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NCT ID: NCT06285110 Recruiting - Hiv Clinical Trials

HIV-1 Subtype-specific Drug Resistance in Patients Failing Dolutegravir (DTG) Based Regimen

DTG-Resist
Start date: June 13, 2022
Phase:
Study type: Observational

This is a prospective observational study enrolling People Living with HIV (PLHIV) who are on a Dolutegravir-based AntiRetroviral Treatment (ART) regimen and experiencing virologic failure. Virologic failure is defined as two consecutive viral load measurements of >1000 copies/mL of blood. The main aim of the study is to identify the drug-resistance mutations in the viral genome that are associated with this failure. To achieve this goal, patients fulfilling the eligibility criteria will be invited for a single study visit for the collection of blood. The extracted HIV virus will be sequenced through whole genome sequencing methods to identify the drug-resistance mutations. The study is conducted in 15-20 countries within six regions of the IeDEA cohort (International epidemiology Databases to Evaluate AIDS).

NCT ID: NCT06087315 Recruiting - Sepsis Clinical Trials

Evaluation of a Multi-country Medical Oxygen Program

REAL-MOXY
Start date: November 27, 2023
Phase:
Study type: Observational

REAL-MOXY is a set of 5 mixed methods studies designed to understand how oxygen and pulse oximetry are used (or not used) at a facility level, to identify opportunities and barriers for strengthening oxygen systems for beneficiaries, users and managers.

NCT ID: NCT05754034 Recruiting - Acute Hypoxemia Clinical Trials

Building Respiratory Support in East Africa Through High Flow Versus Standard Flow Oxygen Evaluation

BREATHE
Start date: October 11, 2023
Phase: N/A
Study type: Interventional

Acute hypoxemia is common and deadly in resource variable settings. While studies in high income countries (HICs) have indicated a possible benefit to high flow oxygen as compared with standard flow oxygen, rigorous studies in low or lower middle income countries (LMICs) have not been performed. Studies in sepsis have demonstrated that interventions that improve outcomes in one context may actually be neutral or harmful in a different context. The goal of this study is to test whether high flow oxygen results in better outcomes for hypoxemic adult patients, as compared with standard flow oxygen, in five LMIC hospitals. The main questions it aims to answer are: 1. For hypoxemic adults in these LMIC study settings, does high flow oxygen or standard flow oxygen result in lower mortality? 2. What are the facilitators and barriers to using high flow oxygen in these settings? 3. Does high flow or standard flow oxygen use more oxygen? Participants will be randomized to receive either high flow oxygen through a large nasal cannula, or to receive standard flow oxygen, through nasal cannulas, face masks, or non-rebreather masks. Researchers will compare the outcomes for the two groups, to see if one group of patients has better outcomes than the other. The study will also examine how much oxygen is used by the two patient groups, as well as other factors relevant to the feasibility of implementation of high flow oxygen in these sites.

NCT ID: NCT05698537 Recruiting - Epilepsy Clinical Trials

Risk Factors and Etiologies of Epilepsy in Urban and Rural Rwanda

REpiCa
Start date: May 31, 2022
Phase:
Study type: Observational

Epilepsy is one of the most common chronic brain disorders. Up to 85% of persons living with epilepsy (PwE) live in the developing world. In sub-Saharan Africa (SSA), Rwanda has one of the highest prevalence rates (±5%). Higher prevalence in low-and middle-income countries (LMICs) can partly be attributed to differences in risk factors for epilepsy of which a great number are preventable. Expanding knowledge on risk factors and etiologies of epilepsy in Rwanda can lower the portion of preventable epilepsies and decrease the high number of Rwandan PwE. This project will focus on the investigation of risk factors and etiologies of epilepsy in urban and rural Rwanda using a nationwide approach.

NCT ID: NCT05668624 Recruiting - Blood Pressure Clinical Trials

Sustainable Household Energy Adoption in Rwanda (SHEAR)

SHEAR
Start date: November 17, 2022
Phase: N/A
Study type: Interventional

Investigators will conduct a randomized controlled trial substituting traditional forms of household energy (biomass for cooking and kerosene for lighting) with liquified petroleum gas (LPG) stoves/fuel and solar power (in areas marker for solar grids by the Government of Rwanda) in rural Rwanda. Eligible households (n=650) using traditional forms of energy will be recruited from eastern Rwanda. In each household, investigators will recruit either one adult female and one adult male or just one adult, and one child (aged 8-15 years). Following baseline health and exposure assessment, a randomized treatment arm (n=250 homes) will receive a full subsidy for LPG fuel and solar power, a control arm (n=250 homes) will continue to use traditional energy, and a random-subsidy arm (n=150 homes) will be randomized to a discounted price (at baseline and every 6-months) for solar and LPG in a pay-as-you-go (PAYG) service model (i.e., pre-pay a desired amount through mobile money). The random subsidy arm will then decide whether or not to cook with the discounted LPG or their traditional stove. Participants will be followed for 3 years with repeated measures of household air pollution (HAP) exposure (48-hour fine particulate matter (PM2.5) and black carbon (BC)), energy use, health, and preferences. Primary health endpoints include blood pressure (BP) in adults and lung-function growth in children; secondary endpoints include BP in children and lung-function change in adults. To complement the trial, the random-subsidy arm will generate policy-relevant information on causal relationships between energy costs, solar and LPG usage, and HAP exposures. The investigators propose 3 aims: Aim 1. In an ITT framework, investigators will evaluate the effect of a household energy intervention on exposure to HAP and indicators of morbidity separately among Rwandan women, men, and children within n=500 households. Aim 2. Using exposure-response modeling, investigators will characterize associations between exposure to HAP and indicators of morbidity separately among Rwandan women, men, and children within n=650 households (500 trial households + 150 random subsidy households). Aim 3. Using a random-encouragement design, investigators will investigate causal relationships between randomized energy costs, measured energy usage, and estimated exposure to HAP among n=400 households (150 random subsidy households + 250 full subsidy treatment arm households).

