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Behavior and Behavior Mechanisms clinical trials

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NCT ID: NCT04077151 Completed - HIV/AIDS Clinical Trials

Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - Demonstration Project

Start date: March 14, 2022
Phase: N/A
Study type: Interventional

To address the critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation of PrEP in transgender youth communities, the study will be conducted in 3 integrated phases. In Phase 1, a pharmacokinetic (PK) study exploring the interactions of cs-HT for both TW and TM youth on TDF/FTC will be conducted. Simultaneously, in Phase 2, ethnographic data via focus groups (FGs) and in-depth interviews (IDIs) to inform the development of a tailored intervention to improve uptake and adherence to PrEP for transgender youth will be collected. In Phase 3, a small demonstration trial of PrEP use in transgender youth, utilizing the ethnographically developed intervention to improve uptake and adherence, while also monitoring renal and bone safety outcomes will be implemented. The project has the following important specific aims: Aim 1: To evaluate the differential PK of TDF/FTC in a cohort of transgender youth on cs-HT by conducting a PK trial of daily TDF/FTC among 24 TW taking estradiol and 24 TM taking testosterone (ages 15-24 years) using video-based directly observed therapy (DOT) to insure daily adherence and maximize drug exposure. Aim 2: To develop a culturally, developmentally, and gender-affirmative intervention to increase uptake of and adherence to PrEP among TW and TM youth that is grounded in theory (Information-Motivation-Behavioral Skills Model of Behavior Change, Gender Affirmation, Empowerment Theory) and incorporates the PK data from Aim 1. Investigators will conduct FGs with young TW (N=20-30) and TM (N=20-30) and conduct IDIs with participants from the PK study (Total N=10-14). Investigators will solicit continuous input and feedback from TW and TM on the project's Youth Advisory Board. Aim 3: To conduct a small randomized controlled trial within a PrEP demonstration project comparing the newly developed intervention with standard of care (SOC) in TW (N=50) and TM (N=50) ages 15-24 years.

NCT ID: NCT04077138 Completed - HIV/AIDS Clinical Trials

Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - Intervention Development

Start date: January 1, 2019
Phase:
Study type: Observational

To address the critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation of PrEP in transgender youth communities, the study will be conducted in 3 integrated phases. In Phase 1, a pharmacokinetic (PK) study exploring the interactions of cs-HT for both TW and TM youth on TDF/FTC will be conducted. Simultaneously, in Phase 2, ethnographic data via focus groups (FGs) and in-depth interviews (IDIs) to inform the development of a tailored intervention to improve uptake and adherence to PrEP for transgender youth will be collected. In Phase 3, a small demonstration trial of PrEP use in transgender youth, utilizing the ethnographically developed intervention to improve uptake and adherence, while also monitoring renal and bone safety outcomes will be implemented. The project has the following important specific aims: Aim 1: To evaluate the differential PK of TDF/FTC in a cohort of transgender youth on cs-HT by conducting a PK trial of daily TDF/FTC among 24 TW taking estradiol and 24 TM taking testosterone (ages 15-24 years) using video-based directly observed therapy (DOT) to insure daily adherence and maximize drug exposure. Aim 2: To develop a culturally, developmentally, and gender-affirmative intervention to increase uptake of and adherence to PrEP among TW and TM youth that is grounded in theory (Information-Motivation-Behavioral Skills Model of Behavior Change, Gender Affirmation, Empowerment Theory) and incorporates the PK data from Aim 1. Investigators will conduct FGs with young TW (N=20-30) and TM (N=20-30) and conduct IDIs with participants from the PK study (Total N=10-14). Investigators will solicit continuous input and feedback from TW and TM on the project's Youth Advisory Board. Aim 3: To conduct a small randomized controlled trial within a PrEP demonstration project comparing the newly developed intervention with standard of care (SOC) in TW (N=50) and TM (N=50) ages 15-24 years.

