HIV InfectionsNCT00690976
Proyecto SOL: A Risk Reduction Intervention for Hispanic Men Who Have Sex With Men (MSM)
A study testing Proyecto SOL and HCT in people with HIV Infections, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
The purpose of this project is to determine the acceptability, feasibility, and the preliminary efficacy of an HIV prevention behavioral intervention (Proyecto SOL) to reduce behaviors associated with HIV acquisition among Hispanic men who have sex with men (HMSM). Read more about this study
- Who is it for?
- Ages 18 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Proyecto SOL and HCT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Mar 2010
- 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 49 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- self-identify as Hispanic or Latino;
- be between 18 and 49 years of age;
- be a resident of South Florida (Miami-Dade, Broward or Palm Beach counties) and not planning to move out of the area for the next 9 months;
- self-identify as male;
- have had at least one episode of unprotected anal sex with a man in the preceding 3 months;
- have had 2 or more male sex partners in the preceding 3 months;
Show all 9Show fewer
- be HIV negative or of unknown serostatus;
- speak English and/or Spanish;
- provide informed consent.
Who cannot join
- have previously participated in any Phase of this study;
- self-identify as transgender;
- not being a resident of South Florida.
Trial locations and contacts
1 site in 1 country.
United States1 site
NOVA Southeastern University
Fort Lauderdale, Florida, 33328-2018
About this study
Official title: Proyecto SOL: A Risk Reduction Intervention for Hispanic MSM
The purpose of this project is to determine the acceptability, feasibility, and the preliminary efficacy of an HIV prevention behavioral intervention (Proyecto SOL) to reduce behaviors associated with HIV acquisition among Hispanic men who have sex with men (HMSM). The primary goal of the intervention is to motivate and assist participants in forming and carrying out a "Safer Options for Life" plan, thereby reducing their risk of HIV acquisition or transmission.
- Conditions
- HIV Infections
- Being tested
- Proyecto SOL, HCT
- Keywords
- HIV Seronegativity, HIV risk behavior, Unprotected sex, men who have sex with men, gay, Latino, Unsafe Sex
- Medical subject headings
- HIV Infections, Unsafe Sex, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proyecto SOLBehavioural
Group intervention
HCTBehavioural
Offer of HIV counseling and testing
| Study group | Role | What they receive |
|---|---|---|
| 1.Group Intervention | Experimental | A group-based intervention consisting of 4 sessions lasting approximately 90 minutes each. Using a variety of pedagogical and interactive approaches, facilitators will introduce new concepts and skills. Receives: Behavioral: Proyecto SOL |
| 2. HCT | Active comparator | Offer of HIV counseling and testing Receives: Behavioral: HCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unprotected sex
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2010
- Study completionMar 2010
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Nova Southeastern University, University of Miami, DePaul University
- Investigators
- Isa Fernandez, PhD, Principal investigator, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690976
- Sponsor's protocol ID
- CDC-NCHHSTP-5123
- Status last verified
- Mar 2010
- First submitted
- 3 Jun 2008
- Last updated
- 11 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proyecto SOL: A Risk Reduction Intervention for Hispanic MSM
- ClinicalTrials.gov ID
- NCT00690976
- Acronym / sponsor ID
- CDC-NCHHSTP-5123
- Conditions
- HIV Infections
- Keywords
- HIV Seronegativity, HIV risk behavior, Unprotected sex, men who have sex with men, gay, Latino, Unsafe Sex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Nova Southeastern University, University of Miami, DePaul University
- Study start
- Jul 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 5 Jun 2008 (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 project is to determine the acceptability, feasibility, and the preliminary efficacy of an HIV prevention behavioral intervention (Proyecto SOL) to reduce behaviors associated with HIV acquisition among Hispanic men who have sex with men (HMSM). The primary goal of the intervention is to motivate and assist participants in forming and carrying out a "Safer Options for Life" plan, thereby reducing their risk of HIV acquisition or transmission.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.Group Intervention | Experimental | Behavioral: Proyecto SOLA group-based intervention consisting of 4 sessions lasting approximately 90 minutes each. Using a variety of pedagogical and interactive approaches, facilitators will introduce new concepts and skills. |
| 2. HCT | Active comparator | Behavioral: HCTOffer of HIV counseling and testing |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- self-identify as Hispanic or Latino;
- be between 18 and 49 years of age;
- be a resident of South Florida (Miami-Dade, Broward or Palm Beach counties) and not planning to move out of the area for the next 9 months;
- self-identify as male;
- have had at least one episode of unprotected anal sex with a man in the preceding 3 months;
Key exclusion criteria (3 listed)
- have previously participated in any Phase of this study;
- self-identify as transgender;
- not being a resident of South Florida.
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 |
|---|---|---|
| Proyecto SOLGroup intervention | Behavioural | 1.Group Intervention |
| HCTOffer of HIV counseling and testing | Behavioural | 2. HCT |
Primary outcome
Unprotected sex
Time frame: three 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 11 Mar 2010.
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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.
Isa 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 Proyecto SOL and HCT in people with HIV Infections, run by Centers for Disease Control and Prevention 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 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 11 Mar 2010. 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?
Unprotected sex (time frame: three 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 11 Mar 2010.