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NCT ID: NCT04262882 Completed - Contraceptive Usage Clinical Trials

Multilevel Family Planning Intervention

Start date: May 14, 2021
Phase: N/A
Study type: Interventional

This study seeks to develop and evaluate a multi-level intervention to satisfy couples' unmet need for family planning in rural Uganda. The study will evaluate the acceptability, feasibility, and preliminary efficacy of the intervention at increasing contraceptive uptake and continuation and improving intermediate outcomes of knowledge, attitudes, perceived community norms, partner communication and equity among couples in rural Uganda.

NCT ID: NCT04209569 Completed - Nutrition Poor Clinical Trials

One Nutrition in Complex Environments (ONCE)

ONCE
Start date: January 17, 2020
Phase: N/A
Study type: Interventional

This study asks the research question "Does enabling families (particularly mothers and other caregivers) to 'assess and act' on drivers of malnutrition through a targeted SBC+ package succeed in a sustained reduction of risk factors thereby improving child health and nutrition?" This study aims to implement and measure the effects of a multi-level multi-sectoral behavior change information intervention in Agago District of Northern Uganda and determine potential for scale up in a complex environment. The study design is a three-arm cluster randomized controlled superiority design (cRCT) with a 1:1:1 allocation ratio. The study arms will be: Group 1: NIPP arm; Group 2: NIPP+ arm; and Group 3: Non-intervention control arm. A barrier analysis will be conducted to ensure appropriate targeting and contextualization of the NIPP and NIPP+ approaches prior to implementation. Each intervention arm will receive a 12-week intervention (NIPP or NIPP+) with active monitoring and longitudinal follow ups post intervention at 2, 6, and 12-months post-intervention. The total sample size for the Barrier Analysis will be a maximum of 450 caregivers; for the main intervention, 900 households (300/arm) will be purposely sampled from the randomly selected communities. Respondents for the qualitative portion will be purposely selected.

NCT ID: NCT04203628 Completed - Tuberculosis Clinical Trials

Evaluation of Four Stool Processing Methods Combined With Xpert MTB/RIF Ultra for Diagnosis of Intrathoracic Paediatric TB (TB-Speed - Stool Processing)

Start date: January 13, 2020
Phase: N/A
Study type: Interventional

There is a growing interest for the use of stool samples as an alternative to respiratory samples for the diagnosis of intrathoracic TB in children unable to produce sputum. Unlike respiratory samples, stool samples require processing before molecular testing. Several groups have already evaluated different processing methods. However, it is difficult to know which method has the best accuracy and potential for use at Primary Health Care level, due to the difference in study designs and populations. Therefore, in this study, the investigators propose to evaluate the accuracy of different promising stool processing methods in the same population within the same study with an adapted design. Furthermore, no study has so far evaluated for stool testing the new Xpert MTB/RIF Ultra cartridge that has a lower level of detection than the previous Xpert MTB/RIF cartridge. The investigators propose to evaluate the accuracy of Xpert MTB/RIF Ultra (Ultra) performed on stool samples collected from children with presumptive TB and processed using four different processing methods (Standard sucrose flotation method, optimized sucrose flotation method, SPK, and SOS) against bacteriological results from respiratory specimens and to perform a head-to-head comparison of the diagnostic accuracy and feasibility of these different methods in Uganda and Zambia. The selection of processing methods was based on accuracy results, degree of simplification allowing their introduction at PHC level, and finding from the TB-Speed in-vitro stool processing study. The standard sucrose flotation method is kept to assess if results obtained with the optimised sucrose-flotation method in our in-vitro study can be reproduced in-vivo

NCT ID: NCT04144491 Completed - Diarrhea Clinical Trials

Effect of L. Rhamnosus Yoba on RTI and Other Health Outcomes Among Children (3-6 Years) in Uganda

Start date: September 16, 2019
Phase: N/A
Study type: Interventional

This is a nutritional trial with two arms: 1) Intervention arm of Probiotic Yoghurt containing Lactobacillus rhamnosus yoba 2012 and 2) Control arm of custard-like dairy product. The study subjects are 200 children between the age of 3-6 years that attend a school in Southwestern Uganda, Sheema district. Children will be randomized and enrolled in either the yoghurt (100 children) or the placebo (100 children) arm. The children will be monitored for 3 weeks in the baseline in regards to the incidence of common childhood diseases. During these three weeks, stool, saliva and urine samples will be collected. Also measurement of anthropometric indicators (weight and height) will take place. Subsequently, the children will consume either 100ml yoghurt or 100ml placebo product, once per day for five days per week for nine weeks, while being daily monitored in regards to the incidence of common childhood diseases. The same samples (stool, urine and saliva) and assessments (anthropometric) will take place at end line.

