Efficacy of a Digital Health Preventive Intervention for Adolescents With HIV or Sexually Transmitted Infections and Substance Use Disorder: Protocol for a Randomized Controlled Trial.

BACKGROUND: HIV or sexually transmitted infections remain a significant public health concern in the United States, with adolescents affected disproportionately. Adolescents engage in HIV/STI risk behaviors, including drug use and condomless sex, which increase the risk for HIV/STIs. At-risk adolescents, many of whom are racial minorities, experience HIV/STI disparities. Although at-risk adolescents are disproportionately affected by HIV/STI risk behaviors and infections and although the Centers for Disease Control and Prevention recommends routine HIV/STI testing for adolescents, relatively few adolescents report having ever been tested for HIV/STI. With expected increases in health clinic visits as a result of the Affordable Care Act combined with technological advances, health clinics and mobile health (mHealth), including apps, provide innovative contexts and tools to engage at-risk adolescents in HIV/STI prevention programs. Yet, there is a dearth of efficacious mHealth interventions in health clinics to prevent and reduce both condomless sex and drug use and increase HIV/STI testing for at-risk adolescents. OBJECTIVE: To address this gap in knowledge, we developed a theory-driven, culturally congruent mHealth intervention (hereon referred to as S4E [Storytelling 4 Empowerment]) that has demonstrated feasibility and acceptability in a clinical setting. The next step is to examine the preliminary efficacy of S4E on adolescent HIV/STI testing and risk behaviors. This goal will be accomplished by 2 aims: the first aim is to develop a cross-platform and universal version of S4E. The cross-platform and universal version of S4E will be compatible with both iOS and Android operating systems and multiple mobile devices, aimed at providing adolescents with ongoing access to the intervention once they leave the clinic, and the second aim is to evaluate the preliminary efficacy of S4E, relative to usual care control condition, in preventing or reducing drug use and condomless sex and increasing HIV/STI testing in a clinical sample of at-risk adolescents aged 14-21 years living in Southeast Michigan. METHODS: In this study, 100 adolescents recruited from a youth-centered community health clinic will be randomized via blocked randomization with random sequences of block sizes to one of the 2 conditions: S4E mHealth intervention or usual care. Theory-driven and culturally congruent, S4E is an mHealth adaptation of face-to-face storytelling for empowerment, which is registered with the Substance Abuse and Mental Health Services Administration's National Registry of Evidence-Based Programs and Practices. RESULTS: This paper describes the protocol of our study. The recruitment began on May 1, 2018. This study was registered on December 11, 2017, in ClinicalTrials.gov. All participants have been recruited. Data analysis will be complete by the end of March 2024, with study findings available by December 2024. CONCLUSIONS: This study has the potential to improve public health by preventing HIV/STI and substance use disorders. TRIAL REGISTRATION: ClinicalTrials.gov NCT03368456; https://clinicaltrials.gov/study/NCT03368456. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47216.

The Health Access Initiative: A Training and Technical Assistance Program to Improve Health Care for Sexual and Gender Minority Youth.

PURPOSE: This article describes the Health Access Initiative (HAI), an intervention to improve the general and sexual health care experiences of sexual and gender minority youth (SGMY) by providing training and technical assistance to providers and staff. The training consisted of an online and in-person training, followed by site-specific technical assistance. We present the findings of a pilot evaluation of the program with 10 diverse clinics in Michigan. METHODS: This program was developed using community-based participatory research principles. Based on a framework of cultural humility, program activities are guided by the Situated Information-Motivation-Behavioral Skills Model. The mixed method program evaluation used training feedback surveys assessing program feasibility, acceptability, and effectiveness; pre/post surveys assessing knowledge, attitudes, and practices toward SGMY; and in-depth interviews with site liaisons assessing technical assistance and structural change. RESULTS: The HAI is a highly feasible and acceptable intervention for providers and staff at a variety of health care sites serving adolescents and emerging adults. The results from 10 clinics that participated in the HAI indicate strong intervention efficacy, with significant and meaningful improvements seen in the knowledge of, attitudes toward, and practices with SGMY reported by providers and staff at 6-month follow-up compared with baseline, as well as in qualitative interviews with site liaisons. CONCLUSIONS: The HAI is a promising intervention to improve the quality of primary and sexual health care provided to SGMY. Expanded implementation with continued evaluation is recommended. The HAI may also be adapted to address specific health needs of SGMY beyond sexual health.

