HIVPhase 3NCT01427543
The HJ MILE HIV Prevention Intervention for Post-incarcerated Men
A Phase 3 study testing MILE intervention in people with HIV and Risk Reduction Behavior, run by University of Southern California at 1 site in United States.
Trial summary
The goal of this study is to determine whether a culturally congruent, group intervention can reduce HIV risk behaviors among recently incarcerated, bisexual, African American men. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Risk Reduction Behavior
- What is being tested?
- MILE intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Apr 2013
- Phase
- Phase 3
- 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-identified as African American or Black
- male
- 18 years of age or greater
- Los Angeles County resident
- Been incarcerated in the last 12 months
- oral or anal sex with a man in the last 12 months
- any unprotected anal or vaginal sex in the last 3 months
- two or more sex partners in the last 3 months
Who cannot join
- Female or transgendered
- not self-identified as African American or Black
- any self-reported illicit drug injection in the last 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Health Justice
Los Angeles, California, 90012
About this study
Official title: The HJ MILE HIV Prevention Intervention for Post-incarcerated Bisexual African American Men
The goal of this study is to determine whether a culturally congruent, group intervention can reduce HIV risk behaviors among recently incarcerated, bisexual, African American men.
Read the detailed description
The goal of this study is to evaluate the efficacy of the Men in Life Environments (MILE) intervention, adapted from the Men of African American Legacy Empowering Self (MAALES) Project, an innovative and culturally congruent intervention designed to reduce HIV risk-related behaviors and improve psychosocial outcomes in recently incarcerated African American men who have sex with men and women (MSMW). The MILE intervention is guided by the Theory of Reasoned Action and Planned Behavior, the Critical Thinking and Cultural Affirmation (CTCA) Model, and the Empowerment Theory. The small group MILE intervention involves six two-hour group sessions held over three weeks and is lead by two African-American co-facilitators. The investigators will test the intervention with a total of 260 African American MSMW, evenly randomized to intervention and control conditions. For this study, participants will be interviewed at baseline, shortly after completion of the intervention (~ 4 weeks after baseline), and again 3 months following the second interview. This project will be among the first to develop and test an HIV risk-reduction intervention designed specifically for African American post-incarcerated MSMW. Study aims are as follows:
Aim 1: To evaluate the impact of the MILE intervention on rates of condom use, having sex while under the influence of drugs and alcohol, and number of sex partners among recently incarcerated bisexual African American MSMW.
Hypothesis: Compared to the control condition, the MILE intervention condition will be more effective in decreasing episodes of unprotected anal and vaginal intercourse, incidents of sex under the influence of drugs and alcohol and numbers of intercourse partners at the 3-month follow-up assessment.
Aim 2: To evaluate the impact of the MILE intervention on uptake of testing for sexually transmitted infections (STI) among recently incarcerated African American MSMW.
Hypothesis: Compared to the control condition, the MILE intervention participants will be more likely to accept STI testing after the post-intervention assessment.
Aim 3: To describe social support and social networks of recently incarcerated African American MSMW and to examine whether these factors are associated with HIV risk in this population.
The MILE intervention will be implemented by The Center for Health Justice (CHJ) - a community-based HIV prevention and care advocacy organization that has been working with incarcerated and post-incarcerated populations since 1997. The adaptation and implementation of this intervention by CHJ should increase the dissemination and applicability of the intervention to other locales should it prove to be effective.
- Conditions
- HIV, Risk Reduction Behavior
- Being tested
- MILE intervention
- Keywords
- behavioral intervention, HIV risk reduction, African Americans, incarceration, bisexual, reduce risk behaviors
- Medical subject headings
- Risk Reduction Behavior, Bisexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MILE interventionBehavioural
Participants will be asked to attend 6 - 2 hour group sessions over the course of 3 weeks. The intervention aims to reduce HIV risk taking related to sex risk and alcohol and drug use.
| Study group | Role | What they receive |
|---|---|---|
| MILE group sessions | Experimental | Participants will attend 6 - 2 hour long, interactive, culturally congruent, group sessions that address knowledge, beliefs, attitudes, and skills related to reducing HIV risk behaviors. Receives: Behavioral: MILE intervention |
| Control | No intervention | These subjects will be provided with access to post-incarcerations services that will be provided by the Center for Health Justice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Condom use
This measure captures the percentage of times that participants self-report using a condom during vaginal and anal sex.
