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Family-Based HIV Prevention for Latinos

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ClinicalTrials.gov Identifier: NCT00582101
Recruitment Status : Completed
First Posted : December 28, 2007
Last Update Posted : June 6, 2012
Sponsor:
Information provided by (Responsible Party):
Celia Lescano, Ph.D., Rhode Island Hospital

Tracking Information
First Submitted Date  ICMJE December 19, 2007
First Posted Date  ICMJE December 28, 2007
Last Update Posted Date June 6, 2012
Study Start Date  ICMJE May 2007
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2008)
Number (#) of unprotected sex acts [ Time Frame: baseline, 3, and 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 27, 2007)
# of unprotected sex acts [ Time Frame: baseline, 3, and 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2007)
parent-child communication [ Time Frame: baseline, 3, and 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Family-Based HIV Prevention for Latinos
Official Title  ICMJE Family-Based HIV Prevention for Latinos
Brief Summary

The proposed project will develop and test an HIV prevention intervention for Latino families. This study will:

  1. Conduct a pilot "run-through" of an adapted family-based intervention with three cohorts (about 24 families) to determine the feasibility, acceptability, and appropriateness for the target population.
  2. Revise the family-based HIV prevention intervention based on the results of the pilot "run-through" and structured exit interviews.
  3. Recruit and randomize 100 families into the Latino family-based HIV prevention intervention or a general health promotion condition.
  4. Estimate the effect size of the Latino family-based HIV prevention intervention from assessment of changes in HIV-related sexual behavior and attitudes and parental monitoring/supervision over 6 months.

Based on a thorough review of the literature, the following is anticipated:

  1. The revised intervention will be feasible, acceptable, and appropriate for Latino families and will be enthusiastically received.
  2. The family-based HIV prevention intervention will result in safer adolescent sexual behavior, greater change with regard to primary outcome measures of behavior (recent sexual activity, the number of unprotected sex acts, proportion of condom use, and intentions to use condoms), safer HIV-related attitudes, improved parent-child communication skills, and greater parental monitoring than the Latino families in the general health promotion condition.
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. However, data regarding HIV prevention interventions for Latino adolescents, as distinct from other ethnic groups, have not been published to date. This K Award will conduct an initial study of a family-based intervention specifically for Latino families. With the support of a NIMH Minority Supplement Award, Dr. Lescano has adapted a family-based intervention from a multi-site trial for non-minority youth. Using a qualitative approach, Dr. Lescano has added to the intervention family context issues relevant to Latinos such as acculturation, religiosity, gender role and sexual socialization, parent-child communication, and monitoring practices. The initial phase of the K Award will be a run-through of the adapted family-based intervention with three cohorts (8 families per group) to further assess participant reaction and appropriateness. The intervention will then be revised based on feedback using structured exit interviews. Next, 100 Latino families with an adolescent between the ages of 13 and 18 will be randomized into either the family based HIV prevention intervention or a general health promotion (GHP) condition that focuses on healthy behaviors such as diet and exercise. Groups consist 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. The project will estimate the effect size 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 and 6 months post-intervention. The work done in this K Award will provide pilot data that will lead to submission of an R01 to determine the efficacy of the intervention, compared to a adolescent-only, skills-based HIV prevention group and a general health promotion group, in a larger sample of Latinos. An efficacious intervention is urgently needed for Latino communities.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Behavioral: Family-Based HIV Prevention for Latinos
    7-hour one-day workshop with adolescents and parents in separate and joint sessions
    Other Name: Latino STYLE
  • Behavioral: General Health Promotion
    7 hour one-day workshop on general health promotion topics
Study Arms  ICMJE
  • Experimental: Family-based HIV
    Intervention: Behavioral: Family-Based HIV Prevention for Latinos
  • Active Comparator: Family-based HP
    Intervention: Behavioral: General Health Promotion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 27, 2007)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adolescent must be English-speaking and can converse in Spanish with parent
  • Parent must be Spanish-speaking
  • Adolescent and parent must be living together for at least 3 months prior to workshop
  • Both parent and adolescent self-identify as being of Hispanic/Latino origin

Exclusion Criteria:

  • Adolescent HIV positive
  • Adolescent pregnant or intending to get pregnant
  • Active psychosis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00582101
Other Study ID Numbers  ICMJE 1K01MH078783-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celia Lescano, Ph.D., Rhode Island Hospital
Study Sponsor  ICMJE Rhode Island Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Celia M Lescano, PhD Rhode Island Hospital
PRS Account Rhode Island Hospital
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP