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NCT ID: NCT02023658 Completed - HIV Clinical Trials

Systems Analysis and Improvement to Optimize pMTCT

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

Despite significant increases in global health investment and the availability of low-cost, efficacious interventions designed to reduce mother to child HIV transmission in low and middle income countries with high HIV burden, the translation of these scientific advances into effective delivery strategies has been slow, uneven and incomplete. As a result, pediatric HIV infection remains largely uncontrolled. Enhancing the implementation of pMTCT interventions through contextually appropriate systems analysis and improvement approaches can potentially reduce drop-offs along the pMTCT cascade, leading to dramatic improvements in infant and maternal outcomes. The goal of this proposal is to develop a model for systematic assessment and improvement of pMTCT services in sub-Saharan Africa. In specific aim 1, we will identify health system factors and service delivery approaches associated with high and low performing pMTCT services in Côte d'Ivoire, Kenya and Mozambique. In specific aim 2 we will adapt evaluate the feasibility and impact of a systems analysis tool and associated performance enhancement approach for pMTCT services in Côte d'Ivoire, Kenya and Mozambique. This systems analysis tool and associated performance enhancement approach is currently being developed and piloted for pMTCT services in Mozambique. The results of this implementation research are expected to generate knowledge of global health significance, and by disseminating the study results and intervention tools through the broad PEPFAR network, can rapidly impact pMTCT service delivery enhancements across the highest need countries.

NCT ID: NCT01992900 Completed - Malaria,Falciparum Clinical Trials

A Pharmacokinetic/Pharmacodynamic Study of Eurartesim Dispersible Formulation in Infants With P.Falciparum Malaria

Start date: November 2013
Phase: Phase 2
Study type: Interventional

There is a need for paediatric formulations that permit accurate dosing and enhance patient compliance. However, for the treatment of malaria, scarce paediatric-friendly formulations are available on the market. Thus, a new water dispersible formulation of eurartesim has been developed for oral administration. Aim of this study is to provide data on pharmacokinetic profile, safety and efficacy of this new paediatric formulation and compare it with the crushed film coated tablet in infant patients (6 to ≤12 months of age) suffering from uncomplicated Plasmodium falciparum malaria. Furthermore, a Pharmacokinetic/Pharmacodynamic(PK/PD) modelling will be built up to establish PK/PD relationship in adult and paediatric populations.

NCT ID: NCT01972321 Completed - Malaria Clinical Trials

ICCM of Common Childhood Diseases: Mozambique and Uganda

inSCALE
Start date: April 2013
Phase: N/A
Study type: Interventional

The aim of the inSCALE project is to test the effect of innovative approaches to increase coverage of integrated community case management, which provides community based-care for diarrhoea, pneumonia and malaria, resulting in more children receiving timely and appropriate care for these three most common childhood illnesses

NCT ID: NCT01945268 Completed - Heart Failure Clinical Trials

Influenza Vaccine To Prevent Adverse Vascular Events:Pilot

IVVE:Pilot
Start date: April 2015
Phase: Phase 4
Study type: Interventional

A multi-centre, randomized, placebo controlled, trial. Participants at high-risk for vascular events from the network of INTER- CHF will be randomized to inactivated influenza vaccine or placebo and followed prospectively over three influenza seasons. 600 participants will be enrolled prior to influenza season and randomized to either influenza vaccine or saline placebo.

NCT ID: NCT01930084 Completed - HIV Clinical Trials

ENGAGE4HEALTH: A Combination Intervention Strategy for Linkage and Retention in Mozambique

E4H
Start date: April 2013
Phase: N/A
Study type: Interventional

Purpose: To compare the effectiveness of a combination intervention strategy (CIS), consisting of point of care (POC) CD4+ testing immediately following HIV diagnosis and accelerated ART initiation for eligible participants delivered by facility personnel, and cellular appointment reminders delivered by study personnel, to the standard of care (SOC) on linkage to and retention in HIV care at 12 months among adults testing positive for HIV in Mozambique. Additionally, the protocol will assess the incremental effectiveness of CIS+ non-cash financial incentives (FI) compared to CIS without FI on study outcomes.

NCT ID: NCT01911494 Completed - Pre-eclampsia Clinical Trials

Community Level Interventions for Pre-eclampsia

CLIP
Start date: September 2013
Phase: N/A
Study type: Interventional

This project is being undertaken to test the hypothesis that implementing a community based package of care for women with hypertensive disorders of pregnancy will result in overall improvement in maternal and neonatal outcomes. This is based on the premise that there are three main modifiable reasons why women (and their fetuses/newborns) die due to pregnancy complications: 1) delays by the woman herself in recognizing the seriousness of her condition; 2) delays in her being assessed and then transported to a center capable of providing effective and life-saving interventions; and 3) delays in the health facility in providing those interventions. The treatments for pre-eclampsia that are poorly accessed in LMIC are 1) magnesium sulfate (MgSO4) for prevention and treatment of the grand mal seizures of eclampsia; 2) oral antihypertensive medication to lower maternal BP to reduce the risk of stroke. The CLIP pilot and definitive cRCT will investigate whether the community level intervention including implementation of the CLIP package (oral antihypertensive therapy when indicated, intramuscular (i.m.) MgSO4 when indicated; and appropriate referral to an CEmOC facility when indicated) of care will reduce the incidence of all-cause maternal morbidity and mortality.

NCT ID: NCT01910493 Completed - HIV-positive Clinical Trials

Evaluation of the Impact of Mobile Phone Messages on ART and PMTCT Adherence in Mozambique

SMSaude
Start date: November 2011
Phase: N/A
Study type: Interventional

Mobile phone SMS are increasingly used to promote positive health behaviour with an aim to improve health outcomes. However, robust data on the efficacy of SMS on health seeking behaviour and patient outcomes in resource-limited settings is sparse. The SMSaude study aims to assess whether regular SMS-reminders improve retention on antiretroviral therapy (ART) and prevention of mother to child transmission of HIV (PMTCT) programmes in Mozambique.

NCT ID: NCT01734434 Completed - Clinical trials for Pregnancy, Newborn Health

Study to Identify Factors Influencing Access of Pregnant Women and Their Infants to Local Healthcare Systems

Start date: November 2012
Phase:
Study type: Observational

This study collected information regarding the factors that might influence access of pregnant women to the local healthcare system. The main visits of the study screened & enrollment, delivery and 90 day infant follow-up. Data were collected mainly from questionnaires administered to pregnant women at these visits. The questionnaires contained the following standard questions which were asked at each visit, in addition to some visit-specific questions related to delivery and health status of infants up to 90 days of age. The standard questions related to the following aspects: - Logistics of transportation to the study site (type, time it takes, cost incurred) - Accessibility to a telephone/cell phone - Provisions of alternative child care during site visits if there are other children under the subject's care

NCT ID: NCT01697007 Completed - HIV Clinical Trials

A Phase II Trial to Assess the Safety and Immunogenicity of DNA Priming Administered by the ID Zetajet® With or Without ID Derma Vax™ Electroporation Followed by IM MVA Boosting in Healthy Volunteers in Tanzania and Mozambique

TaMoVac II
Start date: November 2012
Phase: Phase 2
Study type: Interventional

Electroporation will increase the efficiency of DNA priming in terms of immune responses and will lead to a dose sparing DNA vaccine regimen. Furthermore increased DNA vaccine concentration will reduce the number of shots necessary to deliver the full dose and induce comparable immune responses as with lower DNA vaccine concentrations.

NCT ID: NCT01688310 Completed - Surgical Technique Clinical Trials

A Randomized Controlled Trial of Open Surgical vs. Minimally-invasive Voluntary Adult Male Circumcision

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

This proposed randomized controlled trial will provide important data which will inform and enable the Mozambican government and global health programs to more effectively scale-up circumcision services. The investigators postulate that voluntary medical male circumcision using the Gomco clamp coupled with tissue adhesive meets WHO criteria for the ideal method: it is much easier to learn, faster, safer for both surgeons and patients, heals sooner, and is more cost effective than any other currently available technique.