Measured: Last 3 months
Sex under the influence of alcohol and drugs
Self-reported vaginal or anal sex while under the influence of alcohol or drugs.
Measured: Last 3 months
Number of sex partners
Participant's self-report of number of sex partners in the last 3 months.
Measured: Last 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startJul 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Charles Drew University of Medicine and Science, Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Ricky Bluthenthal, University of Southern California
- Investigators
- Ricky Bluthenthal, Ph.D., Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427543
- Sponsor's protocol ID
- HS-10-00590
- Other IDs
- 5UR6PS001098
- Status last verified
- Oct 2018
- First submitted
- 30 Aug 2011
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dangerfield DT 2nd, Harawa NT, Smith LR, Jeffries WL 4th, Baezconde-Garbanati L, Bluthenthal R. Latent Classes of Sexual Risk Among Black Men Who Have Sex with Men and Women. Arch Sex Behav. 2018 Oct;47(7):2071-2080. doi: 10.1007/s10508-017-1142-y. Epub 2018 Mar 14.
PubMed 29541914Harawa NT, Guentzel-Frank H, McCuller WJ, Williams JK, Millet G, Belcher L, Joseph HA, Bluthenthal RN. Efficacy of a Small-Group Intervention for Post-Incarcerated Black Men Who Have Sex with Men and Women (MSMW). J Urban Health. 2018 Apr;95(2):159-170. doi: 10.1007/s11524-018-0227-9.
PubMed 29541962Joseph HA, Pan Y, Mendoza M, Harawa NT, Lauby J, Hosek SG, Bluthenthal RN, Milnamow M, Fernandez MI, Jeffries WL 4th, Belcher L, Millett GA. HIV Acquisition and Transmission Potential Among African American Men Who Have Sex with Men and Women in Three U.S. Cities. Arch Sex Behav. 2018 Jan;47(1):183-194. doi: 10.1007/s10508-017-1052-z. Epub 2017 Nov 9.
PubMed 29124541Li MJ, Frank HG, Harawa NT, Williams JK, Chou CP, Bluthenthal RN. Racial Pride and Condom Use in Post-Incarcerated African-American Men Who Have Sex With Men and Women: Test of a Conceptual Model for the Men in Life Environments Intervention. Arch Sex Behav. 2018 Jan;47(1):169-181. doi: 10.1007/s10508-016-0734-2. Epub 2016 Apr 26.
PubMed 27115618
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HJ MILE HIV Prevention Intervention for Post-incarcerated Bisexual African American Men
- ClinicalTrials.gov ID
- NCT01427543
- Acronym / sponsor ID
- HS-10-00590
- Conditions
- HIV, Risk Reduction Behavior
- Keywords
- behavioral intervention, HIV risk reduction, African Americans, incarceration, bisexual, reduce risk behaviors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Charles Drew University of Medicine and Science, Centers for Disease Control and Prevention
- Study start
- Jul 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 1 Sep 2011 (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 goal of this study is to determine whether a culturally congruent, group intervention can reduce HIV risk behaviors among recently incarcerated, bisexual, African American men.
Detailed description
The goal of this study is to evaluate the efficacy of the Men in Life Environments (MILE) intervention, adapted from the Men of African American Legacy Empowering Self (MAALES) Project, an innovative and culturally congruent intervention designed to reduce HIV risk-related behaviors and improve psychosocial outcomes in recently incarcerated African American men who have sex with men and women (MSMW). The MILE intervention is guided by the Theory of Reasoned Action and Planned Behavior, the Critical Thinking and Cultural Affirmation (CTCA) Model, and the Empowerment Theory. The small group MILE intervention involves six two-hour group sessions held over three weeks and is lead by two African-American co-facilitators. The investigators will test the intervention with a total of 260 African American MSMW, evenly randomized to intervention and control conditions. For this study, participants will be interviewed at baseline, shortly after completion of the intervention (~ 4 weeks after baseline), and again 3 months following the second interview. This project will be among the first to develop and test an HIV risk-reduction intervention designed specifically for African American post-incarcerated MSMW. Study aims are as follows:
Aim 1: To evaluate the impact of the MILE intervention on rates of condom use, having sex while under the influence of drugs and alcohol, and number of sex partners among recently incarcerated bisexual African American MSMW.
