SyphilisPhase 1/2NCT00207506
Lay Health Advisors for Sexually Transmitted Disease Prevention
A Phase 1/2 study testing HoMBReS: A lay health advisor approach to STD prevention in people with Syphilis and Gonorrhea, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
Non-professional community leaders may be at a great advantage in reaching otherwise hard to reach populations for the purpose of advising on sexually transmitted disease (STD) prevention (lay health advisors), health care access, and model health behavior. 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
- Syphilis, Gonorrhea, Chlamydia Infections
- What is being tested?
- HoMBReS: A lay health advisor approach to STD prevention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 354 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Oct 2007
- Phase
- Phase 1/2
- 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
- LHA (lay health advisor) and participants:
- To be eligible for participation in this study as a lay health advisor (LHA), an LHA must:
- self-identify as Latino or Hispanic;
- work as a migrant or seasonal farmworker;
- be a member of the Liga Hispana de Fútbol de NC;
- be 18 years of age;
- be literate in Spanish; and
- provide informed consent.
Who cannot join
- Based on the characteristics of the league population, the researchers anticipate that few potential LHAs or participants will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: HoMBReS: A Lay Health Advisor Approach to Sexually Transmitted Disease Prevention
Non-professional community leaders may be at a great advantage in reaching otherwise hard to reach populations for the purpose of advising on sexually transmitted disease (STD) prevention (lay health advisors), health care access, and model health behavior. Latino migrant farm workers are at increased risk for STD and might benefit from such lay health advisors. The study will examine whether this strategy is a useful one for STD prevention in Latino migrant farm workers in rural and small town areas of North Carolina.
Read the detailed description
This is a demonstration project which includes the development, implementation, and evaluation of HoMBReS: Hombres Manteniendo Bienestar y Relaciones Saludables (Men Maintaining Wellness and Healthy Relationships). Applying a community-based participatory research (CBPR) approach, this 3-year study uses a quasi-experimental delayed-intervention comparison group design to assess the feasibility of implementing and the potential efficacy of an adult soccer league-based lay health advisor intervention. The intervention is designed to: reduce sexual risk behaviors among Latino seasonal farmworkers; enhance access to sexually transmitted disease/HIV healthcare services; and develop effective data collection methods among Latino men.
- Conditions
- Syphilis, Gonorrhea, Chlamydia Infections, HIV Infections
- Being tested
- HoMBReS: A lay health advisor approach to STD prevention
- Keywords
- Latino, Lay Health, Access, Prevention, HIV Seronegativity, HIV
- Medical subject headings
- Syphilis, Gonorrhea, Chlamydia Infections, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HoMBReS: A lay health advisor approach to STD preventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced STD morbidity
Reduced risk behavior
Secondary outcomes (1)
Improved access to services
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyphilisStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Scott Rhodes, PhD, Principal investigator, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207506
- Sponsor's protocol ID
- CDC-NCHSTP-4337
- Other IDs
- U36/CCU300860
- Status last verified
- Sep 2012
- First submitted
- 13 Sep 2005
- Last updated
- 11 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HoMBReS: A Lay Health Advisor Approach to Sexually Transmitted Disease Prevention
- ClinicalTrials.gov ID
- NCT00207506
- Acronym / sponsor ID
- CDC-NCHSTP-4337
- Conditions
- Syphilis, Gonorrhea, Chlamydia Infections, HIV Infections
- Keywords
- Latino, Lay Health, Access, Prevention, HIV Seronegativity, HIV
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Oct 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 21 Sep 2005 (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.
Non-professional community leaders may be at a great advantage in reaching otherwise hard to reach populations for the purpose of advising on sexually transmitted disease (STD) prevention (lay health advisors), health care access, and model health behavior. Latino migrant farm workers are at increased risk for STD and might benefit from such lay health advisors. The study will examine whether this strategy is a useful one for STD prevention in Latino migrant farm workers in rural and small town areas of North Carolina.
Detailed description
This is a demonstration project which includes the development, implementation, and evaluation of HoMBReS: Hombres Manteniendo Bienestar y Relaciones Saludables (Men Maintaining Wellness and Healthy Relationships). Applying a community-based participatory research (CBPR) approach, this 3-year study uses a quasi-experimental delayed-intervention comparison group design to assess the feasibility of implementing and the potential efficacy of an adult soccer league-based lay health advisor intervention. The intervention is designed to: reduce sexual risk behaviors among Latino seasonal farmworkers; enhance access to sexually transmitted disease/HIV healthcare services; and develop effective data collection methods among Latino men.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- To be eligible for participation in this study as a lay health advisor (LHA), an LHA must:
Key exclusion criteria (1 listed)
- Based on the characteristics of the league population, the researchers anticipate that few potential LHAs or participants will be excluded.
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 |
|---|---|---|
| HoMBReS: A lay health advisor approach to STD prevention | Behavioural | – |
Primary outcome
Reduced STD morbidity
Reduced risk behavior
1 secondary outcome
Improved access to services
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 Sep 2012.
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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.
Scott Rhodes, PhD principal investigator
Wake Forest University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HoMBReS: A lay health advisor approach to STD prevention in people with Syphilis and Gonorrhea, 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 8 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 11 Sep 2012. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Reduced STD morbidity. The study lists 2 primary outcomes in all. 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 Sep 2012.