Risk Reduction BehaviorNCT01626898
HIV Prevention Among Latino MSM: Evaluation of a Locally Developed Intervention
A study testing HOLA en Grupos and General Health intervention (comparison intervention ) in people with Risk Reduction Behavior, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
Wake Forest University is partnering with Chatham Social Health Council (a community-based organization) to conduct a randomized controlled trial to evaluate the efficacy of Hombres Ofreciendo Liderazgo y Apoyo (HOLA) en Grupos (Men Giving Leadership and Support in Groups), a Spanish-language HIV risk 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
- Risk Reduction Behavior
- What is being tested?
- HOLA en Grupos and General Health intervention (comparison intervention )
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male gender
- Self-identify as Latino or Hispanic
- 18 years of age or older
- Speak Spanish
- Have had sex with another man since attaining age 18
- Have not participated in HOLA, HOLA en Grupos, HoMBReS or other Latino Partnership interventions developed and delivered by the Chatham Social Health Council or Wake Forest University during the past 12 months
Who cannot join
- Have had sex with at least one woman since attaining age 18 but who have not had sex with at least one man since attaining age 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157-1063
About this study
Wake Forest University is partnering with Chatham Social Health Council (a community-based organization) to conduct a randomized controlled trial to evaluate the efficacy of Hombres Ofreciendo Liderazgo y Apoyo (HOLA) en Grupos (Men Giving Leadership and Support in Groups), a Spanish-language HIV risk behavior intervention for Latino men who have sex with men (MSM) in rural North Carolina.
Participants in the HOLA intervention, when compared to those in the comparison intervention, will report: increased consistent use of condoms during sexual intercourse; increased use of HIV and sexually transmitted disease (STD) counseling, testing, and treatment services; greater knowledge concerning the impact of HIV on communities (including Latino and MSM)and HIV risk behaviors and prevention strategies; more positive attitudes towards abstinence and condom use; increased self-efficacy to use and assert the use of condoms with sex partners; increased condom-use mastery scores; decreased barriers to risk reduction (e.g. health-compromising aspects of machismo); and enhanced partner and provider communication and sexual negotiation skills.
Read the detailed description
Wake Forest University is partnering with Chatham Social Health Council to conduct a randomized controlled trial to evaluate the efficacy of Hombres Ofreciendo Liderazgo y Apoyo (HOLA) en Grupos (Men Giving Leadership and Support in Groups) HIV risk behavior intervention for Latino men who have sex with men (MSM), ages 18 and over, in rural North Carolina.
The Spanish language HOLA en Grupos was developed by the Chatham Social Health Council in close collaboration and partnership with the local Latino community, including Latino MSM, and representatives from a local community-based participatory research (CBPR) partnership that has been in existence for nearly ten years, and has been delivered by the Council to Latino MSM in an area the includes 6 largely rural counties for two years.
HOLA en Grupos consists of four 4-hour group sessions that combine presentations by facilitators who are trained Latino MSM community members, activities, and scenes from a DVD, and is delivered over a period of two weeks to groups of about 10 participants. HOLA en Grupos was designed to increase HIV prevention knowledge, condom use and mastery, decrease barriers to risk reduction (e.g., health-compromising aspects of machismo), enhance sexual negotiation skills, and increase use of HIV testing, counseling, and treatment services among intervention participants.
The Spanish language comparison condition consists of four 4-hour group sessions designed to increase participants' knowledge about cancer, diabetes, alcohol abuse, and cardiovascular disease, and is delivered over a period of two weeks to groups of about 10 participants. The content focus of the comparison condition reflects the desire of community partners to provide this type of information to community members.
A total of 300 Latino MSM (150 per condition) will be screened and if eligible, recruited in waves of 20 men (10 per condition). Eligible individuals must self-identify as Latino or Hispanic, be ≥ 18 years of age, report MSM behavior since age ≥ 18, and provide informed consent. Individuals who have participated in the HOLA en Grupos, or interventions for Latino heterosexual men (HoMBReS or HoMBReS-2), will be excluded from the study. Study assessments will be conducted at baseline and 6-month follow-up.
