Research Participation Decision-Making Among Youth and Parents of Youth with Chronic Health Conditions: A Dissertation

The purpose and aims of this qualitative descriptive study were to describe how past experiences with research (including communication, information, values and support) may contribute to research fatigue among youth and parents of youth with HIV, CF, and T1D. Eighteen parents and youth were purposively recruited from outpatient subspecialty clinics at a major academic medical center. They took part in qualitative interviews, completed a demographics form, and the Decisional Conflict Scale. Youth participants also completed the Erikson Psychosocial Stage Inventory. Two major themes emerged: blurred lines and hope for the future. Research fatigue was not found in this sample. Results point to challenges with informed consent in settings where research and clinical care are integrated, and suggest that protective factors allow for continued participation without excess burden on youth and parents. Strategies to minimize research fatigue and support engagement in research are offered

Communicative Competence for Researchers working with LGBTQ Communities

The ethical principles of respect and justice oblige the use of culturally sensitive approaches when engaging participants in research, however cultural competence training is lacking for researchers who work with LGBTQ populations. The purpose of this study was to explore how researchers can create a welcoming research environment for LGBTQ research participants in the context of historical distrust of medical research as a barrier to research participation among minority populations. Grounded by a framework of communicative competence, this study explored elements of preferred communication during recruitment and informed consent for research involving LGBTQ participants. Grammatical, sociolinguistic, strategic and discourse competence domains aided exploration of the preferences held by participants in LGBTQ sub-groups, as well as the perceived barriers to research. Thirty-six participants, who self-identified as part of the LGBTQ community and were recruited through our community partner, the Center for Health Impact, took part in either focus groups or individual interviews. Preliminary analysis reveals community engagement and building trust are key, particularly in an academic medical center where a patient\u27s clinical experiences may impact their willingness to become a research participant. Participants offered insight into each competence domain, covering: terminology to promote inclusivity, body language to avoid, reducing stigma by being up front and feedback on crafting a more LGBTQ-friendly basic demography questionnaire. These findings will aid in the refinement of an LGBTQ-focused version of our Simulation-based Community-engaged Research Intervention for Informed Consent Protocol Testing and Training (SCRIIPTT) to build communicative competence among clinical researchers

Research Participation Decision-Making Among Youth and Parents of Youth With Chronic Health Conditions

The aims of this qualitative descriptive study were to describe how past experiences with research (including communication, information, values, and support) may contribute to research fatigue among youth and parents of youth with HIV, cystic fibrosis, and Type 1 diabetes. Eighteen parents and youth were purposively recruited from outpatient subspecialty clinics at a major academic medical center. They took part in qualitative interviews and completed a demographics form and the Decisional Conflict Scale. Youth participants also completed the Erikson Psychosocial Stage Inventory. Two major themes emerged: Blurred Lines and Hope for the Future. Research fatigue was not found in this sample. Results point to challenges with informed consent in settings where research and clinical care are integrated and suggest that protective factors allow for continued participation without excess burden on youth and parents. Strategies to minimize research fatigue and support engagement in research are offered

Alendronate improves bone mineral density in perinatally HIV-infected children and adolescents with low bone mineral density for age

BACKGROUND: Perinatally HIV-infected (PHIV) children and adolescents with low bone mineral density (BMD) may be at higher risk of osteoporosis and fractures in later life than their uninfected peers. Bisphosphonate therapy has been shown to reduce fractures in adults with osteoporosis, but has not been formally studied in HIV-infected youth. METHODS: Fifty-two PHIV 11- \u3c 25 years of age with low lumbar spine (LS) BMD (Z-score \u3c -1.5) were randomized to receive once-weekly alendronate or placebo in a double-blind cross-over study designed to assess the safety and efficacy of 48 and 96 weeks of alendronate in the US and Brazil (ClinicalTrials.gov # NCT000921557). All participants received daily calcium carbonate and vitamin D supplementation and were asked to engage in regular weight-bearing exercise. Safety and efficacy are summarized for the initial 48 weeks of the trial. RESULTS: Grade \u3e /= 3 abnormal laboratory values, signs, or symptoms developed in 5 of 32 (16%) participants on alendronate and 2 of 18 (11%) on placebo (p \u3e 0.99). No cases of jaw osteonecrosis, atrial fibrillation, or non-healing fractures were reported. Mean increases (95% confidence interval) in LS BMD over 48 weeks were significantly larger on alendronate [20% (14%, 25%)] than placebo [7% (5%, 9%), p \u3c 0.001]. Similar improvements were seen for whole body BMD. CONCLUSIONS: In this small study in PHIV children and adolescents with low LS BMD, 48 weeks of alendronate was well-tolerated, showed no safety concerns, and significantly improved LS and whole body BMD compared to participants on vitamin D/calcium supplementation and exercise alone