Reducing HIV Risk Among Mexican Youth

HIV Infections Clinical Trial

Official title:

Reducing HIV Risk Among Mexican Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01084395
• Other study ID #: H03-00001528-MI
• Secondary ID: R01NR008059
• Status: Completed
• Phase: N/A
• First received: March 9, 2010
• Last updated: March 17, 2010
• Start date: September 2002
• Est. completion date: September 2006

Study information

• Verified date: March 2010
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1620
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• AIDS
• HIV Infections
• Sexually Transmitted Diseases

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Mexico	Preparatory Schools	Monterrey	NL

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

Gallegos EC, Villarruel AM, Gómez 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. — View 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. Spanish. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General Parent-Adolescent Communication		pretest, posttest, 6 month follow-up, 12 month follow-up	No
Primary	Parent-Adolescent Sexual Risk Communication		Pretest, Posttest, 6 month follow-up, 12 month follow-up	No
Primary	Comfort With Communication		Pretest, Posttest, 6 month follow-up, 12 month follow-up	No
Primary	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	No
Primary	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	No

External Links

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