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NCT ID: NCT03238131 Completed - Onchocerciasis Clinical Trials

IVM Alone vs ALB + IVM Against Onchocerciasis

Start date: April 2012
Phase: Phase 3
Study type: Interventional

Onchocerciasis is a vector-borne nematode parasitic disease that causes severe disability. Onchocerciasis affects approximately 33 million people, mostly in 30 countries in sub-Saharan Africa (with small foci in Latin America and Yemen) 1This disease causes blindness and severe skin disease and it is spread by black flies. O. volvulus adult worms live in subcutaneous nodules. O. volvulus adult worms are larger and less sensitive to available drug treatments than those of the species that cause Lymphatic Filariasis (LF). They also have a longer lifespan (approximately 14 years rather than the estimated 7 years for LF parasites). Several programs and developments have greatly improved the Onchocerciasis. situation since the 1970's when the Onchocerciasis Control Programme (OCP) in West Africa (green countries in the map) was initiated. OCP relied exclusively on vector (black fly) control in its early years. However, following the appearance of Ivermectin (Mectizan) on the scene in the late 1980's, OCP transitioned to become a drug distribution program with annual IVM MDA in 11 countries. OCP ended in 2002. This was replaced by the African Program for Onchocerciasis Control (APOC) which coordinates community directed distribution of IVM MDA in 28 African countries (including the former OCP countries). OCP and APOC have done a good job of reducing parasite infection intensities and Onchocerciasis disease rates in many endemic countries. Unfortunately, there is no real end in sight for the APOC approach (apart from a funding endpoint in 2015); while it may be possible to eliminate Onchocerciasis. in selected areas by MDA with IVM (alone, or combined with vector control), disease control programs in most African countries will require active maintenance for many years to come. While IVR has good activity against the parasite larvae that cause disease in the skin and eye (microfilariae or Mf), it does not kill O. volvulus adult worms, and they resume production of Mf that can lead to transmission of new Onchocerciasis. cases by black flies after a few months. APOC activities are focused on areas with high infection rates (where disease risks are highest). However, extensive areas in Africa where fewer than 20% of adult men have Onchocerciasis nodules detectable by palpation are not receiving interventions for Onchocerciasis at this time. These areas are not disease free. (Onchocerciasis dermatitis can be severe in hypoendemic areas), and they also may serve as a source for reintroduction of the parasite into previously controlled areas after interventions stop.

NCT ID: NCT03237585 Recruiting - Domestic Violence Clinical Trials

Impact Assessment of the Rural Response System to Reduce Violence Against Women in Ghana

GhanaCHiPS
Start date: October 1, 2015
Phase: N/A
Study type: Interventional

AIM: To assess the community level impact of the Gender Centre's Rural Response System (RRS) in reducing violence against women (VAW) in Ghana. METHODS: Design: An unmatched cluster randomised controlled trial with two arms i) Intervention arm- Receive Gender Centre's RRS /COMBAT package for communities as well as state agencies. Control arm - No intervention. Qualitative component Setting: Rural and urban communities in the Central Region of Ghana. i). Rural and urban communities in four (4) Districts located in the Central Region of Ghana. Two districts are along the Coast (Abura and Komenda) while the other two (Agona and Upper Denkyira) are inland districts. ii). State Agencies (DOVVSU/Police, CHRAJ, Social Welfare, and Health Services). Interventions: Carried out in two Districts - Agona district and Komenda district. Workings of the intervention arm will be facilitated by the Gender Studies and Human Rights Documentation Centre in Ghana. Sample size: A total of 3280 adults (1640 women and 1640 men) from 20 clusters per trial arm (approximately 82 households per cluster) will be recruited at baseline and again at post-intervention survey. Sampling format will be a community survey with independent samples design (i.e. in each community, the people surveyed at baseline may not necessarily be the same people who are surveyed at post intervention. Clusters refer to the selected localities and their participating communities in each district. Evaluation design: Pre-test all study participants with a standardized instrument then introduce the independent variable (intervention) to the experimental group while withholding it from the control group. After 24 months of intervention, post-test both groups with the same instrument and under the same conditions as the pretest (baseline). Compare the amount of change in dependent variable for both experimental and control groups. Data analysis: The data will be analysed by intention to treat. The past 12 months prevalence of IPV will be compared between arms in the study.

NCT ID: NCT03081195 Not yet recruiting - Family Relations Clinical Trials

SMART Africa (Strengthening Mental Health Research and Training)

SMART
Start date: May 1, 2017
Phase: N/A
Study type: Interventional

The objective of this research study is to examine the implementation of and outcomes associated with an evidence-based practice (EBP), specifically Multiple Family Group (MFG) targeting youth disruptive behavior challenges and success, through a scale up intervention study in Uganda, and two pilot studies that will be conducted in Kenya and Ghana

NCT ID: NCT03070795 Recruiting - Clinical trials for Cesarean Section Complications

Outcomes of Early Versus Delayed Oral Feeding After Cesarean Section in Korle-bu Teaching Hospital

Start date: February 23, 2017
Phase: N/A
Study type: Interventional

study compares the outcomes of feeding mothers early (4 hours ) after cesarean section compared to delayed feeding (on post operation day 1) in terms of gastrointestinal function and maternal satisfaction with the feeding schedule.

