Research projects



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 is...


PAVIA is ...


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.




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).




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


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 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

Protocol Title 

Evaluation of Pharmacokinetics and Safety/Tolerability of Higher Doses of Rifampicin in Children with Newly Diagnosed, Uncomplicated Tuberculosis

Version Number 

Version 4 Dated 10th Dec. 2019, Inco-operating version 5 dated 14th April 2021 and version 6 dated October 2021


Principal Investigator 

Dr Hadija Hamisi Semvua


+255-754 377777

Email address 

h [dot] semvua [at] kcri [dot] ac [dot] tz (h [dot] semvua [at] kcri [dot] ac [dot] tz), hadija [dot] semvua [at] gmail [dot] com

Study Sites 

Kilimanjaro Christian Medical Centre (KCMC), Kilimanjaro Clinical Research Institute (KCRI) and Hydom Manyara, Tanzania

Protocol Acronym

HIGHRIF C study 


EDCTP (European Development Clinical Trial Partnership) 

Fund category 

Carrier Development Fellowship (CDF)

Sponsor representative

Kilimanjaro Clinical Research Institute (KCRI) –GSF/KCMC Hospital

Study duration  

54 Months –Working under No cost extension permit 

Study design

This study is a hospital-based open-label trial, Phase IIA assessing pharmacokinetics and safety/tolerability of higher doses of rifampicin when co-administered with other TB drugs (isoniazid, pyrazinamide and ethambutol) in children aged 1-14 years who are newly diagnosed with uncomplicated TB 

Study hypothesis

Higher doses of rifampicin in combination with other TB drugs result in higher exposures to this pivotal TB drug in children similar to those in adults, on high dose rifampicin will be safe and tolerable to children and may, in turn, yield a better outcome 

Study population 

Children aged 1 to 14 years who are diagnosed either with pulmonary TB, extra pulmonary TB, score chart, or based on physician decision

The objective of the study 

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:

  1. 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.
  2. 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.
  3. To assess possible relationships between pharmacokinetic parameters of rifampicin and adverse events (pharmacodynamics in relation to toxicity).
  4. 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 

Study Arms

THREE arms were enrolled in the study 

1.     The first arm was the control arm and the dose was 20mg/kg body weight 

2.     The second arm was a high dose of 30mg/kg body weight 

3.     The third arm was 40mg/kg body weight 


Kick-off meeting was on 1st July 2020.

Site Initiation was conducted on 23rd November 2020. 

Sample size

40 children were supposed to be enrolled in FOUR arms. Each arm to have 10 participants. The study has enrolled 30 participants. The fourth ARM will depend on safety result and Trial Steering Committee decision


Protocol training, Pharmacovigilance and SOPs training was conducted between April to July 2020

Work packages

There are three work packages, one is research activity, second is training of PhD and master students, and third is capacity building and strengthen PK unit at KCRI Biotechnology lab.

Investigational Medicinal Product

Rifampicin syrup 20mg/ml

Follow up plan for the patients

The children will be followed up for 42 days.


The study has screened  44 participants in all sites-KCRI 37, Hydom 7


The study has enrolled 31 participants (11 of the first ARM, 10 of the second ARM) and 10 of the third ARM.

PK sampling

Full PK sampling has been done on 30 participants (10 of the first ARM, 10 of the second ARM, and 10 of third ARM).

Sample have been analyses at Radboud University. The outcome results was shared to the TSC and dissemination to the sites.

Protocol Violation


Protocol deviation

During the start of the study, the informed consent was not having version number. This was corrected and the informed consent were given version number.


The study has reported one SAE


The study has ended on 31st December 2023. Manuscript for publication will be shared. Based on the decision from the data safety monitoring/Steering committee members, the study will not enrol the fourth ARM due to time factor and budget constraints.




 European & Developing Countries Clinical Trials Partnership (EDCTP).











Highrif-2 study




HIV prevention study






Oesophageal cancer study


Next gen


TB diagnostics