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Family-Based HIV Prevention for Latinos

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Family-Based HIV Prevention for Latinos
General Health Promotion
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, prevention, families, Latinos, communication, sexuality, monitoring, health promotion, HIV Prevention, HIV Seronegativity

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rhode Island Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Family-based HIV

Family-based HP

Arm Description

Outcomes

Primary Outcome Measures

Number (#) of unprotected sex acts

Secondary Outcome Measures

parent-child communication

Full Information

First Posted
December 19, 2007
Last Updated
June 5, 2012
Sponsor
Rhode Island Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00582101
Brief Title
Family-Based HIV Prevention for Latinos
Official Title
Family-Based HIV Prevention for Latinos
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rhode Island Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The proposed project will develop and test an HIV prevention intervention for Latino families. This study will: 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. Revise the family-based HIV prevention intervention based on the results of the pilot "run-through" and structured exit interviews. Recruit and randomize 100 families into the Latino family-based HIV prevention intervention or a general health promotion condition. 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: The revised intervention will be feasible, acceptable, and appropriate for Latino families and will be enthusiastically received. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, prevention, families, Latinos, communication, sexuality, monitoring, health promotion, HIV Prevention, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family-based HIV
Arm Type
Experimental
Arm Title
Family-based HP
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Family-Based HIV Prevention for Latinos
Other Intervention Name(s)
Latino STYLE
Intervention Description
7-hour one-day workshop with adolescents and parents in separate and joint sessions
Intervention Type
Behavioral
Intervention Name(s)
General Health Promotion
Intervention Description
7 hour one-day workshop on general health promotion topics
Primary Outcome Measure Information:
Title
Number (#) of unprotected sex acts
Time Frame
baseline, 3, and 6 months
Secondary Outcome Measure Information:
Title
parent-child communication
Time Frame
baseline, 3, and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celia M Lescano, PhD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

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Family-Based HIV Prevention for Latinos

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