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Risk Reduction Behavior | HIV Prevention Among Latino MSM: Evaluation of a Locally Developed Intervention

Risk Reduction Behavior research study

What is the primary objective of 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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Risk Reduction Behavior

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral: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.

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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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 interventionThe 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.

Study Status

Completed

Start Date: August 2012

Completed Date: August 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Increased self-reported consistent use of condoms during sexual intercourse

Secondary Outcome: Increased self-reported use of HIV and sexually transmitted disease (STD) counseling, testing, and treatment services

Study sponsors, principal investigator, and references

Principal Investigator: Scott D Rhodes, PhD

Lead Sponsor: Centers for Disease Control and Prevention

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01626898

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