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NCT ID: NCT03360201 Recruiting - Mental Health Clinical Trials

An Evaluation of a Family Counseling Intervention ("Tuko Pamoja") in Kenya: a Single Case Series Design

Start date: July 10, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate a family counseling intervention, entitled "Tuko Pamoja" (Translation "We are Together" in Kiswahili). The intervention, delivered by lay counselors and through existing community social structures, is expected to improve family functioning and individual mental health among members. The sample includes highly distressed families with a child or adolescent (ages 8-17) exhibiting emotional or behavioral concerns; as such, particular emphasis is placed on adolescent-focused outcomes, including mental health and well-being.

NCT ID: NCT03357510 Not yet recruiting - Iron-deficiency Clinical Trials

The Effect of the Prebiotic Galacto-oligosaccharide on Iron Absorption With Micronutrient Powders in Kenyan Infants

Start date: December 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether single doses of the prebiotic galacto-oligosaccharide (GOS) added to iron-fortified meals with micronutrient powders increase iron absorption compared to a 3 weeks pre-feeding of GOS.

NCT ID: NCT03338699 Not yet recruiting - Circumcision Clinical Trials

Evaluation of the ShangRing vs. Mogen Clamp for Early Infant Male Circumcision (EIMC) in Sub-Saharan Africa

Start date: March 2018
Phase: N/A
Study type: Interventional

The study will evaluate the safety and acceptability of the topical anesthesia-based, no-flip ShangRing technique vs. Mogen clamp for Early Infant Male Circumcision (EIMC) in neonates and infants up to 60 days of life. The study will consist of 2 phases; a pilot phase and a field study. In the pilot phase, male infants of up to 60 days of life will be enrolled in three sub-Saharan countries, specifically Kenya, Tanzania, and Uganda. Infants will be randomized in 1:1 fashion to undergo EIMC using either the Mogen clamp or no-flip ShangRing technique using topical anesthesia. Upon completion of the pilot trial and assuming satisfactory safety results, a larger non-comparative field study of ShangRing EIMC will be initiated, as performed by non-physician providers in routine practice settings in the three sub-Saharan African countries. Total study duration will be 3 years. The pilot phase is anticipated to encompass a total of 1 year. Completion of the field study is expected to take 2 years. Study Endpoints include: 1. To compare the rates of adverse events (AEs) with the ShangRing or Mogen clamp 2. To compare pain control, time to complete wound healing and parent satisfaction with EIMC using the ShangRing or Mogen clamp 3. To compare operative time and provider preference. 4. To assess the rate of spontaneous ring detachment with the ShangRing as a method to decrease the need for follow-up visits after circumcision. 5. To assess the subpreputial microbiome of the infants prior to and after the initiation of circumcision Three correlative studies will be conducted: 1. Penile microbiome study: In the pilot trial, the subpreputial microbiome of the infants undergoing circumcision will be assessed to better understand the spectrum of bacteria that may exist and play a role in infant circumcision. 2. Demand creation study: During both the pilot phase and the field study, it will be assessed whether device-driven EIMC can be safely and effectively integrated into maternal and child health services as a method to promote demand creation. 3. Cost impact study: During both the pilot phase and the field study, a comparative cost analysis of EIMC with ShangRing versus Mogen clamp will be performed, in addition to a cost analysis of ShangRing EIMC as performed in routine clinical settings in the field study. The costing of demand creation will also be assessed.

NCT ID: NCT03284866 Not yet recruiting - HIV Infection Clinical Trials

HPV Vaccine Therapy in Reducing High-Grade Cervical Lesions in Patients With HIV and HPV

COVENANT
Start date: June 2018
Phase: Phase 3
Study type: Interventional

This randomized phase III trial studies how well human papillomavirus (HPV) vaccine therapy works in reducing high-grade cervical lesions in patients with human immunodeficiency virus (HIV) and HPV. Vaccines made from HPV peptides or antigens may help the body build an effective immune response to kill the HPV virus and prevent cervical lesions from developing or coming back after being removed.

NCT ID: NCT03259269 Recruiting - Clinical trials for Tuberculosis, Multidrug-Resistant

Expand New Drugs for TB [endTB]

Start date: February 9, 2016
Phase: N/A
Study type: Observational

This observational study will examine the safety and efficacy of bedaquiline and delamanid used (individually, not together) in routine, multidrug regimens for treatment of MDR-TB. The information gathered in this study will inform doctors how best to use these TB drugs in the future.

