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  • A research assistant recruited males and females, 14–24 years of age, from the waiting room of a public health STI Clinic in Seattle, Washington. They were screened for eligibility and gave assent or consent via computer. With approval of the University of Washington (UW) Human Subjects Division, prior to participation in the study, assent was obtained from those participants less than 18 years old and consent was obtained for those 18 years and older. As approved by the UW Human Subjects Division, parental consent was waived for participants under 18 years of age, as 14 years is the legal minimum age to consent for STI/HIV services in Washington State. A partial waiver of consent was also granted by UW Human Subjects Division to omit information about randomization into the control or experimental group to receive an ICBI for safer-sex as we were concerned this knowledge may influence participant answers and bias the study results. To enhance recruitment, fliers advertising the study were posted at locations in the community targeting demographically similar populations. These locations included two medical clinics and one drop-in center serving homeless youth; one pediatric clinic and one family practice clinic, both providing care to underserved populations. A research assistant screened interested participants from these locations for eligibility by telephone. To be eligible for the study participants were required to speak and read English; report at least one episode of unprotected (either no condom or no birth control: e.g. pills, patch, injection, ring, intrauterine device (IUD) and implant) vaginal sex in the last two months; report no current pregnancy in self or vaginal sex partners; and not actively seeking pregnancy. In addition, for follow-up and retention, participants were asked to provide contact information for self and friends or family. Females were screened by urine pregnancy test and excluded if pregnant. Pregnant females were counseled by a clinician and offered referral to obstetric medical care. At the baseline visit all participants entered their demographic information and sexual history via computer assisted self-interview (CASI) and provided urine samples for STI testing. There were two study computers and one research assistant and on the rare occasion when there were two participants in clinic at the same time each completed the study in a private clinic room and had a different study start time. They did not know how long the other participant had been on the computer as they were in different rooms and once each participant finished the study they continued with their clinic visit. After entering their sexual history into the computer, the control group continued their clinic visit per the clinic’s standard of care. Each intervention participant then received an interactive computer-based intervention before continuing with the routine clinic visit. If evaluated by a clinician during the visit (per clinic standard some patients undergo STI testing without seeing a clinician), participants in both allocation arms completed a short exit interview with the research assistant to identify what safer-sex topics they discussed with the clinician during the visit. The intervention is based on concepts adopted from the Options Projects developed by Jeffrey Fisher [42]. The Options Project is a brief clinician-delivered intervention with elements of motivational interviewing, and uses the theory-based model of Information, Motivation and Behavioral Skills [43]. The Options Project was initially tested in a population of substance-addicted, HIV-positive adults [44] and delivered over the course of multiple and frequent provider visits. The intervention in the present study was designed for a one-time clinic visit with healthy adolescents and young adults. Instead of being delivered by a clinician, the intervention was presented by a computer to mimic a clinician-patient risk reduction interaction. A Seattle technology company, DatStat Inc., assisted in the computer programming of the intervention. The intervention was pilot tested with five participants to assess usability and comprehension. Participants in the intervention group were provided with three options for interacting with the computer: using a static male physician avatar, a female physician avatar (photographic images of a provider conversing as if with the patient) or no avatar (text only). They then received personalized feedback about their protective and risky sexual behaviors from the avatar or via text only. The computer program identifies all risky and protective behaviors as reported in the participant’s sexual history and the avatar presents the results to them. For example, in a screen shot the avatar states, “I see you are protecting yourself by 1) using birth control every time you have sex and 2) talking with your partners about using condoms.” In the next screen shot the avatar states, “But I am worried that you are at risk for STI/HIV because 1) You don’t use condoms every time you have sex and 2) You and your partners don’t get tested for STI/HIV before you have sex for the first time.” After the feedback was provided participants were asked to choose what they want to discuss further: STI/HIV and male condom use, or birth control use and unintended pregnancy. Participants were asked to rank, on a scale from 1 to 10, the perceived importance of using condoms or birth control and how confident they were that they could use condoms or birth control more consistently. Depending on each participant’s relative importance and confidence rankings, the avatar asked why using condoms or birth control was important to the participant; what were the participant’s perceived barriers to using condoms