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Item Development and evaluation of a web-based assent for adolescents considering an HIV vaccine trial(Taylor & Francis, 2015-08) Blake, Diane R.; Lemay, Celeste A.; Maranda, Louise S.; Fortenberry, J. Dennis; Kearney, Margaret H.; Mazor, Kathleen M.; Department of Pediatrics, IU School of MedicineHIV vaccine trials with minors will likely require parental permission and informed assent from adolescents. For this to be a valid process, the information needs to be presented in a manner that promotes adolescent comprehension. Previous studies suggest that adolescent comprehension of assent is often insufficient. We developed an interactive web-based assent that included interspersed quiz questions for a hypothetical HIV vaccine trial. Efficacy of the web-based assent was compared to a standard paper assent with and without interspersed questions. One hundred twenty teen participants, ages 15-17 years, from five community organizations were randomized to self-administered web-based assent (n=60) or investigator-administered paper assent with (n=29) or without (n=31) interspersed quiz questions. After reviewing the assent, participants completed a 27-item comprehension test. Comprehension scores were compared between groups. The mean number of correctly answered questions were 21.2 for the full paper group and 21.1 for the web-based group (t118=-0.08, p=0.94). Scores were 20.2 for the paper without interspersed questions sub-group and 22.1 for the paper with interspersed questions sub-group (t58=1.96, p=0.055). Participants in the web-based group performed as well on the comprehension test as those in the paper group, and those in the paper with questions sub-group performed better than those in the paper without questions sub-group, suggesting that interspersed quiz questions may improve understanding of a traditional paper assent. The minimal investigator time and standardized administration of the web-based assent as well as ability to tailor the assent discussion to topics identified by incorrect comprehension test responses are advantages worthy of further investigation.Item Facility-Level Factors Influencing Retention of Patients in HIV Care in East Africa(Plos, 2016-08-10) Rachlis, Beth; Bakoyannis, Giorgos; Easterbrook, Philippa; Genberg, Becky; Braithwaite, Scott; Cohen, Craig R.; Bukusi, Elizabeth A.; Kambugu, Andrew; Bwana, Mwebesa Bosco; Somi, Geoffrey R.; Geng, Elvin H.; Musick, Beverly; Yiannoutsos, Constantin T.; Wools-Kaloustian, Kara; Braitstein, Paula; Department of Biostatistics, Richard M. Fairbanks School of Public HealthLosses to follow-up (LTFU) remain an important programmatic challenge. While numerous patient-level factors have been associated with LTFU, less is known about facility-level factors. Data from the East African International epidemiologic Databases to Evaluate AIDS (EA-IeDEA) Consortium was used to identify facility-level factors associated with LTFU in Kenya, Tanzania and Uganda. Patients were defined as LTFU if they had no visit within 12 months of the study endpoint for pre-ART patients or 6 months for patients on ART. Adjusting for patient factors, shared frailty proportional hazard models were used to identify the facility-level factors associated with LTFU for the pre- and post-ART periods. Data from 77,362 patients and 29 facilities were analyzed. Median age at enrolment was 36.0 years (Interquartile Range: 30.1, 43.1), 63.9% were women and 58.3% initiated ART. Rates (95% Confidence Interval) of LTFU were 25.1 (24.7-25.6) and 16.7 (16.3-17.2) per 100 person-years in the pre-ART and post-ART periods, respectively. Facility-level factors associated with increased LTFU included secondary-level care, HIV RNA PCR turnaround time >14 days, and no onsite availability of CD4 testing. Increased LTFU was also observed when no nutritional supplements were provided (pre-ART only), when TB patients were treated within the HIV program (pre-ART only), and when the facility was open ≤4 mornings per week (ART only). Our findings suggest that facility-based strategies such as point of care laboratory testing and separate clinic spaces for TB patients may improve retention.Item Inclusion of Adolescents in STI/HIV Biomedical Prevention Trials: Autonomy, Decision Making, and Parental Involvement(American Psychological Association, 2018-09) Rosenthal, Susan L.; Morris, Marilyn C.; Hoffman, Lily F.; Zimet, Gregory D.; Pediatrics, School of MedicineIn order to develop new methods for prevention and treatment of sexually transmitted infection (STI) and human immunodeficiency virus (HIV), clinical trials must be conducted in relevant populations. In the U.S., half of all STI incident infections are among 15-24 year olds (Satterwhite et al., 2013), making healthy adolescents a highly relevant population. The inclusion of adolescents in STD/HIV prevention research is critical for developing appropriate strategies to promote adolescent sexual health. Results from adult studies may not generalize to adolescents, given their biological and psychosocial developmental status (Hwang et al., 2009). In order to understand the extent to which these differences are applicable to safety, efficacy, and acceptability, the products must be tested in minors. Enrolling adolescents who have not reached the legal age of majority in sexual health research, though, poses legal and ethical challenges. Investigators have been described as facing moral conflict between their responsibility to protect the scientific rigor of the study and the well-being of the participants (Merritt, 2005). Institutional Review Boards (IRBs) must balance the interests of minors, their parents, and the institution (Knopf et al., 2016). Data suggest that adolescents are under-represented in biomedical trials of HIV and STD prevention (Tolley et al., 2014; Hoffman et al., 2016). We propose that the inclusion of these adolescents in sexual health research is not only ethically permissible but is ethically required.