HIV Prevention Among Latino MSM: Evaluation of a Locally Developed Intervention

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2012 by Centers for Disease Control and Prevention
Sponsor:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01626898
First received: June 21, 2012
Last updated: June 22, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Risk Reduction Behavior
Behavioral: HOLA en Grupos
Behavioral: General Health intervention (comparison intervention )

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: HIV Prevention Among Latino MSM: Evaluation of a Locally Developed Intervention

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Increased self-reported consistent use of condoms during sexual intercourse [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Increased self-reported use of HIV and sexually transmitted disease (STD) counseling, testing, and treatment services [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: August 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HOLA en Grupos
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.
Behavioral: HOLA en Grupos
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.
Active Comparator: General health 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.
Behavioral: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626898

Contacts
Contact: Scott D Rhodes, PhD 336-713-5080 srhodes@wakehealth.edu
Contact: Cynthia Miller 336-713-5080 cytmiller@wakehealth.edu

Locations
United States, North Carolina
Wake Forest University Health Sciences Not yet recruiting
Winston-Salem, North Carolina, United States, 27157-1063
Principal Investigator: Scott D Rhodes, PhD         
Sponsors and Collaborators
Investigators
Study Director: Scott D Rhodes, PhD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01626898     History of Changes
Other Study ID Numbers: U01PS001570
Study First Received: June 21, 2012
Last Updated: June 22, 2012
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on July 20, 2014