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NCT ID: NCT02964091 Completed - Chronic Hepatitis C Clinical Trials

Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World

SHARED
Start date: October 2016
Phase: Phase 4
Study type: Interventional

The main purpose of the study is to evaluate the efficacy, safety and tolerability of a medication, ledipasvir/sofosbuvir (LDV/SOF), used to treat individuals with chronic hepatitis C virus (HCV) in Rwandan adults. A sub-cohort of participants will have limited laboratory monitoring to determine the minimum laboratory tests necessary.

NCT ID: NCT02935686 Completed - Healthy Clinical Trials

A Safety, Tolerability and Immunogenicity Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Tetravalent Ad26.Mos4.HIV Along With Either Clade C gp140 Plus Adjuvant OR With a Combination of Mosaic and Clade C gp140 Plus Adjuvant in Healthy HIV Uninfected Adults

IPCAVD-012
Start date: March 31, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The primary purpose of this study is to assess safety/tolerability of the different vaccine regimens and of a late boost vaccination; and to assess envelope (Env)-binding antibody (Ab) responses of the 2 different vaccine regimens.

NCT ID: NCT02832544 Completed - Clinical trials for Rheumatic Heart Disease

INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies, Non-Inferiority

INVICTUS-VKA
Start date: August 22, 2016
Phase: Phase 3
Study type: Interventional

This program is a comprehensive evaluation of rheumatic valvular heart disease (RVHD), Atrial fibrillation (AF)/flutter and stroke. A prospective, randomized, parallel group, open-label clinical trial of rivaroxaban versus standard vitamin K antagonists (VKA) therapy to evaluate non-inferiority of rivaroxaban to VKA, with testing for superiority if non-inferiority is satisfied.

NCT ID: NCT02788045 Completed - Healthy Clinical Trials

Safety, Tolerability and Immunogenicity Study of Different Vaccine Regimens of Trivalent Ad26.Mos.HIV or Tetravalent Ad26.Mos4.HIV Along With Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults

Start date: July 8, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety/tolerability of the 2 different vaccine regimens of priming with trivalent Ad26.Mos.HIV and boosting with trivalent Ad26.Mos.HIV and Clade C gp140 plus adjuvant or priming with tetravalent Ad26.Mos4.HIV and boosting with Ad26.Mos4.HIV and Clade C glycoprotein (gp)140 plus adjuvant. Immune responses of the different vaccine schedules will be assessed.

NCT ID: NCT02603250 Completed - Anemia Clinical Trials

Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda

Start date: September 2015
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the use of a noninvasive Hb device (Pronto® with DCI-mini™ sensors) as an accurate method for measuring Hb levels among children between 6 and 59 months against the standard reference hematology analyzer. The secondary purpose is to evaluate the accuracy of two HemoCue® Hb 201+ capillary blood collection methods against the standard reference hematology analyzer. The study hypothesizes that the Pronto® with DCI-mini™ sensor will approximate Hb values within ±1.0 g/dL and secondly, it will correctly classify participants as anemic or not anemic with less than 31% disagreement when compared to the standard reference hematology analyzer among children 6 to 59 months of age. Additionally, the two different HemoCue® Hb 201+ capillary blood collection methodologies will both approximate Hb values within ±1.0 g/dL and secondly, it will correctly classify participants as anemic or not anemic with less than 35% disagreement when compared to the standard reference hematology analyzer among children 6 to 59 months of age.

NCT ID: NCT02514122 Completed - Pain Clinical Trials

Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda

Start date: June 2015
Phase: Phase 2/Phase 3
Study type: Interventional

A randomized double blind control trial to investigate the safety and efficacy of subcutaneous ketamine for control of post operative pain in low resource settings.