- Conditions
- Risk Reduction Behavior
- Being tested
- HOLA en Grupos, General Health intervention (comparison intervention )
- Medical subject headings
- Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOLA en GruposBehavioural
HOLA en Grupos consists of four 4-hour group sessions that combine presentations by facilitators who are trained Latino MSM community members, activities, and scenes from a DVD, and is delivered over a period of two weeks to groups of about 10 participants. HOLA en Grupos is designed to increase HIV prevention knowledge, condom use and mastery, decrease barriers to risk reduction (e.g., health-compromising aspects of machismo), enhance sexual negotiation skills, and increase use of HIV testing, counseling, and treatment services among intervention participants.
General Health intervention (comparison intervention )Behavioural
The Spanish comparison condition consists of four Spanish-language 4-hour group sessions designed to increase participants' knowledge about cancer, diabetes, alcohol abuse, and cardiovascular disease, and is delivered over a period of two weeks to groups of about 10 participants.
| Study group | Role | What they receive |
|---|---|---|
| HOLA en Grupos | Experimental | The Spanish language HOLA en Grupos intervention consists of four 4-hour group sessions that combine presentations by facilitators who are trained Latino MSM community members, activities, and scenes from a DVD, and is delivered over a period of two weeks to groups of about 10 participants. Receives: Behavioral: HOLA en Grupos |
| General health intervention | Active comparator | The Spanish language comparison condition consists of four 4-hour group sessions designed to increase participants' knowledge about cancer, diabetes, alcohol abuse, and cardiovascular disease, and is delivered over a period of two weeks to groups of about 10 participants. Receives: Behavioral: General Health intervention (comparison intervention ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased self-reported consistent use of condoms during sexual intercourse
Measured: 6 months post-intervention
Secondary outcomes (1)
Increased self-reported use of HIV and sexually transmitted disease (STD) counseling, testing, and treatment services
Measured: 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Risk Reduction BehaviorStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Scott D Rhodes, PhD, Study director, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626898
- Sponsor's protocol ID
- U01PS001570
- Status last verified
- Feb 2016
- First submitted
- 21 Jun 2012
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Rhodes SD, Alonzo J, Mann L, Song EY, Tanner AE, Arellano JE, Rodriguez-Celedon R, Garcia M, Freeman A, Reboussin BA, Painter TM. Small-Group Randomized Controlled Trial to Increase Condom Use and HIV Testing Among Hispanic/Latino Gay, Bisexual, and Other Men Who Have Sex With Men. Am J Public Health. 2017 Jun;107(6):969-976. doi: 10.2105/AJPH.2017.303814. Epub 2017 Apr 20.
PubMed 28426301
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Prevention Among Latino MSM: Evaluation of a Locally Developed Intervention
- ClinicalTrials.gov ID
- NCT01626898
- Acronym / sponsor ID
- U01PS001570
- Conditions
- Risk Reduction Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Aug 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 25 Jun 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.
Wake Forest University is partnering with Chatham Social Health Council (a community-based organization) to conduct a randomized controlled trial to evaluate the efficacy of Hombres Ofreciendo Liderazgo y Apoyo (HOLA) en Grupos (Men Giving Leadership and Support in Groups), a Spanish-language HIV risk behavior intervention for Latino men who have sex with men (MSM) in rural North Carolina.
Participants in the HOLA intervention, when compared to those in the comparison intervention, will report: increased consistent use of condoms during sexual intercourse; increased use of HIV and sexually transmitted disease (STD) counseling, testing, and treatment services; greater knowledge concerning the impact of HIV on communities (including Latino and MSM)and HIV risk behaviors and prevention strategies; more positive attitudes towards abstinence and condom use; increased self-efficacy to use and assert the use of condoms with sex partners; increased condom-use mastery scores; decreased barriers to risk reduction (e.g. health-compromising aspects of machismo); and enhanced partner and provider communication and sexual negotiation skills.
Detailed description
Wake Forest University is partnering with Chatham Social Health Council to conduct a randomized controlled trial to evaluate the efficacy of Hombres Ofreciendo Liderazgo y Apoyo (HOLA) en Grupos (Men Giving Leadership and Support in Groups) HIV risk behavior intervention for Latino men who have sex with men (MSM), ages 18 and over, in rural North Carolina.
The Spanish language HOLA en Grupos was developed by the Chatham Social Health Council in close collaboration and partnership with the local Latino community, including Latino MSM, and representatives from a local community-based participatory research (CBPR) partnership that has been in existence for nearly ten years, and has been delivered by the Council to Latino MSM in an area the includes 6 largely rural counties for two years.
