COMPLETED PROJECTS

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.

1. Developing Capacity for HIV Vaccine Research and Oversight
2. Vaccine Cohort Development & Community Engagement
3. 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.

The Action to Control HIV Epidemic through Evidence (ACHIEVE) project that we implement is funded by the US President’s Emergency Plan for AIDS Relief (PEPFAR) through the US Centers for Disease Prevention and Control (CDC)

The foot prints of our impact in improving the health care system is indelibly planted across the country where we have worked and currently work in implementing several health programs.

The Action to Control HIV Epidemic through Evidence (ACHIEVE) project that we implement is funded by the US President’s Emergency Plan for AIDS Relief (PEPFAR) through the US Centers for Disease Prevention and Control (CDC)

The project is currently focused in four states, Nasarawa State, Rivers State, Kastina State and the Federal Capital Territory. It provides the following services in the health facilities that we support.

• HIV Testing Services (HTS)
• Laboratory diagnosis and tracking of status of people living with HIV
• Prevention of Mother-to-Child Transmission (PMTCT) of HIV
• Anti-retroviral Treatment (ART) for adult and children (including pregnant women)
• Care and support for people living with HIV/AIDS and people affected by HIV/AIDS
• Monitoring and evaluation of patients and program progress.
• Support to Orphans and Vulnerable Children (OVC),
• Gender-Based Violence (GBV) support services
• Training in all the above areas.

The study aims to support the establishment of HIV-1 recent infection surveillance using the Rapid Test for Recent Infection (RTRI) in Nigeria. RTRI will be used to provide continuous epidemiological data on person, geographical location, and time of newly diagnosed individuals to inform HIV prevention and control strategies in Nigeria.

The RTRI will be introduced into routine HIV testing services (HTS) as a supplementary test for clients who are positive on the Determine Test as part of the National Testing Algorithm. Those who are RTRI recent will additionally receive a viral load test to confirm their recent infection status. The initial phase will cover 135 health facilities in five states, including Federal Capital Territory (FCT), Lagos, Benue, Akwa Ibom, and Rivers states. The second phase will be a scale-up to additional 40 health facilities across three states including Cross River, Enugu and Nasarawa States.

Study Principal Investigator is Dr. Anthony Okwuosah.

The objective of this project is to characterize and compare the oral microbiomes in HIV infected, HIV exposed but uninfected, and HIV unexposed and uninfected children. The team at the Institute of Human Virology Nigeria (IHVN) with support from the University of Benin Teaching Hospital (UBTH) and oversight from the University of Maryland Baltimore (UMB) are responsible for the implementation of the clinical aspect of the study.

Sexual Reproductive Health (SRH) Project

The Integrating Sexual and Reproductive Health (SRH)/Family Planning (FP) into HIV/AIDS Services in Four States in Nigeria project is aimed at improving sexual and reproductive health in FCT, Nasarawa, Rivers, and Katsina States, Nigeria. The project is also to reduce unintended pregnancies and complications among people living with HIV.

Project goals include:

• Increase access to and utilization of SRH/FP services for 78, 633 PLHIV in 40 selected healthcare facilities in the four States.
• Integrate of RH/FP services in 40 select antiretroviral treatment clinics and one-stop shops in all four states.
• Strengthen the capacity of healthcare workers in the facilities.
• Strengthen the referral and follow-up system between and within 40 healthcare facilities in the four states.

States and Health Facilities providing Sexual Reproductive Health Services

Nasarawa State: Dalhatu Araf Specialist Hospital (DASH), Lafia; Federal Medical Center, Keffi; Mararaba Gurku Medical Center, Mararaba; Lafia Key Population One Stop Shop; Our Lady of Apostles Hospital, (OLAH) Akwanga; General Hospital Akwanga; Model Comprehensive Center Shabu; General Hospital Nasarawa Eggon; General Hospital Doma; General Hospital Garaku; Primary Health Center, Masaka and General Hospital Wamba.

