HIV InfectionsMotiv82ChangeNCT00877695
Motiv82Change: an HIV Prevention Study for Young Latino Men
A study testing Entre Culturas: Navigating Culture, Identity, and HIV Risk in people with HIV Infections, run by Nova Southeastern University at 1 site in United States.
Trial summary
The purpose of this study is to develop and pilot test a culturally and developmentally tailored Motivational Enhancement Intervention (MEI) to reduce risky sex (unprotected anal sex and multiple partners) among young Hispanic men who have sex with men (YHMSM). 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
- HIV Infections
- What is being tested?
- Entre Culturas: Navigating Culture, Identity, and HIV Risk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jun 2012
- 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
- To be eligible, participants must:
- be male;
- self-identify as Hispanic/Latino;
- be 18 - 29 years of age;
- live in South Florida;
- have had at least 1 episode of unprotected anal sex with a man in the last 6 months;
Show all 9Show fewer
- have had at least 2 male sex partners in the last 6 months;
- be HIV negative or not known to be HIV positive; and
- have not previously participated in this study.
Who cannot join
- 1. living with HIV infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Nova Southeastern University (Miami Office)
Miami, Florida, 33137
About this study
Official title: Young Hispanic Men "Entre Culturas": Navigating Culture, Identity and HIV Risk
The purpose of this study is to develop and pilot test a culturally and developmentally tailored Motivational Enhancement Intervention (MEI) to reduce risky sex (unprotected anal sex and multiple partners) among young Hispanic men who have sex with men (YHMSM).
Read the detailed description
Stage 1, divided into Stage 1a and Stage 1b, focuses on development, refinement, and pilot testing of interventions. The formative research leading to and including intervention development is completed in Stage 1a. A pilot study to provide acceptability/feasibility data and obtain effect size estimates of the intervention's strength in changing a desired outcome is conducted in Stage 1b. If Stage 1b results are "promising," the intervention moves to full scale efficacy testing in Stage 2 using the classic experimental design of a randomized control trial (RCT). The intervention is ready for Stage 3 effectiveness testing only after its efficacy has been demonstrated in at least two Stage 2 trials.
- Conditions
- HIV Infections
- Being tested
- Entre Culturas: Navigating Culture, Identity, and HIV Risk
- Keywords
- HIV, HIV Seronegativity, prevention, Hispanic, Latino, MSM, men
- Medical subject headings
- HIV Infections, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entre Culturas: Navigating Culture, Identity, and HIV RiskBehavioural
Also called Young Hispanic MSM, HIV prevention interventions, Motiv8 2Change
A pilot test of a culturally and developmentally tailored MEI to reduce risky sex (unprotected anal sex and multiple partners) among young Hispanic men who have sex with men (YHMSM) to be delivered face-to-face (FtF) and through the Internet using a real-time implementation approach. A tailored MEI for two delivery modalities, and a health education control (HEALTH) comparable in time and number of sessions. We will test the MEI's acceptability and feasibility, obtain effect size estimates of the intervention's strength to reduce risky sex, and determine if it is ready for efficacy testing.
| Study group | Role | What they receive |
|---|---|---|
| Motive8 2 Change FtF | Experimental | This arm of the motivational enhancement intervention (MEI) will be delivered face to face (FtF) using a real-time, dynamic implementation approach. The intervention consisted of 2 sessions lasting approximately 60 to 90 minutes. The sessions focused on increasing participants' awareness of the multiple influences on behaviors from self, family, culture and community and how these influences impact the way we think and behave including sexually. Through a series of exercises the participant develops strategies for understanding and managing his own triggers that helps them to make healthy life choices. Both Motiv8 2Change arms used the exact same intervention, with the exception that one was delivered face to face and the other through the internet. Receives: Behavioral: Entre Culturas: Navigating Culture, Identity, and HIV Risk |
| Motive8 2Change -Internet | Experimental | This arm of the motivational enhancement intervention (MEI) will be delivered via the Internet face to face (FtF) using a real-time, dynamic implementation approach.The intervention consisted of 2 sessions lasting approximately 60 to 90 minutes. The sessions focused on increasing participants' awareness of the multiple influences on behaviors from self, family, culture and community and how these influences impact the way we think and behave including sexually. Through a series of exercises the participant develops strategies for understanding and managing his own triggers that helps them to make healthy life choices. Both Motiv8 2Change arms used the exact same intervention, with the exception that one was delivered face to face and the other through the internet. Receives: Behavioral: Entre Culturas: Navigating Culture, Identity, and HIV Risk |
| delayed | No intervention | Not described |
| Motiv8 2Change Careers | Active comparator | Comparable in number of sessions and duration to the experimental arms, but focused on resume development and interviewing skills. This arm consisted of 2 sessions. In the first session participants reviewed different career choices and created a winning resume. The second session focused on job interviewing skills. It included role plays with feedback. It also contains ethically mandated information regarding HIV prevention. It was delivered on line by a trained facilitator. Receives: Behavioral: Entre Culturas: Navigating Culture, Identity, and HIV Risk |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome measure for the Stage 1b trial will be reduction in at least one of the two main outcome variables - number of unprotected anal sex acts and number of sex partners (both in the last 3 months).
