Effectiveness, Acceptability, and Feasibility of a Telehealth HIV Pre-Exposure Prophylaxis Care Intervention Among Young Cisgender Men and Transgender Women Who Have Sex With Men: Protocol for a Randomized Controlled Trial.

BACKGROUND: Despite its promise for HIV prevention, the uptake of pre-exposure prophylaxis (PrEP) has been slow, and there have been substantial inequities in PrEP access. Young men who have sex with men and transgender women of color are most in need of PrEP and least likely to have that need fulfilled. PrEP telehealth care, which provides remote PrEP care via electronic communication, seems well suited to address several of the challenges of PrEP provision, including discomfort with stigmatizing and difficult-to-access health care systems, transportation challenges, and privacy concerns, and address disparities in PrEP access. Research suggests that PrEP telehealth care has promise and is a favored option for many prospective recipients of PrEP. However, despite growing attention to telehealth approaches as an avenue for increasing access to PrEP amidst the COVID-19 pandemic, there have been no published randomized controlled trials (RCTs) on PrEP telehealth care to date, making it difficult to draw strong conclusions about the advantages or disadvantages of telehealth compared with usual PrEP care. We developed PrEPTECH, a telehealth intervention that focuses specifically on alleviating issues of stigma, access, cost, and confidentiality for young people with risk factors for HIV infection who are seeking PrEP care. Leveraging data from the 2017 observational pilot study, we redesigned and enhanced PrEPTECH. OBJECTIVE: This study aims to assess the effectiveness, acceptability, and feasibility of a telehealth HIV PrEP care intervention, PrEPTECH, in increasing PrEP uptake. METHODS: This is the protocol for an RCT of young cisgender men and transgender women who have sex with men in 4 regions within the United States: the San Francisco Bay Area, California; Los Angeles County, California; Miami-Dade County, Florida; and Broward County, Florida. Participants in the intervention arm received access to a web-based telehealth program, PrEPTECH, which offers a fully web-based pathway to PrEP, whereas those in the control arm received access to a dynamic web page containing publicly available informational resources about PrEP. Follow-up data collection occurred at 3 and 6 months. An analysis will be conducted on outcomes, including PrEP initiation, persistence, adherence, coverage, and medication prescription, as well as PrEPTECH acceptability and feasibility. RESULTS: The study was funded in 2019 and received institutional review board approval in 2020. The PrEPTECH intervention was developed over the next 1.5 years. Study recruitment was launched in February 2022 and completed in September 2022, with 229 participants recruited in total. Data collection was completed in April 2023. CONCLUSIONS: The results of this RCT will offer valuable evidence regarding the effectiveness, acceptability, and feasibility of telehealth HIV PrEP care interventions among young cisgender men and transgender women who have sex with men. TRIAL REGISTRATION: ClinicalTrials.gov NCT04902820; https://clinicaltrials.gov/ct2/show/NCT04902820. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/47932.

Inconsistencies in Adolescent Self-Reported Sexual Behavior: Experience from Four Randomized Controlled Trials.

To examine the degree, correlates, and implications of inconsistent self-report data on sexual risk behaviors of adolescents. We analyzed data from four longitudinal group-randomized controlled trials of evidence-based HIV/STI/pregnancy prevention programs in Texas and California from 2000 to 2010. Across- and within-time logical inconsistencies in sexual behavior survey responses were analyzed using multilevel logistic regression. Rates of any inconsistencies ranged from 12 to 18% across the four trials. In all trials, rates were higher in males than in females. Age, normative beliefs, and race/ethnicity were most strongly associated with inconsistencies. We found substantial rates of inconsistencies in adolescents' self-reports of their sexual behavior, which did not occur at random. Studies should routinely report observed rates of inconsistencies and methods used to adjust for them so that any biases in the population to which the study generalizes are understood by public health practitioners and policy-makers looking to adopt programs for their particular population.

Who Benefits from School-Based Teen Pregnancy Prevention Programs? Examining Multidimensional Moderators of Program Effectiveness Across Four Studies.

Recent research has suggested the importance of understanding for whom programs are most effective (Supplee et al., 2013) and that multidimensional profiles of risk and protective factors may moderate the effectiveness of programs (Lanza & Rhoades, 2012). For school-based prevention programs, moderators of program effectiveness may occur at both the individual and school levels. However, due to the relatively small number of schools in most individual trials, integrative data analysis across multiple studies may be necessary to fully understand the multidimensional individual and school factors that may influence program effectiveness. In this study, we applied multilevel latent class analysis to integrated data across four studies of a middle school pregnancy prevention program to examine moderators of program effectiveness on initiation of vaginal sex. Findings suggest that the program may be particularly effective for schools with USA-born students who speak another language at home. In addition, findings suggest potential positive outcomes of the program for individuals who are lower risk and engaging in normative dating or individuals with family risk. Findings suggest potential mechanisms by which teen pregnancy prevention programs may be effective.

You-Me-Us: Results of a Cluster Randomized Trial of a Healthy Relationships Approach to Sexual Risk Reduction.

By middle adolescence, most young people have been involved in at least one romantic relationship, a context in which many sexual interactions occur. Indeed, researchers have suggested the importance of attending to relationships in programs focused on sexual risk, yet few evidence-based programs have a strong relationships focus. Our study examined the impact of a healthy relationship program called You-Me-Us that included a classroom curriculum and a school-wide peer norms approach. We evaluated the intervention using a small group randomized trial that included nine participating urban middle schools (defined as schools that include grades 6-8) in three urban school districts. We invited all 7th grade students within the study schools to enroll. Students completed three surveys during 7th and 8th grades (baseline plus two follow up surveys at 6 and 18 months following baseline). A total of 911 youth with positive consent and assent were enrolled in the study. Follow up survey response rates among those taking the baseline were 92% at 6 months and 80% at 18 months. Multilevel regression models were used to adjust for the correlation among students within the same school, and the correlation of repeated measurements taken on the same student over time. The intervention reduced vaginal sexual initiation by about half at the 6-month follow-up, and this approached significance. Further, youth in the intervention condition were less likely to believe it is okay for people their age to have vaginal sex without using condoms if the girl is on birth control. None of the remaining variables differed significantly by intervention condition. This study provides insights on using a healthy relationship approach for younger urban adolescents. This approach produced a programmatically significant reduction in sexual initiation that did not reach standard levels of statistical significance, and warrants further exploration.

Blended Learning for Sexual Health Education: Evidence Base, Promising Practices, and Potential Challenges.

BACKGROUND: Blended learning is a combination of online learning and face-to-face instruction, and is increasingly being used in K-12 settings. A meta-analysis conducted for the Department of Education suggests blended learning is more effective than either group-based or online learning alone, particularly in K-12 settings. METHODS: This paper provides a narrative review of the literature from 2000 to 2017 on blended learning as it applies to sexual health education programs, and discusses outcomes, best practices and potential challenges of blended learning that may be important for practitioners and researchers considering this approach. RESULTS: Blended learning approaches are being used successfully in sexual health education programs, including school-based programs, and have yielded positive behavioral and psychosocial changes. Similar to traditional group-based programs, not all outcomes tested in these programs showed positive impact. Designing blended learning programs can be challenging, but there is a large best-practice literature that can inform practitioners interested in using it. CONCLUSIONS: Blended learning approaches are viable for sexual health education and offer numerous advantages to group-based only programs, such as confidential personalization and an instructional approach that is familiar and engaging for participants.

Replication of It's Your Game Keep It Real! in Southeast Texas.

