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NCT ID: NCT04025827 Completed - Stunting Clinical Trials

Weight Patterns in the Month After Birth

Start date: April 22, 2019
Phase:
Study type: Observational

This is a prospective cohort study that will be conducted in four low income countries to describe newborn weight patterns in the first month after birth and their association with clinical and demographic factors including dietary intake.

NCT ID: NCT04023799 Completed - HIV Prevention Clinical Trials

Couple User Preferences in Dual Purpose Prevention Products

CUPID
Start date: January 21, 2020
Phase:
Study type: Observational

MTN-045 is a cross-sectional study that will utilize questionnaires, including Discrete-Choice Experiments (DCE) and joint decision tasks, to assess couples' preferences related to dual purpose prevention (DPP) products that could be used to prevent unintended pregnancies and HIV infection. Post-survey explanatory in-depth interviews (IDIs) will be conducted with a subset of participants to explore DPP product-related decisions..

NCT ID: NCT04021121 Completed - Clinical trials for Tuberculosis, Meningeal

Adjunctive Linezolid for the Treatment of Tuberculous Meningitis

ALTER
Start date: May 5, 2021
Phase: Phase 2
Study type: Interventional

This is a phase II randomized open-label trial of high versus standard dose rifampin (RIF) with or without linezolid (LZD) for the first 4 weeks of treatment for Tuberculosis Meningitis (TBM) at Masaka Regional Referral Hospital in Uganda. Initial randomization will be to high (35 mg/kg/day) versus standard (10 mg/kg/day) dose oral rifampin for the first 4 weeks of intensive therapy. Participants will then undergo a second randomization to linezolid 1200 mg daily versus no linezolid for the first 4 weeks of therapy. The primary aims are (1) to determine the cerebrospinal fluid and plasma pharmacokinetics of adjunctive LZD 1200 mg daily in TBM patients receiving high or standard dose RIF and (2) to evaluate the tolerability of a 4-week course of LZD in TBM patients.

NCT ID: NCT04012931 Completed - HIV Clinical Trials

A Study of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to <12 Years) Who Are Virologically Suppressed

Start date: July 18, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the steady state pharmacokinetics (PK) of rilpivirine (RPV) and determine the appropriate dose of RPV in combination with other antiretrovirals (ARVs) in participants aged greater than or equal to 2 to less than 12 years and to evaluate the safety and tolerability of RPV in combination with other ARVs in participants of same age group over a 48-week treatment period with primary endpoint at Week 24.

NCT ID: NCT04000503 Completed - Cervical Cancer Clinical Trials

Integrated Cervical Cancer Screening in Mayuge District Uganda (ASPIRE Mayuge)

ASPIRE
Start date: August 1, 2019
Phase: N/A
Study type: Interventional

The purpose of this pragmatic cluster randomized control trial is to test the effectiveness of cervical cancer screening follow-up completion using two implementation approaches for self-collected HPV testing in a rural, low-resource setting: 1) community health workers recruiting women door-to-door and 2) community health workers recruiting women at community health meetings. This study will also help to further understand how current patient referral systems are working between health facilities, patient and provider preferences for integrated care and health system related barriers to integrated cervical cancer screening. Hypothesis: More women will receive screening via the community health meeting but the engagement to care (i.e., visual inspection with acetic acid-our main outcome) will be greater in the door-to-door arm.

NCT ID: NCT03990402 Completed - Asthma Clinical Trials

Achieving Control of Asthma in Children In Africa

ACACIA
Start date: May 16, 2019
Phase:
Study type: Observational

The main aim of the study is to identify altogether 3000 children aged between 12 and 16 years old with asthma symptoms in six sub-Saharan African countries. The study furthermore aims to assess their asthma control, current treatment, knowledge of and attitudes to asthma, as well as the barriers to achieving good asthma control.

NCT ID: NCT03984188 Completed - COPD Clinical Trials

Effectiveness of Low-Dose Theophylline for the Management of Biomass-Associated COPD

Start date: February 23, 2021
Phase: Phase 3
Study type: Interventional

Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death worldwide, and over 90% of COPD-related deaths occurring in low- and middle-income countries (LMICs). Household air pollution (HAP) - from burning solid fuels such as wood, dung, agricultural crop waste, and coal for energy - is the primary risk factor for COPD in these settings. Biomass-related COPD has a distinct histopathology, phenotype and inflammatory profile when compared to tobacco mediated COPD. Despite the high global burden of biomass-related disease, little is known about the effectiveness of pharmacotherapies for biomass-related COPD; to date, no clinical trials have focused specifically on treatment of biomass-related COPD. This study proposes to assess the health impact of biomass-related COPD and test the effectiveness of low dose theophylline compared to standard therapy among adults with biomass-related COPD in Uganda with the aim to assess whether low-dose theophylline improves respiratory symptoms, decreases the inflammatory profile of serum biomarkers and whether administration attenuates the effect of HAP on lung function. The study additionally aims to assess whether low-dose theophylline is a cost-effective intervention based on the incremental cost-effectiveness ratio and a range of willingness to pay thresholds.

