(see Dr. Guthrie's cv for additional studies not described here)
Project DRUM-S (U19 AI101961; Guthrie, sub Principal Investigator), is an NIH Integrated Preclinical/Clinical Program (IPCP), an award mechanism designed to conduct interdisciplinary research in a preclinical setting with the goal of developing safe and effective biomedical prevention products. This particular project seeks to develop a topical microbicide that can be used in either the rectum or the vagina, or both. Dr. Guthrie's team is focused on developing psychometrically validated user sensory perception and experience (USPE; perceptibility) scales for rectal use, building on their previous work (below) in vaginal USPEs. Target populations include both men who have sex with men (regardless of sexual orientation) and women who have anal sex. The Guthrie lab works closely with bioengineers and formulation scientists, as well as the lead Principal Investogator (Buckheit; ImQuest BioScience) which developed the pharmaceutical agent being tested.
Project 4 of the Oak Crest Institute of Science's Integrated Preclinical/Clinical Program (U19 AI113048: Guthrie, sub Principal Investigator). This U19 is working to develop an innovative intravaginal ring drug delivery system. Dr. Guthrie's role is to conduct the formative work necessary for development of perceptibility and acceptability measures similar in purpose and scope to those her team has developed for vaginal formulations composed of soft materials (such as vaginal gels, films and suppositories). Positing that biomechanical and materials properties of intravaginal rings can also be felt and evaluated by users, and, further, positing that these sensory experiences play a critical role in user opinions and decision-making regarding future use, Dr. Guthrie's team is working to develop USPE measures applicable to the intravaginal ring use experience.
Project WISH (K24 HD062645: Guthrie, Principal Investigator), is an NICHD-funded midcareer development award with 2 primary goals. One goal involves the further development of Dr Guthrie's career into sexual and reproductive health (SRH) more broadly (i.e., beyond HIV prevention). The research study involves translating perceptibility- and adherence-related work to the realm of contraception and sexual lubricant use. The goal is to develop a framework for understanding "Effective Use" of SRH products. The second primary goal of the K24 award is to provide protected time for Dr. Guthrie to mentor junior faculty and post-doctoral trainees in qualitative and mixed methods research design and implementation. Dr. Guthrie, along with Dr. Rochelle Rosen, a long-time colleague and medical anthropologist, co-lead an introductory seminar on qualitative and mixed methods every year, and Dr. Guthrie directs a skills-based workshop series in qualitative design and methods.
Dr. Guthrie also works with her colleagues on other behavioral health projects. Her methodologies focus on qualitative and mixed methods: in this capacity, she studies numeroud other behavioral health concerns, including diabetes, smoking cessation, intimate partner violence, linkages to care, and pulmonary arterial hypertension, among others.
(... more to come...)
The FAB Project (R01 AI112002: Guthrie sub Principal Investigator), is a Preclinical Innovation Program award designed to promote innovative strategies in nonvaccine biomedical prevention. Dr. Guthrie's team is responsible for facilitating the iterative development of vaginal drug delivery formulations from drug-eluting fiber technology. The project iterates between user-centered design and preclinical safety and efficacy studies, wirth the goal of developing both a pericoital and sustained release version of the drug-eluting fiber forms.
Project WIND and Project 6 (preclinical study) (U19 AI096398: Guthrie, Project WIND Lead Investigator; Co-Investigator for parent U19), is an NIH Integrated Preclinical/Clinical Program (IPCP), as award mechanism designed to conduct interdisciplinary research in a preclinical setting with the goal of developing safe and effective biomedical prevention products. This particular project seeks to develop an HIV prevention product using a novel topical formulation (vaginal film) and delivering a new class of active pharmaceutical ingredient (plant-derived monoclonal antibodies). Dr. Guthrie's team is tasked with using qualitative methods to determine how best to help potential participants understand the product and how it works, so that appropriate informed consent procedures and other support for participation in the study can be developed. Further, they will us the formative data to adapt existing USPE scales for use with vaginal film products.
