The study provided information on whether the benefits of initiating ART at CD4+ cell counts above 500 cells/mm3 outweigh the risks. The international randomized trial determined that starting ART early reduces the occurrence of serious morbidity and mortality. START began enrolment in April 2009 and involved 35 countries including Nigeria with IHVN anchoring the study in the country.
MARGIN study focused on determining microbiome diversity of children who are HIV exposed and uninfected, and those who are HIV exposed and infected. It was a longitudinal study of the impact of maternal microbiota on changes in infants gastrointestinal microbiota during the first 24 months of life among 150 HIV- unexposed uninfected children (HIV-EU) and 150 HIV-unexposed children. It is estimated that 15% of all infants born in sub-Saharan Africa are HIV-EU.
Findings from the MARGIN Study include;
- In contrast to the mostly consistent microbial communities identified in the mothers, the microbiomes of HIV-exposed, uninfected and HIV-unexposed, uninfected infants showed striking differences based on the mother’s status
- At 6 months post-partum: α-diversity (Shannon index) in the meconium/stool of HEU infants is significantly higher, when compared to HUU infants. Trend towards higher diversity in HEU infants is maintained when adjusted for cotrimoxazole prophylaxis and breastfeeding.
- The bacterial community composition of the infants’ meconium and stool changed over time, and correlated to the mother’s HIV status. HUU infants had more abundant populations of Bifidobacteriaceae and Enterococcaceae, whereas HEU infants had more Ruminococcaceae, Pseudomonadaceae, and Enterobacteriaceae in their stools.
NICCAV, funded by the Canadian Global Health Research Initiative (GHRI) was implemented from October 2010 through December 2014 to build capacity for HIV vaccine research in Nigeria. The study whose Principal Investigator was, Dr. Alash’le Abimiku, built local capacity to implement vaccine trial in Nigerian by addressing three core objectives.
- Developing Capacity for HIV Vaccine Research and Oversight
- Vaccine Cohort Development & Community Engagement
- Building Laboratory Capacity to Support HIV Vaccine Trials
NICCAV study has provided a platform for future collaboration/partnerships with funders for a future HIV prevention trial in Nigeria.
Strengthening Human Resource for Health-Pre Service (SPEARHEAD) Program.
Strengthening Human Resource for Health-Pre Service (SPEARHEAD) Program was a Pre-Service training grant funded by the Centers for Disease Control and Prevention (CDC) to increase and improve the capacity of Nigerian Nurses, Midwives, Doctors, Community Health Workers and Public Health Practitioners to respond to the HIV/AIDS epidemic in Nigeria.
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The program supported the review and updating of HIV/AIDS curricula for Nursing /Midwifery Schools, Colleges of Health Technology, Residency Training Programs and Postgraduate degrees in Public Health.
The program also trained institutional trainers and mentors for effective delivery of the new curricula through capacity building in HIV care and management, adult learning techniques and clinical mentorship. SPEARHEAD supported capacity building in continuous quality improvement, leadership and program management for students and tutors.
It was implemented at 18 Schools of Nursing, 17 Schools of Midwifery,17 Schools of Health technology,12 Teaching Hospitals and 6 Schools of Public Health in Nigeria. At least 777 tutors and 2, 135 students were trained through the program.
In-patient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) study is an international multi-center trial of the safety, tolerability and efficacy of anti-coronavirus hyper-immune intravenous immunoglobulin (hIVIG) for the treatment of adult hospitalized patients at the onset of clinical progression of COVID-19.
This trial will compare (hIVIG) with matched placebo while Remdesivir will be given to both arms of the study as part of routine care. The aim of the study is to evaluate the potential efficacy of the hIVIG (antibodies) as a potential treatment approach for preventing further disease progression and mortality related to COVID-19.
In future versions of the protocol one or more drugs from a different class and with different mechanisms of action may be studied and compared with other ongoing clinical trials. Such treatments could be studied along with hIVIG if it is found effective and safe in the initial phase of the study.