NCT ID: NCT02510313 Completed - Clinical trials for Child Development, Social Protection

Strong Families, Thriving Children "Sugira Muryango"_Activity C

Start date: April 10, 2018
Phase: N/A
Study type: Interventional

The proposed study will test the effectiveness of the Strong Families, Thriving Children "Sugira Muryango" program as delivered by community based workers and aligned with the Rwandan social protection system. Sugira Muryango is a preventive, family-based model that uses home visiting and coaching to encourage responsive parent-child interactions and discourage violence and harsh punishment targeting families living in extreme poverty. Integration of scalable, cost-effective interventions into poverty-reduction and other social welfare programs has great potential as an effective means to promote child development and reduce familial violence and in a range of culturally diverse, low-resource settings.

NCT ID: NCT02464423 Completed - Clinical trials for Human Immunodeficiency Virus

Improving Adherence Among HIV+ Rwandan Youth: A TI-CBTe Indigenous Leader Model

Start date: January 2013
Phase: N/A
Study type: Interventional

Like most of sub-Saharan Africa, Rwandan youth are the epicenter of the AIDS epidemic, accounting for 40% of new infections. Antiretroviral (ART) adherence is a global health priority, but Rwandan youth are more than twice as likely to be on second line therapy than adults, and with a median population age of 18.7 years old, adherence is essential for Rwanda's future. Resources to provide youth-centered medical and psychosocial care are limited in Rwanda, and young people with HIV face many obstacles to adherence, namely the long-term consequences of genocide, depression, and gender-based violence, as well as logistical issues, negative attitudes, and insufficient parent/caregiver support. Preliminary data underscore the utility of culturally-adapted, trauma-informed cognitive behavioral therapy (TI-CBT) in reducing depression and traumatic distress among youth and adults in Rwanda. This project proposes a 2-arm randomized controlled trial (RCT) to test and compare the efficacy of adherence-enhanced Trauma Informed Cognitive Behavioral Therapy (i.e., TI-CBTe) to usual care in increasing ART adherence among Rwandan youth from two clinics caring for the largest number of youth with HIV in Rwanda. This proposal answers a compelling need for innovative programs to increase ART adherence among HIV+ youth. If effective, the study will build Rwanda's capacity to provide much needed services; and, involvement by the Rwanda Biomedical Center will ensure wide dissemination.

NCT ID: NCT02348580 Completed - Clinical trials for Active Learning Methods and Life-skills Education

Effectiveness Study of Teacher Training and Social and Financial Education in Rwanda's Primary and Secondary Schools

Start date: September 2013
Phase: N/A
Study type: Interventional

The study uses experimental methods to evaluate the effectiveness of an educational intervention in Rwanda. The intervention, designed by Aflatoun and AMIR, involves training teachers on the use of active-learning methods to implement a social and financial education curriculum with students in primary and secondary schools. Teachers then implement the social and financial curriculum with students in order to improve their personal, social, and financial competencies. Teacher training will take place in November-December 2013 and the curriculum implementation will be evaluated in the 2014 school year. The study will examine the following hypotheses: 1. Did teachers use of active learning methods in class increase due to the training received? 2. Did students' levels of engagement and on-task behaviour increase as a result of the intervention's pedagogy and content? 3. Did the following competencies of students improve due to the intervention? 1. Self-efficacy 2. Social skills 3. Financial literacy 4. Planning attitudes 5. Savings attitudes 6. Savings behavior 7. Entrepreneurship 4. Did the intervention change student's pass rates on the primary six (P6) and secondary three (S3) final examinations for the classes in which it was implemented? 5. Did the intervention change student drop out rates in the classes which it was implemented?

NCT ID: NCT02315703 Completed - Healthy Clinical Trials

Safety, Tolerability, and Immunogenicity Study of Homologous Ad26 Mosaic Vector Vaccine Regimens or Heterologous Ad26 Mosaic and MVA Mosaic Vector Vaccine Regimens With Glycoprotein 140 (gp140) for Human Immunodeficiency Virus (HIV) Prevention

Start date: December 22, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of various regimens containing adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV), Modified Vaccinia Ankara (MVA)-Mosaic, and/or HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) components and to compare envelope binding antibody responses between the different vaccine regimens.