NCT ID: NCT03699722 Completed - Clinical trials for Behavior and Behavior Mechanisms

A Women-Focused PrEP Intervention

Just4Us
Start date: November 3, 2018
Phase: Phase 1
Study type: Interventional

Many women at high risk for acquiring HIV infection are not aware of preexposure prophylaxis (PrEP), an efficacious, self-administered, woman-controlled, HIV prevention product. The objective of this study is to evaluate the feasibility and acceptability of a theory-based intervention to promote PrEP uptake and adherence in a pilot trial among 80 women. The study will also measure intention to use PrEP and actual initiation of PrEP use. The investigators hypothesize that the intervention will be acceptable and feasible and that the intervention group will report higher levels of PrEP uptake, intention to use and adhere to PrEP, and other variables regarding PrEP uptake, comparing baseline, post-intervention and 3 month follow-up assessments.

NCT ID: NCT03652623 Completed - HIV/AIDS Clinical Trials

Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - PK Study

Start date: July 23, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

To address the critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation of PrEP in transgender youth communities, the study will be conducted in 3 integrated phases. In Phase 1, a pharmacokinetic (PK) study exploring the interactions of cs-HT for both TW and TM youth on TDF/FTC will be conducted. Simultaneously, in Phase 2, ethnographic data via focus groups (FGs) and in-depth interviews (IDIs) to inform the development of a tailored intervention to improve uptake and adherence to PrEP for transgender youth will be collected. In Phase 3, a small demonstration trial of PrEP use in transgender youth, utilizing the ethnographically developed intervention to improve uptake and adherence, while also monitoring renal and bone safety outcomes will be implemented. The project has the following important specific aims: Aim 1: To evaluate the differential PK of TDF/FTC in a cohort of transgender youth on cs-HT by conducting a PK trial of daily TDF/FTC among 24 TW taking estradiol and 24 TM taking testosterone (ages 15-24 years) using video-based directly observed therapy (DOT) to insure daily adherence and maximize drug exposure. Aim 2: To develop a culturally, developmentally, and gender-affirmative intervention to increase uptake of and adherence to PrEP among TW and TM youth that is grounded in theory (Information-Motivation-Behavioral Skills Model of Behavior Change, Gender Affirmation, Empowerment Theory) and incorporates the PK data from Aim 1. The investigators will conduct FGs with young TW (N=20-30) and TM (N=20-30) and conduct IDIs with participants from the PK study (Total N=10-14). Investigators will solicit continuous input and feedback from TW and TM on the project's Youth Advisory Board. Aim 3: To conduct a small randomized controlled trial within a PrEP demonstration project comparing the newly developed intervention with standard of care (SOC) in TW (N=50) and TM (N=50) ages 15-24 years.

NCT ID: NCT03439969 Completed - Gingivitis Clinical Trials

A 8-month Study on the Use of Intra-oral Camera and Text Messages on Gingivitis Control

Start date: June 1, 2014
Phase: N/A
Study type: Interventional

To investigate the effects of using an intra-oral camera (IOC) during supportive periodontal therapy, and oral hygiene mobile text messages (SMS) between appointments on clinical, behavioral and psychological parameters of patients with gingivitis.

NCT ID: NCT03392350 Completed - Hypertension Clinical Trials

Randomized Trial of the Impact of Body Scanning and Intensive Behavioral Intervention on Behavioral Change and Health Outcomes

Start date: June 15, 2012
Phase: N/A
Study type: Interventional

We evaluated the effectiveness of a combination of a comprehensive health assessment consisting of the combination of a screening full body scan employing graphic patient education and motivational techniques followed by intensive, individualized behavioral training and management program on improved adherence to beneficial lifestyle behaviors, as well as possibly reduced risk of disease.

