HIV RESEARCH DIVISION
The HIV research branch is housed under the KEMRI’s Centre for Global Health Research (CGHR) in Kisumu Kenya. Founded within a strong collaboration between KEMRI and the Centers for Disease Control and Prevention (CDC), Division of HIV/AIDS Prevention (DHAP), the HIV Research (HIVR) Branch has increasingly become one of the important regional hubs in the support of a wide variety of clinical research and prevention projects.
The HIVR branch constitute of 88 research staff that support clinical trials, epidemiological studies and laboratory programmatic support.
The clinical trials and epidemiology team comprise the different principal investigators, study coordinators, clinicians and nurses who ensure studies are successfully executed. The staff are registered with respective relevant regulatory authorities and have the relevant training in conducting clinical trials, including cumulative experience in conducting clinical and non-clinical research.
The data management/analysis team has developed competency in data analysis software including R, STATA, SAS, SPSS, Nvivo, and Epi Info. They have developed Audio-Computer Assisted Self Interview (ACASI) and Computer-Assisted Self Interview (CAPI) data collection systems, and also developed data entry applications using VB.NET and SQL Server. The team is experienced in data capture systems including eData, iDatafax and Medidata RAVE system.
The quality assurance/quality control team has a specific mandate of ensuring and maintaining a quality culture in all operations within the branch, to enhance credible and reliable research in all activities through development of standard operating procedures, quality management plans and continuous training of staff on International accepted standards of Good Clinical Practice and Human Subject protection.
The regulatory office liaises with CDC institutional review board (IRB), KEMRI CGHR Center Scientific Committee (CSC), KEMRI’ Scientific and Ethics Review Unit (SERU), Ethics Committee of the Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH) and Kenya Pharmacy and Poisons Board (KPPB) to ensure protocols are submitted for ethical review as required, and all regulatory approvals are in place and active.
The community engagement team has been able to assemble a regional Community Advisory Board (CAB), a group of community stakeholders representing several interest groups including women, youth, female sex workers, Muslims, MSMs among other groups, to advise mainly on research implementation within the community. The team has successfully engaged various stakeholders including Ministry of Health, Ministry of Education and Ministry of Social Services, non-governmental organizations including community based organizations, faith based and educational institutions.
The laboratory unit has a long-standing history of providing laboratory support to several WHO associated groups and CDC-funded programs. The laboratory has the following sections: Hematology, Chemistries, Early Infant HIV Diagnosis, Viral load, Serology, Sexually transmitted infections, Drug resistance testing. The unit is ISO 15189-2012 certified, Division of AIDS (DAIDS) certified to conduct specific tests for US national institute of health (NIH) funded research.
The pharmacy team consists of trained pharmacists and pharmaceutical technologist with extensive experience in conducting clinical trials and handling investigational products, including vaccines, blinded studies and therapeutic interventions. The pharmacy, together with its operating procedures, has been reviewed and approved by pharmacy affairs branch under NIH DAIDS to conduct NIH funded studies.
The behavioral / social science team is a dynamic team capable of employing social science methods to develop high quality research tools, collect, analyze, interpret and disseminate findings. They have experience conducting formative research, behavioral intervention studies, acceptability and feasibility studies, and evaluating community engagement processes including ethics related studies
Established in 2001, the HIV Research (HIV-R) branch has been engaged in both community-based epidemiologic and clinical studies. Between 2003 and 2005, the branch conducted cross-sectional surveys of HIV prevalence and risk factors in the rural communities of Asembo and Gem. At the clinical research center facility in Kisumu, HIV-R conducted a site-monitored clinical trial of Mother-to-Child HIV transmission, the Kisumu Breastfeeding Study (KiBS; KEMRI SSC protocol # 691), and an HIV intervention preparedness incidence cohort study, the Kisumu Incidence Cohort Study (KICoS; KEMRI SSC protocol #.1125), and the Nuvaring acceptability study (KEMRI SSC protocol 2609). In December 2013, the HIV research branch together with the Tuberculosis (TB) branch became a DAIDS network clinical research site under the Emory CDC Clinical Trial Unit (CTU), after which the site became part of the Aids Clinical Trial Group (ACTG) and has so far been involved in ten clinical trials. In 2016, the site was also confirmed as a HIV Prevention Trials Network (HPTN) site and has so far conducted three clinical trials (HPTN 052, HPTN 075, HPTN 081) with two of these ongoing. In 2016, the site was selected as a protocol specific site for Microbicide Trial Network (MTN) 034.
