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NCT ID: NCT02135003 Completed - Quality of Life Clinical Trials

Non-enrolment and Non-adherence to HIV Care in a Community-based Program, Rakai, Uganda

Start date: October 2010
Phase: N/A
Study type: Interventional

Hypothesis 1: The proportion of pre-ART patients whose CD4 cell counts decline to ART-eligibility within 48 weeks will be lower in intervention compared to the non-intervention arm. Hypothesis 2: PLHIV who receive the PSCB intervention will experience lower rates of morbidity or death over the follow-up period compared to patients not receiving the intervention Hypothesis 3: PLHIV who receive the PCSB intervention will have better adherence to scheduled clinic appointments compared to those not receiving the intervention

NCT ID: NCT02128087 Completed - Clinical trials for Human Immunodeficiency Virus

Improving Drug Adherence Among Adolescents in Uganda Using SMS Reminders

RATA
Start date: February 2013
Phase: N/A
Study type: Interventional

In this project the investigators develop and test a short message service (SMS) intervention based on the Information Motivation and Behavior skills (IMB) model. Reminding Adolescents To Adhere (RATA) prompts youths at two clinics in Uganda to take their medications and offers social support via weekly text messages. The investigators propose to adapt their previous successful SMS-intervention to the specific needs of youths and to evaluate the relative effectiveness of one-way versus two-way text messages (where two-way messages allow youths to respond to messages and we hypothesize that this may increase perceived social support that may be important for youth populations). We will also test the effectiveness of SMS messages over the longer-term (2 years), for which currently no information is available.

NCT ID: NCT02124109 Completed - Clinical trials for Rheumatic Heart Disease

The Genetic Basis of Acquired Heart Disease in Africa

Start date: April 3, 2014
Phase:
Study type: Observational

Background: - An acquired heart disease is one that a person gets after they are born. Two of these are rheumatic heart disease (RHD) and endomyocardial fibrosis (EMF). They are found more commonly in people who live in Africa than in other places in the world. Researchers want to learn more about these diseases. They especially want to know what role genes and other factors play in them. Objective: - To identify genetic risk factors for RHD and EMF in sub-Saharan Africa. Eligibility: - Children and adults with RHD or EMF. - Healthy volunteers over age 10. Design: - Participants will come from existing study groups in Uganda and Nigeria. - Participants may be required to provide a sample of their DNA. They will do this with either a blood or saliva sample or a swab of the mouth. - Collected samples will be labeled with a code and sent to a lab in the United States for analysis. Remaining portions of participants samples will be stored for an unlimited period of time. They may be used in future studies. - Some genetic and health information from participants might be placed into one or more scientific databases. - Participant names and identifying information will be kept private. But there is a small chance someone could trace them from their genetic information.

NCT ID: NCT02100865 Completed - Pneumonia Clinical Trials

Solar Powered Oxygen Delivery

Start date: February 2014
Phase: Phase 2
Study type: Interventional

Globally, approximately 2.1 million children die of pneumonia each year. Most deaths occur in resource-poor settings in Africa and Asia. Oxygen (O2) therapy is essential to support life in these patients. Large gaps remain in the case management of children presenting to African hospitals with respiratory distress, including essential supportive therapies such as supplemental oxygen. We hypothesize that a novel strategy for oxygen delivery, solar-powered oxygen, can be implemented in remote locations and will be non-inferior to standard oxygen delivery by compressed gas cylinders.

NCT ID: NCT02098031 Completed - Growth Clinical Trials

Improving the Nutrition Status of Infants in South-Western Uganda

Start date: March 2014
Phase: N/A
Study type: Interventional

Undernutrition and growth restriction due to poor diet and inadequate nutrient intake continues to be a global challenge, particularly in the developing countries including Uganda. The etiology of inadequate nutrient supply to infants may relate to lack of resources or knowledge or a combination of both. Poor nutrient intake and impaired growth may affect brain and cognitive development. This study aims to evaluate nutrient intake, growth and cognitive function among children between 6 and 36 months living in the fertile Kabale and Kisoro region in south-western Uganda. The investigators hypothesize that nutrition education to mothers can bring about improved dietary intake and nutritional status among children aged 6-36 months. A follow-up study is planned for the period January 2019 - December 2022.