Despite the recent efforts of the Office of Adolescent Health to replicate programs with demonstrated efficacy, there are still few evidence-based HIV, sexually transmitted infection (STI), and teen pregnancy prevention programs that have been replicated in "real-world" settings. To test the effectiveness of It's Your Game…Keep It Real! (IYG), an evidence-based STI and pregnancy prevention program for middle schools, the curriculum was implemented by teachers in urban and suburban middle schools in Southeast Texas from 2012 to 2015. IYG was evaluated using a group-randomized wait-list controlled effectiveness trial design in which 20 middle schools in nine urban and suburban school districts in Southeast Texas were randomized equally, using a multi-attribute randomization protocol, to either the intervention condition (received IYG) (n = 10 schools comprising 1936 eligible seventh graders) or the comparison condition (received usual care) (n = 10 schools comprising 1825 eligible seventh graders). All students were blinded to condition prior to administering the baseline survey. The analytic sample comprised 1543 students (n = 804, intervention; n = 739, comparison) who were followed from baseline (seventh grade) to the 24-month follow-up (ninth grade). Multilevel regression analyses were conducted to assess behavioral and psychosocial outcomes at follow-up. There were no significant differences in initiation of vaginal or oral sex between study conditions at follow-up. However, at 12-month follow-up, compared with students in the comparison condition, students in the intervention condition reported increased knowledge, self-efficacy, and perceived favorable norms related to HIV/STIs, condoms, and/or abstinence; decreased intentions to have sex; and increased intentions to use birth control. Knowledge outcomes were statistically significant at 24-month follow-up. This IYG effectiveness trial did not replicate the behavioral effects of the original IYG efficacy trials. However, it adds to the growing literature on the replication of evidence-based programs, and underscores the need to better understand how variations in implementation, setting, and measurement affect the behavioral impact of such programs.Clinical trial registration clinicaltrials.gov (NCT03533192).

Examining the Effects of an Adolescent Pregnancy Prevention Program by Risk Profiles: A More Nuanced Approach to Program Evaluation.

PURPOSE: The objective of the study was to examine whether latent class analysis (LCA) could (1) identify distinct subgroups of youth characterized by multiple risk and protective factors for early sexual initiation and (2) allow for a more nuanced assessment of the effects of a middle school program to prevent teen pregnancy/HIV/sexually transmitted infection. METHODS: LCA was applied to data from the baseline (seventh grade) sample of 1,693 sexually inexperienced students participating in a randomized controlled trial of It's Your Game…Keep It Real in Harris County, Texas. Multilevel analysis was applied within subgroups defined by the latent classes to assess for potential differential program effects. RESULTS: LCA identified 3 distinct profiles of youth: family disruption, other language household, and frequent religious attendance. Multilevel analyses found differential effects of the program across these profiles with a significant and substantial reduction (30%) in initiation of vaginal sex by ninth grade for students in the family disruption profile only. CONCLUSIONS: Application of LCA may hold promise for conducting more nuanced evaluations and refinements of behavior change interventions for youth.

Dual Contraceptive Method Use Among Youth in Alternative Schools.

Dual contraceptive method use, or using a highly effective contraceptive method plus a barrier method like condoms, is gaining attention as a strategy for preventing unplanned pregnancy and sexually transmitted diseases. We investigated rates of dual method use among a sample of youth in urban alternative schools, and explored the relationship between dual method use and sexual partner type. The study analyzed data from 765 students enrolled in 11 district-run continuation high schools in northern California. We explored the association between dual method use and sexual partner type (steady only, a mix of steady and non-steady, and non-steady only) using logistic regression. Differences in dual rates by partner type were statistically significant, with higher rates of dual methods use reported among young people reporting non-steady sexual partners only, as compared to those with steady partners only. The data illustrate that young people in alternative school settings could gain from further intervention on the benefits, skills, and challenges of using two methods of contraception as opposed to one with both steady and non-steady sexual partners.

It's Your Game Keep It Real in South Carolina: A Group Randomized Trial Evaluating the Replication of an Evidence-Based Adolescent Pregnancy and Sexually Transmitted Infection Prevention Program.

OBJECTIVES: To evaluate the effectiveness of an evidence-based HIV/sexually transmitted infection (STI)/pregnancy prevention program for middle schools implemented by school staff in South Carolina. METHODS: Twenty-four schools, representing 3143 youths, participated in a randomized trial from 2011 to 2014. Students completed surveys before programming (fall of seventh grade), after completing the 2-year It's Your Game…Keep It Real program (spring of eighth grade), and 1-year postprogram (spring of ninth grade). RESULTS: There was no statistically significant effect on initiation of vaginal sex between baseline and eighth grade. Significantly fewer students in the comparison condition reported initiating sex at ninth grade, relative to the intervention condition. No group differences existed on other behavioral outcomes that addressed sexual activity in the past 3 months at ninth grade. Seven of 26 psychosocial outcomes (3 knowledge, 1 attitude, 1 self-efficacy, 2 personal limits) were positively affected at eighth grade; 4 remained significant at ninth grade. CONCLUSIONS: The original studies' behavioral effects were not replicated in this population, possibly as a result of this being an effectiveness trial instead of an efficacy trial, counterfactual exposure design issues, or postprogram exposure to evidence-based programming.