or birth control; and what information and skills were needed to increase use of condoms or birth control. Participants were offered video modules targeting sexual health knowledge and skills, including demonstrations of how to use condoms and birth control (e.g. pills, patch, injection, ring, IUD, and implant) [45]; a vignette of a teenage couple dispelling pregnancy prevention myths [46]; and a vignette of a young adult couple negotiating condom use with each other [47]. At the end of the intervention, each participant was asked to identify a sexual risk behavior they planned to change, and to make it a personal goal to adopt that change before the study follow-up visit in 3 months. At the three-month follow-up visit, intervention and control group participants completed the follow-up survey. They entered their interim sexual histories electronically via CASI. These questions were similar to those at the baseline survey except they accounted for the follow-up time period. Topics included condom and birth control use with vaginal intercourse; number of sex partners; and interim diagnosis of STI or pregnancy since baseline interview. Each participant in the intervention group was asked additional questions about what progress had been made toward their behavior change goal. Participants in both groups provided urine samples for STI testing and females provided urine for pregnancy testing. Participants each received USD 25 for completing the baseline visit and USD50 for completing the 3-month follow-up visit. They were also provided bus tickets home from each visit if needed. The primary outcome at follow-up was the number of unprotected (no condoms) sex events during the last 2 months. Secondary outcomes included the number of unprotected (no birth control as reported by females) sex events during the last 2 months; the number of sex partners during the last 2 months; and incident CT and GC infection and unintended pregnancy. Aptima test kits for CT and GC were provided by GenProbe. Sample size was calculated for the outcome of unprotected (no condom) sex in the last 2 months. The study had 80% power to determine a risk difference of 14 percentage points in the rate of unprotected sex in the last 2 months between the two treatment arms with a 2-tailed test and alpha value of 0.05. A sample size of 460 was chosen to allow for an anticipated 16% loss to follow-up, yielding outcome data on 392 participants. Due to slow recruitment, our final sample was 272. NQuery Advisor by StatsSols version 3.0 was used to calculate sample size. STATA 12.0 by StataCorp LLC was the statistical software used in the analysis. The level of significant was defined at p<0.05. Randomization was computer generated and research staff and participants were blinded to the allocation to intervention or control arm. As each participant gave consent and was enrolled into the study via computer, allocation to treatment arm and subsequent delivery of the intervention all occurred in one sitting using the same computer while the participant was alone in a private clinic room. Research staff were blinded to group assignment for the duration of the participant encounter. Participants were also blinded as to whether or not they were receiving the intervention. During the consent process participants were informed that researchers were testing a new method to discuss sexual health with adolescents and young adults. Randomization was stratified by gender (male or female); age (14–18 years or 19–24 years); and clinic visit type (expedited visit or clinician visit). These group determinations for stratification were based on psychosocial developmental and life-stage differences between adolescents and young adults. As standard of care in the STI Clinic at that time, all patients were screened for risk behaviors at intake and triaged to the needed level of care, either to a clinician visit with a mid-level provider or to an expedited visit where patients provide specimens only for testing without a clinician encounter. Visit type was included in the stratification to account for different levels of care that participants may have received during their visit and, therefore, varying levels of exposure to risk-reduction discussions with a clinician. Approval for this study was granted on June 16, 2011 by the Human Subjects Division of the University of Washington. Recruitment began February 2, 2012 and all follow-up completed by June 2013. This is a pilot study and the funding agency did not consider it a randomized clinical trial, therefore it was not registered. After study completion and in consultation with staff at clinicaltrials.gov, as a conservative measure, we registered the study as a clinical trial. The authors confirm that all ongoing and related trial for this intervention are registered. This study is registered with ClinicalTrials.gov identification number: NCT03027531 https://clinicaltrials.gov/show/NCT03027531. T-test and chi square were used to assess differences between allocation arms at baseline in demographic characteristics and reported sexual behaviors. The primary outcome of unprotected sex (no condom use), and the secondary outcomes of number of sex partners and unprotected sex (no birth control as reported by females), were compared between the intervention and control groups at 3 months. Poisson regression with robust error variance was used to account for skewed responses to count variables. Binomial regression was used to model the secondary outcomes of incident CT and GC infection and unintended pregnancy (females only). Models were also adjusted for baseline differences between intervention and control group for self-reported history of STI; ever transactional sex; and birth control use (females only).
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