Ethical Aspects of Involving Adolescents in HIV Research: A Systematic Review of the Empiric Literature.

OBJECTIVE: To evaluate the ethics of involving adolescents in HIV research, we conducted a systematic review of the empiric literature. METHODS: Electronic databases Ovid Medline, Embase, and CINAHL were systematically searched using controlled vocabulary terms related to ethics, HIV, specified age groups, and empiric research studies. We reviewed titles and abstracts, including studies that collected qualitative or quantitative data, evaluated ethical issues in HIV research, and included adolescents. Studies were appraised for quality, data were extracted, and studies were analyzed using narrative synthesis. RESULTS: We included 41 studies: 24 qualitative, 11 quantitative, 6 mixed methods; 22 from high-income countries (HIC), 18 from low- or middle-income countries (LMIC), and 1 from both HIC and LMIC. Adolescent, parent, and community perspectives assert the benefits of involving minors in HIV research. Participants in LMIC expressed mixed views regarding parental consent requirements and confidentiality, given adolescents' both increasing autonomy and continued need for adult support. In studies in HIC, sexual or gender minority youth would not participate in research if parental consent were required or if there were confidentiality concerns. There was variation in the comprehension of research concepts, but adolescents generally demonstrated good comprehension of informed consent. Informed consent processes can be improved to increase comprehension and study accessibility. Vulnerable participants face complex social barriers that should be considered in study design. CONCLUSIONS: Data support the inclusion of adolescents in HIV research. Empiric research can inform consent processes and procedural safeguards to ensure appropriate access.

Capacity to Consent to Research Among Adolescent-Parent Dyads in Rakai, Uganda.

OBJECTIVES: To assess the cognitive capacity of early, middle, and late adolescents and their parents or guardians to provide informed consent to a population-based cohort study. STUDY DESIGN: Adolescent-parent/guardian dyads including 40 early (n = 80; 10-14 years), 20 middle (15-17 years), and 20 late (18-19 years) adolescents were recruited from the Rakai Community Cohort Study, an open demographic cohort in Uganda. Participants were administered the MacArthur Competence Assessment Tool for Clinical Research, a structured open-ended assessment; interviews were recorded and transcribed. Twenty transcripts were scored independently by two coders; the intraclass correlation coefficient was 0.89. The remaining interviews were scored individually. We compared mean scores for early and middle/late adolescents using a one-sided t test and score differences between parent/guardian and adolescent dyads using two-sided paired t tests. RESULTS: Early adolescents (mean score, 28.8; 95% CI, 27.1-30.5) scored significantly lower (P < .01) than middle/late adolescents (32.4; 31.6-33.1). In paired dyad comparisons, we observed no statistically significant difference in scores between parents/guardians and middle/late adolescents (difference, -0.2; 95% CI, -1.0-0.6). We found a statistically significant difference in scores between parents/guardians and early adolescents (difference, 3.0; 95% CI, 1.2-4.8). CONCLUSIONS: The capacity of adolescents-of different ages and in diverse settings-to comprehend risks, benefits, and other elements of informed consent is a critical but understudied area in research ethics. Our findings support the practice of having middle and late adolescents provide independent informed consent for sexual and reproductive health studies. Early adolescents may benefit from supported decision-making approaches.

Identifying Barriers to HPV Vaccination for Patients With Sickle Cell Disease and Childhood Cancer Survivors.

Human papillomavirus (HPV) vaccination prevents the development of HPV-associated malignancies. Adolescent and young adult survivors of childhood cancers and patients with sickle cell disease (SCD) are vulnerable patient populations who would significantly benefit from HPV vaccination. In this multimethod study, a retrospective chart review found a notable difference between the rate of HPV vaccinations and other age-appropriate vaccinations in 177 childhood cancer survivors and in 70 patients with SCD. We then sought to describe patient and caregiver beliefs regarding HPV vaccination, through semistructured interviews with 21 patients and 48 caregivers. Interviews were analyzed with a thematic content approach to understand attitudes regarding the HPV vaccination. Qualitative interviews noted that many caregivers and adolescents had baseline misconceptions regarding the HPV vaccination in general and in context with their chronic illness. It was found that a strong recommendation from a trusted subspecialty provider would create reassurance about vaccination and reduce misconceptions and concerns about side effects in the context of a chronic illness. Counseling from subspecialists could have a strong impact on understanding the HPV vaccine in the context of chronic illness. This would likely help overcome many of the barriers to vaccination that are encountered by patients with SCD or oncology survivors.

The role of trauma and positive youth development in polysubstance use among rural middle school students: a latent class analysis.

