Clinical Trials Directory

Trials / Completed

CompletedNCT02897804

Engineering an Online STI Prevention Program

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
3,997 (actual)
Sponsor
Penn State University · Academic / Other
Sex
All
Age
18 Years – 30 Years
Healthy volunteers
Accepted

Summary

The overall objective of the proposed research is to reduce the incidence of sexually transmitted infections (STIs) among college students. The investigators propose to accomplish this by using the innovative, engineering-inspired multiphase optimization strategy (MOST) to develop a highly effective, appealing, economical, and readily scalable internet-delivered behavioral intervention targeting the intersection of alcohol use and sexual risk behavior. The rate of STIs on college campuses is alarming: one in four college students is diagnosed with an STI at least once during their college experience. Sexual activity when drinking alcohol is highly prevalent among college students. Alcohol use is known to contribute to the sexual risk behaviors that are most responsible for the transmission of STIs, namely unprotected sex, contact with numerous partners, and "hook-ups" (casual sexual encounters). Few interventions have been developed that explicitly target the intersection of alcohol use and sexual risk behaviors, and none have been optimized. In order to reduce the incidence of STI transmission among this and other high-risk groups, a new approach is needed. MOST is a comprehensive methodological framework that brings the power of engineering principles to bear on optimization of behavioral interventions. MOST enables researchers to experimentally test the individual components in an intervention to determine their effectiveness, indicating which components need to be revised and re-tested. Given the high rates of alcohol use and sex among college students, the college setting provides an ideal opportunity for intervening on alcohol use and sexual risk behaviors. The proposed study will include a diverse population of college students on 4 campuses which will increase the generalizability of the findings. The specific aims are to (1) develop and pilot test an initial set of online intervention components targeting the link between alcohol use and sexual risk behaviors, (2) use the MOST approach to build an optimized preventive intervention, and (3) evaluate the effectiveness of the newly optimized preventive intervention using a fully powered randomized controlled trial (RCT). This work will result in a new, more potent behavioral intervention that will reduce the incidence of STIs among college students in the US, and will lay the groundwork for a new generation of highly effective STI prevention interventions aimed at other subpopulations at risk.

Detailed description

As part of the MOST approach, the investigators will conduct a series of screening experiments to build an optimized intervention. The current study is the first (of two) screening experiments.

Conditions

Interventions

TypeNameDescription
BEHAVIORALKnowledge aloneIncrease knowledge related STIs, STI risk, alcohol impairment, condom use skills, alcohol use behavior tracking skills, testing \& treatment services.
BEHAVIORALSelf-efficacy aloneIncrease self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
BEHAVIORALPerceived benefits aloneIncrease perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
BEHAVIORALPerceived benefits and self-efficacyIncrease perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
BEHAVIORALInjunctive normsCorrect misperceptions regarding approval of alcohol misuse \& sexual risk taking.
BEHAVIORALInjunctive norms and self-efficacyCorrect misperceptions regarding approval of alcohol misuse \& sexual risk taking and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
BEHAVIORALInjunctive norms and perceived benefitsCorrect misperceptions regarding approval of alcohol misuse \& sexual risk taking and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
BEHAVIORALInjunctive norms, perceived benefits, and self-efficacyCorrect misperceptions regarding approval of alcohol misuse \& sexual risk taking; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
BEHAVIORALDescriptive norms aloneCorrect misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors.
BEHAVIORALDescriptive norms and self-efficacyCorrect misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
BEHAVIORALDescriptive norms and perceived benefitsCorrect misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
BEHAVIORALDescriptive norms,perceived benefits,self-efficacyCorrect misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
BEHAVIORALDescriptive and injunctive normsCorrect misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors and correct misperceptions regarding approval of alcohol misuse \& sexual risk taking.
BEHAVIORALDescriptive norms, injunctive norms,self-efficacyCorrect misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse \& sexual risk taking; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
BEHAVIORALDescriptive and injunctive norms, benefitsCorrect misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse \& sexual risk taking; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
BEHAVIORALDescriptive and injunctive norms, benefits,efficacyCorrect misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse \& sexual risk taking; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and Increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
BEHAVIORALExpectancies aloneDecrease the expectation that alcohol is needed to have good sexual encounter.
BEHAVIORALExpectancies and self-efficacyDecrease the expectation that alcohol is needed to have good sexual encounter and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
BEHAVIORALExpectancies and Perceived BenefitsDecrease the expectation that alcohol is needed to have good sexual encounter and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
BEHAVIORALExpectancies, perceived benefits, self-efficacyDecrease the expectation that alcohol is needed to have good sexual encounter; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
BEHAVIORALExpectancies and injunctive normsDecrease the expectation that alcohol is needed to have good sexual encounter and correct misperceptions regarding approval of alcohol misuse \& sexual risk taking.
BEHAVIORALExpectancies, injunctive norms, and self-efficacyDecrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions regarding approval of alcohol misuse \& sexual risk taking; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
BEHAVIORALExpectancies, injunctive norms, benefitsDecrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions regarding approval of alcohol misuse \& sexual risk taking; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
BEHAVIORALExpectancies, injunctive norms, benefits, efficacyDecrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions regarding approval of alcohol misuse \& sexual risk taking; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
BEHAVIORALExpectancies and descriptive normsDecrease the expectation that alcohol is needed to have good sexual encounter and correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors.
BEHAVIORALExpectancies, descriptive norms, and self-efficacyDecrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
BEHAVIORALExpectancies, descriptive norms, and benefitsDecrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
BEHAVIORALExpectancies,descriptive norms, benefits, efficacyDecrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
BEHAVIORALExpectancies, descriptive and injunctive normsDecrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; and correct misperceptions regarding approval of alcohol misuse \& sexual risk taking.
BEHAVIORALExpectancies, descr& injun norms, efficacyDecrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse \& sexual risk taking; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
BEHAVIORALExpectancies, desc & injun norms, benefitsDecrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse \& sexual risk taking; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
BEHAVIORALExpectancies,desc & injun norms,benefits,efficacyDecrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse \& sexual risk taking; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.

Timeline

Start date
2016-08-01
Primary completion
2016-11-01
Completion
2017-06-01
First posted
2016-09-13
Last updated
2019-01-09

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02897804. Inclusion in this directory is not an endorsement.