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Direct and Spillover Impacts of a Community-Level HIV/AIDS Program - FCC

Direct and Spillover Impacts of a Community-Level HIV/AIDS Program: Evidence From a Randomized Controlled Trial in Mozambique

The HIV/AIDS crisis in Sub-Saharan Africa has left millions of children orphaned. These children, who are potentially infected with HIV themselves, are highly vulnerable and face some serious risks to their health and overall well-being. A variety of health and economic interventions to help orphans and vulnerable children (OVCs) (and the households in which they live) are being carried out in Mozambique by World Education Inc./Bantwana (WEI/B), funded by USAID. The program is known in Portuguese as Força à Comunidade e Crianças or FCC (in English, "Strengthening Family and Communities"). This study will collect survey and administrative data to assess the impact of the FCC program on OVCs and the households in which they live. A baseline survey was administered to define a sample of households and individuals to follow over time through the upcoming follow-up survey and to measure baseline household characteristics. Follow-up data collection will begin in March 2019. It has several components: 1. Household survey The follow-up survey will provide measurements of the rich set of intermediate and final outcomes for the estimation of treatment effects of the FCC program. 2. Data collection on HIV testing and school attendance This study will supplement survey-reported HIV testing rates with an objective, administrative measure of HIV testing at health clinics. At the time of the follow-up survey, the survey team will recommend that eligible individuals in the household be tested for HIV at a specified local health clinic. To allow tracking of those who follow through with testing, consenting individuals will be given coupons redeemable for a small financial incentive once they have completed an HIV test. In addition to self-reported data on school participation by children, this study will also measure school participation directly. Both school enrollment (presence in school registration records) and school attendance (physical presence of children in school during unannounced school visits by research staff) will be measured. Project staff will visit schools in study communities to check attendance rates of specific school-aged children who were listed in the baseline survey in their community. 3. Informational treatments aimed at raising HIV testing rates To allow insight into the mechanisms through which the FCC program has its effects, this study will provide additional simple treatments in the context of the follow-up survey to explore possible FCC mechanisms: stigma reduction, HIV/AIDS information, and HIV treatment (antiretroviral therapy, or ART) information.

NCT03880175 — HIV/AIDS
Status: Completed
http://inclinicaltrials.com/hiv-aids/NCT03880175/

Resistance Training in People Living With HIV/AIDS

Effects of Resistance Training in People Living With HIV/AIDS

The aim of this study will be to verify effects of resistance training in people living with HIV/AIDS.

NCT03879993 — HIV/AIDS
Status: Completed
http://inclinicaltrials.com/hiv-aids/NCT03879993/

Short-term Steroid Therapy in Patients With P. Jirovecii Pneumonia Due to HIV / AIDS

Shortened Steroid Therapy in Patients With Moderate and Severe Pneumonia Due to P. Jirovecii Associated With HIV / AIDS

The treatment guidelines for Pneumocystis pneumonia (PCP) suggest adding 40mg of prednisone (or its equivalent in methylprednisolone) twice per day on days 1 through 5, 40 mg days 6 through 10, and 20 mg daily on days 11 through 21 in subjects with moderate and serious PCP. Steroids have shown to improve clinical outcome and reduction in mortality in HIV-infected patients the effectiveness of adjuvant steroid treatment for PCP has been observed if it starts within the first 24 to 48 hours. Possibly, there is a long-term benefit with their use in the recovery of function and limitation of chronic pulmonary complications; recently, benefits have been observed in decreasing the incidence of Inflammatory Immune Reconstitution Syndrome (IRIS) due to Mycobacterium tuberculosis. On the other hand, steroids could increase the morbidity related to adverse reactions as well as paradoxical worsening of associated herpes virus infection, which are attributed to IRIS or as a result of immunosuppression generated by their use. Recently, it has been shown that gradually steroids withdrawal is not necessary in patients who have received less than 21 days of treatment. This non-inferiority work aims to confirm the null hypothesis that a reduced steroid scheme in patients with moderate PCP (8 days) and severe pneumonia (14 days) is sufficient to limit long-term ventilatory complications and acute postinflammatory syndrome, compared to the conventional 21-day scheme. It also has been hypothesized that it could be associated with fewer cases of IRIS due to herpes virus type 1,2,3 and 8.

NCT03856229 — HIV/AIDS
Status: Enrolling by invitation
http://inclinicaltrials.com/hiv-aids/NCT03856229/

Cognitive Aids for the Management of Deteriorating Surgical Patients - CAMDS

Cognitive Aids for the Management of Deteriorating Surgical Patients

Background and Goal of Study: Adherence to best practice management of emergencies improves through the use of cognitive aids. Aim of this study was to develop and validate cognitive aids for management of deteriorating surgical ward patients (CAMDS) in order to improve adherence to best practice and hereby reduce the likelihood of failure to rescue. Materials and Methods: Fifty surgical teams will be randomly assigned to manage 150 standardised high fidelity simulation cases of deteriorating patients using the CAMDS or not. There are 10 standardised patient scenarios; pneumonia, pneumothorax, bradycardia, cardiac arrest shockable and non-shockable rhythm, bleeding, myocardial infarction, anaphylaxis, sepsis and loss of consciousness. Two independent observers will score the team's performance in adhering to all the management steps. To assess perceived usability of the CAMDS participants will be asked about eight aspects of the CAMDS. These items will be scored on a Likert scale (0= strongly disagree to 4= strongly agree).

NCT03812861 — Surgery--Complications
Status: Completed
http://inclinicaltrials.com/surgery-complications/NCT03812861/

Prevention of HIV/AIDS and STDs in Women Over Fifty

Prevention of HIV/AIDS and STDs in Women Over Fifty

In response to the increasing rates of HIV/STD infections among women over the age of 50, especially minority women, and in the attempt to reduce HIV/STD risks for over ten million older adult American women who are impacted by gray divorce and at risk for unsafe sex, the investigators will create, test, and commercialize a novel positive psychology-based "SmartWeb" intervention to promote wellbeing, HIV/STD awareness, and safe sex practices among culturally-diverse older divorced or separated women who are dating. This large end-user market for the proposed HIV/STD risk reduction intervention will greatly facilitate commercialization through advertisements, marketing research based on data mining, and in collaboration with manufacturers of condoms, and other large companies offering health products and services to older women.

NCT03810170 — Hiv
Status: Completed
http://inclinicaltrials.com/hiv/NCT03810170/

Using "Decision Aids" to Help the Infant Family to Decide the Use of Oral Rotavirus Vaccine

Using "Decision Aids" to Help the Infant Family to Decide Whether the Baby Will Receive the Self-paid Oral Rotavirus Vaccine: A Randomized Controlled Trial.

Using decision aids (DA) is one way to provide information to infant family and to involve them in making decisions about their baby's vaccination. We developed a DA administered after consultation for baby's family deciding on whether the baby will receive the self-paid oral rotavirus vaccine

NCT03804489 — Rotavirus Vaccines
Status: Not yet recruiting
http://inclinicaltrials.com/rotavirus-vaccines/NCT03804489/

PlusCare: Mobile Platform to Increase Linkage to Care in Adolescents Living With HIV/AIDS

PlusCare: Mobile Platform to Increase Linkage to Care in Adolescents Living With HIV/AIDS

While major advancements in medical technology over the past decade have significantly improved the life expectancy of persons infected with human immunodeficiency virus (HIV), HIV-positive youth today face new barriers to the treatment of HIV as a chronic, manageable illness. The mobile system proposed will help improve linkage to care through mobile technology support for the case management of youth living with HIV. Results of this project will determine the impact of this system on case management processes and outcomes and have implications for the care of youth living with other chronic, complex illnesses.

NCT03758066 — HIV/AIDS
Status: Completed
http://inclinicaltrials.com/hiv-aids/NCT03758066/

Quality Control of CE-Certified Phonak Hearing Aids - Sonova2018_05

Quality Control of CE-Certified Phonak Hearing Aids - Sonova2018_05

Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

NCT03751891 — Hearing Loss, Sensorineural
Status: Completed
http://inclinicaltrials.com/hearing-loss-sensorineural/NCT03751891/

Technological Intervention for Reducing Alcohol Use Among People Living With HIV/AIDS - TRAC

A Telemedicine and mHealth Intervention for Reducing Alcohol Consumption Among People Living With HIV/AIDS

While advances in medication have led to greatly improved outcomes for people living with HIV/AIDS, less than one-third of all people living with the disease are adherent enough to their medication to achieve viral suppression. Alcohol consumption has been shown to have a significant effect on HIV medication adherence, so the proposed research will aim to reduce alcohol use among people living with HIV/AIDS through a technology-driven intervention. This eight-session intervention will be delivered using a combination of videoconferencing, smart phones, and Bluetooth-enabled breathalyzers for monitoring of alcohol consumption, with an overall goal of reducing alcohol use, mitigating adherence issues, and achieving optimal prevention and treatment responses for people living with HIV/AIDS.

NCT03746600 — HIV/AIDS
Status: Completed
http://inclinicaltrials.com/hiv-aids/NCT03746600/

Decision Aids for Patients With Nonvalvular Chronic Atrial Fibrillation (DA4AFib) - (DA4AFib)

Decision Aids for Patients With Nonvalvular Chronic Atrial Fibrillation (DA4AFib)

To assist patients and clinicians to reach SDM about treatment options for patients with nonvalvular chronic Atrial Fibrillation screening the investigators aim to develop an evidence-based decision aid for use before the clinical encounters. Our goal is to promote evidence-based patient-centered care. Ideally, this care should reflect the research evidence about anticoagulation treatment. It should also reflect the values and preferences of the informed patient.

NCT03744936 — Atrial Fibrillation
Status: Completed
http://inclinicaltrials.com/atrial-fibrillation/NCT03744936/