To perform high impact HIV prevention, treatment and health systems research with domestic and global relevance.
To be a leading center for HIV research aimed towards eliminating HIV infection.
The HIV research contributes to KEMRIs research goal within the broader areas of ‘infectious and parasitic diseases’, contributing directly to the objective which is to conduct research aimed at developing tools and technologies for reduction of disease burden due to infectious and parasitic agents, with specific focus on HIV/AIDS.
The HIVR Branch conducts research related to epidemiology, prevention, management and treatment of HIV and associated conditions, including (but not limited to) HIV and other sexually transmitted infections; Tuberculosis and other opportunistic infections; non-communicable diseases affecting HIV-infected individuals; nutritional, genetic and metabolic conditions of importance in HIV treatment or prevention; structural, mental and behavioral factors affecting HIV pathogenesis, treatment and prevention; and other conditions affecting HIV-infected or at risk individuals. It also conducts research on health systems and incorporates economic evaluation research, such as Point-of-Care and use of other novel testing devices, as well as promising practices designed to improve linkage to and engagement in patient and population-based care.
The branch’s strategic plan for the period 2017-2022 has the following objectives:
- To conduct impactful research
- To strengthen and maintain collaboration with stakeholders
- To improve organizational/branch brand
- To ensure efficient use of resources
- To enhance funding opportunities that support research
- To promote innovation
- To improve and maintain quality standards
- To increase staff development and retention
- To improve facilities and technology
- A Mobile Phone Game to Prevent HIV among Young Africans – Collaborative research project with Emory University, KEMRI PI – Dr Victor Mudhune
- A Randomized Comparison of Three Regimens of Chemotherapy with Compatible Antiretroviral Therapy for Treatment of Advanced AIDS-KS in Resource-Limited Settings – Collaborative research project with CDC & Emory University CTU and the ACTG network, KEMRI PI – Dr Vincent Otieno Oliver
- Management Using the Latest Technologies in Resource-Limited Settings to Optimize Combination Therapy After Viral Failure (MULTI-OCTAVE) – Collaborative research project with CDC & Emory University CTU and the ACTG network, KEMRI PI – Dr Mumbi Makanga
- A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection – Collaborative research project with CDC & Emory University CTU and the HPTN network, KEMRI PI – Dr Dismas Oketch, CDC PI – David Schnabel
- A Phase 2a Crossover Trial Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population – Collaborative research project with CDC & Emory University CTU and the MTN network, KEMRI PI – Dr Mumbi Makanga
- Feasibility of HIV Prevention Cohort Studies among Men who have Sex with Men in Sub-Saharan Africa – Collaborative research project with CDC and HPTN network, KEMRI PI – Arthur Ogendo, CDC PI – David Schnabel
- A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women – Collaborative research project with CDC & Emory University CTU and the HPTN network, KEMRI PI – Dr Dismas Oketch
- HPTN 052 Study “A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy plus HIV Primary Care versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 In Serodiscordant Couples” – this study was conducted by the HIV research branch team in collaboration with CDC and HPTN network completed in 2013, that showed a 96 percent reduction in HIV transmission in discordant couples (long-term partners where one partner is HIV-positive and the other is HIV-negative) when the infected partner is on antiretroviral therapy. The findings were named 2011 scientific breakthrough of the year by times magazine.
- The KIBS Study “A Phase IIb open label, one arm trial to reduce mother to child transmission among breastfeeding HIV infected women in a resource limited setting using maternal Highly Active Antiretroviral Therapy (HAART) from 34 weeks gestation through 6 months postpartum” – this study was conducted by the HIV research branch team in collaboration with CDC DHAP and completed in 2009, that showed that antiretroviral therapy reduces risk of mother-to-child HIV transmission among pregnant and breastfeeding women. The findings were adopted by the Kenya PMTCT national guidelines in 2008 as option B+ for PMTCT as funded by PEPFAR for implementation.
The HIV research laboratory was amongst the first independent laboratory in Kenya to be ISO 15189-2005 accredited in 2008. They have successfully retained this accreditation to date. The Laboratory was recertified under ISO 15189 -2012, is WHO accredited for HIV drug-resistance testing (DRT) and act as WHO referral lab for DRT in the entire west, central and east Africa. Moreover the lab is also endorsed for molecular tests by the Kenya Medical Laboratory Technician and Technologist Board and the RUSH virology QA program (Chicago, IL).