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Randomized Control Trial of Family-Based HIV Prevention for Latinos (LatinoSTYLE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of South Florida
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Celia Lescano, University of South Florida
ClinicalTrials.gov Identifier:
NCT01635335
First received: June 30, 2012
Last updated: September 30, 2014
Last verified: September 2014
  Purpose

The proposed project will test an HIV prevention intervention for Latino parent-adolescents dyads. This randomized controlled trial will:

  1. Recruit and randomize 320 parent-adolescent dyads into a Latino family-based HIV prevention intervention or a family-based General Health Promotion condition.
  2. Determine the efficacy of the Latino Family-based HIV prevention intervention from assessment of changes in HIV-related sexual behavior and attitudes over 18 months among a sample of 320 Latino parent-adolescent dyads.
  3. Determine the efficacy of the Latino Family-based HIV prevention intervention from assessment of changes in family relationships and parental monitoring/supervision over 18 months among a sample of 320 Latino parent-adolescent dyads.
  4. Examine the association of other important constructs, such as religiosity, acculturation, cultural values, and sexual socialization with the primary outcomes.

Based on a thorough review of the literature and preliminary data from a recent, small pilot study, the investigators hypotheses are:

  1. Compared to the General Health Promotion Control condition, the Family-Based HIV Prevention intervention will result in greater change with regard to primary outcome measures of safer sexual behavior (recent sexual activity, the number of unprotected sex acts, and intentions to use condoms) and safer HIV-related attitudes.
  2. Compared to the General Health Promotion Control condition, the Family-Based HIV Prevention intervention will result in greater change with regard to family relationships and parental monitoring/supervision through improved parent-child communication skills and they will mediate the intervention impact.
  3. Religiosity, acculturation, cultural values, and sexual socialization will have meaningful associations with the primary outcomes and will act as moderators of intervention impact.

Condition Intervention Phase
HIV
Sexually Transmitted Infections
Behavioral: Latino STYLE
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Family-Based HIV Prevention for Latino Youth

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Change in sexual activity status [ Time Frame: baseline and 3, 6, 12, and 18 months post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Unprotected Sex Acts [ Time Frame: baseline and 3, 6, 12, and 18 months post-intervention ] [ Designated as safety issue: No ]
    change in the number of incidences of unprotected vaginal or anal intercourse

  • Change in intentions to use condoms [ Time Frame: baseline and 3, 6, 12, and 18 months post-intervention ] [ Designated as safety issue: No ]
  • Change in parent-adolescent communication [ Time Frame: baseline and 3, 6, 12, and 18 months post-intervention ] [ Designated as safety issue: No ]
  • change in parental monitoring of adolescent [ Time Frame: baseline and 3, 6, 12, and 18 months post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 640
Study Start Date: August 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIV-specific
7-hour multiple family workshop focused on providing information and skills related to HIV prevention. Specific focus on parent-adolescent communication and parental monitoring.
Behavioral: Latino STYLE
7-hour family-based workshop with 3-hour follow-up booster 3 months later
Active Comparator: General Health Promotion
7-hour multiple family workshop focused on providing information related to various adolescent health risk behaviors, including smoking, alcohol, violence, nutrition, and exercise.
Behavioral: Latino STYLE
7-hour family-based workshop with 3-hour follow-up booster 3 months later

Detailed Description:

Latinos are disproportionately represented among those diagnosed with HIV and Latino adolescents are at risk for engaging in sexual behaviors that can lead to HIV. To date, data regarding HIV prevention interventions for Latino adolescents, as distinct from other ethnic groups, have been rare. Thus, an efficacious HIV prevention intervention is urgently needed for Latino adolescents. The current proposal is aimed at filling that gap by evaluating a newly developed family-based intervention that incorporates cultural constructs into the Social-Personal Framework.

This R01 builds on the Principal Investigator's NIMH-funded K Award, which piloted a culturally-specific family-based intervention with 80 Latino parent-adolescent dyads and demonstrates promising results. Extending this work, 320 Latino parent-adolescent dyads with an adolescent between the ages of 14 and 17 will be randomized into either the family based HIV prevention intervention or a family-based general health promotion control condition. In both conditions, the interventions will use a multi-family group format consisting of 6 to 8 parent and youth dyads in a one-day, 7-hour workshop. Both interventions employ activities for youth and parents separately (e.g., focus on adolescent vulnerability) and parents and adolescents together (e.g., address parent/adolescent communication). The project will determine the efficacy of the Latino Family-based HIV prevention intervention from assessment of changes in the adolescents' HIV-related sexual behavior and attitudes, gender and sexual socialization, parent-child communication, and parental monitoring. Measures will be completed at baseline and at 3, 6, 12, and 18 months post-intervention.

HIV/AIDS is a significant problem in the Latino community. Developing culturally sensitive HIV prevention interventions for Latino youth, in particular, is a public health priority. Family-based interventions are likely to be well received by the Latino population. Therefore, this project will examine the efficacy of a family-based HIV prevention intervention for Latino youth and parents to decrease the incidence of HIV among Latinos. Its innovation is in being one of the first to work with Latinos specifically in a family-based intervention where parents and adolescents come together to discuss important sexuality-related topics.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adolescents and parents self-identify as Latino/Hispanic
  • Adolescents between the ages of 14 and 17
  • Parent is Spanish-Speaking and feels comfortable speaking Spanish in groups
  • Adolescent is English-speaking and feels comfortable speaking English in groups
  • Adolescent meets behavioral inclusion criteria (not disclosed)

Exclusion Criteria:

  • Adolescent self-discloses HIV positive status
  • Currently or intending to be pregnant during the course of the study
  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: NCT01635335

Contacts
Contact: Celia Lescano, Ph.D. 813-974-1855 lescano@usf.edu

Locations
United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33612
Contact: Celia Lescano, PhD    813-974-1855    lescano@usf.edu   
Contact: Ercilia Calcano, MPH    813-974-9311    errodri3@usf.edu   
Principal Investigator: Celia Lescano, PhD         
Sub-Investigator: Stephanie Marhefka, PhD         
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Celia Lescano, Ph.D. University of South Florida
  More Information

Additional Information:
No publications provided

Responsible Party: Celia Lescano, Research Associate Professor, University of South Florida
ClinicalTrials.gov Identifier: NCT01635335     History of Changes
Other Study ID Numbers: 5R01MH087232, 5R01MH087232
Study First Received: June 30, 2012
Last Updated: September 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
HIV prevention
adolescents
Latinos
Hispanics
family
health promotion
disease prevention
family communication
parental supervision

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Genital Diseases, Female
Genital Diseases, Male
Infection
Virus Diseases

ClinicalTrials.gov processed this record on November 19, 2014