We introduced case management and homeless outreach to chronically homeless, alcohol-dependent, frequent emergency department (ED) visitors using existing resources. We assessed the difference in differences of ED visits 6 months pre- and postintervention using a prospective, nonequivalent control group trial. Secondary outcomes included changes in hospitalizations and housing. The differences in differences between intervention and prospective patients and retrospective controls were -12.1 (95% CI = -22.1, -2.0) and -12.8 (95% CI = -26.1, 0.6) for ED visits and -8.5 (95% CI = -22.8, 5.8) and -19.0 (95% CI = -34.3, -3.6) for inpatient days, respectively. Eighteen participants accepted shelter; no controls were housed. Through intervention, ED use decreased and housing was achieved.
Purpose
Despite their heightened risk of sexually transmitted infections (STI), minor adolescents (< 18 years old) are often excluded from clinical trials. The results of trials of adults should not be assumed to generalize to minors.
Methods
Two public clinical trial registries were first searched using microbicide or PrEP with STD, STI, HIV, or HSV and with gel, ring, or film, and then searched using prevention/sexually transmitted diseases with gel. Studies were classified based on the information provided in the registry.
Results
The searches yielded 111 unique studies. Only 9.0% (n = 10) included minors. They were under-represented in Phase 0-II studies and over-represented in studies of individuals infected with human immunodeficiency virus (HIV).
Conclusion
Minor adolescents should be included during all stages of development and before they have acquired an infection. Future studies should examine the challenges of including minor adolescents in trials, and how to overcome these barriers.
Adolescents, despite their disproportionate burden of disease, often are excluded from sexually transmitted infection and HIV biomedical prevention clinical trials. The 3 principles of the Belmont Report (justice, respect for persons, and beneficence, U.S. Department of Health and Human Services, 1979) can inform our understanding of the ethical imperative to include minors in these trials. Investigators and institutional review boards need to have an understanding of what constitutes no more than minimal risk, that is, what is part of adolescent well-child care. Although cognitive development extends into the young adult years, evidence suggests that in most situations research decision-making capacity of an older minor is similar to that of a young adult. Depending on the specifics of the study, parental involvement may range from parental consent while protecting confidentiality to adolescent self-consent with a waiver of parental consent. Regardless of the level of parental involvement, protection of adolescents enrolled in trials will require strategies that guard against the risk of accidental loss of confidentiality. We outline a number of ways in which pediatric psychologists can assist clinical trial investigators and institutional review boards to ethically recruit and enroll minors into biomedical prevention trials. Furthermore, a pediatric psychologist can contribute to needed research on adolescent decision making and parental involvement to develop more sophisticated approaches to involving minors in HIV and sexually transmitted infection biomedical clinical trials.
STUDY OBJECTIVE
To understand how adolescents and parents describe a sexually transmitted infection prevention study to a friend.
DESIGN
Adolescents and parents participating in a study about willingness to participate in a hypothetical microbicide clinical trial were interviewed separately and asked to describe the clinical trial to a friend. Qualitative responses were written down verbatim and coded using a thematic framework analysis.
SETTING
Adolescent medicine clinics in New York City.
PARTICIPANTS
The participants consisted of adolescents, 14–17 years old, and a parent (n = 301 dyads) who spoke English or Spanish. Most adolescents (72%) identified as Hispanic and 65% reported minimal sexual experience (i.e. nothing more than kissing).
INTERVENTIONS
None
MAIN OUTCOME MEASURES
Qualitative responses were content coded for: 1) overall approach, 2) opinion rendered, and 3) details mentioned using thematic framework. The relationship of demographics, sexual history and recruitment method to how adolescents/parents described the study was evaluated.
RESULTS
Adolescents differed from parents in their overall approach to describing the study (p < 0.01) with more adolescents than parents providing a “purpose with detail” (54% adolescents vs 31% parents) and less providing a “commentary” description (6% adolescents vs 28% parents). Fewer adolescents (25%) provided an opinion compared to parents (75%) (p < 0.01). A higher proportion of adolescents (70% adolescents vs 48% parents) provided a detail (p < 0.01). Adolescents provided a greater number of details than parents (p < 0.01).
CONCLUSION
Adolescents in this sample were more focused on the details of the study. Parents were focused on their impression of the study. Adolescents and parents may need to be approached differently about reproductive health studies.
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