Estimates of Intraclass Correlation Coefficients From Longitudinal Group-Randomized Trials of Adolescent HIV/STI/Pregnancy Prevention Programs.

INTRODUCTION: Group-randomized trials (GRTs) are one of the most rigorous methods for evaluating the effectiveness of group-based health risk prevention programs. Efficiently designing GRTs with a sample size that is sufficient for meeting the trial's power and precision goals while not wasting resources exceeding them requires estimates of the intraclass correlation coefficient (ICC)-the degree to which outcomes of individuals clustered within groups (e.g., schools) are correlated. ICC estimates vary widely depending on outcome, population, and setting, and small changes in ICCs can have large effects on the sample size needed to estimate intervention effects. This study addresses a gap in the literature by providing estimates of ICCs for adolescent sexual risk-taking outcomes under a range of study conditions. METHOD: Multilevel regression analyses were applied to existing data from four federally funded GRTs of school-based HIV/STI/pregnancy prevention programs to obtain a variety of ICC estimates. RESULTS: ICCs ranged from 0 to 0.15, with adjustment for covariates and repeated measurements reducing the ICC in the majority of cases. Minimum detectable effect sizes with 80% power and 0.05 significance levels ranged from small to medium Cohen's d (0.13 to 0.53) assuming 20 schools of 100 students each. CONCLUSIONS: This study provides the first known set of ICC estimates for investigators to use when planning studies of school-based programs to prevent sexual risk behaviors in youth. The results provide further evidence of the importance of using the appropriate adjusted ICC estimate at the design stage to maximize resources in costly GRTs.

An exploratory study of adolescent pimping relationships.

In the last decade, public attention to the problem of commercially sexually exploited children (CSEC) has grown. This exploratory qualitative study examines adolescent pimping relationships, including how urban youth perceive these types of relationships. Study data stem from interviews with three young adult informants with first-hand knowledge of adolescent pimping, as well as three gender-specific focus group discussions with a convenience sample of 26 urban high school students who have first- or second-hand knowledge of adolescent pimping. Findings indicate that respondents believe teen pimping exists in their schools and communities, and that those exploited typically do not self-identify as victims. Respondents also believed that younger pimps are more likely to use violence to induce compliance among the girls they exploit, whereas older pimps are more likely to emotionally manipulate young women into exploitation. Further, respondents indicated that some young people agreed to exchange or sell sex for money as a favor to their boyfriends or girlfriends, and some young people believed that selling sex is acceptable under certain circumstances. The growing attention to CSEC provides an important opportunity to expand prevention efforts to reach those most affected and at risk for exploitation. The findings highlight critical areas for augmenting traditional content in school-based HIV/STI and sexuality education classes.

"They were only joking": efforts to decrease LGBTQ bullying and harassment in seattle public schools.

BACKGROUND: Seattle Public Schools has implemented policies and programs to increase safety, family involvement, and student achievement for lesbian, gay, bisexual, transgender, and questioning (LGBTQ) youth. This case study examines students' perceptions of bullying and harassment in the school environment, and teacher intervention when these problems arise in the presence of strong district policies and programs aimed at reducing LGBTQ bullying and harassment in schools. METHODS: We surveyed students in Gay-Straight Alliance (GSA) groups at 13 secondary schools (N = 107). We also conducted focus groups with GSA students and students not involved in the GSAs in 7 of 13 schools (N = 16 groups, including 154 students). RESULTS: GSA students who were lesbian, gay, bisexual, or questioning (LGBQ) were significantly more likely than straight students to experience several types of harassment. On the basis of student report, the 2 most common intervention strategies by teachers for verbal harassment included stopping the harassment and explaining why it is wrong; teachers intervened in physical harassment by trying to stop the harassment. Students provided input on how to strengthen teacher interventions, including the need for more consistency in responding and following up. Students also noted a need for more focus on educating those who harass, rather than just asking them to stop. CONCLUSIONS: Seattle Public Schools has made great strides in creating safe and welcoming schools for LGBTQ students, but still have to work further toward reaching this goal. Data from students on how they experience their school environment can help identify areas for improvement.

