Testing a Latino Web-based Parent-adolescent Sexual Communication Intervention
Phase: NA
Conditions: HIV/AIDS and Infections, Sexually Transmitted Diseases, Pregnancy Prevention
Sponsor: University of Pennsylvania

   School of Nursing 
   Office of the Dean 
   Claire M. Fagin Hall 
   418 Curie Boulevard, Suite 430 
   Philadelphia, PA 19104-4217 
   Tel 215-898-8283 Fax 215-573-2114 
   nursingdean@nursing.upenn.edu 
   http://www.nursing.upenn.edu 
Antonia M. Villarruel, PhD, RN, FAAN 
Professor and Margaret Bond Simon Dean of Nursing 
Senior Fellow, Leonard Davis Institute of Health Economics
April 23, 2019 
Descriptive Title: Testing a Latino web-based parent-adolescent sexual communication intervention 
Agency Name: National Institutes of Health 
Protocol #: 820216 
ClinicalTrials.gov ID: NCT03063385 
Antonia M. Villarruel PhD, RN, FAAN 

Latino adolescents are at high risk for HIV/AIDS, other sexually transmitted infections (STIs), and 
unintended pregnancies. Puerto Rican adolescents, in particular, experience disparities in these areas, yet 
few adolescent and even fewer parent interventions have been developed to address these important 
issues with this underserved population. Parent-adolescent programs are an effective approach to reduce 
adolescent sexual risk behavior and associated negative consequences. A web-based parent 
communication intervention provides an opportunity to strengthen and enhance programs that are 
designed for adolescents by providing additional support for safer sex decisions, and to increase parents’ 
access to sexual health education programs by decreasing barriers that keep them from participating in 
these interventions (e.g., low cost, can be viewed privately, at parents convenience, minimizes competing 
time with work and family). The purpose of this proposed study is to evaluate a brief theoretically 
informed (i.e., Ecodevelopmental Theory, Theory of Reasoned Action/Planned Behavior, Social Cognitive 
Theory 1-6), culturally appropriate, and linguistically tailored web-based parental communication 
program, Cuídalos (“Take care of them”), designed to improve parent-adolescent sexual communication 
and reduce adolescent sexual risk behavior. Recent findings from an NIH funded R21 randomized control 
trial (RCT) testing a brief computer-based version of the Cuídalos program indicated that the program 
increased parent-adolescent general communication and sexual risk communication with English and 
Spanish speaking U.S. Latinos. 7 Further, despite limited or no previous computer use, parents reported 
they liked and learned from the program, and that it was easy to use and accessible. 
In this proposed RCT, and based on recommendations from parents who participated in the initial 
Cuídalos7 intervention trial, we plan to modify the program by: 1) increasing the amount of content 
related to sexual communication (e.g., more case studies and interactive activities); 2) adding a module 
on stigma (towards HIV/AIDS); 3) increasing access by moving from a computer-based to a web-based 
platform; and 4) increasing the flexibility in how the program is used (e.g., ability to view the entire 
program or specific modules more than once). In order to examine the efficacy of the program, we will 
recruit 680 parents and one of their adolescents from schools, community-based and governmental 
organizations in Puerto Rico, and will randomly assign parents to receive: 1) the Cuídalos intervention; or 
2) a web-based health promotion control intervention focused on the prevention of diabetes and 
cardiovascular disease. Parents and adolescents will complete measures at pre-intervention and at 3-
(parents only), 6-, and 12 month follow-ups.
We will address the five following specific aims: 
1: Determine whether the Cuídalos intervention increases parents’ comfort with, as well as the amount 
of, general and sexual risk-specific communication with adolescents and whether it decreases stigma 
(towards HIV/AIDS) at 3-,6-, and 12- month follow-ups as compared to the general health promotion 
control intervention. 
2: Determine whether the Cuídalos intervention decreases self-reported adolescent intercourse and 
unprotected intercourse at 6-, and 12- month follow-ups as compared to the general health promotion 
control intervention. 
3: Identify theory-based variables (e.g., attitudes, subjective norms, perceived behavioral control, and 
intentions) that mediate the intervention effects of Cuídalos on parents’ self-reported comfort with and 
amount of communication with their adolescents. 

4: Determine whether the effects of the Cuídalos intervention on adolescents sexual behavior and parent-
adolescent communication are moderated by individual (adolescents: sexual experience, gender, age, 
stigma; parents: gender, age, computer access and experience, frequency and time engaged in the 
program), and microsystem (adolescents: parent-adolescent communication) factors. 
5: Examine the cost-effectiveness of the web-based Cuídalos intervention on adolescent sexual behavior. 
Results from this study will inform the use and efficacy of a web-based Cuídalos program for Puerto Rican 
parents. This study is an innovative and timely effort given the existing disparities in sexual health 
outcomes among Latino youth, the lack of culturally and linguistically effective interventions for Latino 
parents and adolescents, and the absence of web-based interventions with Latinos. If the program is 
efficacious, the web-based format will accelerate the translation of this program into public health 
practice and will be an important contribution in supporting adolescent sexual health behaviors. 

University of Pennsylvania 
Office of Regulatory Affairs 
3624 Market St., Suite 301 S 
Philadelphia, PA 19104-6006 
Ph: 215-573-2540/ Fax: 215-573-9438 
INSTITUTIONAL REVIEW BOARD 
(Federalwide Assurance # 00004028) 
03-Jun-2015
Antonia M Villarruel 
Claire M. Fagin Hall 
amvillar@nursing.upenn.edu 
Attn: Chiu-Fang Liu 
chiufang@nursing.upenn.edu 
PRINCIPAL INVESTIGATOR 
: Antonia M Villarruel 
TITLE 
: Testing a Latino web-based parent-adolescent sexual communication 
intervention 
SPONSORING AGENCY 
: National Institutes Of Health 
PROTOCOL # 
: 820216 
REVIEW BOARD 
: IRB #8 
Dear Dr. Villarruel: 
The documents noted below submitted as modification to the above-referenced protocol, were reviewed and 
administratively incorporated to the regulatory file on 01-Jun-2015. 
The following documents were included in the review: 
-HS ERA Modification, confirmation code: biajbdei, submitted 5.26.15
-Puerto Rican IRB Approval Letter, dated 6.17.14
-Grant Transfer Request and Progress Report, uploaded 5.4.15
-CITI Training Report of Completion for Antonia Villarruel, passed on 5.2.15
If you have any questions about the information in this letter, please contact the IRB administrative staff. Contact 
information is available at our website: http://www.upenn.edu/IRB/directory. 
Thank you for your cooperation. 
Sincerely, 
IRB Administrator