Randomized Control Trial of Family-Based HIV Prevention for Latinos

HIV Clinical Trial

— LatinoSTYLE  

Official title:

A Randomized Controlled Trial of Family-Based HIV Prevention for Latino Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635335
• Other study ID #: 5R01MH087232
• Secondary ID: 5R01MH087232
• Status: Completed
• Phase: Phase 2
• First received: June 30, 2012
• Last updated: September 20, 2016
• Start date: August 2010
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 542
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV
• Sexually Transmitted Diseases
• Sexually Transmitted Infections

Intervention

Behavioral:
• Latino STYLE
7-hour family-based workshop with 3-hour follow-up booster 3 months later

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sexual activity status		baseline and 3, 6, 12, and 18 months post-intervention	No
Secondary	Change in Unprotected Sex Acts	change in the number of incidences of unprotected vaginal or anal intercourse	baseline and 3, 6, 12, and 18 months post-intervention	No
Secondary	Change in intentions to use condoms		baseline and 3, 6, 12, and 18 months post-intervention	No
Secondary	Change in parent-adolescent communication		baseline and 3, 6, 12, and 18 months post-intervention	No
Secondary	change in parental monitoring of adolescent		baseline and 3, 6, 12, and 18 months post-intervention	No

External Links

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