HOLA en Grupos consists of four 4-hour group sessions that combine presentations by facilitators who are trained Latino MSM community members, activities, and scenes from a DVD, and is delivered over a period of two weeks to groups of about 10 participants. HOLA en Grupos was designed to increase HIV prevention knowledge, condom use and mastery, decrease barriers to risk reduction (e.g., health-compromising aspects of machismo), enhance sexual negotiation skills, and increase use of HIV testing, counseling, and treatment services among intervention participants.
The Spanish language comparison condition consists of four 4-hour group sessions designed to increase participants' knowledge about cancer, diabetes, alcohol abuse, and cardiovascular disease, and is delivered over a period of two weeks to groups of about 10 participants. The content focus of the comparison condition reflects the desire of community partners to provide this type of information to community members.
A total of 300 Latino MSM (150 per condition) will be screened and if eligible, recruited in waves of 20 men (10 per condition). Eligible individuals must self-identify as Latino or Hispanic, be ≥ 18 years of age, report MSM behavior since age ≥ 18, and provide informed consent. Individuals who have participated in the HOLA en Grupos, or interventions for Latino heterosexual men (HoMBReS or HoMBReS-2), will be excluded from the study. Study assessments will be conducted at baseline and 6-month follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HOLA en Grupos | Experimental | Behavioral: HOLA en GruposThe Spanish language HOLA en Grupos intervention consists of four 4-hour group sessions that combine presentations by facilitators who are trained Latino MSM community members, activities, and scenes from a DVD, and is delivered over a period of two weeks to groups of about 10 participants. |
| General health intervention | Active comparator | Behavioral: General Health intervention (comparison intervention )The Spanish language comparison condition consists of four 4-hour group sessions designed to increase participants' knowledge about cancer, diabetes, alcohol abuse, and cardiovascular disease, and is delivered over a period of two weeks to groups of about 10 participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male gender
- Self-identify as Latino or Hispanic
- 18 years of age or older
- Speak Spanish
- Have had sex with another man since attaining age 18
Key exclusion criteria (1 listed)
- Have had sex with at least one woman since attaining age 18 but who have not had sex with at least one man since attaining age 18
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 |
|---|---|---|
| HOLA en GruposHOLA en Grupos consists of four 4-hour group sessions that combine presentations by facilitators who are trained Latino MSM community members, activities, and scenes from a DVD, and is delivered over a period of two weeks to groups of about 10 participants. HOLA en Grupos is designed to increase HIV prevention knowledge, condom use and mastery, decrease barriers to risk reduction (e.g., health-compromising aspects of machismo), enhance sexual negotiation skills, and increase use of HIV testing, counseling, and treatment services among intervention participants. | Behavioural | HOLA en Grupos |
| General Health intervention (comparison intervention )The Spanish comparison condition consists of four Spanish-language 4-hour group sessions designed to increase participants' knowledge about cancer, diabetes, alcohol abuse, and cardiovascular disease, and is delivered over a period of two weeks to groups of about 10 participants. | Behavioural | General health intervention |
Primary outcome
Increased self-reported consistent use of condoms during sexual intercourse
Time frame: 6 months post-intervention
1 secondary outcome
Increased self-reported use of HIV and sexually transmitted disease (STD) counseling, testing, and treatment services
Time frame: 6 months post-intervention
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 3 Feb 2016.
- Derived from this study: PubMed 28426301Rhodes SD, Alonzo J, Mann L, Song EY, Tanner AE, Arellano JE, Rodriguez-Celedon R, Garcia M, Freeman A, Reboussin BA, Painter TM. Small-Group Randomized Controlled Trial to Increase Condom Use and HIV Testing Among Hispanic/Latino Gay, Bisexual, and Other Men Who Have Sex With Men. Am J Public Health. 2017 Jun;107(6):969-976. doi: 10.2105/AJPH.2017.303814. Epub 2017 Apr 20.
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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 D Rhodes, PhD study director
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOLA en Grupos and General Health intervention (comparison intervention ) in people with Risk Reduction Behavior, 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 6 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 3 Feb 2016. 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?
Increased self-reported consistent use of condoms during sexual intercourse (time frame: 6 months post-intervention). 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 NCT01626898, which also lists 1 linked publication.
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 3 Feb 2016; AzTrials last refreshed its copy on 8 Nov 2026.