Pilot Study of a Multilevel Mobile Health App for Substance Use, Sexual Risk Behaviors, and Testing for Sexually Transmitted Infections and HIV Among Youth: Randomized Controlled Trial.

BACKGROUND: Preventing and reducing substance use disorders, sexually transmitted infections (STIs)/HIV, and teen pregnancy, and the associated risk behaviors (ie, substance use and sexual risk behaviors) among youth remain public health priorities in the United States. Equally important is improving the uptake of STI/HIV testing among the youth. Mobile health (mHealth) apps may be a solution to ameliorate these public health concerns; however, few mHealth preventive interventions have demonstrated efficacy in reducing substance use or sexual risk behaviors or improving the uptake of STI/HIV testing among the youth, particularly in clinic settings. OBJECTIVE: This small-scale study aimed to examine the feasibility of conducting a pilot randomized controlled trial (RCT). We evaluated the effects of Storytelling 4 Empowerment (S4E), relative to enhanced usual practice, on the potential mechanisms by which behavior change occurs, namely clinician-youth risk communication, prevention knowledge, and substance use and sexual risk refusal self-efficacy. We also assessed the ability to measure targeted outcomes of past 30-day substance use (ie, alcohol, tobacco, and other drug use), condomless sex, and alcohol or drug use before sex, as well as the uptake of STI/HIV testing. METHODS: Employing community-based participatory research principles, 50 youths aged 13 to 21 years were recruited from a youth-centered community health clinic in Southeast Michigan, randomized sequentially to either S4E or enhanced usual practice, and assessed at baseline, immediately postintervention, and 30 days postintervention. S4E consists of 3 modules, including alcohol and drug use, tobacco, and STI/HIV. RESULTS: Relative to youth in the enhanced usual practice group, S4E participants demonstrated higher youth-clinician risk communication (mean 3.22, SD 1.67) and increases in prevention knowledge (∆ score mean 0.36, SD 0.51) and self-efficacy (∆ score mean 0.16, SD 0.47). In addition, youth in the S4E group showed reductions in the proportions of past 30-day overall substance use (Cohen h=0.71, 95% CI 0.15 to 1.27), as well as past 30-day alcohol (Cohen h=0.71, 95% CI 0.15 to 1.27), tobacco (Cohen h=0.17, 95% CI -0.39 to 0.73), and drug use (Cohen h=1.28, 95% CI 0.72 to 1.84). The results also suggest a reduction in the proportion of youths who reported past 30-day condomless sex (Cohen h=0.18, 95% CI -0.38 to 0.74) and alcohol use before sex (Cohen h=0.44, 95% CI -0.12 to 1.00). Finally, the findings also demonstrated an increase in the proportion of youths who reported STI/HIV testing over time (Cohen h=0.16, 95% CI -0.39 to 0.72). CONCLUSIONS: The findings suggest the feasibility of a small-scale pilot RCT. S4E demonstrated shifts in the hypothesized direction, reducing substance use, sexual risk behaviors, and improving the uptake of STI/HIV testing among youth in a clinic setting. The findings suggest that a larger RCT may be warranted. TRIAL REGISTRATION: ClinicalTrails.gov NCT03855410, https://clinicaltrials.gov/ct2/show/NCT03855410.

A multilevel mHealth drug abuse and STI/HIV preventive intervention for clinic settings in the United States: A feasibility and acceptability study.

