Methodological Challenges in Biomedical HIV Prevention Trials

2008 ◽  
Keyword(s):  
Hiv Prevention ◽  
Biomedical Hiv Prevention ◽  
Methodological Challenges ◽  
Prevention Trials

scholarly journals Innovative Approaches to Obtain Minors’ Consent for Biomedical HIV Prevention Trials: Multi-Site Quasi-Experimental Study of Adolescent and Parent Perspectives

10.2196/16509 ◽  
2020 ◽  
Vol 9 (3) ◽  
pp. e16509 ◽  
Author(s):  
Amelia Knopf ◽  
Mary A Ott ◽  
Claire Burke Draucker ◽  
J Dennis Fortenberry ◽  
Daniel H Reirden ◽  
...  
Keyword(s):  
Hiv Prevention ◽  
Parental Involvement ◽  
Human Subjects ◽  
Consent Process ◽  
Parental Consent ◽  
Open Label ◽  
Open Label Study ◽  
Biomedical Hiv Prevention ◽  
Quasi Experimental ◽  
Prevention Trials

Background Despite the high burden of new HIV infections in minor adolescents, they are often excluded from biomedical HIV prevention trials, largely owing to the ethical complexities of obtaining consent for enrollment. Researchers and ethics regulators have a duty to protect adolescents—as a special category of human subjects, they must have protection that extends beyond those afforded to all human subjects. Typically, additional protection includes parental consent for enrollment. However, parental consent can present a risk of harm for minor adolescents. Research involving minor adolescents indicate that they are unwilling to join biomedical trials for stigmatized health problems, such as HIV, when parental consent is required. This presents a significant barrier to progress in adolescent HIV prevention by creating delays in research and the translation of new scientific evidence generated in biomedical trials in adult populations. Objective This protocol aims to examine how parental involvement in the consent process affects the acceptability of hypothetical participation in biomedical HIV prevention trials from the perspectives of minor adolescents and parents of minor adolescents. Methods In this protocol, we use a quasi-experimental design that involves a simulated consent process for 2 different HIV prevention trials. The first trial is modeled after an open-label study of the use of tenofovir disoproxil fumarate and emtricitabine as preexposure prophylaxis for HIV. The second trial is modeled after a phase IIa trial of an injectable HIV integrase inhibitor. There are 2 groups in the study—minor adolescents aged 14 to 17 years, inclusive, and parents of minor adolescents in the same age range. The adolescent participants are randomized to 1 of 3 consent conditions with varying degrees of parental involvement. After undergoing a simulated consent process, they rate their willingness to participate (WTP) in each of the 2 trials if offered the opportunity. The primary outcome is WTP, given the consent condition. Parents undergo a similar process but are asked to rate the acceptability of each of the 3 consent conditions. The primary outcome is acceptability of the consent method for enrollment. The secondary outcomes include the following: capacity to consent among both participant groups, the prevalence of medical mistrust, and the effects of the study phase (eg, phase IIa vs the open-label study) and drug administration route (eg, oral vs injection) on WTP (adolescents) and acceptability (parents) of the consent method. Results Enrollment began in April 2018 and ended mid-September 2019. Data are being analyzed and dissemination is expected in April 2020. Conclusions The study will provide the needed empirical data about minor adolescents’ and parents’ perspectives on consent methods for minors. The evidence generated can be used to guide investigators and ethics regulators in the design of consent processes for biomedical HIV prevention trials. International Registered Report Identifier (IRRID) DERR1-10.2196/16509

scholarly journals Adherence Support Approaches in Biomedical HIV Prevention Trials: Experiences, Insights and Future Directions from Four Multisite Prevention Trials

2013 ◽  
Vol 17 (6) ◽  
pp. 2143-2155 ◽  
Author(s):  
K. Rivet Amico ◽  
Leila E. Mansoor ◽  
Amy Corneli ◽  
Kristine Torjesen ◽  
Ariane van der Straten
Keyword(s):  
Hiv Prevention ◽  
Future Directions ◽  
Biomedical Hiv Prevention ◽  
Adherence Support ◽  
Prevention Trials

scholarly journals How Biomedical HIV Prevention Trials Incorporate Behavioral and Social Sciences Research: A Typology of Approaches

2018 ◽  
Vol 23 (8) ◽  
pp. 2146-2154 ◽  
Author(s):  
Amy Corneli ◽  
Karen Meagher ◽  
Gail Henderson ◽  
Holly Peay ◽  
Stuart Rennie
Keyword(s):  
Social Sciences ◽  
Hiv Prevention ◽  
Biomedical Hiv Prevention ◽  
Prevention Trials
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