NCT ID: NCT05580666 Recruiting - Clinical trials for HIV Disease Progression

Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)

REVIVE
Start date: May 8, 2023
Phase: Phase 3
Study type: Interventional

A double blinded, placebo-controlled, multicenter trial to evaluate effectiveness of azithromycin prophylaxis on mortality in advanced HIV.

NCT ID: NCT05555303 Recruiting - Clinical trials for Tuberculosis, Multidrug-Resistant

Preventing Acquired Resistance: Strengthen TB Treatment by Adding Amikacin in the First Treatment Week of Multidrug-resistant Tuberculosis

Stake
Start date: March 1, 2023
Phase: Phase 2
Study type: Interventional

Acquired drug-resistance is a major challenge for tuberculosis (TB) care programs. The 2020 WHO guidelines recommends replacing second-line injectables by bedaquiline in rifampicin-resistant TB (RR-TB) treatment regimens. However, recent reports show too high rates of acquired bedaquiline resistance. This may be explained by the delayed onset of action of bedaquiline. The investigators will study whether high-dose amikacin (a second-line injectable), administered during the first week of RR-TB treatment, is safe in 20 patients treated for RR-TB in Rwanda. If safe, further studies will assess whether adding amikacin in the first treatment week protect against acquired bedaquiline resistance. This study is embedded in an ongoing "Master study" of the ShORRT (short oral RR-TB) treatment regimen in Rwanda, a before/after study, with a retrospective cohort (before; the previously recommended second-line injectable-containing RR-TB regimen) and a prospective cohort (after: the newly recommended ShORRT regimen).

NCT ID: NCT05538299 Recruiting - Silicosis Clinical Trials

Silicosis Treatment, Action, Screening and Surveillance in Rwanda Trials

STARSS
Start date: July 31, 2022
Phase:
Study type: Observational [Patient Registry]

Silicosis is the most prevalent occupational lung disease in low- and middle-income countries (LMICs) with "tens of millions" estimated to suffer from the disease according to the World Health Organization (WHO). To date, there is little published data on silicosis in LMICs and the burden of silicosis in Rwanda has not been well-defined. Silicosis among local mine workers is a common reason for hospitalization and death at Rwinkwavu District Hospital, located in Rwanda's Kayonza District. The objectives of this study are: 1. To assess the prevalence of silicosis among workers in four mines located in the Kayonza District of Rwanda 2. To adapt a validated screening tool testing in Dutch construction workers for Rwandan miners 3. To implement an occupational health education program and assess the change of before and after intervention that target towards proper use of PPE and individual risk assessment in mine workers using knowledge-attitudes-practice tool

NCT ID: NCT05516056 Recruiting - ERAS Clinical Trials

ERAS After Cholecystectomy in Kigali, Rwanda

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Enhanced Recovery After Surgery (ERAS) pathway represents a peri-operative multimodal management aiming at a decrease in surgical aggression and an improved patient rehabilitation, in order to reduce postoperative morbidity, length of hospital stay and, as an important secondary consequence, overall costs. ERAS pathways have been successfully implemented in many surgical managements in the Western world, but very few data exist on ERAS in developing countries. This project aims at the prospective evaluation of ERAS pathway implementation in cholecystectomies in CHUK, Rwanda. The first 50 patients will be prospectively evaluated and compared to the last 50 patients who underwent cholecystectomy before ERAS pathway implementation.

NCT ID: NCT05364138 Recruiting - Breast Cancer Clinical Trials

Evaluating Scaleup of an Adapted Breast Cancer Early Diagnosis Program in Rwanda

Start date: July 31, 2023
Phase:
Study type: Observational

Breast cancer incidence is increasing in low- and middle-income countries (LMICs) and breast cancer mortality is high in these regions largely due to late stage diagnoses. This is true in the low-income East African country of Rwanda, where there are no national protocols in place to guide evaluation and referral of breast symptoms at primary health facilities. This study will use quantitative and qualitative methods to examine implementation of the Women's Cancer Early Detection Program (WCEDP) in order to understand optimal strategies to scale and sustain breast cancer early diagnosis in Rwanda and other limited-resource settings. The WCEDP is an adaptation of a prior intervention in Burera District, which focused on building community awareness of breast symptoms, improving clinicians' clinical breast assessment (CBA) skills, and implementing weekly breast clinics at the primary health care center and hospital levels. The Burera intervention was associated with improvements in health care workers' knowledge and skills, increases in care-seeking and receipt of care by women with breast symptoms, and an increase in early-stage breast cancer diagnoses.