NCT01626898

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

February 3, 2016

Status Verified

February 1, 2016

Enrollment Period

3 years

First QC Date

June 21, 2012

Last Update Submit

February 2, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Increased self-reported consistent use of condoms during sexual intercourse

    6 months post-intervention

Secondary Outcomes (1)

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

    6 months post-intervention

Study Arms (2)

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.

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.

Behavioral: General Health intervention (comparison intervention )

Interventions

HOLA en GruposBEHAVIORAL

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.

HOLA en Grupos

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.

General health intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male gender
  • Self-identify as Latino or Hispanic
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157-1063, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Scott D Rhodes, PhD

    Wake Forest University Health Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2012

First Posted

June 25, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

February 3, 2016

Record last verified: 2016-02

Locations