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

Primary Purpose

HIV, Sexually Transmitted Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Latino STYLE
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring HIV prevention, adolescents, Latinos, Hispanics, family, health promotion, disease prevention, family communication, parental supervision

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of South Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HIV-specific

General Health Promotion

Arm Description

7-hour multiple family workshop focused on providing information and skills related to HIV prevention. Specific focus on parent-adolescent communication and parental monitoring.

7-hour multiple family workshop focused on providing information related to various adolescent health risk behaviors, including smoking, alcohol, violence, nutrition, and exercise.

Outcomes

Primary Outcome Measures

Change in sexual activity status

Secondary Outcome Measures

Change in Unprotected Sex Acts
change in the number of incidences of unprotected vaginal or anal intercourse
Change in intentions to use condoms
Change in parent-adolescent communication
change in parental monitoring of adolescent

Full Information

First Posted
June 30, 2012
Last Updated
September 20, 2016
Sponsor
University of South Florida
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01635335
Brief Title
Randomized Control Trial of Family-Based HIV Prevention for Latinos
Acronym
LatinoSTYLE
Official Title
A Randomized Controlled Trial of Family-Based HIV Prevention for Latino Youth
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Florida
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The proposed project will test an HIV prevention intervention for Latino parent-adolescents dyads. This randomized controlled trial will: Recruit and randomize 320 parent-adolescent dyads into a Latino family-based HIV prevention intervention or a family-based General Health Promotion condition. 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. 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. 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: 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. 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. Religiosity, acculturation, cultural values, and sexual socialization will have meaningful associations with the primary outcomes and will act as moderators of intervention impact.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Sexually Transmitted Infections
Keywords
HIV prevention, adolescents, Latinos, Hispanics, family, health promotion, disease prevention, family communication, parental supervision

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
542 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIV-specific
Arm Type
Experimental
Arm Description
7-hour multiple family workshop focused on providing information and skills related to HIV prevention. Specific focus on parent-adolescent communication and parental monitoring.
Arm Title
General Health Promotion
Arm Type
Active Comparator
Arm Description
7-hour multiple family workshop focused on providing information related to various adolescent health risk behaviors, including smoking, alcohol, violence, nutrition, and exercise.
Intervention Type
Behavioral
Intervention Name(s)
Latino STYLE
Intervention Description
7-hour family-based workshop with 3-hour follow-up booster 3 months later
Primary Outcome Measure Information:
Title
Change in sexual activity status
Time Frame
baseline and 3, 6, 12, and 18 months post-intervention
Secondary Outcome Measure Information:
Title
Change in Unprotected Sex Acts
Description
change in the number of incidences of unprotected vaginal or anal intercourse
Time Frame
baseline and 3, 6, 12, and 18 months post-intervention
Title
Change in intentions to use condoms
Time Frame
baseline and 3, 6, 12, and 18 months post-intervention
Title
Change in parent-adolescent communication
Time Frame
baseline and 3, 6, 12, and 18 months post-intervention
Title
change in parental monitoring of adolescent
Time Frame
baseline and 3, 6, 12, and 18 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celia Lescano, Ph.D.
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32330945
Citation
Lescano CM, Castillo HL, Calcano E, Mayor M, Porter M, Rivera-Torgerson Y, Dion C, Marhefka SL, Barker D, Brown LK; Latino STYLE Research Group. Latino STYLE: Preliminary Findings From an HIV Prevention RCT Among Latino Youth. J Pediatr Psychol. 2020 May 1;45(4):411-422. doi: 10.1093/jpepsy/jsaa019.
Results Reference
derived
Links:
URL
http://www.facebook.com/projectlatinoSTYLE
Description
related info

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Randomized Control Trial of Family-Based HIV Prevention for Latinos

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