Family-Based HIV Prevention for Latinos

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celia Lescano, Ph.D., Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT00582101
First received: December 19, 2007
Last updated: June 5, 2012
Last verified: June 2012

December 19, 2007
June 5, 2012
May 2007
September 2010   (final data collection date for primary outcome measure)
Number (#) of unprotected sex acts [ Time Frame: baseline, 3, and 6 months ] [ Designated as safety issue: No ]
# of unprotected sex acts [ Time Frame: baseline, 3, and 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00582101 on ClinicalTrials.gov Archive Site
parent-child communication [ Time Frame: baseline, 3, and 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Family-Based HIV Prevention for Latinos
Family-Based HIV Prevention for Latinos

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
  • 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
  • Experimental: Family-based HIV
    Intervention: Behavioral: Family-Based HIV Prevention for Latinos
  • Active Comparator: Family-based HP
    Intervention: Behavioral: General Health Promotion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
13 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00582101
1 K01 MH078783-01
Yes
Celia Lescano, Ph.D., Rhode Island Hospital
Rhode Island Hospital
Not Provided
Principal Investigator: Celia M Lescano, PhD Rhode Island Hospital
Rhode Island Hospital
June 2012

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