The Thai Red Cross AIDS Research Centre
To assess the safety and the efficacy of Highly Active Anti-Retroviral Treatment (HAART) for the Prevention of Mother-To-Child Transmission of HIV (PMTCT)
NCT02151838 — HIV-infected Pregnant Women Who Request HAART From the TRCSPMTCT
Status: Completed
http://inclinicaltrials.com/hiv-infected-pregnant-women-who-request-haart-from-the-trcspmtct/NCT02151838/
Using Multimedia Approaches to Communicate Probabilities in Patient Decision Aids for Low-Literacy Populations: Randomized Trial
The goal of this research study is to compare how people who are 45-75 years old respond to 3 different versions of a program about screening tests for colorectal cancer. Researchers want to use this study as part of a long-term project to learn the best ways to communicate health information to patients.
NCT02151032 — Colorectal Cancer
Status: Completed
http://inclinicaltrials.com/colorectal-cancer/NCT02151032/
PET Imaging and Lymph Node Assessment of IRIS in Persons With AIDS
Background: - Sometimes people with HIV, the virus that causes AIDS, can have new or worsening symptoms soon after starting HIV medications. Often these symptoms are caused by immune reconstitution inflammatory syndrome (IRIS). Researchers want to study why and how people develop IRIS and how best to prevent and treat it. Objectives: - To learn the causes and effects of IRIS,and how to best manage it. Eligibility: - Adults 18 and older with HIV and low CD4 counts,, about to start HIV medicines; or those already taking HIV medicines with symptoms thought to be related to IRIS. Design: - Participants not on ART will have screening blood tests for CD4 count, HIV viral load and genetic testing. - After the screening blood tests and before starting HIV medicines., participants will return for more than 1 visit for the following: - review of medical history<TAB> - physical and eye exams - blood, urine, and tuberculosis (TB) tests - electrocardiogram (EKG) - chest x-ray - apheresis: a blood drawing procedure where blood is removed from a vein, white blood cells are separated and collected, and the rest of the blood is returned to the person using another vein - - PET scan - a procedure where a small amount of radioactive material is injected in a vein. The participant then lies on a table that slides into a scanner which takes images of the body. - lymph node biopsy - stool collection by swab - After completion of the above, HIV medicines will be started. - Follow-up visits will be at 2, 4, 8, and 12 weeks after starting ART, then every 12 weeks. Some of the tests above may be repeated. - Participants already on HIV medicines who may have IRIS will be screened over a 4 week time period to see if they really are experiencing IRIS. The screening process will include all of the items listed above. Follow-up visits will be at Weeks, 4, 8, 12 and then every 12 weeks. - The study will last 1 year for both groups but may be extended to 2 years (3 additional appointments) for some participants....
NCT02147405 — Immune Reconstitution Inflammatory Syndrome
Status: Recruiting
http://inclinicaltrials.com/immune-reconstitution-inflammatory-syndrome/NCT02147405/
Evaluating the Real-world Effectiveness of Varenicline and Bupropion for Long-term Smoking Cessation
Clinically proven medications such as nicotine replacement therapy, bupropion and varenicline are available to help smokers quit but there are not widely used. The primary objective of this study is to evaluate the real-world long-term effectiveness of of bupropion and varenicline treatment in a community sample of smokers interested in quitting. The investigators hypothesize that varenicline treatment will result in higher quit rates at end of treatment and at one year after treatment compared to bupropion. Smoking status will be biochemically confirmed at various time points using salivary cotinine measures. Furthermore, since 50% of the variation in quit success is genetically determined, and the effectiveness of different cessation medication may differ considerably in sub-groups of smokers carrying certain genetic variants, the investigators will collect saliva samples from consenting participants to evaluate the moderating effect of genetics on treatment response.
NCT02146911 — Nicotine Dependence
Status: Completed
http://inclinicaltrials.com/nicotine-dependence/NCT02146911/
Return to Work Randomized Controlled Trial: Counseling After Fatigue Treatment in HIV/AIDS
The current study is a randomized clinical trial comparing Behavioral Activation counseling with supportive counseling for HIV+ participants presenting with clinically significant fatigue whose energy has improved with armodafinil, who have the goal of returning to work or vocational training but have not done so on their own. A second cohort of HIV+ participants without significant fatigue at baseline, but who also have the goal of returning to work, will also be randomized to either Behavioral Activation counseling or supportive counseling. In both cohorts, the primary outcome is level of success regarding an employment related goal.
NCT02140775 — Fatigue
Status: Completed
http://inclinicaltrials.com/fatigue/NCT02140775/
Patient-centered Dissemination of Evidence-based Medicine: Share EBM
The active strategy for dissemination and implementation of Share Evidence Based Medicine (EBM) will yield greater reach of clinicians, be adopted by the practices more readily, and a greater uptake of use amongst encounters will be seen. The Institute for Clinical Systems Improvement (ICSI) is a nonprofit organization with expertise in large-scale practice improvement at the state and national level. Largely funded by health organizations in Minnesota, ICSI has a sustainable model to translate evidence into practice, through clinical practice guidelines, shared decision making, and practice redesign. A partnership between these two organizations (ICSI and Mayo Clinic) may lead to a sustainable and innovative approach to the dissemination of evidence-based health information at the point of care. The objective of the current study is therefore to leverage the expertise of these two organizations to compare the impact of an active to a passive dissemination and implementation strategy of the ShareEBM toolkit. The aim of the study is to disseminate evidence-based information through the use of decision aids during encounters. The overall purpose of the qualitative evaluation is to understand why decision aids were used more or less in certain practices and what factors contributed to or hindered this uptake.