Project MIST (R33 AI076967; Morrow, sub Principal Investigator) is an NIH Microbicide Innovation Program (MIP) award, an award mechanism designed to accelerate and advance innovation in the development of anti-HIV microbicides. The project is designed to expand the findings of Project LINK (below) by specifically exploring the impact of formulation volume on user sensory perceptions and experiences (USPE), as well as being the first study to explore USPE in vaginal film use. Like Project LINK, the ultimate goal is to develop a framework for developing vaginal formulations that meet specific preclinical criteria for user sensory perception and experience measures (developed in Project LINK), thus conserving resources (by removing unacceptable products from the pipeline early) and accelerating acceptable products through the development pipeline and increasing the likelihood of greater adherence during clinical trials.
Project LINK (R21/R33 MH80591; Morrow, Principal Investigator) is an NIH Microbicide Innovation Program (MIP) award, an award mechanism designed to accelerate and advance innovation in the development of anti-HIV microbicides. The project is designed to provide proof-of-concept that vaginal microbicide users can feel and discriminate variations in product formulations, and that these perceptions impact the user's willingness to use the product. The ultimate goal is to develop a framework for developing vaginal gels that meet specific preclinical criteria for acceptability dimensions, thus conserving resources (by removing unacceptable products from the pipeline early) and accelerating acceptable products through the development pipeline and increasing the likelihood of greater adherence during clinical trials.
Project MAPLE (U19 AI077289 (Buckheit, PI): Long Acting Acceptable Microbicides: Novel Delivery, Activity & Pharmacodynamics, Project 3) was one of three studies within the larger U19 mechanism. Its purpose was to explore the biophysical and biomechanical variables that impact product acceptability with respect to long-acting vaginal gels (LAGs) and intravaginal rings (IVRs). The goal was to provide guidance for the development of acceptable LAGs and IVRs for use as anti-HIV microbicides.
AID.1233-14-07567(Coffey, PI) was a USAID-funded study exploring the "Feasibility and Acceptability of SILCS Diaphragm as a Microbicide Delivery System." The study aim was to test the deployment characteristics, as well as feasibility and acceptability of, a delivery system combining a microbicide gel and the SILCS diaphragm to effectively deliver a vaginal gel formulated microbicide.
The Phoenix Project (R01 MH 064455; Morrow, Principal Investigator) was a NIMH-funded project with the primary goal of designing and evaluating measures of factors hypothesized to be related to vaginal microbicide acceptability. Several scales were identified and psychometrically validated. They include a "Willingness to Use Microbicides" scale, a "Relationship Quality " measure, a "Microbicide Confidence" Scale, a scale measuring the "Importance of Microbicide Characteristics," and a cognitive/behavioral Risk Index. Analyses support conceptualization of microbicide acceptability as a multi-factorial construct highly impacted by person-, product-, and context-related factors.
Dr. Guthrie (nee Morrow) served as the acceptability studies chair in both the HIV Prevention Network (HIVNET) and the HIV Prevention Trials Network (HPTN). Across four Phase-1 clinical safety trials of candidate vaginal microbicides (HPTN 009, HPTN 020, HPTN 050, HPTN 049) she and her teams have confirmed the overall acceptability of gel-formulated microbicides, and have explored factors hypothesized to be related to microbicide acceptability. These include the relationship context, the need or desire for a microbicide that not only prevents or reduces the likelihood of HIV infection, but also provides protection from other STDs and pregnancy, the need or desire to use a microbicide "covertly," such that the partner is unaware of its use, and the product's impact on sexual pleasure.
As Principal Investigator of Project START, a Centers for Disease Control and Prevention (CDC)-funded HIV/STD behavioral prevention intervention development and evaluation project designed for young men leaving the incarcerated setting, she and her colleagues successfully conducted formative qualitative and quantitative studies culminating in the development of two intervention strategies. Primary outcome data from a randomized trial showed that the enhanced intervention (which focused on both HIV/STD prevention and transitional needs as men re-entered their communities) resulted in greater proportions of safer sex behavior than the standard intervention (a single-session HIV/STD prevention session). The intervention has completed development as a CDC REP study and currently enjoys its status as a CDC DEBI (Diffusion of Effective Behavioral Interventions) program.