NCT ID: NCT03062228 Recruiting - Pregnancy Clinical Trials

KBTH-GIRHL Healthy Birth Weight Study: A Cross-Section

KBTH-HBWS
Start date: April 28, 2016
Phase: N/A
Study type: Observational

This study was designed and conducted in an effort to establish a comparison group for the Ghana PrenaBelt Trial (NTC02379728). The Ghana PrenaBelt Trial examined the effect, on birth weight, of a belt-like device to help pregnant women to avoid sleeping on their back during sleep in the third trimester. This study will seek to establish the typical birth weight of babies born to a cohort of healthy pregnant Ghanian women who are similar in characteristics to the women in the Ghana PrenaBelt Trial but who have not been educated to avoid back sleep during pregnancy nor have received a device to prevent back sleep.

NCT ID: NCT03044899 Completed - Surgery Clinical Trials

African Surgical Outcomes Study (ASOS)

ASOS
Start date: February 1, 2016
Phase: N/A
Study type: Observational [Patient Registry]

STUDY OBJECTIVE To confirm the incidence of in-hospital postoperative complications in adult surgical patients in Africa. STUDY DESIGN Seven day, African national multi-centre prospective observational cohort study of adult (≥18 years) patients undergoing surgery. Patients will be followed up for a maximum of 30 days. We will follow the original International Surgical Outcomes Study (ISOS) study design. The primary outcome is in-hospital postoperative complications in adult surgical patients in Africa. Secondary outcomes include in-hospital mortality and the relationship between postoperative complications and postoperative mortality. The intention is to present a representative sample of surgical outcomes across all African countries. This study will run between February and March 2016.

NCT ID: NCT03036059 Recruiting - Clinical trials for Lymphatic Filariasis

Twice Yearly Treatment for the Control of LF

Start date: May 19, 2017
Phase: Phase 4
Study type: Interventional

The Global Program for the Elimination of Lymphatic Filariasis (GPELF) has been in operation sing the year 2000, with the aim of eliminating the disease by the year 2020, following 5-6 rounds of effective annual Mass Drug Administration (MDA). The treatment regimen is Ivermectin (IVM) in combination with Diethylcarbamazine (DEC) or Albendazole (ALB). In Ghana, MDA has been undertaken since 2001. While the disease has been eliminated in many areas, transmission has persisted in some implementation units that had experienced 15 or more rounds of MDA. Alternative intervention strategies, including twice yearly MDA and sleeping under insecticidal nets have significantly accelerated transmission interruption in some settings of high transmission intensity. Thus, it is evident that new intervention strategies could eliminate residual infection in areas of persistent transmission and speed up the LF elimination process. This study therefore seeks to test the hypothesis that biannual treatment of LF endemic communities will accelerate interruption of LF transmission. Two cluster randomized trials will be implemented in LF endemic communities in Ghana. The interventions will be yearly or twice-yearly MDA delivered to entire endemic communities. Allocation to study group will be by clusters identified using the prevalence of LF. Clusters will be randomised to one of two groups: receiving either (1) annual treatment with IVM+ALB; (2) annual MDA with IVM +ALB, followed by an additional MDA 6 months later. The primary outcome measure is the prevalence of LF infection, assessed by four cross-sectional surveys. Entomological assessments will also be undertaken to evaluate the transmission intensity of the disease in the study clusters. Costs and cost-effectiveness will be evaluated. Among a random subsample of participants, microfilaria prevalence will be assessed longitudinally. A nested process evaluation, using semi-structured interviews, focus group discussions and a stakeholder analysis, will investigate the community acceptability, feasibility and scale-up of each delivery system.

NCT ID: NCT02895269 Recruiting - Psychosis Clinical Trials

COllaborative Shared Care to IMprove Psychosis Outcome

COSIMPO
Start date: September 2016
Phase: N/A
Study type: Interventional

COSIMPO is a randomised controlled trial in which a collaborative shared care for psychosis implemented by complementary alternative providers (traditional and faith healers) and conventional primary health care providers (PHCP) is compared with care as usual in which no formal collaboration takes place between the two groups of health providers. COSIMPO is therefore a test of a complex task sharing approach for the care of patients with severe mental disorders.

NCT ID: NCT02878265 Completed - Malaria Clinical Trials

The Effect of Vitamin A With and Without Zinc and Multivitamin Supplementation on Malaria Morbidity in Ghanaian Children

Start date: November 2011
Phase: Phase 3
Study type: Interventional

The aim of this study was to determine the effect of combining vitamin A (VA), zinc (Z) and multivitamins (MV- A, B1, B2, B6, B12, C, D and E) on malaria morbidity

NCT ID: NCT02817919 Recruiting - Malaria Clinical Trials

Cohort Event Monitoring in Sub Saharan Africa

CEMISA
Start date: May 2016
Phase: N/A
Study type: Observational

This cohort event monitoring will document real-life safety experiences following the intake of Injectable AS. Specifically, the study will record common adverse events that are associated with the use of Inj. AS and associating factors such as age and gender that make some of these events more likely. The sample size of 3000 patients will enable the documentation of causally-related events that occur at frequencies of 1 in 1000 or more. Since quinine, the previous gold standard for treating severe malaria may still be used by facilities in addition to artesunate and artemether, the study will concurrently monitor the safety of these products though focus of the study is the capture of adverse events following exposure to Inj. AS. The concurrent monitoring of both quinine and artemether will also enable treatment practices in the study areas to be documented.