BACKGROUND: Rural youth often begin developing polysubstance use and other risk behaviors during middle school. However, little polysubstance use research focuses on rural middle school youth. Our research uses Latent Class Analysis to understand existing patterns of rural middle school polysubstance use and risk and protective factors associated with polysubstance use. METHODS: We used survey data from a rural middle school pregnancy prevention program (N = 2,708). The survey included measures of demographics, lifetime substance use, trauma (adverse childhood experiences and bullying victimization) and aspects of youth development (parent communication on drugs and alcohol, parent connectedness and school connectedness). We used latent class analysis to produce participant polysubstance use profiles and multinomial regression to examine associations between polysubstance use, demographics, trauma and aspects of youth development. RESULTS: We categorized our participants into four latent classes. Our analysis classified 2.2% of participants as Regular Polysubstance users, 6.9% as Polysubstance experimenters, 19% as Vape + Alcohol experimenters and 71.9% as Non-Users. More adverse childhood experiences were associated with greater risk of polysubstance use and experimentation. Bullying was positively associated with greater risk of vape and alcohol experimentation. Higher reported parental and school connectedness were associated with lower risk of high frequency polysubstance use. Higher reported school connection was also associated with lower risk of polysubstance experimentation. CONCLUSION: Rural substance use prevention programs should begin during middle school, as polysubstance use development is common among rural middle schoolers. These programs should be trauma informed and focus on connectedness as a modifiable factor to reduce risk of polysubstance use development. TRIAL REGISTRATION: This article does not report results of a health care intervention on human participants.

Ethical considerations for research involving pregnant women living with HIV and their young children: a systematic review of the empiric literature and discussion.

BACKGROUND: The proper and ethical inclusion of PWLHIV and their young children in research is paramount to ensure valid evidence is generated to optimize treatment and care. Little empirical data exists to inform ethical considerations deemed most critical to these populations. Our study aimed to systematically review the empiric literature regarding ethical considerations for research participation of PWLHIV and their young children. METHODS: We conducted this systematic review in partnership with a medical librarian. A search strategy was designed and performed within the following electronic databases: Ovid MEDLINE, Embase and CINAHL. We screened titles and abstracts using the following inclusion criteria: (1) a study population of PWLHIV or children under 5 years of age; and (2) collection of qualitative or quantitative data regarding ethics of research participation. Excluded were reviews, commentaries, policy statements, clinical care-related ethics concerns, abstracts, case studies, or studies unrelated to HIV research. Studies were appraised for quality, data were extracted, and studies were qualitatively analyzed using a principle-based ethical framework within the Belmont Report. RESULTS: Of the 7470 titles identified, 538 full-text articles were reviewed for eligibility and only three articles met full criteria for inclusion within this review. While we allowed for inclusion of studies involving young children born to mothers with HIV, only articles focused on PWLHIV were identified. Within the results of these studies, four themes emerged: (1) adequacy of informed consent; (2) consideration of paternal involvement; (3) balancing risks; and (4) access to research and treatment. A strength of this review is that it included perspectives of international research investigators, community leaders, and male partners. However, only two studies collected empiric data from PWLHIV regarding their experiences participating in research CONCLUSION: Researchers and funding agencies should be aware of these considerations and appreciate the value of and critical need for formative research to ensure clinical trials involving PWLHIV promote ethical, well-informed research participation and, ultimately, improve care outcomes. More research is needed to create a comprehensive ethical framework for researchers when conducting studies with PWLHIV.

Tapping into Community Resiliency in Rural Adolescent Pregnancy Prevention: An Implementation Sciences Approach.

Although rural youth experience marked inequities in adolescent pregnancy, there is little guidance for implementing evidence-based programs (EBPs) in rural settings. When implementation occurs in rural communities, it frequently focuses on deficits, rather than strengths or capacity for growth. Using the consolidated framework for implementation research (CFIR), we describe a resiliency-focused implementation of two middle school EBPs in rural Midwestern communities, including the intervention, outer and inner settings, individuals, implementation processes and preliminary outcomes. Data included program staff interviews, feedback from local partners, community meetings notes, and participant surveys. Using the CFIR, we describe the engagement of rural communities themselves in a resilience-based implementation of adolescent pregnancy prevention EPBs. Communities self-described as rural, traditional and religious. They identified adolescent pregnancy, substance use, and academic success as priorities. To address infrastructure needs and build on local strengths, funds were used to hire local partners to implement the program. As small communities, stakeholders were closely networked and wanted to address local needs. Local partners selected the EBP based upon community values and priorities. Champions, including local partner organizations and schools were locally based and were well connected. Intensive training of local staff and piloting with adaptation assured fidelity and sustainability, while increasing community implementation skills and comfort. In Clinton County, enrollment was 1946 with students receiving the program in 6th, 7th, and/or 8th grades. In Southern Indiana, 7275 students received the program once in either 6th, 7th, or 8th. We conclude that the CFIR can facilitate the implementation of a community resilience-focused adolescent pregnancy prevention intervention in rural communities.

Factors Influencing Pediatric Resident Exposure to Adolescents in their Continuity Clinic.