NCT ID: NCT03982277 Completed - Tuberculosis Clinical Trials

Safety and Efficacy of High Dose Rifampicin in Tuberculosis (TB)-HIV Co-infected Patients on Efavirenz- or Dolutegravir-based Antiretroviral Therapy

SAEFRIF
Start date: April 30, 2019
Phase: Phase 2
Study type: Interventional

Higher doses of rifampicin has been associated with a faster drop in bacterial load over time, and shorter treatment regimens with high dose rifampicin are being proposed. Sub-therapeutic rifampicin concentrations are common in TB patients and have been demonstrated in several studies carried out among patients with tuberculosis receiving the standard dose (10mg/kg) of rifampicin. Insufficient exposure to isoniazid and rifampicin, which are the cornerstones of TB treatment, has been associated with drug resistance, treatment failure and delayed bacterial clearance from sputum. Evidence has indicated that the current dose of rifampicin (10mg/kg) is inadequate for many patients. Several studies have suggested that dose escalation (to 20-35mg/kg) is safe, and that higher doses (35mg/kg) may accelerate clearance of TB bacteria from the sputum of infected individuals and achievement of target concentrations.15,16 However, these studies have almost entirely been conducted among HIV negative TB patients, or TB-HIV co-infected patients without severe immunosuppression who are not yet receiving antiretroviral therapy (ART). TB-HIV co-infected patients on multiple additional drugs, including ART, are at increased risk of drug-drug interactions and drug related toxicities, including hepatotoxicity. Increasing the dose of rifampicin is a promising approach; however, there is paucity of data on the safety of higher doses of rifampicin in HIV infected patients on ART, and almost no information on the enzyme induction effect of high dose rifampicin on Efavirenz (EFV) and Dolutegravir (DTG). In this study, the investigators will not only evaluate for the enzyme induction effect of 35mg/kg of rifampicin on the most widely used first-line antiretrovirals, but will also look at the safety of these combinations in a population in which there is still scarce safety data. The aim of this study is to determine the safety of higher doses of rifampicin and its effect on the pharmacokinetics of efavirenz and dolutegravir in TB-HIV co-infected patients.

NCT ID: NCT03974178 Completed - Clinical trials for Trypanosoma Brucei Rhodesiense; Infection

Efficacy and Safety of Fexinidazole in Patients With Human African Trypanosomiasis (HAT) Due to Trypanosoma Brucei Rhodesiense

Start date: September 29, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

This study aims at evaluating the efficacy and safety of a new oral treatment drug against Human African trypanosomiasis (HAT) due to T.b rhodesiense. 34 patients will be recruited in 2 sites located in Malawi and Uganda. All patients will receive the study drug fexinidazole.

NCT ID: NCT03966833 Completed - Mental Depression Clinical Trials

Using Group Interpersonal Psychotherapy to Improve the Well-Being of Adolescent Girls

Start date: May 26, 2019
Phase: N/A
Study type: Interventional

Adolescent girls in developing countries face high rates of adversity and are at an elevated risk of depression and other forms of psychological distress. Untreated depression can have negative consequences on life outcomes such as early pregnancies, social exclusion and school dropout. These can result in a cycle of poverty for young women and their families. Despite this being a very pressing problem there is little evidence on what types of interventions can help break the vicious cycle of poor mental health and poverty. This research program aims to evaluate, through the use of a cluster-Randomized Control Trial (cluster- RCT), the effect of group-based interpersonal psychotherapy (IPT-G) and unconditional cash transfers on adolescent girls' mental health and social functioning. Working with Strong Minds Uganda in collaboration with BRAC Uganda's Empowerment and Livelihood for Adolescents (ELA) clubs, the evidence generated from this research will create a better understanding of whether adolescent mental health improves through this cost-effective approach, and whether improved mental health impacts other outcomes of interest.