Reducing HIV Risk Among Mexican Youth

NCT ID: NCT01084395

Last Updated: 2010-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1620 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2006-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections AIDS Sexually Transmitted Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Adolescent Safer Sex Intervention

Group Type EXPERIMENTAL

Adolescent Safer Sex Intervention

Intervention Type BEHAVIORAL

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.

Parent Safer Sex Intervention

Group Type EXPERIMENTAL

Parent Safer Sex Communication Intervention

Intervention Type BEHAVIORAL

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

Group Type OTHER

Adolescent Health Promotion Control Condition

Intervention Type OTHER

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

Group Type OTHER

Parent Health Promotion Control Condition

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Cuidate

Eligibility Criteria

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Inclusion Criteria

* Families (adolescents \[aged 14 to 17 years of age\] and one of their parents)
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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University of Michigan

Principal Investigators

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Antonia M. Villarruel, PhD, FAAN

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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Preparatory Schools

Monterrey, Nuevo León, Mexico

Site Status

Countries

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Mexico

References

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Villarruel AM, Cherry CL, Cabriales EG, Ronis DL, Zhou Y. A parent-adolescent intervention to increase sexual risk communication: results of a randomized controlled trial. AIDS Educ Prev. 2008 Oct;20(5):371-83. doi: 10.1521/aeap.2008.20.5.371.

Reference Type RESULT
PMID: 18956979 (View on PubMed)

Gallegos EC, Villarruel AM, Loveland-Cherry C, Ronis DL, Yan Zhou M. [Intervention to reduce adolescents sexual risk behaviors: a randomized controlled trial]. Salud Publica Mex. 2008 Jan-Feb;50(1):59-66. doi: 10.1590/s0036-36342008000100012. Spanish.

Reference Type RESULT
PMID: 18297183 (View on PubMed)

Gallegos EC, Villarruel AM, Gomez MV, Onofre DJ, Zhou Y. Research brief: sexual communication and knowledge among Mexican parents and their adolescent children. J Assoc Nurses AIDS Care. 2007 Mar-Apr;18(2):28-34. doi: 10.1016/j.jana.2007.01.007.

Reference Type RESULT
PMID: 17403494 (View on PubMed)

Related Links

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http://www.selectmedia.org/customer-service/evidence-based-curricula/cuidate/

Curriculum materials (designed for Latino youth), overview of the curriculum, goals of the curriculum, types of activities, format and length, module outline, recommended training

Other Identifiers

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R01NR008059

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H03-00001528-MI

Identifier Type: -

Identifier Source: org_study_id

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