There are about 249 clinical studies being (or have been) conducted in Ghana. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This DOLF study will investigate the safety and effectiveness of IDA treatment in persons with onchocerciasis when it is administered after pre-treatment with ivermectin to clear or greatly reduce microfilariae from the skin and eyes.
Soil-transmitted helminths (STHs) are a group of parasitic worms that infect millions of children in sub-tropical and tropical countries, resulting in malnutrition, growth stunting, intellectual retardation and cognitive deficits. To control the morbidity due to these worms, school-based deworming programs are implemented, in which anthelminthic drugs are administered to children without prior diagnosis. The continued fight against these worms is aided by the London declaration on neglected tropical diseases, which helps sustain and expand global drug donation program, resulting in an unprecedented growth of deworming programs. However, the high degree of drug pressure makes deworming programs vulnerable to the development of anthelmintic resistance because they only rely on one drug with sometimes suboptimal efficacy and there is no availability of alternative drugs. Moreover, at present, there is no surveillance system to monitor the emergence and spread of anthelmintic resistance. It remains unclear to what extent the efficacy of drugs may have dropped and whether anthelmintic resistance is already present. This project aims to strengthen the monitoring and surveillance of drug efficacy and anthelmintic resistance in STH programs. As such, it will support deworming programs in their quest to eliminate STHs as a public health problem. The overall aim of this study is to pilot a surveillance system to assess anthelmintic drug efficacy and the emergence of AR in 9 countries were drug pressure has been high over a long period of time. The specific objectives are to: 1. Assess the prevalence of moderate/heavy intensity infections of the different STH 2. Assess the drug efficacy of a single dose of BZ drugs against STH infections in these countries 3. Assess the frequency of the ß-tubulin SNPs linked to BZ resistance 4. Identify implementation-related barriers and opportunities for monitoring drug efficacy and AR in national PC programs for STH. 5. Expand the Starworms repository of STH field samples
Malaria poses a serious burden in sub-Sahara Africa. Efforts are ongoing to scale up interventions that work. These include the use of Long Lasting Insecticidal Nets (LLIN), Intermittent Preventive Treatment in children (IPTc), and test, treat and track (TTT). There is the need, however, for mass testing, treatment and tracking (MTTT) of the whole population to reduce the parasite load before implementing the aforementioned interventions. Though, Seasonal Malaria Chemoprophylaxis (SMC) is adopted for selected localities in Ghana, the impact of such interventions could be enhanced, if associated with MTTT in order to reduce the parasite load at baseline. MTTT of children in Ghana has demonstrated a parasite load reduction from 25% to 1%. However, unanswered questions include - could this be scaled up? What proportion of the community could be covered over a given time? What would it take to accomplish large scale MTTT? In designing interventions that aim at reducing the burden of malaria in children under five, for example, MTTT has largely been left out. Adults who are not often targeted by such interventions remain reservoirs that fuel transmission. This study explores the scale-up of interventions that work using existing community volunteer teams to lower cost. These volunteers will play a surveillance role by conducting home-based management of malaria. To avoid challenges posed by stockouts, short message service (SMS) will be used to monitor the level of stocks for malaria medicine and Rapid Diagnostic Tests (RDTs). It is hypothesized that there are more asymptomatic malaria cases (those who carry the parasite but are not ill) than symptomatic cases reported by hospital records in the Pakro sub district and that, carrying out MTTT in combination with home-based management of malaria in specific communities could greatly reduce the burden. Through this study, the bottlenecks that hinder scaling-up of MTTT will be documented in order to facilitate the process.
Tuberculosis (TB) remains the major cause of morbidity and mortality among patients with HIV. Sub-optimal diagnostics contributes towards poor patient outcome and there is an urgent need to identify non-sputum-based point-of-care diagnostic tests. The urine based lateral flow lipoarabinomannan TB diagnostic test (LF-LAM) is a simple, inexpensive point-of-care test. In 2015, the World Health Organization endorsed LF-LAM for conditional use among patients with advanced HIV, but uptake of the test in clinical practices has been poor. The investigators aim to identify point-of-care (POC) strategies that can improve TB case detection and clinical outcomes among patients with advanced HIV. The project includes a main study and two sub-studies. The main study is a multicenter stepped wedge cluster-randomized controlled trial of LF-LAM implementation among patients with advanced HIV with 8-weeks follow-up. LF-LAM will be added to standard care and implemented stepwise at three hospitals in Ghana. Education in national TB treatment guidelines in collaboration with the Tuberculosis Control programme in Ghana, and Clinical audit of clinical staff with feedback, will be used to assess and strengthen LF-LAM implementation. The primary outcome time to TB treatment, for which a sample size of 690 participants will provide >90% power to detect a minimum of 7 days reduction. Secondary outcomes are: TB related morbidity, TB case detection, time to TB diagnosis and overall early mortality at 8 weeks. The HIV-associated TB epidemiology including genotypic analyses of M. tuberculosis isolates obtained through the main study will be described. In sub study A, focused ultrasound of lungs, heart and abdomen will be performed in a sub cohort of 100 participants. In sub study B, the investigators will establish a biobank and data warehouse for storage of blood, urine and sputum samples collected from participants that enter the study at Korle-Bu Teaching hospital. It is expected that LF-LAM will lead to earlier diagnosis and treatment of TB. Findings may further guide scaling-up of LF-LAM. The HIV-associated epidemic including genotypic properties and resistance properties which is important for improved management will be detailed. The investigators further expect to evaluate the potential of bedside ultrasound as a clinical tool in management of HIV/TB co-infected patients. The unique Ghanaian HIV-cohort and biobank may facilitate rapid evaluation of future prognostic biomarkers and new point-of-care TB diagnostic tests.