NCT ID: NCT02094508 Completed - Malaria Clinical Trials

Impact of TMP-SMX Prophylaxis on Malaria Infection and Immunity in Children in Uganda

Start date: March 7, 2014
Phase:
Study type: Observational

Background: - Malaria is a disease that affects many children and adults in Uganda and Africa. If it is not treated, it can make some people severely ill. TMP-SMX (Trade names Bactrim, Septrin) is a drug that is given to children born to HIV-positive mothers to help prevent infection. Studies have shown that TMP-SMX also may kill malaria infection in the very early stages of infection in the body, which may positively impact the way the body can fight malaria infection. Researchers want to know if giving TMP-SMX for 6 months longer than usual helps children fight malaria better in this way. Objective: - To find out if taking TMP-SMX for longer than usual helps fight off malaria in infants. Eligibility: - Infants 0-6 weeks of age who are HIV negative. Design: - Infants will be screened with a medical history and physical exam. A small amount of blood will be taken. The mothers medical records will be reviewed. Mothers will be asked about when they breastfeed. - Participants will take TMP-SMX according to their doctor s orders. In Uganda, mothers will get a mosquito net with insecticide on it as per standard of care. - Participants will come to the clinic once a month, every month, until the study ends in 2 3 years. Each visit will repeat the screening visit. - Participants will also visit the clinic every month for a medical history, physical exam, and different blood tests. - Six weeks after breastfeeding is stopped, children taking TMP-SMX will come into the clinic and will either be taken off the drug or will continue taking the drug for 6 more months. - If a child becomes sick, it is important that the mother bring him or her to the RHSP clinic in Rakai.

NCT ID: NCT02083380 Completed - Clinical trials for Uncomplicated Plasmodium Falciparum Malaria

Phase IIb Study to Investigate the Efficacy of OZ439 & Piperaquine Phosphate Co-administered to Adults & Children With Uncomplicated Plasmodium Falciparum.

Start date: July 2014
Phase: Phase 2/Phase 3
Study type: Interventional

A randomised, double-blind single-dose (loose combination) study in patients with uncomplicated Plasmodium falciparum malaria. The study will test for efficacy/futility through analyses, using Bayesian methodology. Adults and children will be included through progressive step-down in age following safety analyses. This study investigates the efficacy exposure-response of OZ439/PQP combination in the target populations and if it meets its efficacy objectives, will inform dose setting for Phase III studies.

NCT ID: NCT02082652 Completed - HIV Clinical Trials

A Pharmacokinetic Evaluation of Etonogestrel (ENG) Implant and Antiretroviral Therapy

Start date: October 2014
Phase: Phase 4
Study type: Interventional

Antiretroviral therapy (medicines used to treat HIV) can interact with hormonal contraceptives which might decrease their effectiveness. The single-rod etonogestrel contraceptive implant is being more commonly used in low- and middle-income countries because if the ease of insertion and removal. Efavirenz and nevirapine are first-line HIV medicines in Sub-Saharan Africa and this study will help determine an effective way to use these medicines with the etonogestrel implant. The investigators hypothesize that women receiving nevirapine- or efavirenz-based antiretroviral therapy will have lower etonogestrel levels in their blood after six months of insertion as compared to women not taking antiretroviral therapy.

NCT ID: NCT02057796 Completed - HIV-1 Infection Clinical Trials

Systematic Empirical vs. Test-guided Anti-TB Treatment Impact in Severely Immunosuppressed HIV-infected Adults Initiating ART With CD4 Cell Counts <100/mm3

STATIS
Start date: September 2014
Phase: Phase 4
Study type: Interventional

In countries with a high tuberculosis (TB) prevalence, TB and invasive bacterial infections are leading causes of early death in patients who initiate antiretroviral therapy (ART) with advanced immunodeficiency. We hypothesize that a systematic 6-month empirical TB treatment initiated 2 weeks before the introduction of ART in HIV-infected adults with severe immunosuppression (CD4<100/mm3) and no overt evidence of TB will reduce the risk of death and invasive bacterial infections. This strategy will be compared to one of extensive TB testing using point-of-care tests (Xpert MTB/RIF® and urine lipoarabinomanan LAM) and chest X-ray to identify and treat only patients with at least one positive test suggestive of TB.

NCT ID: NCT02056106 Completed - Depression Clinical Trials

Comparative Trial of Antidepressant Treatment Models in HIV Care in Uganda

INDEPTH-Uganda
Start date: January 2013
Phase: Phase 4
Study type: Interventional

This study compares two models for implementing antidepressant treatment in 10 HIV clinics in Uganda. Using a cluster randomization, 5 clinics implement a task-shifting, protocolized model, and 5 others rely on clinical acumen. The protocolized model includes (1) routine depression screening at each clinic visit for all adult patients by trained expert patients at triage, (2) training nurses to diagnose depression and prescribe and monitor antidepressant treatment using an algorithm-based protocol, and (3) monthly supervision and monitoring by hired study psychiatrists. The clinical acumen model also includes routine depression screening and ongoing supervision, but it relies on the clinical acumen of trained primary care providers to further evaluate and treat patients who show signs of depression at screening, as opposed to a structured protocol. The primary aim is to test the hypothesis that the nurse-driven protocolized model will result in greater uptake of antidepressant treatment and better quality of depression care outcomes. The study will also test the hypotheses that treatment of depression results in improved HIV treatment adherence, work functioning and consistent condom use.