IHVN will be implementing this trial in 2 of our long term collaborating sites namely National Hospital Abuja and University of Abuja Teaching Hospital (UATH) with support from the Nigeria COVID-19 Research Consortium (NCRC). Patients will be recruited and consented from the hospital isolation centers. Hopefully, this study will provide a platform for research into new areas of infectious disease study and establish collaboration with more global partners.
The Principal Investigator of the Nigerian Study Site is Dr Eriobu Nnakelu. The ITAC Nigerian team will be supervised by the International Coordinating Center (ICC) overseeing other countries such as Japan, Israel, Argentina and Thailand. ITAC is funded by the US National Institute of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID) and is planned to last for 1 year or less depending on the rate of participant recruitment.
Strategic HIV and AIDS Response Program (SHARP) Nigeria Project
The Strategic HIV and AIDS Response Program (SHARP) Task Order 3 project is a USAID funded project addressing HIV in Kano, Jigawa, Bauchi, Yobe, Borno and Adamawa States Nigeria by providing HIV prevention, care and treatment services. It is run from 2020 to 2022. Click Here for more.
This study evaluated the impact of mentor mother programs on PMTCT service uptake and retention at primary health care facilities in Nigeria. The study utilized the power of peer experience of HIV positive women who have successfully completed the PMTC process at least once, trained them to provide counseling and other support to PMTCT-naïve pregnant women and mothers. These positive pregnant women and mothers were guided through recruitment, counseling and community support in hard-to-reach communities. The study also trained mentors mothers. Comparison between mentor mother sites and non-mentor mother sites at the end of the study showed that, in terms of ANC attendance and hospital delivery for PLHIV, there was six fold improvement. Retention in care after delivery was over 35% for mentor mother sites. There was also about 30% improvement in Early Infant Diagnosis and three-fold increase in presentation for Early Infant Diagnosis.
This study focused was a longitudinal prospective cohort study that employed a behavioral survey as well as clinical evaluations to measure HIV and Sexually Transmitted Infection (STI) incidences of, and determine the best practices for, engaging Men who have Sex with Men (MSM) into prevention and care services. The National Institutes of Health (NIH) study had three aims.
- To evaluate the network-based recruitment and quantification of the acceptability of test and treat.
- To measure the impact of the TRUST intervention on prevention outcomes, and
- To define an optimal service delivery model for MSM in Nigeria.
Findings showed that;
- In contrast to the mostly consistent microbial communities identified in the mothers, the microbiomes of HIV-exposed, uninfected and HIV-unexposed, uninfected infants showed striking differences based on the mother’s status
- At six months post-partum: α-diversity (Shannon index) in the meconium/stool of HIV Exposed Uninfected infants is significantly higher, when compared to HIV Unexposed Uninfected infants. Trend towards higher diversity in HIV Exposed Uninfected infants is maintained when adjusted for cotrimoxazole prophylaxis and breastfeeding.
- The bacterial community composition of the infants’ meconium and stool changed over time, and correlated to the mother’s HIV status. HIV Exposed Uninfected infants had more abundant populations of Bifidobacteriaceae and Enterococcaceae, whereas HIV Exposed Uninfected infants had more Ruminococcaceae, Pseudomonadaceae, and Enterobacteriaceae in their stools.
Institute of Human Virology Nigeria (IHVN) implemented, SHaRING, a project targeted at building sustainable and highly trained human resources in health care, through pre and in-service laboratory trainings. The trainings ensured high quality laboratory tests to support HIV prevention, care and treatment programs in Nigeria. The project supported laboratory systems strengthening by addressing two main areas for capacity building; Pre-service laboratory training and In-service laboratory trainings. The project was funded by United States Government Presidents Emergency Plan for AIDS Relief (PEFPFAR) through Centers for Disease Control and Prevention (CDC) with Professor Alash’le Abimiku as Principal Investigator.
