Reducing HIV Risk Among Mexican Youth

Study Overview
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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.

Official Title
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Reducing HIV Risk Among Mexican Youth

Conditions
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HIV Infections, AIDS, Sexually Transmitted Diseases

Intervention / Treatment
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* Behavioral: Adolescent Safer Sex Intervention
* Behavioral: Parent Safer Sex Communication Intervention
* Other: Adolescent Health Promotion Control Condition
* Other: Parent Health Promotion Control Condition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Families (adolescents [aged 14 to 17 years of age] and one of their parents)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adolescent Safer Sex Intervention<br> | Behavioral: Adolescent Safer Sex Intervention<br>* 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.<br>* Other names: Cuidate;|
| Experimental: Parent Safer Sex Intervention<br> | Behavioral: Parent Safer Sex Communication Intervention<br>* 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.<br>|
| Other: Adolescent Health Promotion Control<br> | Other: Adolescent Health Promotion Control Condition<br>* 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.<br>|
| Other: Parent Health Promotion Control<br> | Other: Parent Health Promotion Control Condition<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parent, Adolescent, Mexico, Safer Sex Communication, Randomized Controlled Trial, HIV/AIDS, STD, Sexual Behavior