Research projects
CURRENT RESEARCH PROJECTS
REMIND-TB
In REMIND-TB we will look at the effectiveness of evriMED on adherence to treatment among drug susceptible tuberculosis patients. EvriMED is a real time medication monitoring device from which TB treatment will be taken. We will conduct a pragmatic cluster randomized trial in Kilimanjaro region with two arms, one arm will use evriMED and the other arm will use standard care. This project is done in collaboration with Radboud University (Nijmegen, the Netherlands) and the University of Amsterdam (Netherlands). This project has been financed by Wave 6 of the TB Reach Programme of
Stop TB Partnership.
EXIT-TB
Exit-TB is...
PAVIA
PAVIA is ...
ONDOILO
In the ONDOILO (meaning voice) study we want to improve dialogue between Maasai and health care workers on family planning methods. Using a participatory action research approach, we will develop an Interactive Voice Response Calling system through which Maasai and health care workers can communicate. Maasai couples and health care workers in Esilalei (Monduli, Arusha) will use the system for six months. This project is done in collaboration with the African Roots Foundation. ONDOILO has been funded by Voice Global, an initiative of the Dutch Ministry of Foreign Affairs.
REMIND
The REMIND study is a clinical trial among people living with HIV in Moshi (Kilimanjaro, Tanzania). We will compare the effect of Wisepill, a real time medication monitoring device, short messages service (SMS) reminder texts and standard care on adherence to ARV treatment and treatment outcomes. PLHIV will be followed for one year and adherence to treatment, virological outcomes, quality of life, stigmatisation, depression and social support will be measured at several timepoints. The project is carried out in collaboration with the University of Amsterdam (Netherlands) and Radboud University (Nijmegen, the Netherlands). This clinical trial is sponsored by the European & Developing Countries Clinical Trials Partnership (EDCTP).
OPTION B+
Our research program currently includes two studies focused on improving care for HIV-infected pregnant and postpartum women in Tanzania. In 2016, we received grant funding from the U.S. National Institutes of Health (R21 AI124344) to examine the implementation of the Option B+ guidelines for prevention of mother-to-child transmission of HIV (PMTCT) in Tanzania. In 2018, we received additional grant funding (R21 TW011053) to develop and pilot test an intervention to address HIV stigma at entry into antenatal care. This research is co-led by Dr. Melissa Watt from the Duke Global Health Institute and Dr. Blandina Mmbaga from Kilimanjaro Clinical Research Institute.You can read more about our research at our website here
COYOMEN
In CoYoMen we investigate the use and needs of contraceptives of young unmarried sexually active men in Moshi (Tanzania) and Addis Abeba (Ethiopia). It is a qualitative study in which youn men are receiving two-weekly SMS on their practices and needs considering contraceptives. They are followed for six months and if there is a need of contraceptives, they are invited for an in-depth interview. Focus group discussions will be done at the end of the study. This study is done in collaboration with Segel Research & Consultancy (Addis Ababa, Ethiopia) and is funded by the Grand Challenges Schemeof the Bill & Melinda Gates Foundation.
SimpliciTB
SimpliciTB is a mult-centre phase 3 clinical trial evaluating a new shorter drug regimen (all-oral BPaMZ) in drug susceptible and resistant pulmonary tuberculosis across 4 continentsled by TB Allience.
High Rif C Study
TITLE OF THE STUDY: Evaluation and safety/Tolerability of Higher doses of Rifampicin in children with Newly Diagnosed, Uncomplicated Tuberculosis.
INTRODUCTION
This is the project that deals with the evaluation of the pharmacokinetic and safety/Tolerability of high doses of rifampicin in children and to assess which higher rifampicin doses in children yield similar exposures in plasma to those achieved in adults who received 35mg/kg rifampicin daily, as it is thought that similar exposures in plasma will yield similar response. This clinical trial is funded by the European & Developing Countries Clinical Trials Partnership (EDCTP).
PURPOSE
The main purpose of this study is to evaluate the possible higher doses of rifampicin which can be used by children and yield similar exposures in plasma to those achieved in adults who received higher dose of rifampicin. For adults the highest dose reached was 35mg per kg body weight.