HIV prevalence among men with have sex with men (MSM) in Ghana is at least eight times higher than that of the general population (2%). MSM in Ghana face high levels of stigma due to HIV status (actual or perceived), same-sex behavior, and gender non-conformity. These stigmas are documented barriers to HIV prevention and treatment. In our preliminary work in Ghana (N=137), one-third of MSM had never been tested for HIV. This study is a randomized controlled trial to evaluate the feasibility, acceptability and estimate effect size of a multi-component, multi-level (organizational, interpersonal, and intrapersonal-level) intersectional stigma-reduction intervention to increase HIV testing frequency among MSM in Ghana where HIV, same-sex behavior and gender non-conformity are highly stigmatized. To date, stigma-reduction interventions in Ghana have focused on uni-level targets (e.g., health care facilities (HCFs)) and addressed one type of stigma (e.g., HIV), without engaging the intersectional character of the multiple stigmas that MSM encounter. Our specific aims are: 1. to evaluate the feasibility and acceptability of a novel multi-component, multi-level intervention to address intersectional stigma. 2. to estimate effect size of the intervention for scale up to a definitive efficacy trial. Our primary endpoint are: For MSM: HIV testing, intervention feasibility and acceptability For HCFs: intervention feasibility, acceptability and appropriateness Our secondary endpoints are: MSM: Intersectional stigma reduction HCF: Intersectional stigma reduction This study will combine three theory-based interventions that were previously implemented separately in Ghana for reducing stigma at HCF-level, increasing HIV testing at the peer group-level, and increasing peer social support at the individual-level. Convergence Framework will be used for combining interventions. The ADAPT-ITT framework guides our approach to enhancing the interventions' content on intersectional stigma. To achieve these aims a systematic adaptation that will be used to refine the individually developed HCF, peer- and individual-level interventions to produce a comprehensive multi-level intersectional stigma reduction intervention.
Current dietary assessment methods rely on self-report food intake such as food frequency questionnaires, 24-hr dietary recall, or diet diaries, and the prevalence of misreporting with these tools is estimated at 30-88%.A reliable and convenient way to measure the quantity of cowpea consumed by an individual. The hope is to identify a novel set of dietary biomarkers that will measure cowpea consumption, be free from participant recall bias, and serve to quantify legume intake. A total of 40 subjects, 20 children (9-21 months) and 20 pregnant women (>18 yr) will consume 3 distinct daily intake dosages of cooked cowpeas with the daily intake increased every 5 days. Urine samples will be collected 3 times during each 5-day period and blood spots will be collected during a washout period and at the end of the final 5-day period. Urine samples will undergo metabolite detection via ultra-performance liquid chromatography tandem mass spectrometry in positive and negative ion mode. Peaks are quantified using area-under-the-curve (AUC) and each metabolite is quantified in terms of its median-scaled relative abundance for the metabolite across the entire data set. A repeated measures 2-way ANOVA will be used to compare cowpea metabolite abundances over time and with respect to variation in an individual baseline levels.
The primary objective of this research is to exhaustively document the course and outcomes of hospitalization, labor, delivery, and early postpartum course of up to 15,000 mother-newborn pairs in settings where the occurrence of adverse outcomes is high. The Investigators will gather detailed laboratory, physiologic, and clinical information, and precisely characterize major adverse diagnoses and outcomes. The resulting high-quality, granular, and generalizable data will be used to develop new algorithms to signal actionable intrapartum diagnoses and prospectively stratify women according to their risk for adverse maternal and neonatal outcomes.
This is a randomized, blinded, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA™ 2000 device in healthy volunteers in Ghana.
This study aims to evaluate clinical outcomes and antibiotic prescription patterns following the use of diagnostic algorithms, point of care (PoC) rapid diagnostic tests, and behaviour change interventions in cases of acute febrile illnesses in children, adolescents and adults presenting at out patient clinics in lower and middle income countries. The study is to be implemented in 2 phases- the first run from 2020 to 2021 and the 2nd phase from 2021 to 2022 to include COVID-19 PoCTs.
This study intends to build on the previous research and gather data in an actual use study / patient registry of pericoital LNG 1.5mg to understand women's acceptability of the product along with associated side effects, and monitoring for their correct and incorrect use. These findings will contribute to the discussion around the feasibility of pericoital LNG as an additional contraceptive by adding to the body of evidence.