A Phase 2 interventional study of Latino STYLE in HIV and Sexually Transmitted Infections, sponsored by University of South Florida. Completed at 1 site in United States. Open to participants aged 14 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-21.
Sponsored by University of South Florida · Phase 2, Interventional, and Prevention
The proposed project will test an HIV prevention intervention for Latino parent-adolescents dyads. This randomized controlled trial will:
Based on a thorough review of the literature and preliminary data from a recent, small pilot study, the investigators hypotheses are:
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.
424 studies on the registry are indexed under Sexually Transmitted Diseases; 71 are open to participants now.
This study's enrollment of 542 is above the median of 470 across 346 interventional studies indexed under Sexually Transmitted Diseases.
Browse Sexually Transmitted Diseases studies →University of South Florida is the lead sponsor of 333 studies on the registry; 63 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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
Change in sexual activity status
Time frame: baseline and 3, 6, 12, and 18 months post-intervention
Change in Unprotected Sex Acts
change in the number of incidences of unprotected vaginal or anal intercourse
Time frame: baseline and 3, 6, 12, and 18 months post-intervention
Change in intentions to use condoms
Time frame: baseline and 3, 6, 12, and 18 months post-intervention
Change in parent-adolescent communication
Time frame: baseline and 3, 6, 12, and 18 months post-intervention
change in parental monitoring of adolescent
Time frame: baseline and 3, 6, 12, and 18 months post-intervention
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sexually Transmitted Diseases→
University of South Florida