Adequate training in adolescent primary care is a challenge for pediatric residency programs. We examined residents' pediatric continuity clinic exposure to and comfort with adolescents, and their knowledge about best practices. Comfort was predicted by patient numbers, training level, and completing the adolescent rotation. Knowledge was predicted by completing the adolescent rotation.

Parent-Child Sexual Communication Among Middle School Youth.

Middle school youth (N = 1472) in Central Indiana completed a survey about parent-adolescent sexual communication. Being older, female, mixed race, ever had sex, ever arrested, and higher HIV knowledge were associated with more frequent sexual communication.

Expanding adolescent access to hormonal contraception: an update on over-the-counter, pharmacist prescribing, and web-based telehealth approaches.

PURPOSE OF REVIEW: Hormonal contraceptives are largely responsible for recent declines in unintended adolescent pregnancies, with oral contraceptives being the most commonly used. Young people face multiple barriers to accessing effective contraception in clinical settings. This article reviews innovations in contraceptive access. RECENT FINDINGS: The three biggest innovations are over-the-counter oral contraceptives (OTC-OCs), pharmacist-prescribing, and web-based telehealth platforms. In many countries, oral contraceptives are available OTC, and FDA trials for OTC-OCs are underway in the United States. Many states have passed legislation allowing pharmacists to prescribe contraceptives after a brief health screening. Web-based telehealth platforms also provide prescription contraceptive access. There is a small but growing body of literature that demonstrates young people's interest in, and capacity to consent to, hormonal contraceptives in nontraditional settings. State-to-state variability in minor consent, pharmacist prescribing, and telehealth laws act as barriers to young people's access to these newer options. SUMMARY: Access to hormonal contraception is expanding outside of clinical settings, reducing barriers. Adolescents' unique needs should be considered in the design, implementation, and evaluation of these new approaches. More data is needed to ensure that adolescents are not excluded from expanded contraceptive access options, as they are disproportionately affected by unintended pregnancy.

Sexual Health Research With Young Black Men Who Have Sex With Men: Experiences of Benefits and Harms.

Young Black men who have sex with men (YBMSM) are often underrepresented in sexual health research because of concerns about safety, privacy, and the potential for research harms. Empirical data are needed to understand YBMSM experience of participating in research, benefits and harms (discomfort), to inform policy and regulatory decisions. Using qualitative methods, this article examines 50 YBMSM, aged 15-19 years, experiences of benefits/harms, challenges of participating in sexual health research, and contextual factors impacting research experiences. Participants were asked about benefits and harms experienced in answering questions about sexual orientation, first same-sex attraction, and same-sex sexual experiences after completing an in-depth interview. Interviews were transcribed and coded. Inductive open coding was used to identify themes within and between interviews. Participants were able to describe perceived direct benefits resulting from research interview participation, including awareness of risky sexual behaviors, a safe space to share early coming out stories and same-sex sexual experiences, and a sense of empowerment and comfort with one's sexual orientation. Indirect benefits described by participants included perceptions of helping others and the larger gay community. Few participants described harms (discomfort recalling experiences). Our data suggest that participating in qualitative sexual health research focused on sexual orientation, sexual attraction, and early same-sex sexual experiences may result in minimal harms for YBMSM and multiple benefits, including feeling more comfortable than in a general medical visit.

Contraception options and provision to adolescents.

Adolescent pregnancy is a significant cause of global morbidity and mortality. Adolescents who become pregnancy have lower educational attainment, are more likely to live in poverty, and have lower wellbeing. Increasing access to hormonal contraceptives and long acting reversible contraception is highly effective in reducing adolescent pregnancies. This narrative review covers key aspects of the provision of contraception to adolescents, including confidentiality, counseling, and data supporting expanded access to adolescents. We provide information for pediatric providers to start adolescent patients on contraceptives, including a detailed description of each method, including effectiveness, use, starting, side effects and benefits. Tools for counseling and prescribing are provided.

Willingness to Disclose Sexually Transmitted Infection Status to Sex Partners Among College-Aged Men in the United States.

Disclosure of sexually transmitted infections (STIs) to sexual partners is critical to the prevention, treatment, and control of STIs. We examine personal intra and interpersonal influences on willingness to disclose STI status among college-aged men. Participants (n = 1064) were aged 17 to 24 years and recruited from a variety of university and community venues. Using independent-samples t test, Pearson χ test, and binary logistic regression, we examined the relationship between willingness to disclose an STI and intrapersonal and interpersonal factors, including age, masculinity values, interpersonal violence, partner cell phone monitoring, alcohol and/or drug use, condom use, number and characteristics of sex partners, and previous STI. Results reveal that among college-aged men, type of sex partner and masculinity values are significant variables in predicting whether or not an individual is willing to disclose. These data can inform STI control programs to more effectively address the complex issues associated with STI disclosure to sex partners.