NCT02136199 — Diabetes, Depression, Cardiovascular Disease,Hypercholesterolemia, Osteoporosis
Status: Completed
http://inclinicaltrials.com/diabetes-depression-cardiovascular-disease-hypercholesterolemia-osteoporosis/NCT02136199/
Asha Improving Health and Nutrition of Indian Women With AIDS and Their Children
Building upon the successful qualitative Phase I of the study, Phase II commences in month 10. The Project manager and research staff will recruit 600 women living with AIDS (WLA) and their oldest child between the ages of 3 and 8. The WLA will be recruited from Primary Health Centers (PHCs) randomly selected from 72 closest PHCs in terms of HIV prevalence in the rural Andhra Pradesh (AP) area of Nellore. WLA will be recruited by means of approved flyers posted in selected PHCs. Interested WLA will approach the research staff, stationed at the PHC to be screened for eligibility via a consent script. Once eligibility is determined for the WLA, based upon the following criteria: age, HIV and ART status (validated by ART and HIV card); having a child (3-8 years) and whether or not the WLA was a participant of the previous intervention group from the Asha pilot study, a parental consent will be obtained from the WLA for permission to include her oldest child in the study. The oldest child between 3-8 years of age will be brought in to the research office or PHC (after mother speaks with the child at home). All children will have blood work drawn and physical health assessment on their first visit (total of 15 minutes). All eligible WLA will undergo a second consent for enrollment. General Procedure: Following informed consent, the WLA will be randomly assigned into one of four programs 1) Asha Support Only; 2) Asha Support + Training; 3) Asha Support + Food; or 4) Asha Support + Training + Food. After blood draw and physical assessment of the WLA, an appointment will be made for the assigned interviewer (blinded to program) to visit the WLA at their home preferably (or other location of choice) to conduct several 24 hour dietary assessments. Urine will be collected in labeled bottles on the morning after the 3rd day of the diet recall by the interviewer and sent directly to the lab in a cooler. Also, on the same day, the baseline assessment will be entered into the PC tablets; 50 minutes estimated with breaks). After a longer break, the WLA will then be asked to respond to additional questions about the sociodemographic and psychomotor development of their child (about 30 minutes). Interviewers will visit the WLA monthly until the end of the intervention (month 6) to provide individual weekly Asha Support and conduct group sessions and collect ongoing data, 24-hour recall, and ART pill count for WLA, and follow up questionnaires at 6-, 12- and 18-months.
NCT02136082 — HIV Infection
Status: Completed
http://inclinicaltrials.com/hiv-infection/NCT02136082/
Quantiferon Gold Test for Detecting TB Infection in HIV/AIDS Patients in South Africa
The purpose of this study is to use a cluster randomized trial to compare the effectiveness of linking the Quantiferon-gold in-tube test (QGIT) with routine CD4 testing to the routine use of the tuberculin skin test (TST), the current standard of care for diagnosing latent tuberculosis infection (LTBI) in South Africa. The investigators hypothesize that QGIT clinics will identify LTBI and initiate isoniazid preventive therapy (IPT) in a higher proportion of patients and in a significantly faster timeframe. The cost-effectiveness of linking QGIT with routine CD4 compared to routine TST will also be evaluated, and the process of implementation of QGIT into the routine cluster of differentiation 4 (CD4) blood draw will be evaluated using a mixed method approach to identify steps that can be modified for future scale-up of the intervention.
NCT02119130 — HIV
Status: Completed
http://inclinicaltrials.com/hiv/NCT02119130/
Reducing AIDS Stigma Among Health Professionals in India
This Randomized Controlled Trial has been designed to test the efficacy of a behavioral intervention to reduce HIV-related stigma among nursing students and ward attendants in 16 sites in South India and 8 sites in North India.
NCT02101697 — Stigmatization
Status: Completed
http://inclinicaltrials.com/stigmatization/NCT02101697/
Cognitive Aids With Roles Defined (CARD) for Obstetrical Crises: A Multisite Cohort Study
Crisis resource management represents the set of non technical skills, such as communication, leadership, delegation, and prioritization, that allow effective teamwork for optimal patient care during an urgent and critical situation. The Cognitive Aids with Roles Defined (CARD) is a new concept of cognitive aid addressing the well-documented issue of teamwork in crisis management. It relies on large identification cards specially designed for each team members profession and role. During a life threatening clinical situation, the CARD protocol focuses on clarification of individual roles and distribution of tasks for crisis management rather than creating an additional algorithm identifying either a list of actions to be taken or the dose of a medication. This study aims to evaluate the clinical impact of introducing the CARD protocol in obstetrical emergency situations ("code 333") in clinical practice at The Ottawa Hospital. Hypothesis: CARD protocol will: (i) decrease the total time taken to deliver the baby, and (ii) improve clinical outcome for the mother and baby compared to traditional management without the CARD protocol.
NCT02093078 — Obstetrical Emergency Situations
Status: Completed
http://inclinicaltrials.com/obstetrical-emergency-situations/NCT02093078/