 12 months
- Has not participated in an HIV prevention intervention in the past 3 months
- Able to complete ACASI and MyLife sessions in English
Who cannot join
- Identify as a transgender female
- Plan to move out of Los Angeles County before the end of their follow-up period (within 7 months)
Trial locations and contacts
1 site in 1 country.
United States1 site
In The Meantime Men's Group, Inc.
Los Angeles, California, 90019
About this study
Official title: Evaluating Locally Developed Homegrown HIV Prevention Interventions
The purpose of the MyLife MyStyle Evaluation Project is to determine whether the MyLife MyStyle group-level intervention reduces HIV sexual-risk behaviors among 18- to 29-year-old African American men who have sex with men (MSM). Specifically, the project will test whether participants of the MyLife MyStyle program will report at least a 15% absolute decrease in frequency of unprotected anal sex with male partners at three and six months post-intervention compared with the wait-list control participants.
Read the detailed description
In Los Angeles County, as well as nationally, the primary mode of HIV transmission for African American men is sexual contact with another man. According to national data from 45 states with name-based HIV surveillance in 2006, the majority of all new HIV infections among African American males were associated with sex with other men. The disproportionate impact of HIV in AAMSM in Los Angeles County is also observed in provisional HIV surveillance data. Between 2002 and 2004, AAMSM composed 16.3% of the new HIV diagnoses among males in Los Angeles County, with an average annual HIV diagnosis rate 2.0 and 2.5 times greater than the rates of new HIV diagnosis for White and Latino MSM, respectively. In addition to demonstrating the highest HIV prevalence and incidence estimates, AAMSM also had the highest proportion of previously unrecognized HIV infection (67%) compared with all other racial/ethnic groups. Given significant and continuing disparities in HIV infection among African Americans in the United States, and specifically among AAMSM, more intervention programs must be planned, implemented, and tested in order to reduce the heavy toll of HIV/AIDS in this population. Components of these intervention programs must be culturally competent and should include promotion of HIV counseling and testing to reduce the high prevalence of unrecognized HIV infection in AAMSM. Interventions should also take into consideration the many co-factors that may hinder AAMSM from addressing their HIV risk such as racism, poverty, stigma, and homophobia. The MyLife MyStyle Evaluation Project aims to implement and evaluate the efficacy of a "homegrown" group-level intervention to reduce HIV risk (unprotected anal sex with male partners) among young African American MSM in Los Angeles County, CA.
- Conditions
- Unsafe Sex
- Being tested
- MyLife MyStyle group-level intervention
- Keywords
- Gay men, African American males, Unprotected anal sex, HIV risk, behavioral intervention, group-level intervention
- Medical subject headings
- Unsafe Sex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyLife MyStyle group-level interventionBehavioural
Three 1.5-hour HIV behavioral risk-reduction group sessions conducted with up to 12 young African American/Black men (ages 18-29 years) over a 1-3 week period.
| Study group | Role | What they receive |
|---|---|---|
| HIV prevention groups | Experimental | Participants randomly assigned to the MyLife Intervention arm receive three 1.5-hour HIV behavioral risk-reduction group sessions over a 1-3 week period. Receives: Behavioral: MyLife MyStyle group-level intervention |
| Wait-list control | No intervention | Participants randomly assigned to the Wait-list Control arm receive the MyLife MyStyle group sessions once they have completed a 6-month follow-up assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced unprotected anal sex with male partners
Proportion of intervention participants reporting any unprotected anal intercourse (either insertive or receptive) with male partners at six-month follow-up (and three months for short-term effects) compared with those in the wait-list control arm.
Measured: up to 6 months following Intervention groups' third (final) session
Secondary outcomes (4)
Increased communication with partners
Increase frequency of communication with partner(s) about safer sex, HIV status, STI status
Measured: 3 months and 6 months following intervention groups' third (final) session
Decrease unprotected sex because condom was not available
Proportion of intervention participants reporting episodes of unprotected anal sex when a condom is not available at six-month follow-up (and three months for short-term effects) compared with those in the wait-list control arm.
Measured: 3 months and 6 months following Intervention groups' third (final) session
Decrease number of sexual partners
Number of sexual partners reported by intervention participants at six-month follow-up (and three months for short-term effects) compared with the number reported by the wait-list control participants.
Measured: 3 months and 6 months following Intervention groups' third (final) session
Increase help-seeking behaviors for sexual health, e.g., STI testing, HIV testing, health screenings
Proportion of intervention participants reporting help-seeking behaviors for sexual health at six-month follow-up (and three months for short-term effects) compared with those in the wait-list control arm.
Measured: 3 months and 6 months following Intervention groups' third (final) session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startApr 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 Unsafe SexStudies 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
- 528 participants (actual)
Sponsor and investigators
- Lead sponsor
- Los Angeles County Department of Public Health
- Sponsor type
- Other government
- Collaborators
- Centers for Disease Control and Prevention, In The Meantime Men's Group, Inc.
