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Family-Based HIV Prevention for Latinos

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00582101
Recruitment Status : Completed
First Posted : December 28, 2007
Last Update Posted : June 6, 2012
Information provided by (Responsible Party):
Celia Lescano, Ph.D., Rhode Island Hospital

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Family-Based HIV Prevention for Latinos
Study Start Date : May 2007
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Number (#) of unprotected sex acts [ Time Frame: baseline, 3, and 6 months ]

Secondary Outcome Measures :
  1. parent-child communication [ Time Frame: baseline, 3, and 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00582101

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United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
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Principal Investigator: Celia M Lescano, PhD Rhode Island Hospital
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Responsible Party: Celia Lescano, Ph.D., Assistant Professor (Research), Rhode Island Hospital Identifier: NCT00582101    
Other Study ID Numbers: 1K01MH078783-01 ( U.S. NIH Grant/Contract )
First Posted: December 28, 2007    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012
Keywords provided by Celia Lescano, Ph.D., Rhode Island Hospital:
health promotion
HIV Prevention
HIV Seronegativity
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases