Trials / Completed
CompletedNCT03408743
Engineering an Online STI Prevention Program: CSE2
The Intersection of Alcohol and Sex: Engineering an Online STI Prevention Program
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2,946 (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 second (of two) screening experiments. The first screening experiment corresponds to clinicaltrials.gov ID # NCT02897804.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Knowledge Alone | Increase knowledge relate d STIs, STI risk, alcohol impairment, condom use skills, alcohol use behavior tracking skills, testing \& treatment services. |
| BEHAVIORAL | Self-efficacy alone | Increase self-efficacy to us e protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex. |
| BEHAVIORAL | Perceived benefits alone | Increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol. |
| BEHAVIORAL | Benefits and self-efficacy | 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. |
| BEHAVIORAL | Injunctive norms alone | Correct misperceptions regarding approval of alcohol misuse \& sexual risk taking. |
| BEHAVIORAL | Injunctive norms and self-efficacy | 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. |
| BEHAVIORAL | Injunctive norms and benefits | 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 and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex. |
| BEHAVIORAL | Injunctive norms, benefits, self-efficacy | 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; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex. |
| BEHAVIORAL | Descriptive norms alone | Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors. |
| BEHAVIORAL | Descriptive norms and self-efficacy | 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. |
| BEHAVIORAL | Descriptive norms and perceived benefits | 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. |
| BEHAVIORAL | Descriptive norms, benefits, self-efficacy | 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. |
| BEHAVIORAL | Descriptive norms and injunctive norms | 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. |
| BEHAVIORAL | Descriptive and injunctive norms, self-efficacy | orrect 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. |
| BEHAVIORAL | Descriptive and injunctive norms, and benefits | 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. |
| BEHAVIORAL | Descriptive & injunctive norms, benefits, efficacy | 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. |
| BEHAVIORAL | Expectancies alone | Decrease the expectation that alcohol is needed to have good sexual encounter. |
| BEHAVIORAL | Expectancies and self-efficacy | Decrease 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. |
| BEHAVIORAL | Expectancies and perceived benefits | Decrease 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. |
| BEHAVIORAL | Expectancies, benefits, self-efficacy | Decrease 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. |
| BEHAVIORAL | Expectancies and injunctive norms | Decrease the expectation that alcohol is needed to have good sexual encounter and correct misperceptions regarding approval of alcohol misuse \& sexual risk taking. |
| BEHAVIORAL | Expectancies, injunctive norms, self-efficacy | Decrease 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. |
| BEHAVIORAL | Expectancies, injunctive norms, and benefits | Decrease 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. |
| BEHAVIORAL | Expectancies, injunctive norms, benefits, efficacy | Decrease 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. |
| BEHAVIORAL | Expectancies and descriptive norms | Decrease 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. |
| BEHAVIORAL | Expectancies, descriptive norms, & self-efficacy | Decrease 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. |
| BEHAVIORAL | Expectancies, descriptive norms, benefits | Decrease 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. |
| BEHAVIORAL | Expectancies, descriptive norms, benefits, efficacy | Decrease 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. |
| BEHAVIORAL | Expectancies, descriptive and injunctive norms | Decrease 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. |
| BEHAVIORAL | Expectancies, descriptive & injunctive norms, efficacy | Decrease 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. |
| BEHAVIORAL | Expectancies, descriptive & injunctive norms, benefits | Decrease 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. |
| BEHAVIORAL | Expectancies, descriptive & injunctive, benefits, efficacy | Decrease 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
- 2017-09-18
- Primary completion
- 2017-12-31
- Completion
- 2017-12-31
- First posted
- 2018-01-24
- Last updated
- 2019-07-05
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03408743. Inclusion in this directory is not an endorsement.