Abuja, Fct, Nigeria

Community, Home-based Education, Screening Services Strategy to Increase Cervical Cancer Control Access for HIV-Positive Women in Nigeria

Despite the increased risk of cervical cancer (CC) among women living with HIV (WLWH), access to CC screening in Nigeria remains limited. While advances in prevention programs and antiretroviral therapy have reduced other AIDS-associated malignancies, CC risk in WLWH persists. This study aims to leverage Nigeria's existing HIV treatment infrastructure to integrate home-based CC (HCC) screening for WLWH. The approach involves adapting the MoMent (MOther MENTor) peer-based HIV support program to include HCC screening and evaluating its implementation and sustainability using the Consolidated Framework for Implementation Research (CFIR) and RE-AIM frameworks. The study has three key aims: - Adapting the MoMent program to promote home-based HPV screening and follow-up treatment through stakeholder deliberation. - Implementing and assessing the program's reach, effectiveness, adoption, and fidelity with a sample of 1,500 WLWH. - Conducting a post-implementation evaluation to identify barriers and enablers for program maintenance and scalability. Stakeholder input, including perspectives from WLWH, peer counselors, clinical managers, and policymakers, will guide the program's design and execution. By integrating stakeholder insights and addressing systemic challenges, the study aims to advance CC control in Nigeria and provide a scalable model for implementing cancer control strategies for people living with HIV in low- and middle-income countries globally.

Adolescent Girls Initiative for Learning and Empowerment: Impact Evaluation of a Safe Space-Based Life Skills Training and Digital Literacy Training in Nigeria Space-Based Life Skills Training and Digital Literacy Training in Nigeria

This study will evaluate the impact of a safe-space based life skills training program as well as a combination of life skills and digital literacy training programs on adolescent girls' empowerment, education, economic and sexual and reproductive health outcomes. The interventions form two sub-components of the Adolescent Girls' Initiative for Learning and Empowerment project. The interventions will be delivered to secondary school girls in Northern Nigeria. The study will be conducted in the Kaduna, Katsina and Kano states of Nigeria. The study has a randomized controlled trial research design where schools are randomly allocated to three groups. Girls in schools assigned to the first treatment group will receive the safe-space based life skills training program. Schools allocated to the second treatment group will deliver a digital literacy training program along with a safe-space based life skills training program. The third group of schools will receive neither training program until the completion of the study. Girls between the age of 15 - 20 form the target group of the study. The study will evaluate the impact of (i) a safe space-based life skills training program on adolescent girls' empowerment, education, economic and sexual and reproductive health outcomes; and (ii) a combination of a safe-space based life skills and digital literacy training programs on adolescent girls' empowerment, education, economic and sexual and reproductive health outcomes. A total of 8,463 girls are drawn from 273 schools in the three states. The study will conduct baseline, midline and endline surveys by interviewing the girls and their respective caregivers. The baseline survey is conducted before the intervention roll-out. The midline survey will be conducted six months after intervention completion, while the endline survey will be conducted two years after the completion of the intervention.

Assessing Diagnostics At Point-of-care for Tuberculosis

The Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT) seeks to identify and rigorously assess promising, design-locked point-of-care (POC) tuberculosis (TB) diagnostic tests (hereafter referred to as "novel tests") in clinical studies conducted in settings of intended use. Rapid diagnosis and effective treatment are critical for improving patient outcomes and reducing TB transmission. However, nearly one-third of people with TB are not diagnosed or reported to public health authorities.The different types of tests required to reduce this "diagnostic gap" have been described in the form of target product profiles (TPPs) defined by the World Health Organization (WHO). The highest priority TPP is that for a point-of-care, non-sputum biomarker-based test to facilitate rapid TB diagnosis using easily accessible samples (i.e., a biomarker-based diagnostic test). The ADAPT study will evaluate the sensitivity, specificity and yield of novel diagnostic tests against a reference standard including sputum Xpert® Mycobacterium tuberculosis/Rifampicin (MTB/RIF) Ultra and sputum mycobacterial culture among adolescents and adults with presumptive TB (based on having TB symptoms, or TB risk factor + positive TB screening test) presenting to outpatient health facilities in high burden countries. In addition, the usability and acceptability of novel TB diagnostic tests will be assessed through direct observations and surveys of routine health workers.