Measured: 16 months
Secondary outcomes (1)
acceptability and feasibility of the intervention
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startAug 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M. Isabel Fernandez, PhD, Principal investigator, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877695
- Sponsor's protocol ID
- Entre Culturas
- Acronym
- Motiv82Change
- Status last verified
- Feb 2013
- First submitted
- 6 Apr 2009
- Last updated
- 4 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Young Hispanic Men "Entre Culturas": Navigating Culture, Identity and HIV Risk
- ClinicalTrials.gov ID
- NCT00877695
- Acronym / sponsor ID
- Motiv82Change / Entre Culturas
- Conditions
- HIV Infections
- Keywords
- HIV, HIV Seronegativity, prevention, Hispanic, Latino, MSM, men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 8 Apr 2009 (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 develop and pilot test a culturally and developmentally tailored Motivational Enhancement Intervention (MEI) to reduce risky sex (unprotected anal sex and multiple partners) among young Hispanic men who have sex with men (YHMSM).
Detailed description
Stage 1, divided into Stage 1a and Stage 1b, focuses on development, refinement, and pilot testing of interventions. The formative research leading to and including intervention development is completed in Stage 1a. A pilot study to provide acceptability/feasibility data and obtain effect size estimates of the intervention's strength in changing a desired outcome is conducted in Stage 1b. If Stage 1b results are "promising," the intervention moves to full scale efficacy testing in Stage 2 using the classic experimental design of a randomized control trial (RCT). The intervention is ready for Stage 3 effectiveness testing only after its efficacy has been demonstrated in at least two Stage 2 trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Motive8 2 Change FtF | Experimental | Behavioral: Entre Culturas: Navigating Culture, Identity, and HIV RiskThis arm of the motivational enhancement intervention (MEI) will be delivered face to face (FtF) using a real-time, dynamic implementation approach. The intervention consisted of 2 sessions lasting approximately 60 to 90 minutes. The sessions focused on increasing participants' awareness of the multiple influences on behaviors from self, family, culture and community and how these influences impact the way we think and behave including sexually. Through a series of exercises the participant develops strategies for understanding and managing his own triggers that helps them to make healthy life choices. Both Motiv8 2Change arms used the exact same intervention, with the exception that one was delivered face to face and the other through the internet. |
| Motive8 2Change -Internet | Experimental | Behavioral: Entre Culturas: Navigating Culture, Identity, and HIV RiskThis arm of the motivational enhancement intervention (MEI) will be delivered via the Internet face to face (FtF) using a real-time, dynamic implementation approach.The intervention consisted of 2 sessions lasting approximately 60 to 90 minutes. The sessions focused on increasing participants' awareness of the multiple influences on behaviors from self, family, culture and community and how these influences impact the way we think and behave including sexually. Through a series of exercises the participant develops strategies for understanding and managing his own triggers that helps them to make healthy life choices. Both Motiv8 2Change arms used the exact same intervention, with the exception that one was delivered face to face and the other through the internet. |
| delayed | No intervention | – |
| Motiv8 2Change Careers | Active comparator | Behavioral: Entre Culturas: Navigating Culture, Identity, and HIV RiskComparable in number of sessions and duration to the experimental arms, but focused on resume development and interviewing skills. This arm consisted of 2 sessions. In the first session participants reviewed different career choices and created a winning resume. The second session focused on job interviewing skills. It included role plays with feedback. It also contains ethically mandated information regarding HIV prevention. It was delivered on line by a trained facilitator. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- be male;
- self-identify as Hispanic/Latino;
- be 18 - 29 years of age;
- live in South Florida;
- have had at least 1 episode of unprotected anal sex with a man in the last 6 months;
Key exclusion criteria (1 listed)
- 1. living with HIV infection
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 |
|---|---|---|
| Entre Culturas: Navigating Culture, Identity, and HIV RiskAlso: Young Hispanic MSM, HIV prevention interventions, Motiv8 2ChangeA pilot test of a culturally and developmentally tailored MEI to reduce risky sex (unprotected anal sex and multiple partners) among young Hispanic men who have sex with men (YHMSM) to be delivered face-to-face (FtF) and through the Internet using a real-time implementation approach. A tailored MEI for two delivery modalities, and a health education control (HEALTH) comparable in time and number of sessions. We will test the MEI's acceptability and feasibility, obtain effect size estimates of the intervention's strength to reduce risky sex, and determine if it is ready for efficacy testing. | Behavioural | Motiv8 2Change Careers, Motive8 2 Change FtF, Motive8 2Change -Internet |
Primary outcome
The main outcome measure for the Stage 1b trial will be reduction in at least one of the two main outcome variables - number of unprotected anal sex acts and number of sex partners (both in the last 3 months).
Time frame: 16 months
1 secondary outcome
acceptability and feasibility of the intervention
Time frame: 16 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 4 Mar 2013.
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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.
M. Isabel Fernandez, PhD principal investigator
Nova Southeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Entre Culturas: Navigating Culture, Identity, and HIV Risk in people with HIV Infections, run by Nova Southeastern University 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 9 inclusion and 1 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 4 Mar 2013. 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?
The main outcome measure for the Stage 1b trial will be reduction in at least one of the two main outcome variables - number of unprotected anal sex acts and number of sex partners (both in the last 3 months). (time frame: 16 months). 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 4 Mar 2013.