BACKGROUND: Drug abuse and sexually transmitted infections (STIs), including the human immunodeficiency virus (HIV), remain significant public health concerns in the United States. Youth are at disproportionate risk of drug use and STIs/HIV, yet interventions aimed at improving STI and HIV testing and reducing STI/HIV risk behaviors through technology-based engagement in clinic settings are limited. The purpose of this study was to examine the feasibility and acceptability of Storytelling 4 Empowerment (S4E), a multilevel mobile-health drug abuse and STI/HIV preventive application (app) for clinic settings. We also explored uptake of STI/HIV testing among youth immediately post-intervention. METHOD: Employing community-based participatory research principles and a multi-method research design, we developed a clinician-facing app, and examined the feasibility and acceptability of S4E among clinicians (n = 6) and youth (n = 20) in an urban youth-centered community health clinic. S4E aimed to improve clinician-youth risk communication and youths' drug use and STI/HIV knowledge, self-efficacy, and refusal skills. We also explored youths' uptake of STI and HIV testing. Quantitative data were analyzed by computing mean scores and proportions, and qualitative analyses followed the tenets of content analysis. RESULTS: Among eligible participants, 86.9% of youth and 85.7% of clinicians enrolled in the study, suggesting the feasibility of recruiting participants from the targeted clinic. Most clinicians identified as non-Hispanic white (83%) and female (66.7%). Among the youth, 70% identified as non-Hispanic white, followed by 30% African American, and 50% identified as female with a mean age of 19.6 (SD = 1.5, Range = 16-21). The quantitative findings suggest that the acceptability of S4E is high, as indicated by the Client Satisfaction Questionnaire (mean score = 25.2, SD: 4.8). Immediately post-intervention, all youth who reported past 90-day condomless sex or having never been tested for STIs or HIV in their lifetime, were tested for both STIs and HIV. Qualitative themes revealed four overarching themes, including S4E: (1) faciliated timely, targeted, and tailored prevention and risk reduction strategies; (2) shaped clinician and youth communication and interaction during the clinic visit; (3) may have improved uptake of STI/HIV testing and increased STI/HIV knowledge and self-efficacy; and (4) had high feasibiliy and acceptability among youth and clninicans. CONCLUSIONS: Findings suggest the feasibility and acceptability of S4E in an urban community-based health clinic setting. A next important step is to examine the efficacy of S4E in a randomized controlled trial design.

Adolescent Experiences of Clinician-Patient HIV/STI Communication in Primary Care.

Effective clinician-patient communication is linked to positive patient health outcomes in adults, yet the research on adolescent populations remains limited. We describe adolescent experiences of clinician-patient HIV/STI communication through qualitative interviews with predominantly African-American adolescent women from a youth-centered primary care clinic. Participants described acknowledging clinicians are professionals, the importance of confidentiality to foster clinician-adolescent communication, and calling for clinician-initiated HIV/STI communication. Adolescents expressed the necessity for clinicians to engage youth in these challenging conversations through an open and understanding approach. Additionally, adolescents described experiences of perceived judgment and uncomfortableness from clinicians, and non-disclosure of HIV/STI risk behaviors to their clinician. Findings underscore the adolescents' desire to engage in HIV/STI communication with healthcare providers, while highlighting important strategies for clinicians. Results can inform health communication research and practice, and the development of interventions aimed at increasing clinician-adolescent HIV/STI communication.

The Usability and Acceptability of an Adolescent mHealth HIV/STI and Drug Abuse Preventive Intervention in Primary Care.