Interventions to reduce sexual risk behaviors among youth in alternative schools: a randomized controlled trial.

PURPOSE: This paper presents results from a randomized controlled trial that assessed the short- and longer-term impact of a skills-based HIV/STI/pregnancy prevention curriculum, service learning, and the combination. METHODS: The study featured a four-arm experimental design involving 47 classrooms (765 youth) from continuation high schools. Classrooms were randomly assigned to one of four conditions: (1) HIV/STI/pregnancy prevention curriculum only; (2) service learning only; (3) HIV/STI/pregnancy prevention curriculum plus service learning; or (4) an attention control curriculum. Students completed 3 surveys over 18 months. Multi-level analysis was used to adjust for the correlation among students within the same classroom and school, and the correlation of repeated measurements. RESULTS: Participants were 53% male (mean age: 16.2 years). The majority of youth reported being Hispanic/Latino or African-American (37.9% and 22.3%, respectively). Students in the HIV/STI/pregnancy prevention curriculum condition were less likely to have vaginal intercourse without a condom in the 3 months prior to the survey [odds ratio (OR) = .58, p = .04]; these effects diminished by final follow-up. The program also significantly reduced students' exposure to risky situations. These changes were not significant in the service learning only or combined intervention conditions relative to control. CONCLUSION: This study is one of a few controlled studies of HIV/STI and pregnancy prevention programs in continuation settings, and suggests the curriculum was effective in changing selected risk behaviors in the short term.

Condom use: slippage, breakage, and steps for proper use among adolescents in alternative school settings.

BACKGROUND: School-based human immunodeficiency virus (HIV)/sexually transmitted infection (STI), and pregnancy prevention programs often focus on consistent and correct condom use. Research on adolescents' experience using condoms, including condom slippage/breakage, is limited. This exploratory study examines proper condom use and the occurrence of condom slippage/breakage among alternative school youth. METHODS: Data are from an HIV/STI prevention trial for youth in continuation school settings (N = 776). Analyses included separate hierarchical logistic regression analyses to explore the relationship between potential correlates and each outcome variable. RESULTS: Students' use of steps for proper condom use varied-73.8% put on the condom before sexual contact, 71.1% squeezed air from the tip, and 92.0% unrolled the condom fully. Notably, 28.5% reported condom slippage/breakage. Results from the regression analyses showed that 4 sets of variables (demographic, substance use, sexual risk behaviors, and condom psychosocial factors) were associated with putting on a condom before sexual contact; none of the variable sets were associated with the other 2 condom steps measured. For slippage/breakage, the demographic and sexual risk behaviors were significant correlates; steps for proper condom use approached statistical significance (p = .058). CONCLUSIONS: This study extends the limited research on how adolescents use condoms, and highlights important targets for prevention interventions.

What works? Process evaluation of a school-based fruit and vegetable distribution program in Mississippi.

BACKGROUND: During the 2004-2005 school year, the Mississippi Department of Education, Office of Child Nutrition, initiated a pilot program to distribute free fruit and vegetable snacks to students during the school day. This article describes the first-year implementation of the Mississippi Fruit and Vegetable Pilot Program. METHODS: The process evaluation addressed where, when, and how produce was distributed; what was distributed; challenges and successes; and recommended modifications. Five of the 25 program schools were selected to participate in the evaluation; selection was based on grade levels served and demographic characteristics. Data were collected from program staff (N = 11) and administrators (N = 6) via interviews and logs; student (N = 42) and parent (N = 19) focus groups; student questionnaires (N = 660); and school staff questionnaires (N = 207). RESULTS: Distributing fresh fruit and vegetable snacks at school was well received by staff and students. Most schools distributed the fresh fruit and vegetable snacks at morning break in classrooms or a central courtyard. Twenty-two types of fresh fruit, 4 types of dried fruit, and 7 types of vegetables were served to students during the program year. Commonly distributed fruit included apples, oranges, pears, bananas, and tangerines. Carrots were the staple vegetable, followed by celery. Key challenges included getting students to try new foods and receiving the produce in a timely manner without spoiling. Main successes included seeing students try new fruit and vegetable snacks, having the program run smoothly, and teacher support. CONCLUSIONS: The program fit well within the school structure and could be an effective component of a multifaceted approach to enhancing child nutrition.

