A Phase I Double Blind Placebo-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of the Combination of DNA-HIV-PT123 and AIDSVAX®B/Ein HIV-1-uninfected Adult Participants With or Without Underlying Schistosoma Mansoni Infection
The primary objective of the proposed phase I trial is to evaluate the safety and tolerability of DNA-HIV-PT123 and AIDSVAX®B/E combination regimen. Though both DNA-HIV-PT123 and AIDSVAX®B/E and the combination of the two vaccines have been evaluated in humans and have shown to be safe and well tolerated, this is the first time the combination regimen is being evaluated in HIV-1 uninfected African populations with and without S. mansoni. The secondary objective of the trial is to evaluate the effect of S. mansoni infection on the immunogenicity of the combination of DNA-HIV-PT123 and AIDSVAX® B/E vaccine regimen. Successful vaccination against most viruses requires efficient Th1 response. There is evidence that helminth infections skew the host immune system of human and animals to T-helper type 2 (Th2) and induce immunosuppression. Therefore, there is a potential that helminth infected populations may not generate the desired immune responses to vaccines designed to drive Th1-type and cytotoxic T-cell responses. Furthermore, the influence of helminth infections on the development of protective antibody responses remains unclear. Limited data in animal models suggests that worm infections reduced efficacy of vaccines. The proposed vaccine trial will generate safety, tolerability and immunogenicity data of a vaccination regimen with simultaneous administration of a candidate HIV DNA vaccine (DNA-HIV-PT123) and a gp120 protein vaccine (AIDSVAX®B/E). This will be the first HIV vaccine trial to prospectively evaluate the impact of the S. mansoni infection on safety and immune responses to HIV vaccines.
NCT02376582 — HIV/AIDS
Status: Completed
http://inclinicaltrials.com/hiv-aids/NCT02376582/
Bureau AIDS, TB, and STI, Thailand Ministry of Public Health
This is a prospective observational cohort study that aims to enroll a total of 2000 Thai MSM and TG at five health facilities in four provinces of Thailand. Each participant will be followed for 18 months. Baseline and historical rates of HIV testing/re-testing, initial CD4 counts, retention in care, and ART adherence at the study clinics, at the study clinics combined, and national data (if available) will be compared with rates after implementation of the Test and Treat strategy. Analysis will also include an assessment of HIV prevalence and incidence. This study will use similar objectives, indicators, and procedures as those used in an ongoing Test and Treat study by the Thai Red Cross AIDS Research Centre in three tertiary care hospitals, and a study to be conducted with PEPFAR Key Populations Implementation Science (KPIS) funding through United States Agency for International Development (USAID), in community-based centers, allowing comparison of uptake and follow-up of MSM and TG using the Test and Treat strategy in a variety of settings.
NCT02369887 — PrEP Test and Treat
Status: Completed
http://inclinicaltrials.com/prep-test-and-treat/NCT02369887/
REMUNE + AMPLIVAX IR103 HIV/AIDS Phase III Safety & Efficacy Study
The primary objective is to compare & evaluate between the treatment groups the changes in decline/reduction of HIV viral load changes in the Remune + Amplivax group vs the Amplivax placebo groups. Additional objectives include changes in WBC White Blood Cell counts & CD4+ & CD8+ T cell counts along with increased HIV immunity.
NCT02366026 — HIV
Status: Not yet recruiting
http://inclinicaltrials.com/hiv/NCT02366026/
Effects of Remote Microphone Hearing Aids on Classroom Listening, Spatial Listening, and Attention in School-Aged Children With Auditory Processing Disorder
Auditory Processing Disorder (APD) is a disorder where the functions of the ear are normal, but the person has difficulty identifying or discriminating sounds and experiences listening difficulties in noise. Remote Microphone Hearing Aids (RMHAs) are wireless listening devices that pick up the speaker's voice and transmit it to a receiver in the listener's ear. In this way, the negative effects of ambient noise, distance from speaker and reverberation are reduced. The research questions are whether RMHAs improve classroom listening, listening in noise performance, listening in spatialised noise and auditory attention, in children with APD. We hypothesize that RMHA use will lead to improved classroom listening and improved speech-in-noise skills after 6 months of RMHA use. Additionally, we hypothesise that listening in spatialised noise and attention skills will remain unchanged following the intervention period. Twenty-six (26) children aged 7-12 with a diagnosis of an APD from the Great Ormond Street Hospital Audiology clinic were included in the study.