NCT ID: NCT03243396 Not yet recruiting - Depression Clinical Trials

Building and Sustaining Interventions for Children: Task-sharing Mental Health Care in Low-resource Settings

BASIC
Start date: January 2018
Phase: N/A
Study type: Interventional

The study will take place in Kanduyi, a sub-county in southern Kenya, and focuses on children orphaned by one or two parents. Growing evidence demonstrates that orphaned children in low- and middle-income countries are at high risk of post-traumatic stress, but mental health professionals are largely unavailable in this area. Research suggests that some mental health treatments can be delivered effectively in low- and middle-income countries using a task sharing approach, in which lay counselors with little or no prior mental health experience are trained to provide treatment. Whetten and Dorsey's past studies have suggested that partnering with two government sectors, education and health, could be a low-cost and sustainable strategy to implement task sharing mental health services. By training teachers (via the education sector) and community health volunteers (via the health sector) to provide mental health care, a larger population could potentially be reached. Before programs are scaled-up country-wide, it's important to know not only what policies to implement but also their predicted implementation success and intervention effectiveness. This study aims to identify implementation strategies and examine whether the education and/or health sectors are productive partners in scaling up task sharing mental health care in future programs.

NCT ID: NCT03235518 Recruiting - Clinical trials for Human Immunodeficiency Virus

A Combination HIV Prevention Strategy for Young Women at Risk for HIV

IPrEP
Start date: June 28, 2017
Phase: N/A
Study type: Observational

The purpose of this study is to conduct formative research to inform the design and implementation of combination prevention interventions, including pre-exposure prophylaxis (PrEP) for female sex workers (FSW), as well as to inform recruitment and retention strategies for female sex workers and their male clients in Kenya.

NCT ID: NCT03228966 Recruiting - HIV/AIDS Clinical Trials

Ped HIV - Echo Study: Kenya

Start date: September 12, 2017
Phase: N/A
Study type: Observational

Background: In children and adults living with HIV, cardiomyopathy is a major source of comorbidity. Traditional echocardiographic measures are insensitive and consequently cardiomyopathy often goes undiagnosed until late stages of disease. Myocardial deformation imaging represents a promising means to identify early dysfunction, but to date there have been no large studies using strain or strain rate to assess cardiac function in children with HIV and to establish predictors of worse cardiac function such as viral burden and ART regimen. These studies are critically important as earlier diagnosis and intervention represent the best means to alter the course of HIV-associated cardiomyopathy. Objectives: To determine the association of biomarker levels, myocardial deformation, and viral load level history in HIV infected children attending Moi Teaching and Referral Hospital (MTRH) clinic. Design: A cross-sectional study on clients attending HIV clinic, MTRH. Setting: Module 4 HIV clinic at MTRH in western Kenya, Africa. Population: HIV-infected children attending clinic in 2017 - 2018 Main Measures: Echocardiographic function assessment, Age, Immune status, other illnesses, ART status. Conclusions: The study will explore the NIH/HIV High Priority Target area of HIV-associated cardiac co-morbidities and will enhance understanding of the relationship between cardiac function and viremia. The investigators expect to be able to reliably define a subset of children with worse cardiac function by risk factors: specific ART regimens, less time virally suppressed, and increased BNP biomarker.

NCT ID: NCT03224390 Active, not recruiting - Clinical trials for Contraception Behavior

A Pilot Study to Estimate the Impact of a Screening and Referral Service on Contraceptive Use

Start date: July 12, 2017
Phase: N/A
Study type: Interventional

The specific aim of this pilot study is to estimate the impact of a new digital health service on the uptake of family planning among Kenyan women with an unmet need for contraception. Enrolled women will be randomized to a control arm or an encouragement arm that will receive a special invitation to try the new service.

NCT ID: NCT03223532 Active, not recruiting - Male Circumcision Clinical Trials

Randomized Trial Comparing PrePex Day 7 Foreskin Removal Procedure (FRP) to a Day 0 PrePex FRP .

Start date: April 26, 2017
Phase: Phase 3
Study type: Interventional

A Prospective, Randomized, Open Label Trial Comparing PrePex™ Day 7 (FRP) to a PrePex Day 0 FRP of Male Circumcision in Resource Limited Settings.