Human Immunodeficiency Virus (HIV)/sexually transmitted infection (STI) risk behaviors among adolescents remain significant public health concerns. Shifts in policy and advances in technology provide opportunities for researchers and clinicians to deliver and evaluate mobile-health (mHealth) prevention programs in primary care, however, research is limited. This study assessed the usability and acceptability of Storytelling 4 Empowerment-a mHealth HIV/STI and drug abuse preventive intervention app-among adolescents in primary care. Informed by principles of community-based participatory research, we recruited a purposive sample of 30 adolescents from a youth-centered community health care clinic in Southeast Michigan. The study sample is primarily African American and female. Adolescents who participated in the Storytelling 4 Empowerment intervention assessed its usability and acceptability, and self-reported their HIV/STI risk behaviors. We used a multiple-methods approach. Adolescents reported high acceptability of the content, process, and format of Storytelling 4 Empowerment, as evidenced by qualitative data and mean scores from the Session Evaluation Form for the HIV/STI and Alcohol/Drug content, overall Storytelling 4 Empowerment intervention, and Client Satisfaction Questionnaire-8. Findings indicate that Storytelling 4 Empowerment is acceptable among adolescents in primary care. A next step is to examine the effect of Storytelling 4 Empowerment on adolescent sexual risk and drug use behaviors and HIV/STI testing.

A Community-Engaged Approach to Developing an mHealth HIV/STI and Drug Abuse Preventive Intervention for Primary Care: A Qualitative Study.

BACKGROUND: Despite ongoing prevention efforts, HIV and other sexually transmitted infections (HIV/STIs) and drug use remain public health concerns. Urban adolescents, many of whom are underserved and racial minorities, are disproportionately affected. Recent changes in policy, including the Affordable Care Act, and advances in technology provide HIV/STI and drug abuse prevention scientists with unique opportunities to deliver mobile health (mHealth) preventive interventions in primary care. OBJECTIVES: The purpose of this community-engaged study was to develop an mHealth version of the Storytelling for Empowerment preventive intervention for primary care (hereinafter referred to as "S4E"). METHODS: A total of 29 adolescents were recruited from a youth-centered primary care clinic in Southeast, Michigan, to participate in qualitative interviews. Participants were predominantly African American (n=19, 65.5%) and female (n=21, 72.4%) with a mean age of 16.23 (SD 2.09). The principles of community-based participatory research (CBPR), in conjunction with agile software development and the recommended core prevention principles of the National Institute on Drug Abuse (NIDA) were employed during S4E development. CBPR principles are aimed at improving the effectiveness of research by addressing locally relevant health problems, working with community strengths, and translating basic science into applied research. Complementing this approach, the NIDA prevention principles are derived from decades of drug abuse prevention research aimed at increasing the effectiveness and uptake of programs, through the development of culturally specific interventions and ensuring the structure, content, and delivery of the intervention fit the needs of the community. Data were analyzed using thematic analysis. RESULTS: A total of 5 themes emerged from the data: (1) acceptability of the mHealth app to adolescents in primary care, (2) inclusion of a risk assessment to improve clinician-adolescent HIV/STI and drug use communication, (3) incorporation of culturally specific HIV/STI and drug use content, (4) incorporation of interactive aspects in the app to engage youth, and (5) perspectives on the appearance of the app. CONCLUSIONS: There is a dearth of mHealth HIV/STI and drug abuse preventive interventions for primary care. Incorporating the principles of CBPR in conjunction with agile software development and NIDA-recommended core prevention principles may be helpful in developing culturally specific mHealth interventions. An important next step in this program of research is to examine the feasibility, acceptability, and efficacy of S4E on adolescent sexual risk and drug use behaviors, and HIV/STI testing. Implications for prevention research and primary care practice are discussed in the context of the Affordable Care Act and technological advances.

Social outcomes of early childbearing: important considerations for the provision of clinical care.

Traditional understanding of adolescent childbearing includes a belief that the social and economic consequences for both mother and child are almost universally negative. Recent research, however, reveals that the outcomes resulting from the birth of children to young mothers are diverse and complex. Social circumstances contributing to adolescent pregnancy and parenting, such as poverty, poor educational opportunity, and violence, are also causes of less than optimal outcomes for young mothers and their children; thus, attributions of cause and effect are difficult to make. By reviewing outcomes research that approaches this question in a number of more creative ways, clinicians can gain a more complete understanding of this phenomenon. It is hoped that health care providers with access to new evidence about the social consequences of adolescent childbearing will have improved success and satisfaction in providing competent, compassionate care to pregnant and parenting adolescents.