NCT ID: NCT04140266 Completed - HIV Infections Clinical Trials

Safety and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant Pairs

Start date: September 24, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and drug detection of the dapivirine vaginal ring and oral Truvada in breastfeeding mother-infant pairs.

NCT ID: NCT04134689 Completed - Tuberculosis Clinical Trials

DOT Selfie: A Mobile Technology Intervention to Evaluate Treatment Adherence Among Tuberculosis Patients

Start date: July 13, 2020
Phase: N/A
Study type: Interventional

This is a randomized controlled trial (RCT) to determine whether Video Observed Treatment (VDOT) using social internet bundle incentives for tuberculosis (TB) is an effective way to improve medication adherence in TB treatment, compared with standard in-person treatment (home-/ community-based). The study will include two study arms: one will receive TB treatment using the standard in-person DOT, and the other through VDOT. All patients (regardless of study arm) will receive daily TB treatment under home- or community-based observation . For patients in the In-person DOT arm, this will be observed and recorded daily by a study nurse. Patients in the VDOT arm however, will be required to record and upload their daily medication intake using a mobile phone App. As a form of incentive, these patients will be rewarded with social internet bundles for every 7 consecutive video uploads. Additionally, they will be sent motivational text messages to encourage treatment compliance. Regardless of study arm, all patients will have 2,4, and 6 monthly clinic visits for clinical and/or sputum assessments. Each patient will also complete a Morisky Medication Adherence Scale (MMAS) questionnaire at treatment completion.

NCT ID: NCT04120337 Completed - Clinical trials for Removal of a Contraceptive Subdermal Implant

Safe Access: Trial With RemovAid Device

Start date: December 23, 2019
Phase: N/A
Study type: Interventional

This randomized trial will compare different approaches to removing a subdermal contraceptive implant from the upper arm of 225 women in Uganda. The experimental approach is a hand-held device (RemovAid) that incises the skin and grasps the implant for extraction. Safety and efficacy endpoints will be compared to the traditional removal approach (scalpel, forceps, tweezers).

NCT ID: NCT04102592 Completed - Malaria Clinical Trials

Getting Malaria "Off the Back" of Women and Children in Western Uganda

Start date: October 28, 2019
Phase: N/A
Study type: Interventional

This is a two-phase, mixed-methods pilot study of insecticide-treated lesus to reduce the incidence of P. falciparum malaria among infants in a rural area of western Uganda. Participants will be recruited from four villages immediately adjacent to the Bugoye Level III Health Centre (Bugoye, Kanyanamigho, Izinga, Rwakingi 1a) in the Kasese District of western Uganda. The purpose of the study is to assess the feasibility and tolerability of using insecticide-treated lesus to reduce the incidence of P. falciparum malaria infection among infants.

NCT ID: NCT04089800 Completed - Maternal Health Clinical Trials

Using a Mobile Phone-based Multimedia Technology to Support Maternal Health in Rural Southwestern Uganda

MatHealth
Start date: September 20, 2019
Phase: N/A
Study type: Interventional

The overall goal of the MatHealth project is to improve maternal health using an enhanced mobile phone-based multimedia application among illiterate women in rural southwestern Uganda. Building on a prototype of a mobile maternal health support technology developed as part of the on-going PhD research by one of our team members, The investigators will redesign the prototype to make it suitable for illiterate populations by engaging the local communities/prospective users to incorporate multimedia components such as videos and audios. Using the enhanced prototype, the investigators will carry out a reasonably large scale field study in Uganda, where the investigators will empirically implement the prototype among the rural community and assess its preliminary impact on maternal health. The investigators hypothesize that implementing the enhanced prototype will result in increased access to high quality, relevant local and culturally acceptable maternal health information that can enable mothers and families demonstrate improved health-seeking and preventative behaviors, including early uptake and adherence to antenatal check-ups and care including HIV testing, good nutrition, birth preparedness, dealing with danger signs, among others; all of which should ultimately contribute to improved maternal and child survival. The investigators will contribute to and benefit from a culture of continuous learning by engaging with the local/user communities, policy makers, and researchers to share lessons learned and best practices.This will potentially facilitate the translation of our research findings into medical care.

NCT ID: NCT04089423 Completed - Clinical trials for Diagnosis of Tuberculosis in People Living With HIV

FujiLAM Prospective Evaluation Trial

Start date: December 13, 2019
Phase:
Study type: Observational

This is a prospective, multicentre cohort study in which the accuracy and the diagnostic yield of the FujiLAM test will be assessed using a microbiological reference standard, an extended microbiological reference standard and a composite reference standard among inpatient and outpatient people living with HIV (PLHIV).