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
  Purpose

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.

Condition Intervention Phase
HIV Infections
Behavioral: Family-Based HIV Prevention for Latinos
Behavioral: General Health Promotion
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Family-Based HIV Prevention for Latinos

Resource links provided by NLM:


Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Number (#) of unprotected sex acts [ Time Frame: baseline, 3, and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • parent-child communication [ Time Frame: baseline, 3, and 6 months ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: May 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Family-based HIV 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
Active Comparator: Family-based HP Behavioral: General Health Promotion
7 hour one-day workshop on general health promotion topics

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.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00582101

Locations
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: Celia M Lescano, PhD Rhode Island Hospital
  More Information

No publications provided

Responsible Party: Celia Lescano, Ph.D., Assistant Professor (Research), Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT00582101     History of Changes
Other Study ID Numbers: 1 K01 MH078783-01
Study First Received: December 19, 2007
Last Updated: June 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
HIV
prevention
families
Latinos
communication
sexuality
monitoring
health promotion
HIV Prevention
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 23, 2014