NCT ID: NCT03317054 Completed - Clinical trials for Behavior and Behavior Mechanisms

Prevalence of Pathologic Gambling in the Workforce: a Cross-sectional Study in Brittany, France

PJPAP
Start date: November 3, 2016
Phase: N/A
Study type: Observational

Introduction: To date, very few studies about links between work and addictive disorders concern behavioral addictive disorders such as gambling. Such behaviours may be adaptative strategy for unsatisfied workers. The common physiopathology of addictive disorders allows us to hypothesize that it is possible that such troubles at work could promote gambling. Our aim was to evaluate the prevalence of gambling among workers and its links with work. Patients and methods: We performed a descriptive cross-sectional monocentric study among all workers who consulted one physician between November 2016 and April 2017, from an occupational health service in Brittany, France. The first step was to ask whether they have gambled during the last year and if it was related to their occupation. The second step was a screening for risky gamblers (using the "Lie or Bet" questionnaire) among these and then to assess more precisely the severity (using the Indice Canadien du Jeu Excessif, ICJE questionnaire).

NCT ID: NCT02549599 Completed - Clinical trials for Behavior and Behavior Mechanisms

Evaluating a Digital Health Information Tool

Chat/Text
Start date: February 2015
Phase: N/A
Study type: Interventional

The primary aim of the proposed project is to conduct a randomized controlled trial to evaluate the efficacy of a digital intervention tool that enables young people to correspond with trained staff via online chat or text messages about urgent questions related to sexual/reproductive health.

NCT ID: NCT02017418 Completed - Clinical trials for Behavior and Behavior Mechanisms

The Effects of a Zeaxanthin Intervention on Visuomotor Function

Start date: February 2012
Phase: N/A
Study type: Interventional

This study was designed to test whether two zeaxanthin formulations (supplements containing different nutritional compounds with zeaxanthin and omega fatty acids being the primary ingredients of interest) influenced visual motor function. Visual motor function refers to the processing speed of the visual system and how individuals respond behavioral to visual stimuli (e.g., reaction time).

NCT ID: NCT01811407 Completed - Clinical trials for Behavior and Behavior Mechanisms

Impacts of Public Announcements of Goals and Outcomes on Goal Completion (Commit to Steps)

Start date: July 2013
Phase: N/A
Study type: Interventional

Physical activity is known to help reduce obesity and the problems that accompany it. Walking has many benefits that make it an excellent way for obese people to increase their physical activity. It is hard, however, for people to stick with walking programs. Setting specific and challenging walking targets that are combined with timely feedback about discrepancies between desired and actual performance lead to higher performance. There is conflicting theory and evidence about the effects of publicly announcing those targets on commitment to the targets and on performance. Our research question is whether public announcements reduce the challenge level of commitments people set, and whether the reputational consequence of public announcements is severe enough to increase performance. The investigators propose a controlled trial that will integrate Facebook with the objective monitoring of walking via the use of pedometers to test the effect of public announcements on commitments and step counts. All participants will wear a pedometer and upload via the internet for 14 to 15 weeks, depending on their date of randomization. The first 2 to 3 weeks the investigators will determine the participant's baseline step counts. The following 12 weeks, the investigators will recommend a daily step count target based on the median number of steps the participants walked the previous week. Each week, participants will set a commitment by stating the number of days in the following week that he/she will meet the computer-set step count target. Commitments will be entered into an interface that will link with Facebook. Participants will select who of their Facebook friends will receive their commitments and/or results via Facebook posts. The interface will distribute those posts in a way that fits in with existing online social practices. There will be 3 experimental conditions. 1.) No public announcements 2.) Public announcement of commitment and 3.) Public announcement of commitment and results. In addition, groups 2 and 3 will provide us with emails of 3 friends or family members who will act as the participant's support team. The investigators will send announcements directly to support team members. The investigators plan to recruit 165 participants primarily by obtaining lists of potentially eligible University of Michigan Health System patients from the clinical data repository, and sending targeted letters to these patients. Because this research - and the physical activity programs it will inform - aims to reach a large number of people efficiently, enrollment will take place online with a click-through consent document. The investigators have extensive experience with delivering online walking programs in similar populations. The investigators hope to learn best practices for using public announcements and online social networks to encourage people to exercise more or to otherwise promote wellness.