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Completed

NCT Number: NCT01084395

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.

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Key information

Conditions

HIV Infections AIDS Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Disease Attributes Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexual Behavior Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Preparatory Schools

Monterrey, Nuevo León, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Adolescent Safer Sex Intervention

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.

Other names: Cuidate

Parent Safer Sex Communication Intervention

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 Condition

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 Condition

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.

Primary outcomes

  1. General Parent-Adolescent Communication

    Time frame: pretest, posttest, 6 month follow-up, 12 month follow-up

  2. Parent-Adolescent Sexual Risk Communication

    Time frame: Pretest, Posttest, 6 month follow-up, 12 month follow-up

  3. Comfort With Communication

    Time frame: Pretest, Posttest, 6 month follow-up, 12 month follow-up

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Mar 10, 2010
Registry last updated
Mar 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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