Clinical trial NCT01084395: Reducing HIV Risk Among Mexican Youth
Official title: Reducing HIV Risk Among Mexican Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
AIDS
Sexually Transmitted Diseases
Keywords: Parent
Adolescent
Mexico
Safer Sex Communication
Randomized Controlled Trial
HIV/AIDS
STD
Sexual Behavior
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2010-03-10
Enrollment: 1620
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: General Parent-Adolescent Communication
timeFrame: pretest, posttest, 6 month follow-up, 12 month follow-up
measure: Parent-Adolescent Sexual Risk Communication
timeFrame: Pretest, Posttest, 6 month follow-up, 12 month follow-up
measure: Comfort With Communication
timeFrame: Pretest, Posttest, 6 month follow-up, 12 month follow-up
measure: Intentions To Have Sexual Intercourse
timeFrame: Pretest, Posttest, 6 month follow-up, 12 month follow-up
measure: Intentions to Use Condoms and Contraceptives
timeFrame: Pretest, Posttest, 6 month follow-up, 12 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Preparatory Schools
state: NL
Study officials:
affiliation: University of Michigan
name: Antonia M. Villarruel, PhD, FAAN
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.