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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


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
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