NCT02353091 — Auditory Processing Disorder
Status: Completed
http://inclinicaltrials.com/auditory-processing-disorder/NCT02353091/
Decision Aids for the Management of Suspicious Occlusal Caries Lesions
The study will determine whether clinicians who use a diagnostic device treat suspicious occlusal carious lesions (SOCL) surgically more often, with the same frequency, or less frequently, than dentists not relying on a diagnostic device. The study will also determine -- among those SOCLs that are opened -- whether the proportion of lesions that extend into the dentin when dentists are using a diagnostic device is more than, the same, or less than when no device is used.
NCT02340767 — Dental Caries
Status: Completed
http://inclinicaltrials.com/dental-caries/NCT02340767/
Pharmacological Aids for Interactive Smoking Cessation
There is an important need for effective smoking cessation programs that both (a) promote the effective use of pharmacological aids, such as nicotine replacement products and bupropion, and (b) provide cognitive-behavioral support for stopping smoking.The Internet is an increasingly attractive intervention medium for delivering behavior change interventions, including smoking cessation.This study examined smoking cessation rates among adults participating in a randomized controlled trial of the Smokefree Partners: 21 Days to Freedom ™ program, a theoretically based, online smoking cessation program that included message tailoring and interactivity combined with the live personal support of a smoking cessation coach. Coaching support was provided almost entirely asynchronously via prescripted but individually tailored emails.
NCT02329249 — Smoking Cessation
Status: Completed
http://inclinicaltrials.com/smoking-cessation/NCT02329249/
Structured Post Market Clinical Follow-up (PMCF) to Evaluate the Quality of a New Hearing Aid Product Generation.
The reason for this study is to evaluate a new hearing aid product generation replacing the one on the market. The goal is to evaluate the audiological performance, usability as well as features and functions.
NCT02298452 — Hearing Loss, Bilateral or Unilateral
Status: Completed
http://inclinicaltrials.com/hearing-loss-bilateral-or-unilateral/NCT02298452/
REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study
The primary objective is to compare & evaluate between the treatment groups the changes in decline/reduction of HIV viral load & increase changes in WBC white blood cell counts in the adult Remune dose vs the low dose Remune placebo groups. Additional objectives include changes in CD4+ & CD8+ T cell counts along with increased HIV immunity.
NCT02291809 — HIV/AIDS
Status: Not yet recruiting
http://inclinicaltrials.com/hiv-aids/NCT02291809/
Facilitating HIV/AIDS and HIV Testing Literacy for Emergency Department Patients
The Centers for Disease Control and Prevention (CDC) recommends that all patients should receive information about HIV/AIDS and HIV testing orally or in writing at every HIV testing encounter. However, for busy emergency departments (EDs), delivering information orally is a barrier to HIV testing, and written brochures likely are not useful for those with lower health or general literacy. Videos might be as or more efficacious than orally-delivered information in improving HIV/AIDS and HIV testing knowledge, particularly for those with lower health literacy skills. However, the resources required to show videos might limit their use in EDs. Pictorial brochures are a promising alternative, but are of unknown efficacy. The objectives of this study are to: (1) determine if HIV/AIDS and HIV testing information should be delivered by a video or pictorial brochure to emergency department (ED) patients to improve short-term (in the ED) knowledge about HIV/AIDS and HIV testing; (2) determine if longer-term retention (over 12 months) of HIV/AIDS and HIV testing knowledge is greater for those who watch a video or review a pictorial brochure; (3) determine if short-term improvement and longer-term retention in HIV/AIDS and HIV testing knowledge is better after watching a video or reviewing a pictorial brochure for those with lower health literacy, and if improvement and retention also varies by language spoken (English or Spanish); and (4) if willingness to be tested again in one year is greater for those who watch the video or review the pictorial brochure, and if this willingness also varies by health literacy level and language spoken.
NCT02284451 — HIV Health Literacy
Status: Enrolling by invitation
http://inclinicaltrials.com/hiv-health-literacy/NCT02284451/
Smart-device Apps as Memory Aids
Patients experience problems with their memories from a variety of causes. There has been much work showing that the use of low tech devices, such as notebooks or diaries, can help patients remain independent. More recently, the use of electronic devices, such as digital voice recorders or pagers, has proved equally beneficial. Many of functions of memory aids could potentially be carried out by a smartphone or tablet using inbuilt functions such as a calendar or maps, as well as through downloadable apps, such as medication reminders. The investigators have surveyed the investigators patients to show that many of them already own smartphones and this number has dramatically increased in the last year. This project aims to investigate the feasibility and efficacy of using smartphone and tablet apps as memory aids in a clinical setting.
NCT02281617 — Memory Disorders
Status: Not yet recruiting
http://inclinicaltrials.com/memory-disorders/NCT02281617/