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Randomized Control Trial of Family-Based HIV Prevention for Latinos

NCT01635335 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 542

Last updated 2016-09-21

No results posted yet for this study

Summary

The proposed project will test an HIV prevention intervention for Latino parent-adolescents dyads. This randomized controlled trial will:

1. Recruit and randomize 320 parent-adolescent dyads into a Latino family-based HIV prevention intervention or a family-based General Health Promotion condition.
2. Determine the efficacy of the Latino Family-based HIV prevention intervention from assessment of changes in HIV-related sexual behavior and attitudes over 18 months among a sample of 320 Latino parent-adolescent dyads.
3. Determine the efficacy of the Latino Family-based HIV prevention intervention from assessment of changes in family relationships and parental monitoring/supervision over 18 months among a sample of 320 Latino parent-adolescent dyads.
4. Examine the association of other important constructs, such as religiosity, acculturation, cultural values, and sexual socialization with the primary outcomes.

Based on a thorough review of the literature and preliminary data from a recent, small pilot study, the investigators hypotheses are:

1. Compared to the General Health Promotion Control condition, the Family-Based HIV Prevention intervention will result in greater change with regard to primary outcome measures of safer sexual behavior (recent sexual activity, the number of unprotected sex acts, and intentions to use condoms) and safer HIV-related attitudes.
2. Compared to the General Health Promotion Control condition, the Family-Based HIV Prevention intervention will result in greater change with regard to family relationships and parental monitoring/supervision through improved parent-child communication skills and they will mediate the intervention impact.
3. Religiosity, acculturation, cultural values, and sexual socialization will have meaningful associations with the primary outcomes and will act as moderators of intervention impact.

Conditions

  • HIV
  • Sexually Transmitted Infections

Interventions

BEHAVIORAL

Latino STYLE

7-hour family-based workshop with 3-hour follow-up booster 3 months later

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of South Florida

    lead OTHER

Principal Investigators

  • Celia Lescano, Ph.D. · University of South Florida

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01635335 on ClinicalTrials.gov