Federal Capital Territory: University of Abuja Teaching Hospital (UATH); Gwarinpa One Stop Shop; Asokoro District Hospital; Maitama General Hospital; National Institute of Pharmaceutical Research and Development (NIPRD), Garki Hospital; General Hospital Nyanya, Gwarinpa General Hospital; Kubwa General Hospital; General Hospital Karshi; Primary Health Center Lugbe; Sisters of Nativity, Jikwoyi.

Katsina State : General Hospital Funtua, General Hospital Katsina; Federal Medical Center Katsina; General Hospital Daura.

Rivers State:  Key Population One Stop Shop Obio-Okpor; General Hospital Ahoada; General Hospital Degema; General Hospital Bori; Rivers State University Teaching Hospital; Pope John Paul Clinic , Khana ; General Hospital Isiokpo; General Hospital Omoku;  Oyigbo Comprehensive Health Care;  General Hospital Okrika;  General Terrabor; Rumuokrushi Model Primary Health Center.

Strategies being adopted to implement the project include; integrating sexual reproductive service delivery in the ante-retroviral treatment clinic flow, offering all people living with HIV who are visiting the facility with SRH services as well as conducting assessment of clients in the community.

The project is funded by BMZ-German Federal Ministry for Economic Cooperation and Development with Gesudes Afrika serving as intermediary.

Gloabal Fund Public-Private Mix (PPM) Project

The focus of the Public-Private Mix Project is to engage the private sector in providing more people with tuberculosis prevention, diagnosis and treatment services. It is a novel project in Nigeria, funded by the Global Fund to Fight AIDS, Tuberculosis and Malaria and running from 2019 to 2020.

One of the targets of this project is to increase private sector contribution in finding more people needing tuberculosis treatment from 11% in 2017 to 35% in 2020. Click Here for more.

The Therapeutics for Inpatients with COVID-19 (TICO) study is a follow up on the In-patient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) study, which was also implemented by the Institute of Human Virology Nigeria (IHVN). TICO is a master protocol to evaluate the safety and efficacy of multiple drugs aimed at modifying the human immune response to SARS-CoV-2 infection, or directly improving viral control in order to limit disease progression.

TICO is a randomized, blinded, controlled study which allows multiple drugs to be tested during the course of the study. This allows for efficient testing of new drugs against placebo and standard of care (SOC) treatment within the same study. An independent Data and Safety Monitoring Board (DSMB) will regularly review interim analyses and summarize safety and efficacy results to delineate which drug(s) are beneficial for the treatment of COVID 19 symptomatic disease.

The primary aim of this study is to evaluate patients who experience sustained recovery from the time after receiving the investigational drug. This study is being implemented in Africa by the International Research Center of Excellence of the Institute of Human Virology Nigeria collaborating with the University of Abuja Teaching Hospital Gwagwalada (UATH) and the Nigerian COVID-19 Research Consortium (NCRC). TICO is funded by the US National Institute of Allergy and Infectious Diseases (NIAID) with the National PI as Dr Eriobu Nnakelu.C.

The D2EFT study is a phase IIIB/IV randomised open-label trial to compare dolutegravir with pharmaco-enhanced darunavir versus dolutegravir with predetermined nucleosides versus recommended standard of care antiretroviral regimens in patients with HIV-1 infection who have failed recommended first line therapy.

The major aim of this study is to find the best 2nd line regimen, among the current range of drugs used in our environment that would have maximal benefit for most patients who have failed first line HIV 1 drugs.

This is without the infrastructure of drug sensitivity testing in a resource constrained environment. Its emphasis is finding a regimen that will fulfil criteria including:

• Efficacy at significantly reducing viral load
• Encouraging adherence due to a lower incidence of drug toxicity, drug to drug interactions or other adverse events,
• Improving participant quality of life

The D2EFT study is designed to support HIV treatment in the sub-Saharan African context and will provide knowledge to significantly improve treatment outcomes and change the current strategy for managing patients who have failed 1st line HIV treatment.

The Accelerating Nutrition Results in Nigeria (ANRiN) project aims at increasing access and utilization of basic nutrition services for pregnant and lactating women, adolescent girls and children under five years of age. ANRiN, which is supported by the World Bank (International Development Association and Global Financing Facility), is being implemented in 12 states representing the six geographical zones of Nigeria.

As of 16^th of October 2023, the project provided 576,179 children under five years and 169, 468 pregnant, lactating women as well as adolescent mothers with nutrition services.

Institute of Human Virology Nigeria is implementing the ANRiN project in nine Local Government Areas (LGAs) in Kano state. These are, Nasarawa, Kano Municipal, Fagge, Gwale, Tarauni, Kumbostso, Dala, Bunkure and Wudil.

The objectives of the project which commenced in May 2021 are,

• Improve knowledge of mothers/care-givers of children 0-23 months of age on improved behaviors related to maternal, infant and young child feeding, notably early, exclusive and continued breastfeeding, appropriate complementary feeding, and early stimulation
• Improve quality of complementary feeding by providing fifteen sachets of micronutrient powders bi-monthly for children 6-23 months
• Provide at least 90 iron-folic acid (IFA) tablets per pregnant women by specifically addressing barriers that inhibit women from taking a full course of IFA tablets during pregnancy through counseling during ante-natal care sessions
• Provide at least three doses of intermittent preventive treatment for malaria during ante-natal care per pregnant woman
• Distribute at least four sachets of zinc/oral rehydration solution (ORS) per year for treatment of diarrhea among children 6-59 months of age
• Semi-annual vitamin A supplementation among children 6-59 months of age.

Semi-annual deworming among children 12-59 months of age.

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.

1. To evaluate the network-based recruitment and quantification of the acceptability of test and treat.
2. To measure the impact of the TRUST intervention on prevention outcomes, and
3. 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.

This study is a cluster randomized trial of innovative interventions targeting challenges of adolescents in transitioning from the pediatric treatment to the adult treatment program. Specific aims are to,

Inform strategies for transitioning services in resource-limited settings
Examine developmental, clinical and other factors for successful transition
Gain insight on implementation barriers among African adolescents to inform targets for structured intervention.
ADAPT Study is an NIH R01 five-year study (2016-2021) conducted in central and Northern Nigeria at selected health facilities that we support with funding from US President’s Emergency Plan for AIDS Relief (PEPFAR) through CDC.

The study is a sub-agreement between ICAP at Columbia University and IHVN to provide technical assistance to Ministries of Health (MOH) to establish a Tracking with Recency Assays to Control the Epidemic (TRACE) program. The ICAP/IHVN TRACE program will monitor HIV epidemic trends, inform rapid programmatic responses at state, local and individual levels in FCT and Rivers State, and accelerate progress towards HIV epidemic control. The project will scale up the use of rapid recency assays at HIV testing sites. It will build data systems to capture recency data to characterize emerging hotspots and help target prevention interventions.

IHVN and ICAP will work as partners in the implementation of recency testing in select 15 health facilities sites in FCT and 31 in Rivers States in Nigeria. This is to involve conducting trainings for TRACE protocol procedures, ensuring laboratory quality control and successful data capture, reporting and monitoring of key recency indicators, and using data to inform program response.

Study Principal Investigator is Dr. Anthony Okwuosah.

The University of Maryland – Institute of Human Virology AIDS International Training and Research Program (UM-IHV AITRP) is instituting a refined research training strategy to build a critical mass of institutional and individual research capacity. Through a “mentor-the-mentor” program, a research training team consisting of a US faculty expert, one or more Nigerian Faculty Mentor and a highly selected trainee participates in research training. The team approach ensures that participating institutions are committed, the capacity of faculty is built and internationally trained research investigators work with their local research institutions.

Principal Investigator of Project is Dr. Patrick Dakum

The FLEMING Fund is a UKaid Department of Health and Social Care programme helping to tackle anti-microbial resistance (AMR) in low- and medium-income countries around the world.

As part of the DAI Consortium, IHVN is providing technical support in the area of human health. Activities include carrying out needs assessment, biosafety/security assessment, and renovation of eighteen laboratories involved in the project.

The project is to strengthen systems for AMR surveillance across human, animal and environmental health sectors as part of One Health.

Training Resources (Slides)