- Responsible party
- Sponsor
- Investigators
- Trista Bingham, MPH, PhD, Principal investigator, Los Angeles County Department of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640392
- Sponsor's protocol ID
- 1 U01SP001573-01
- Acronym
- MLMS
- Status last verified
- Aug 2019
- First submitted
- 11 Jul 2012
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Locally Developed Homegrown HIV Prevention Interventions
- ClinicalTrials.gov ID
- NCT01640392
- Acronym / sponsor ID
- MLMS / 1 U01SP001573-01
- Conditions
- Unsafe Sex
- Keywords
- Gay men, African American males, Unprotected anal sex, HIV risk, behavioral intervention, group-level intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 528 participants (actual)
- Lead sponsor
- Los Angeles County Department of Public HealthOther government
- Collaborators
- Centers for Disease Control and Prevention, In The Meantime Men's Group, Inc.
- Study start
- Apr 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 13 Jul 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 the MyLife MyStyle Evaluation Project is to determine whether the MyLife MyStyle group-level intervention reduces HIV sexual-risk behaviors among 18- to 29-year-old African American men who have sex with men (MSM). Specifically, the project will test whether participants of the MyLife MyStyle program will report at least a 15% absolute decrease in frequency of unprotected anal sex with male partners at three and six months post-intervention compared with the wait-list control participants.
Detailed description
In Los Angeles County, as well as nationally, the primary mode of HIV transmission for African American men is sexual contact with another man. According to national data from 45 states with name-based HIV surveillance in 2006, the majority of all new HIV infections among African American males were associated with sex with other men. The disproportionate impact of HIV in AAMSM in Los Angeles County is also observed in provisional HIV surveillance data. Between 2002 and 2004, AAMSM composed 16.3% of the new HIV diagnoses among males in Los Angeles County, with an average annual HIV diagnosis rate 2.0 and 2.5 times greater than the rates of new HIV diagnosis for White and Latino MSM, respectively. In addition to demonstrating the highest HIV prevalence and incidence estimates, AAMSM also had the highest proportion of previously unrecognized HIV infection (67%) compared with all other racial/ethnic groups. Given significant and continuing disparities in HIV infection among African Americans in the United States, and specifically among AAMSM, more intervention programs must be planned, implemented, and tested in order to reduce the heavy toll of HIV/AIDS in this population. Components of these intervention programs must be culturally competent and should include promotion of HIV counseling and testing to reduce the high prevalence of unrecognized HIV infection in AAMSM. Interventions should also take into consideration the many co-factors that may hinder AAMSM from addressing their HIV risk such as racism, poverty, stigma, and homophobia. The MyLife MyStyle Evaluation Project aims to implement and evaluate the efficacy of a "homegrown" group-level intervention to reduce HIV risk (unprotected anal sex with male partners) among young African American MSM in Los Angeles County, CA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV prevention groups | Experimental | Behavioral: MyLife MyStyle group-level interventionParticipants randomly assigned to the MyLife Intervention arm receive three 1.5-hour HIV behavioral risk-reduction group sessions over a 1-3 week period. |
| Wait-list control | No intervention | –Participants randomly assigned to the Wait-list Control arm receive the MyLife MyStyle group sessions once they have completed a 6-month follow-up assessment. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Identify as African American or Black
- Identify as male
- Age 18 to 29 years
- Reside within Los Angeles County
- Self-reported anal sex with a male partner in the past 12 months
Key exclusion criteria (2 listed)
- Identify as a transgender female
- Plan to move out of Los Angeles County before the end of their follow-up period (within 7 months)
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 |
|---|---|---|
| MyLife MyStyle group-level interventionThree 1.5-hour HIV behavioral risk-reduction group sessions conducted with up to 12 young African American/Black men (ages 18-29 years) over a 1-3 week period. | Behavioural | HIV prevention groups |
Primary outcome
Reduced unprotected anal sex with male partners
Time frame: up to 6 months following Intervention groups' third (final) session
Proportion of intervention participants reporting any unprotected anal intercourse (either insertive or receptive) with male partners at six-month follow-up (and three months for short-term effects) compared with those in the wait-list control arm.
4 secondary outcomes
Increased communication with partners
Time frame: 3 months and 6 months following intervention groups' third (final) session
Decrease unprotected sex because condom was not available
Time frame: 3 months and 6 months following Intervention groups' third (final) session
Decrease number of sexual partners
Time frame: 3 months and 6 months following Intervention groups' third (final) session
Increase help-seeking behaviors for sexual health, e.g., STI testing, HIV testing, health screenings
Time frame: 3 months and 6 months following Intervention groups' third (final) session
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 15 Aug 2019.
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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.
Trista Bingham, MPH, PhD principal investigator
Los Angeles County Department of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyLife MyStyle group-level intervention in people with Unsafe Sex, run by Los Angeles County Department of Public Health 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 7 inclusion and 2 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 15 Aug 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?
Reduced unprotected anal sex with male partners (time frame: up to 6 months following Intervention groups' third (final) session). 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 15 Aug 2019; AzTrials last refreshed its copy on 27 Oct 2026.