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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Family-Based HIV Prevention for Latinos; Behavioral: General Health Promotion

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: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Latino STYLE
Active Comparator: Family-based HP	Behavioral: General Health Promotion; 7 hour one-day workshop on general health promotion topics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number (#) of unprotected sex acts	baseline, 3, and 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
parent-child communication	baseline, 3, and 6 months

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Investigators: Principal Investigator: Celia M Lescano, PhD, Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: December 19, 2007
• First Submitted That Met QC Criteria: December 27, 2007
• First Posted (Estimate): December 28, 2007

Study Record Updates

• Last Update Posted (Estimate): June 6, 2012
• Last Update Submitted That Met QC Criteria: June 5, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: HIV Seronegativity; HIV; communication; prevention; HIV Prevention; Latinos; health promotion; sexuality; monitoring; families
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: 1K01MH078783-01 (U.S. NIH Grant/Contract)