The association between school-based physical activity, including physical education, and academic performance: a systematic review of the literature.

OBJECTIVE: The purpose of this review is to synthesize the scientific literature that has examined the association between school-based physical activity (including physical education) and academic performance (including indicators of cognitive skills and attitudes, academic behaviors, and academic achievement). METHOD: Relevant research was identified through a search of nine electronic databases using both physical activity and academic-related search terms. Forty-three articles (reporting a total of 50 unique studies) met the inclusion criteria and were read, abstracted, and coded for this synthesis. Findings of the 50 studies were then summarized. RESULTS: Across all the studies, there were a total of 251 associations between physical activity and academic performance, representing measures of academic achievement, academic behavior, and cognitive skills and attitudes. Slightly more than half (50.5%) of all associations examined were positive, 48% were not significant, and 1.5% were negative. Examination of the findings by each physical activity context provides insights regarding specific relationships. CONCLUSION: Results suggest physical activity is either positively related to academic performance or that there is not a demonstrated relationship between physical activity and academic performance. Results have important implications for both policy and schools.

Distributing free fresh fruit and vegetables at school: results of a pilot outcome evaluation.

OBJECTIVES: Consumption of fruit and vegetables among children is generally below recommended levels. This evaluation addressed two questions: (1) To what extent did children's attitudes toward, familiarity with, and preferences for fruit and vegetables change during the school year? and (2) To what extent did children's consumption of fruit and vegetables change during the school year? METHODS: During the 2004-2005 school year, the Mississippi Department of Education, Child Nutrition Programs initiated a pilot program to distribute free fruit and vegetables to students (kindergarten through 12th grade) during the school day. Data were collected in 2004-2005 within a one-group pretest/posttest design using a self-report questionnaire (n=725) and 24-hour dietary recalls (n=207) with a sample of students from five schools in Mississippi. Data were analyzed in 2006-2007. RESULTS: Results showed greater familiarity with fruit and vegetables at all grade levels (p<0.05) and increased preferences for fruit among eighth- and 10th-grade students (p<0.01). Eighth-grade students also reported more positive attitudes toward eating fruit and vegetables (p<0.01), increased perceived self-efficacy to eat more fruit (p<0.01), and increased willingness to try new fruit. Finally, results showed increased consumption of fruit, but not vegetables, among eighth- and 10th-grade students (p<0.001). CONCLUSIONS: Distributing free fruit and vegetables at school may be a viable component of a more comprehensive approach for improving students' nutrition attitudes and behaviors. More program emphasis is needed on ways to promote vegetable consumption.

All4You! A randomized trial of an HIV, other STDs, and pregnancy prevention intervention for alternative school students.

This study evaluated All4You!, a theoretically based curriculum designed to reduce sexual risk behaviors associated with HIV, other STDs, and unintended pregnancy among students in alternative schools. The study featured a randomized controlled trial involving 24 community day schools in northern California. A cohort of 988 students was assessed four times during an 18-month period using a self report questionnaire. At the 6-month follow-up, the intervention reduced the frequency of intercourse without a condom during the previous 3 months, the frequency of intercourse without a condom with steady partners, and the number of times students reported having intercourse in the previous 3 months. It also increased condom use at last intercourse. These behavioral effects were no longer statistically significant at the 12- and 18-month follow-ups. The All4You! intervention was effective in reducing selected sexual risk behaviors among students in alternative school settings; however, the effects were modest and short term.