ACTIVE GRANTS

HIV/AIDS PREVENTION AND TREATMENT

FUNDER
NIH; Grant Number: U01 AI068641

DURATION
2019-2021

STUDY DESIGN
Prospective cohort study

STUDY POPULATION
HIV infected individuals on therapy

STUDY SITES
222 sites in 33 countries. 

PI- Dr. Eriobu Nnakelu (IHV-Nigeria as part of the INSIGHT Network (International Network for Strategic Initiatives in Global HIV Trials)

START is an international randomized trial that determined whether starting antiretroviral therapy (ART) early (before CD4 drops to less than 500 cells/mm³), rather than waiting until CD4 drops to less than 350 cells/mm³. The aim is to assess if there are continued differences in clinical outcomes between the two groups.

FUNDER
NIH/ US DOD; Grant Number: CSA2016S-1627

DURATION
2016-2020

STUDY DESIGN
Longitudinal Observational study

STUDY POPULATION
Key Pop. (MSM)

STUDY SITES
2 Nigerian sites

PI: Dr. Man Charurat IHVN Co-Inv: Dr. Nicaise Ndembi

The study aims to investigate strategies for preventing new infections and reducing transmission of HIV among men who have sex with men (MSM) in Nigeria. This study is investigating the use of Treatment as Prevention (TasP) and Pre-exposure Prophylaxis (PreP) preventions. Key findings so far: An association between higher engagement in TasP with disclosure of sexual orientation to health care providers. Also documenting patterns of transmission and trends over time in Nigeria.

FUNDER
NIH; Grant Number: 1RO1HD089866-01

DURATION
2016 – 2021

STUDY DESIGN
Cluster randomized trial

STUDY POPULATION
15 to 19-year old ALHIVs in care for at least 1 year

STUDY SITES
6  Nigerian Sites.

PI: Dr Vicki Tepper; Sub I: Dr. Man Charurat; Sub I: Dr. Ernest Ekong:

Intervention arms: Peer Transition Advocates (PTAs) vs Education Interventionists (EIs) To measure successful transition and viral suppression in ALHIV transitioned to adult clinic.

FUNDER
UNSW Australia; Grant Number: UNSW-D2EFT

DURATION
2019-2021

STUDY DESIGN
A phase IIIB/IV randomized open-label trial

STUDY POPULATION
HIV infected individuals who have failed first line therapy

STUDY SITES
 2 Nigerian sites

PI- Dr. Eriobu Nnakelu (Nigeria), INSIGHT Network Trial

To recruit 200 participants in 2 years. The trial aims to compare:
dolutegravir with pharmaco-enhanced darunavir versus dolutegravir with predetermined nucleosides versus recommended standard of care antiretroviral regimens in patients with HIV infection who have failed recommended first line therapy (the D2EFT study)

FUNDER
NIH; Grant Number: 5UH3HG007008-06

DURATION
2012-2019

STUDY SITES
IHVN-IHAB

PI- Prof Alash’le Abimiku

To upgrade laboratory infrastructure and functions to international standards to support H3Africa investigators in Africa. The bio-repository supports multiple H3Africa investigators to conduct high quality genomics and translational research in Africa using well processed, preserved and quality controlled and protected human biological samples. To be accessible to the H3Africa and larger research community to address health issues and diseases affecting the African continent.

The Impact of Structured Caregiver Peer Support on ART Adherence and Viral Suppression among Children Living with HIV (CaPS Study)

FUNDER
CIPHER/IAS 2019/852-JAS

DURATION
2019-2021

STUDY DESIGN
Randomized Controlled Trial

STUDY POPULATION
Children living with HIV (CLHIV) age 6 months to 10 years and their Caregivers. (The intervention targets caregivers, but outcomes are measured at child-level)

STUDY SITES
6 secondary health facilities in FCT/Nasarawa State

PI: Dr. Tongdiyen Laura Jasper

The study is a two-arm cluster randomized controlled trial that includes unsuppressed children living with HIV (0-10 years old) and their caregivers at six cluster sites in Nigeria. It will explore facilitators and barriers to ART adherence among young children to develop a caregiver peer mentor training curriculum and interventional programme, and also test the impact of caregiver peer support, a locally adapted behavioural intervention, to improve adherence and promote achievement of viral suppression among children.

D2eft-GIC

FUNDER
UNITAID, NIH

DURATION
2021-2022

STUDY SITE
UATH and NHA

PI
Nigerian site

PI
Dr Nnakelu Eriobu

Assessing and Improving Accuracy and Positive Predictive Value of the National HIV Testing Algorithm in Nigeria (HIV Testing Algorithm Study)

FUNDER
CDC

DURATION
2021-2022

STUDY SITE
2 States from each of the 6 geopolitical zones

PI
Alash’le Abimiku (UMB), Mildred Ene-Obong (FMOH), Mahesh Swaminathan (CDC), Bharat Parekh (CDC), Chikwe

MATERNAL, NEONATAL AND CHILD HEALTH

FUNDER
NIH; Grant Number: 1U01HD094658-01

DURATION
2018-2022

STUDY DESIGN

STUDY POPULATION
Stored samples from HIV-exposed infants in a previous study (Infant study)

STUDY SITES
PLASVIREC and Cape Town, SA

PI- Prof. Alash’le Abimiku

This study investigates how breast milk microbiota affects the growth and the ability to respond to childhood vaccinations in HIV exposed but uninfected infants.

TUBERCULOSIS

Triage Test for All Oral DR TB Regimen (T2RiAD)

FUNDER
EDCTP

DURATION
2020-2022

PI
Prof Dr Kogieleum Naidoo, Prof. Alash’le Abimiku

STUDY SITES
Lagos, FCT, Plateau, Kano, Kaduna and Nasarawa.

NON-COMMUNICABLE DISEASES

FUNDER
NIH; Grant number: 5U01HG009784-02

DURATION
2017-2021

STUDY DESIGN
Prospective cohort study

STUDY POPULATION
Female breast cancer patients

STUDY SITES
3 Nigerian sites

PI- Prof Clement Adebamowo

The project uses data from population based cancer registries (PBCR) to study the epidemiological factors associated with incident breast cancer and molecular subtypes. It also aims to research on genome wide association study (GWAS) of breast cancer in general and of molecular subtypes of breast cancer in indigenous Nigerian women.

Feasibility and Acceptability of an M-Health Intervention to Improve Breast Cancer (BRIDGE)

FUNDER
ASCO Project ID: 16504

DURATION
2020-2021

STUDY DESIGN
A mixed-methods approach using qualitative and quantitative methods

STUDY POPULATION
Trained Community Health Workers

STUDY SITES
6 PHCs in Gwagwalada and UATH. 

PI: Dr. Elima Jedy-Agba

The study seeks to utilize simple technological support in dealing with a complex and significant problem- delays to diagnosis in breast cancer. The BRIDGE App is a simple, innovative, clinic-based m-health patient referral service used by trained Community Health Workers (CHWs), in rural settings to promote early detection and reduce delays to diagnosis of breast cancer in Nigeria.

Prevalence and Progression of NCD Risk Factors among People Living with HIV

FUNDER
ISN Products Nigeria Ltd

DURATION
2019-2021

STUDY DESIGN
Prospective cohort study

STUDY POPULATION
200 newly diagnosed HIV positive clients and 200 HIV negative clients

STUDY SITES
KGH, NGH, ADH, UATH and Police Clinic

PI: Prof. Abimiku Co Is: Dr. Elima Jedy-Agba, Evaezi Okoporo, and Gbenga Kayode

The ISN-NCD study is a 2-year study sponsored by ISN Products Nig. Ltd. This study seeks to estimate the burden and progression of non-communicable diseases (NCDs) including hypertension, diabetes, prostate and cervical cancer, and chronic obstructive pulmonary diseases among persons living with HIV. 2

FUNDER
NIH

DURATION
2021-2025

STUDY SITE
Africa

PROGRAM CO-DS
Prof. Tim Rebbeck& Prof. Serigne Gueye

PROGRAM TRAINING LEAD
Dr. Elima Jedy-Agba

FUNDER
ISN Products Nigeria Ltd

DURATION
2019-2021

STUDY SITE
KGH, NGH, ADH, UATH and Police Clinic

PI
Prof. Abimiku

Co Is
Dr. Elima Jedy-Agba, Evaezi Okoporo, and Gbenga Kayode

PHARMACOEPIDEMIOLOGY

FUNDER
EDCTP; Grant Number:CSA2016S-1627

DURATION
2018-2022

STUDY DESIGN
Implementation Science

STUDY SITES
Nigeria, Ethiopia, Swaziland and Tanzania
(Nigeria- UBTH, NAFDAC, IHVN)

Sub Award PI: Pharm. Avong (Nigerian site)

Developing a Pharmacovigilance system in Four African countries

COVID 19

FUNDER
EDCTP; Grant Number:CSA2016S-1627

DURATION
2018-2022

STUDY DESIGN
Implementation Science

STUDY SITES
Nigeria, Ethiopia, Swaziland and Tanzania
(Nigeria- UBTH, NAFDAC, IHVN)

Sub Award PI: Pharm. Avong (Nigerian site)

Developing a Pharmacovigilance system in Four African countries

INFECTION, PREVENTION AND CONTROL

FUNDER
CDC

DURATION
2021-2025

PI
Prof. Alash’le. Abimiku

STUDY SITES
FCT and Nasarawa

COVID 19

FUNDER
UNITAID through the sponsor the Kirby Institute, University of New South Wales (UNSW)

DURATION
2020-2021

STUDY DESIGN
Open label, randomized clinical trial

STUDY POPULATION
Prospective Cohort Study

STUDY SITES
UATH and NHA

PI– Dr Eriobu C. Nnakelu is the Nigerian principal investigator

his study is a sub-study to the parent D2eft study, which is a multi-site, open label, randomized clinical trial. D2eft is evaluating the clinical, immunologic, virologic and quality of life measures of enrolled study participants randomized to three different  combination regimens of 2nd line ART in adult HIV patients who have failed 1st line treatment. With the advent of the Covid-19 pandemic the COHIVE study was developed. It pools together the sample sizes of 5 parent protocols, namely D2eft, ADVANCE, DolPHIN2, NAMSAL and WRHI 052 to characterize the clinical features and course of symptomatic COVID-19 in people living with HIV (PLWH) described overall and by HIV and comorbid factors including pregnancy.

FUNDER
US National Institute of health (NIH) and the US National Institute of Allergy and Infectious Diseases (NIAID) with the University of Minnesota (UoM) as the sponsor

DURATION
2020-2021

STUDY DESIGN
Open label, randomized clinical trial

STUDY POPULATION
Inpatients with COVID 19

STUDY SITES
UATH 

PI– Dr Eriobu C. Nnakelu is the Nigerian principal investigator

The ITAC (Inpatient Treatment with Anticoronavirus Immunoglobulin) study is an International multicenter, adaptive, randomized double-blind, placebo- controlled trial of the safety, tolerability and efficacy of anti-Coronavirus hyperimmune intravenous immunoglobulin for the treatment of adult hospitalized patients at onset of clinical progression of COVID-19. This trial will involve sites around the world strategically chosen to ensure rapid enrollment and will evaluate the use of hyperimmune intravenous immunoglobulin (hIVIG) with matched placebo, when added to Remdesivir as the standard of care, for preventing further disease progression and mortality related to COVID-19

FUNDER
NCRC

DURATION
2020-2021

PI
Dr. Evaezi Okpokoro, Co-PI: Dr. Kelly Elimian & Dr. Anthony Ahumibe

STUDY SITES

FUNDER
NIH-Fogarty

DURATION
2019-2021

STUDY SITES
Cameroon, DRC, Ghana, Nigeria

TRAINING

TRAINING

African-German Research Networks for Health Innovations in Sub-Saharan Africa (NORA Consortium)

FUNDER
National Institute of Allergy & Infectious Diseases

DURATION
2021-2023

PI
Eriobu Nnakelu

IMPLEMENTATION SCIENCE

IMPLEMENTATION SCIENCE

Using Implementation Research to Understand the Impact and Effectiveness of the Paediatric AIDS Breakthrough Partnership in Mozambique, Nigeria and Uganda: A Research Application Proposal of a 4-agency consortium led by the UVRI-IAVI HIV Vaccine Program (based in Entebbe, Uganda)

FUNDER
Aidsfonds, EGPAF, UNICEF and PATA

DURATION
2020-2023

PI
Dr. Okech B, Dr. Nadia Sam-Agudu& Dr. Elima Jedy-Agba