Reducing Mortality in Adults With Advanced HIV Disease (REVIVE)

All participants in the REVIVE trial will be randomized (1:1) at the time of study entry to receive azithromycin prophylaxis or placebo for 28 days and will be followed for 24 weeks to determine the primary outcome measure. Total follow up duration will be 48 weeks.

Enhancing Access to Safe and Nutritious Diets (ENSAND) Evaluation Nigeria

ENSAND seeks to increase the frequency of egg consumption among students in classes 1-3 in public primary schools and their younger siblings aged 6-59 months in local government areas (LGAs) with a high proportion of bottom of the pyramid (BoP) households. GAIN's intervention is two-pronged in Kaduna State. One component will involve improving the egg value chain supplying the Home-Grown School Feeding Program (HGSFP) for primary school children and the other will involve using a social marketing approach to increase parents' willingness to purchase and feed eggs to their young children aged 6-59 months. In Federal Capital Territory (FCT) and Kebbi States, GAIN's intervention will focus only on supplying eggs to primary school children. This evaluation of the ENSAND program will use a parallel group mixed-methods quasi-experimental before-after design to assess the effectiveness of the intervention on children's frequency of egg consumption in Kaduna (intervention) and Kano (control) States. The evaluation will be carried out in 3 intervention and 3 control LGAs, with clustering at the level of the school. Data will be collected through household surveys with caregivers and school-aged children (N=1,332 at baseline and endline), egg value chain actor key informant interviews (KIIs, N=3) and semi-structured interviews (N=191) at baseline, midline, and endline, and focus group discussions (FGDs, N=9 FGDs at midline and endline) with caregivers of young children. Households with school- and pre-school aged children will be identified through the sampled public primary schools, and caregivers and school-aged children will be interviewed at baseline and endline in intervention and control LGAs. The same schools will be used at both times points but cross-sectional samples will be drawn at baseline and endline. Egg value chain actors will be identified in the intervention LGAs in Kaduna to participate in KIIs and semi-structured interviews at baseline, midline, and endline to assess changes in the functioning of the value chain over time. FGDs with caregivers of young children will be conducted at midline and endline. The qualitative findings will be used to understand experiences with the interventions and findings will be triangulated with results from the household and egg value chain interviews. In FCT and Kebbi, the evaluation will be limited to KIIs (N=4) and semi-structured interviews (N=102) with egg value chain actors at baseline, midline, and endline. The findings will be used to validate and triangulate with the monitoring data GAIN will be collecting from value chain actors.

Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: a Cluster RCT

A pragmatic, adaptive, multi-site, cluster randomized trial where households with one or more persons confirmed to have mpox will be randomized to smallpox vaccine or control. The co-primary outcomes are RT-PCR confirmed mpox and symptom severity.

Study of the Role of Genetic Modifiers in Hemoglobinopathies

Hemoglobinopathies, including sickle cell disease (SCD) and beta-thalassemia, are prevalent diseases with variable clinical manifestation and severity that are thought to be governed, in part, by genetic modifiers. Despite the identification and characterization of a few putative genetic modifiers by previous studies, these are as yet insufficient to guide treatment recommendations or risk-stratify patients reliably. Also, it is expected that many additional genetic variants exist that can modify disease and its severity. This large-scale genome-wide association study (GWAS) will utilize SNP chips to investigate the genetic profile of individuals with hemoglobinopathies, thereby addressing the challenges of previous studies related to small sample sizes and low statistical power, while promoting the participation of diverse populations worldwide. The study aims to i) discover new genetic modifiers of hemoglobinopathies, ii) validate previously reported genetic modifiers, iii) pool and analyze existing genomic data, iv) standardize phenotypic descriptions, v) develop a research resource of disease-specific data generated in INHERENT, including genomic, phenotypic, and functional data, and vi) develop risk scores that can be used for patient stratification. The main endpoints include: 1. Worldwide demography, including numbers of patients, main genotypes, and overall disease severity/burden in participating centres 2. Genetic modifiers affecting clinical or laboratory phenotypes of hemoglobinopathies, including 1. overall survival in SCD and/or thalassemia, 2. stroke and/or decreased neurocognitive function in SCD and/or thalassemia, 3. renal impairment in SCD and/or thalassemia, 4. leg ulcers in SCD, 5. priapism in SCD, 6. mild or severe acute pain and/or chronic pain syndromes in SCD, 7. pulmonary hypertension in SCD and/or thalassemia, 8. hyperhemolysis in SCD and/or thalassemia, 9. fetal hemoglobin levels, 10. degree of ineffective erythropoiesis, 11. hepatic fibrosis/cirrhosis and/or cardiac siderosis, 3. Genetic modifiers affecting response to treatment, including 1. response to hydroxyurea, 2. response to iron chelation treatment, 3. response to emerging therapeutic agents

