Reducing HIV Risk Among Mexican Youth

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT01084395
First received: March 9, 2010
Last updated: March 17, 2010
Last verified: March 2010

March 9, 2010
March 17, 2010
September 2002
September 2006   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01084395 on ClinicalTrials.gov Archive Site
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Reducing HIV Risk Among Mexican Youth
Reducing HIV Risk Among Mexican Youth

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV Infections
  • AIDS
  • Sexually Transmitted Diseases
  • 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
  • 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 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 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.
  • Experimental: Adolescent Safer Sex Intervention
    Intervention: Behavioral: Adolescent Safer Sex Intervention
  • Experimental: Parent Safer Sex Intervention
    Intervention: Behavioral: Parent Safer Sex Communication Intervention
  • Adolescent Health Promotion Control
    Intervention: Other: Adolescent Health Promotion Control Condition
  • Parent Health Promotion Control
    Intervention: Other: Parent Health Promotion Control Condition

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1620
September 2006
September 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Families (adolescents [aged 14 to 17 years of age] and one of their parents)
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01084395
H03-00001528-MI, R01NR008059
No
Antonia M. Villarruel, University of Michigan
University of Michigan
National Institute of Nursing Research (NINR)
Principal Investigator: Antonia M. Villarruel, PhD, FAAN University of Michigan
University of Michigan
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP