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Reducing HIV Risk Among Mexican Youth

This study has been completed.
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT01084395
First received: March 9, 2010
Last updated: March 17, 2010
Last verified: March 2010
History of Changes
  Purpose

The broad objective of this project is to test the efficacy of a theory-based HIV risk-reduction intervention, which includes both an adolescent component and parental component, designed to reduce the adolescents' risk of sexually transmitted HIV.


Condition Intervention
HIV Infections
AIDS
Sexually Transmitted Diseases
 Behavioral: Adolescent Safer Sex Intervention
Behavioral: Parent Safer Sex Communication Intervention
Other: Adolescent Health Promotion Control Condition
Other: Parent Health Promotion Control Condition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Reducing HIV Risk Among Mexican Youth

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • General Parent-Adolescent Communication [ Time Frame: pretest, posttest, 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
  • Parent-Adolescent Sexual Risk Communication [ Time Frame: Pretest, Posttest, 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
  • Comfort With Communication [ Time Frame: Pretest, Posttest, 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
  • Intentions To Have Sexual Intercourse [ Time Frame: Pretest, Posttest, 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    Questions regarding this measure were asked to adolescent participants only

  • Intentions to Use Condoms and Contraceptives [ Time Frame: Pretest, Posttest, 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    Questions regarding this measure were asked to adolescent participants only


Enrollment: 1620
Study Start Date: September 2002
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adolescent Safer Sex Intervention Behavioral: Adolescent Safer Sex Intervention
Adolescents are randomly assigned to the HIV risk-reduction intervention condition. Adolescents receive a theory-based intervention designed to reduce HIV risk-associated behavior. The intervention consists of six 50-minute modules implemented over the course of two days. The intervention is highly interactive and includes games, videos, discussion, and role-plays.
Other Name: Cuidate
Experimental: Parent Safer Sex Intervention Behavioral: Parent Safer Sex Communication Intervention
Parents are randomly assigned to the Safer Sex Communication Intervention. Parents learn about HIV and other consequences of unprotected sexual behavior. The intervention contains content that focuses on enhancing parent-adolescent communication.
Adolescent Health Promotion Control Other: Adolescent Health Promotion Control Condition
Adolescents are randomly assigned to the Health Promotion control condition. Adolescents receive an intervention aimed at significant health problems affecting Mexicans that are related, not to sexual behavior, but to other behaviors. These health problems include heart disease, certain cancers, and diabetes. Adolescents are taught that these health problems can be prevented by changing personal behaviors, primarily exercise, diet, cigarette smoking, and alcohol and drug use.
Parent Health Promotion Control Other: Parent Health Promotion Control Condition
Parents are randomly assigned to the Health Promotion control condition. Parents receive an intervention aimed at significant health problems affecting Mexicans that are related, not to sexual behavior, but to other behaviors. These health problems include heart disease, certain cancers, and diabetes. Parents will be taught that these health problems can be prevented by changing personal behaviors, primarily exercise, diet, cigarette smoking, and alcohol and drug use. The intervention also provides content that emphasizes the importance of families.

Detailed Description:

Sexually transmitted HIV infection among adolescents is a growing and significant problem in Mexico. Given the high mortality rate associated with AIDS, the lack of available treatment, and the social stigma associated with the disease, prevention is the key to reducing the threat of AIDS among this important subgroup in Mexico. The study has four specific aims including 1) to determine whether the HIV risk-reduction intervention causes a greater increase in adolescents' intentions to abstain from intercourse and/or avoid unprotected intercourse at post-intervention and decreased self-reported intercourse and unprotected intercourse at 3, 6, 12, and 48 month follow-ups, compared with the general health promotion control intervention; 2) to determine whether the effects of the intervention are moderated by individual, microsystem, and macrosystem variables; 3) to identify theory-based variables that mediate effects of the HIV intervention on adolescents' self-reported behavior; and 4) to determine whether the HIV risk-reduction intervention causes a greater increase in parents' comfort with, and quantity of communication (general and HIV specific) with adolescents at post-intervention, 3, 6, 12, and 48 month follow-up compared with the general health promotion control intervention.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Families (adolescents [aged 14 to 17 years of age] and one of their parents)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084395

Locations
Mexico
Preparatory Schools
Monterrey, NL, Mexico
Sponsors and Collaborators
University of Michigan
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Antonia M. Villarruel, PhD, FAAN University of Michigan
  More Information

Additional Information:
¡CUÍDATE! (designed for Latino youth) intervention description, package information, evaluation study and results, references and contact information  This link exits the ClinicalTrials.gov site
Curriculum materials (designed for Latino youth), overview of the curriculum, goals of the curriculum, types of activities, format and length, module outline, recommended training  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Antonia M. Villarruel, University of Michigan
ClinicalTrials.gov Identifier: NCT01084395     History of Changes
Other Study ID Numbers: H03-00001528-MI, R01NR008059
Study First Received: March 9, 2010
Last Updated: March 17, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Parent
Adolescent
Mexico
Safer Sex Communication
 Randomized Controlled Trial
HIV/AIDS
STD
Sexual Behavior

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

ClinicalTrials.gov processed this record on May 16, 2013