Implementation of Anal Cancer Screening and Treatment in Nigeria

In Aim 1, anal cancer screening and treatment based on standard training protocols of how to screen and treat high-grade intraepithelial lesions (HSILs) to prevent anal cancer as developed in high-income settings will be conducted. Investigators will identify barriers and facilitators with learning the procedure with standard training using the Consolidated Framework for Implementation Research (CFIR). In Aim 2, Investigators will identify strategies to modify the standard training to improve learning on a complicated procedure using the Expert Recommendations for Implementing Change (ERIC) framework. An implementation science committee will co-design and develop an enhanced training on Screening and Treatment of HSIL (e-STH) by matching the barriers identified with CFIR with strategies in ERIC. Investigators will then take an iterative improvement approach to test and refine the implementation of the enhanced training intervention to ensure that HSIL screening and treatment is readily adopted and maintained as part of HIV care. In Aim 3 (CLINICAL TRIAL AIM), Investigators will conduct a Hybrid Type 2 trial using an interrupted time series design to monitor and evaluate outcomes along the implementation continuum. The trial will be conducted at a single clinic to minimize variability. The participant (Physician) will have a pre-period of HSIL screening and treatment for 12 months after standard training. Next, investigators will roll out e-STH for 6 months. Then there will be a post-period of screening for 12 months to evaluate the impact of e-STH. Lastly, there will be 6 months of screening and treatment with minimal involvement of the investigative team to evaluate sustainability. The study will compare e-STH to standard training in proportion of HSIL detected and treated with secondary outcomes evaluating reach, efficacy, implementation, and sustainability.

The Impact of Pre-emptive Home Delivery of ORS + Zinc on Treatment for Child Diarrhea

Mobile Gaming App to Improve Child Nutrition in Nigeria

Undernutrition among children born to teenage mothers deserves urgent attention in Nigeria, where 27.2% of girls (15-19 years) living in rural areas have begun childbearing. Pregnancy elevates the nutrient needs of teenage girls due to competing requirements for fetal development, and growth and maturity in the adolescent mother. The resultant children have a higher likelihood of underweight (13-fold), stunting (8-fold) and wasting (3-fold), and are over 50% more likely to die within the first month of birth, as compared to children of older mothers. Previous studies have found positive associations between maternal education/knowledge and optimum infant and young child feeding (IYCF) practices. Childbirth results in a sharp increase in the responsibilities and work burden of teenage mothers, negatively impacting capacity and self-efficacy for adequate child feeding. Furthermore, attempts to improve IYCF practices often target older women. The overall goal of this study is to develop, validate and evaluate the effects of a mobile gaming app on the infant and young child feeding practices of teenage mothers. A secondary goal is to evaluate the anthropometric and dietary and plasma levels of microminerals of children, 0 - 24 months of age. A mobile app will be developed and validated. It will feature an interactive role-play game on recommended IYCF practices that will help educate teenage mothers about feeding young children. A 6-month randomized controlled trial (RCT) will be conducted in 266 predominantly low-income mother-child dyads (0 - 24 months) from Nigeria. This RCT will compare the influence of the BabyThrive app vs controls who receive a delayed intervention. It will include knowledge and practices regarding exclusive breastfeeding, introduction to solid/semi-solid foods, meal frequency, dietary diversity and amount of food consumed of teenage mothers. Anthropometric measurements and plasma ferritin and zinc of children also will be evaluated.