STUDY PARTICIPANTS
The study will include males and females children aged between 1 to 14 years who are diagnosed to have TB either with pulmonary TB, extra pulmonary TB.
INCLUSION CRITERIA
Patients are required to meet all of the following inclusion criteria in order to be enrolled:
1. The child’s parent is able and willing to provide written, informed consent prior to all trial-related procedures including HIV testing.
2. The patient is aged between 1 and 14 years, inclusive.
3. The patient is newly diagnosed with uncomplicated TB.
Exclusions criteria:
Patients will be excluded if they meet any of the following exclusion criteria:
1. The patient is in poor general condition where any delay in treatment cannot be tolerated per discretion of the Investigator.
2. Rifampicin-resistant bacteria have been detected in the patient’s sputum specimen collected within the pre-treatment period and tested at the study Laboratory.
3. The patient has a history of allergy to isoniazid, rifampicin, pyrazinamide or ethambutol
4. The patient has Hepatitis B.
5. The patient had Hepatitis C.
6. The patient is infected with HIV, as the effect of high dose rifampicin on ARV treatment is unknown.
7. There is any evidence showing that the patient has renal impairment, including but not limited to serum creatinine levels above the upper limit of the laboratory reference range.
8. The patient has abnormal alanine aminotransferase (ALT) and/or aspartate transferase (AST) levels > 1 times the upper limit of the Laboratory reference range (at Visit 1).
9. There is evidence showing the patient has clinically significant metabolic, gastrointestinal, neurological, psychiatric or endocrine diseases, malignancy, or other abnormalities (other than the indication being studied) that may affect the absorption hence pharmacokinetics of TB drugs or that otherwise are not compatible with the study.
Study Status:
The project started enrolment on 25th December 2020, and the research team have continued recruiting the participants. The enrolment is on ARM three where the participants are taking 40mg per kg body weight of rifampicin. The first ARM which was a control the participant were given 20mg per kg body weight of rifampicin, and the second ARM the participants were given 30mg per kg body weight of rifampicin. The enrolment sites have been increased to cover the District hospitals of Kilimanjaro Region, Mount Meru hospital Arusha Region and Hydom hospital Manyara Region. The project has received permission from EDCTP to continue with activities and the study will end December 2023.
Broad objective:
The overall aim of this study is to evaluate the pharmacokinetic and safety/tolerability of high doses of rifampicin in children and assess what
would be the appropriate dose in children to achieve exposures similar to those in adults who received 35 mg/kg rifampicin daily.
Specific objectives:
-
To describe the steady-state pharmacokinetics of increasing doses of rifampicin when administered in combination with isoniazid, pyrazinamide and ethambutol in children who are newly diagnosed with uncomplicated TB.
-
To establish the incidence and severity of adverse events (safety/tolerability) of increasing dosages of rifampicin administered in combination with isoniazid, pyrazinamide and ethambutol in children who are newly diagnosed with uncomplicated TB.
-
To assess possible relationships between pharmacokinetic parameters of rifampicin and adverse events (pharmacodynamics in relation to toxicity).
-
To assess what is be the appropriate dose in children to achieve exposures similar to those in adults who received 35 mg/kg rifampicin daily
here will be FOUR arms
-
The first arm is the control arm and the dose is 20mg/kg body weight
-
The second arm is a high dose of 30mg/kg body weight
-
The third arm of 40mg/kg body weight
-
The fourth arm of higher than 40mg based on the decision from the data safety and monitoring body/Steering committee.
p { font-size: 12pt; line-height: 115%; text-align: left; orphans: 2; widows: 2; margin-bottom: 0.1in; direction: ltr; background: transparent }a:link { color: #0000ff; text-decoration: underline }
p { font-size: 12pt; line-height: 115%; text-align: left; orphans: 2; widows: 2; margin-bottom: 0.1in; direction: ltr; background: transparent }a:link { color: #0000ff; text-decoration: underline }
PREVIOUS RESEARCH PROJECTS
EFA-NEU
MAMS
KiReTAMo
Highrif-2 study
OEBA
HIV prevention study
REDMAL
MALACTRES
Oesophageal cancer study
Next gen
TB diagnostics