Reducing HIV Risk Among Mexican Youth

March 17, 2010 updated by: University of Michigan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1620

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • NL
      • Monterrey, NL, Mexico
        • Preparatory Schools

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Families (adolescents [aged 14 to 17 years of age] and one of their parents)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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.
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General Parent-Adolescent Communication
Time Frame: pretest, posttest, 6 month follow-up, 12 month follow-up
pretest, posttest, 6 month follow-up, 12 month follow-up
Parent-Adolescent Sexual Risk Communication
Time Frame: Pretest, Posttest, 6 month follow-up, 12 month follow-up
Pretest, Posttest, 6 month follow-up, 12 month follow-up
Comfort With Communication
Time Frame: Pretest, Posttest, 6 month follow-up, 12 month follow-up
Pretest, Posttest, 6 month follow-up, 12 month follow-up
Intentions To Have Sexual Intercourse
Time Frame: Pretest, Posttest, 6 month follow-up, 12 month follow-up
Questions regarding this measure were asked to adolescent participants only
Pretest, Posttest, 6 month follow-up, 12 month follow-up
Intentions to Use Condoms and Contraceptives
Time Frame: Pretest, Posttest, 6 month follow-up, 12 month follow-up
Questions regarding this measure were asked to adolescent participants only
Pretest, Posttest, 6 month follow-up, 12 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Antonia M. Villarruel, PhD, FAAN, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

March 9, 2010

First Submitted That Met QC Criteria

March 9, 2010

First Posted (Estimate)

March 10, 2010

Study Record Updates

Last Update Posted (Estimate)

March 19, 2010

Last Update Submitted That Met QC Criteria

March 17, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H03-00001528-MI
  • R01NR008059 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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