It was implemented between October 2012 and September 2016.
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The Pre-service component of the project carried out curriculum development and capacity building for the laboratory workforce under-going training in academic institutions and tertiary institutions for the Medical Laboratory Science Internship program. The focus was to have comprehensive and integrated curricular that adequately addressed HIV/AIDS and co-infection laboratory needs and reflected relevant sections of the National HIV/AIDS laboratory guideline.
The In-service component dealt with capacity building for the laboratory workforce that is already providing services in various capacities at different levels of health care facilities. The aim was to improve the quality and reliability of HIV and TB test results used for diagnosis and monitoring of HIV/TB care and treatment and their co-morbidities.
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IHVN collaborated with key stakeholders such as the Government of Nigeria (GoN): FMoH-HIV/AIDS Division (HAD), Medical Lab Science Council of Nigeria (MLSCN), Association of Medical Laboratory Scientists of Nigeria (AMLSN), 20 universities and 47 colleges offering medical laboratory science program, GoN tertiary health facilities for medical laboratory science internship program; Partners Implementing the HIV and TB program, the Association of Public Health Laboratories (APHL), Clinical and Laboratory Standards Institute (CLSI), African Society for Laboratory Medicine (ASLM) and General and Health Logistics International Limited (GHLI-L) to execute of the activities.
The trainings covered; basic TB smear microscopy, HIV/AIDS diagnosis and monitoring, basic equipment maintenance, laboratory quality management Systems, bio-repository, supply chain management, HIV molecular techniques , TB molecular techniques and TB Culture. All trainings were conducted at IHVN supported training centers located in Abuja, Jos, Zaria, Ife and Kano.
ACCOMPLISHMENTS
- Development of a survey tool for pre-service training needs assessment. This tool was used for assessing the capacity and pre-service training needs in 20 universities and 47 colleges of health technology offering the medical laboratory science programs; and remains a useful tool for the nation’s ability to continue to monitor and evaluate these institutions of learning.
- Development of ‘National Guidelines for HIV diagnosis and Medical Laboratory Monitoring of HIV/AIDS Clients on Anti-Retroviral Therapy (ART)
- Improved curricula for medical laboratory science education These institutions have graduated 834 based on the improved curricula.
- Award of CPD credits to SHaRING trainings: The SHARING negotiated successfully that all trainings conducted under SHaRING were accredited by the MLSCN for award of Continuous Professional Development (CPD) credit units.
- Improved medical laboratory science internship program: SHaRING collaborated with MLSCN to identify gaps in the current medical lab science internship training program in Nigeria. In collaboration with government and teaching hospitals, a total of 282 internship students were trained on Quality Management System, Good Clinical Laboratory Practice.
- Provision of teaching aids to institutions: SHaRING provided projectors to all 67 institutions offering medical lab science as part of efforts to upgrade learning and facilitate communication.
- Capacity building for faculty staff; SHaRING trained a total of 359 faculty staff from all the universities and colleges of health education on adult learning principles and teaching methodologies, Good Clinical Laboratory Practice (GCLP), and Quality Management System (QMS) and HIV molecular techniques/CD4 testing so as to strengthen the capacity of faculty staff to teach HIV/AIDS related content..
In-service training: A total of 2,779 laboratory personnel from Implementing Partners and GoN have been trained over the four-year period on Basic HIV diagnosis and monitoring, Basic TB smear microscopy, Basic equipment maintenance, supply chain management, Good Laboratory Practices Sample collection and Processing, Quality Management System, Bio-repository, Advanced HIV molecular techniques, Advanced TB molecular techniques and TB culture.
Strategic HIV and AIDS Response Program (SHARP) Nigeria Project
The Strategic HIV and AIDS Response Program (SHARP) Task Order 1 USAID funded project is committed to addressing HIV in Sokoto, Zamfara, Niger, Kwara and Kebbi states by providing HIV prevention, care and treatment services. The project is to run from 2020 to 2022. Click Here for more.