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Reducing HIV Risk Among Mexican Youth

Primary Purpose

HIV Infections, AIDS, Sexually Transmitted Diseases

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Adolescent Safer Sex Intervention
Parent Safer Sex Communication Intervention
Adolescent Health Promotion Control Condition
Parent Health Promotion Control Condition
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Parent, Adolescent, Mexico, Safer Sex Communication, Randomized Controlled Trial, HIV/AIDS, STD, Sexual Behavior

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

  • Preparatory Schools

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Other

Other

Arm Label

Adolescent Safer Sex Intervention

Parent Safer Sex Intervention

Adolescent Health Promotion Control

Parent Health Promotion Control

Arm Description

Outcomes

Primary Outcome Measures

General Parent-Adolescent Communication
Parent-Adolescent Sexual Risk Communication
Comfort With Communication
Intentions To Have Sexual Intercourse
Questions regarding this measure were asked to adolescent participants only
Intentions to Use Condoms and Contraceptives
Questions regarding this measure were asked to adolescent participants only

Secondary Outcome Measures

Full Information

First Posted
March 9, 2010
Last Updated
March 17, 2010
Sponsor
University of Michigan
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT01084395
Brief Title
Reducing HIV Risk Among Mexican Youth
Official Title
Reducing HIV Risk Among Mexican Youth
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Michigan
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, AIDS, Sexually Transmitted Diseases
Keywords
Parent, Adolescent, Mexico, Safer Sex Communication, Randomized Controlled Trial, HIV/AIDS, STD, Sexual Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1620 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adolescent Safer Sex Intervention
Arm Type
Experimental
Arm Title
Parent Safer Sex Intervention
Arm Type
Experimental
Arm Title
Adolescent Health Promotion Control
Arm Type
Other
Arm Title
Parent Health Promotion Control
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Adolescent Safer Sex Intervention
Other Intervention Name(s)
Cuidate
Intervention Description
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
Intervention Name(s)
Parent Safer Sex Communication Intervention
Intervention Description
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
Other
Intervention Name(s)
Adolescent Health Promotion Control Condition
Intervention Description
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
Intervention Name(s)
Parent Health Promotion Control Condition
Intervention Description
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 Outcome Measure Information:
Title
General Parent-Adolescent Communication
Time Frame
pretest, posttest, 6 month follow-up, 12 month follow-up
Title
Parent-Adolescent Sexual Risk Communication
Time Frame
Pretest, Posttest, 6 month follow-up, 12 month follow-up
Title
Comfort With Communication
Time Frame
Pretest, Posttest, 6 month follow-up, 12 month follow-up
Title
Intentions To Have Sexual Intercourse
Description
Questions regarding this measure were asked to adolescent participants only
Time Frame
Pretest, Posttest, 6 month follow-up, 12 month follow-up
Title
Intentions to Use Condoms and Contraceptives
Description
Questions regarding this measure were asked to adolescent participants only
Time Frame
Pretest, Posttest, 6 month follow-up, 12 month follow-up

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Families (adolescents [aged 14 to 17 years of age] and one of their parents)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonia M. Villarruel, PhD, FAAN
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Preparatory Schools
City
Monterrey
State/Province
NL
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
18956979
Citation
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.
Results Reference
result
PubMed Identifier
18297183
Citation
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.
Results Reference
result
PubMed Identifier
17403494
Citation
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.
Results Reference
result
Links:
URL
http://www.selectmedia.org/customer-service/evidence-based-curricula/cuidate/
Description
Curriculum materials (designed for Latino youth), overview of the curriculum, goals of the curriculum, types of activities, format and length, module outline, recommended training

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Reducing HIV Risk Among Mexican Youth

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