Current Organisation

Muhimbili University of Health and Allied Sciences

Current Job Title

Assistant Lecturer

Biography

Project Title

St Andrew University, Scotland, UK

EDCTP Project Call

EDCTP Clinical Research & Development Fellowship (R&D F)

Host Organisation

Project Objectives

The following are core objectives: The fellow to acquire skills on clinical trial design, operational planning, conducting, management and scientific reporting by participating in OptiRiMoxTB clinical trial during the 12 months placement at St. Andrews University (UStAn) and its collaborating institutions within SimpliciTB and Pan-African Consortium for Evaluation of Antituberculosis Antibiotics (PanACEA). To use the acquired skills to develop and provide short course trainings (in form of workshops, seminars, and symposium) to enhance skills on clinical trial designing, conducting and reporting among clinical trial researchers and clinical staffs in Tanzania. To use the acquired skills to develop a PhD clinical trial proposal aimed on addressing drug interactions in patients using anti-TB in high HIV burdened areas of SSA.

Study Design

Placement

Project Summary

The Botswana report on increased congenital malformation specifically neural tube defect among deliveries from HIV positive women who had been on Dolutegravir (DTG) based high active antiretroviral therapy (HAART) regimens subjected me into high degree of curiosity. I decided to pass through different references on mitigation measures put forward. World Health Organization (WHO) recommendation involve providing education, counseling and leaving a woman of child bearing age to decide and sign freely obtained consent form. Tough it is a good recommendation it is not realistic in low and middle income countries (LMICs) due to procurement system inclined to one-fit for all. Hence reducing flexibility to accommodate needs of individual HIV infected women of child bearing age. Furthermore, knowing that folic acid deficiency during pregnancy is an important factor for neural tube defect and preclinical studies have concluded that DTG antagonize the metabolism of folic acid brought other pertinent questions. Botswana like many LMICs has no folate fortification program and many women start to attend antenatal care (ANC) during mid of second trimester. Therefore, probability of many women of child bearing age to fall into low limit or subclinical folic acid deficiency is high. Studies show that neural tube defect occurs during first trimester at 4th to 8th week post conception. Hence, mismatch between time of high demand for folic acid and initiation of supplement is obvious and the problem become worse among HIV infected women on DTG due to inherent folate antagonism effect of this drug. After in depth thinking I came out with an idea of providing ceiling daily dose of folic acid supplement to HIV positive women of child bearing age who intend to conceive and continue with intervention for the whole first trimester. The success of this idea may alienate treatment barriers brought about by a one-fit for all practice and reduce fear and panic among HIV positive women. But to prove this idea pragmatic clinical trial is inevitable. I do have extensive experience in designing and conducting several types of observational studies like cross-section, case control and prospective cohort studies. But have weakness when it comes to designing and conducting clinical trial. Therefore, during the “Clinical Research and Product Development Fellowships (CRDF) – Joint call with WHO/TDR, the Special Programme for Research and Training in Tropical Diseases 2019” tenure I will focus more on acquiring competences and skills in clinical study design, systematic reviews, ethical considerations and patient safety, clinical trials operations and study implementation, study and site management. Also, I will concentrate on adding skills and expertise in data management and informatics, communication and team work, leadership and professionalism and clinical trial reporting. The focus will be more on HIV specifically patients on antiretroviral medications. The acquired competences and skills will help me to design and conduct a prospect PhD study which will be a clinical trial titled “Periconception ceiling daily dose of folic acid to improve maternal and birth outcome among HIV infected women on dolutegravir based highly active antiretroviral therapy combinations”. During re-integration phase I expect to register as PhD candidate at MUHAS, applying for ethical consideration at Tanzania National Institute of Medical Research. Then I will proceed with preliminary survey and management of study sites, followed by recruitments of study participants, randomization into intervention and non-intervention groups and commencement of follow-up. During the preliminary survey I will conduct a nested study on HIV positive women level of awareness, acceptability and adherence to DTG based HAART regimens. So near the end of the six months I will perform data analysis, write a manuscript and submit to the peer reviewed international journal for publication. During the next two years I will continue with the study as part of PhD schedule and generate three more articles. The second articles will be on prevalence of NTD in DTG based HAART regimens and non-DTG based HAART group. The third paper will be comparison of prevalence of NTD among deliveries from HIV women on DTG based HAART supplemented with ceiling daily dose of folic acid versus those with DTG based HAART without folic acid supplementation. The fourth paper will focus on comparison of prevalence of NTD among HIV women on DTG based HAART with ceiling daily dose of folic acid supplementation during periconception versus those on non-DTG based HAART without folic acid supplementation. The findings and articles from re-integration phase and next two and half years post fellowship will help me fulfill requirements for PhD and increase a pool of graduates with expertise in clinical trial. Also, the findings will help to provide evidence to support or refute what has been reported from Botswana study hence clearing doubt and social panic. In addition, the study will shade light on timing of folic acid supplementation in women of child bearing age intending to conceive. Furthemore, the findings from this study will provide data for evidence based practice and act as source of literature for policy makers during revising HIV treatment guidelines ultimately improving healthy life among babies born from HIV positive women. Finally this study will have a general impact on revival of issues pertaining to nutrition in HIV infected women.