Hypothesis: Compared to the control condition, the MILE intervention condition will be more effective in decreasing episodes of unprotected anal and vaginal intercourse, incidents of sex under the influence of drugs and alcohol and numbers of intercourse partners at the 3-month follow-up assessment.
Aim 2: To evaluate the impact of the MILE intervention on uptake of testing for sexually transmitted infections (STI) among recently incarcerated African American MSMW.
Hypothesis: Compared to the control condition, the MILE intervention participants will be more likely to accept STI testing after the post-intervention assessment.
Aim 3: To describe social support and social networks of recently incarcerated African American MSMW and to examine whether these factors are associated with HIV risk in this population.
The MILE intervention will be implemented by The Center for Health Justice (CHJ) - a community-based HIV prevention and care advocacy organization that has been working with incarcerated and post-incarcerated populations since 1997. The adaptation and implementation of this intervention by CHJ should increase the dissemination and applicability of the intervention to other locales should it prove to be effective.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MILE group sessions | Experimental | Behavioral: MILE interventionParticipants will attend 6 - 2 hour long, interactive, culturally congruent, group sessions that address knowledge, beliefs, attitudes, and skills related to reducing HIV risk behaviors. |
| Control | No intervention | –These subjects will be provided with access to post-incarcerations services that will be provided by the Center for Health Justice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- self-identified as African American or Black
- male
- 18 years of age or greater
- Los Angeles County resident
- Been incarcerated in the last 12 months
Key exclusion criteria (3 listed)
- Female or transgendered
- not self-identified as African American or Black
- any self-reported illicit drug injection in the last 12 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 |
|---|---|---|
| MILE interventionParticipants will be asked to attend 6 - 2 hour group sessions over the course of 3 weeks. The intervention aims to reduce HIV risk taking related to sex risk and alcohol and drug use. | Behavioural | MILE group sessions |
Primary outcome
Condom use
Time frame: Last 3 months
This measure captures the percentage of times that participants self-report using a condom during vaginal and anal sex.
Sex under the influence of alcohol and drugs
Time frame: Last 3 months
Self-reported vaginal or anal sex while under the influence of alcohol or drugs.
Number of sex partners
Time frame: Last 3 month
Participant's self-report of number of sex partners in the last 3 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 12 Oct 2018.
- Results publication: PubMed 29541914Dangerfield DT 2nd, Harawa NT, Smith LR, Jeffries WL 4th, Baezconde-Garbanati L, Bluthenthal R. Latent Classes of Sexual Risk Among Black Men Who Have Sex with Men and Women. Arch Sex Behav. 2018 Oct;47(7):2071-2080. doi: 10.1007/s10508-017-1142-y. Epub 2018 Mar 14.
- Results publication: PubMed 29541962Harawa NT, Guentzel-Frank H, McCuller WJ, Williams JK, Millet G, Belcher L, Joseph HA, Bluthenthal RN. Efficacy of a Small-Group Intervention for Post-Incarcerated Black Men Who Have Sex with Men and Women (MSMW). J Urban Health. 2018 Apr;95(2):159-170. doi: 10.1007/s11524-018-0227-9.
- Results publication: PubMed 29124541Joseph HA, Pan Y, Mendoza M, Harawa NT, Lauby J, Hosek SG, Bluthenthal RN, Milnamow M, Fernandez MI, Jeffries WL 4th, Belcher L, Millett GA. HIV Acquisition and Transmission Potential Among African American Men Who Have Sex with Men and Women in Three U.S. Cities. Arch Sex Behav. 2018 Jan;47(1):183-194. doi: 10.1007/s10508-017-1052-z. Epub 2017 Nov 9.
- Results publication: PubMed 27115618Li MJ, Frank HG, Harawa NT, Williams JK, Chou CP, Bluthenthal RN. Racial Pride and Condom Use in Post-Incarcerated African-American Men Who Have Sex With Men and Women: Test of a Conceptual Model for the Men in Life Environments Intervention. Arch Sex Behav. 2018 Jan;47(1):169-181. doi: 10.1007/s10508-016-0734-2. Epub 2016 Apr 26.
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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.
Ricky Bluthenthal, Ph.D. principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MILE intervention in people with HIV and Risk Reduction Behavior, run by University of Southern California 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 8 inclusion and 3 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 12 Oct 2018. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Condom use (time frame: Last 3 months). The study lists 3 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 NCT01427543, which also lists 4 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 12 Oct 2018.