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NCT ID: NCT03391375 Active, not recruiting - HIV/AIDS Clinical Trials

Evaluation of the Effect of Late Boost on HIV-uninfected Vaccines From EV06 Trial

Start date: March 15, 2017
Phase: Phase 1
Study type: Interventional

EV07 is an open label phase I clinical trial to evaluate the effect of late boost on HIV-uninfected vaccinees from EV06 trial. The outcome of the EV06 trial has shown that the vaccine regimen is safe and well tolerated. Preliminary antibody immunogenicity analysis has demonstrated that the DNA/gp120 protein vaccine regimen induced strong gp120, gp140 and V1V2 region-focused binding IgG and neutralizing antibody responses. There is also preliminary evidence that S. mansoni infection may modulate antibody responses induced by vaccination1. Based on these preliminary immunogenicity results of the EV06 study, a study with an additional boost with DNA-HIV-PT123 and AIDSVAX®B/E (Late Boost) is warranted in order to better investigate and understand the effects of the late boost on the response rate, magnitude and durability of vaccine induced immune responses. The primary objective of EV07 is to evaluate the ability of the late boost combination of DNA-HIV-PT123 and AIDSVAX® B/E to enhance the pre-existing vaccine induced antibody responses.

NCT ID: NCT03377608 Recruiting - Contraception Clinical Trials

Modifiers of Tenofovir in the Female Genital Tract

Start date: November 17, 2017
Phase: N/A
Study type: Observational

Two-armed, single visit, pharmacokinetic study to compare tenofovir diphosphate concentrations in cervical tissues of women on Depo-Provera contraception vs non-hormonal contraception.

NCT ID: NCT03359915 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

GECo: Implementation and Effectiveness of COPD Self Management Action Plans in Low and Middle Income Countries

GECo2
Start date: December 2017
Phase: N/A
Study type: Interventional

This study will randomise people with clinically significant COPD (GOLD Grade B-D) to usual care or provision of a self-management action plan supported by monthly follow-up visits from a community health worker trained in the use of the action plan. The primary outcome will be health-status: a comparison of the change in St. George's Respiratory Questionnaire (SGRQ) between baseline and 12 months in the two groups. We will randomise 240 people from three low- and middle-income countries, namely Nepal, Peru and Uganda. We will also examine the feasibility of implementing our self-management action plan intervention at scale.

NCT ID: NCT03351504 Enrolling by invitation - Hypertension Clinical Trials

Solar Lighting to Reduce Indoor Air Pollution in Rural Uganda

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

This study evaluates the impact of a solar lighting system on kerosene lamp use, levels of indoor air pollution, and health in women living in rural Uganda. Half of the participants will receive the lighting systems immediately, while the other half will receive them after an 18 month delay.

NCT ID: NCT03350048 Recruiting - Clinical trials for Pulmonary Tuberculosis

Evaluation of Host Biomarker-based Point-of-care Tests for Targeted Screening for Active TB

ScreenTB
Start date: May 2, 2016
Phase: N/A
Study type: Observational

Title: Evaluation of host biomarker-based point-of-care tests for targeted screening for active TB (Screen TB) Introduction: Tuberculosis (TB) places severe pressure on health care services of the developing world. Despite the introduction of the highly sensitive and specific GeneXpert MTB/RIF (GeneXpert) test [1] with a potential turn-around time of two hours, many people in high TB prevalence areas still do not have access to efficient TB diagnostic services due to logistical constraints in these settings. A cost effective, rapid, point-of-care screening test with high sensitivity would identify people with a high likelihood for active TB and would prioritize them for testing with more expensive, technically or logistically demanding assays including GeneXpert or liquid culture, facilitating cost-effective diagnostic work-up in resource-limited settings. A serum cytokine signature for active TB disease, discovered in the AE-TBC project, with a sensitivity of 89% (CI 78 - 95%) and specificity of 76% (CI 68 - 83%), will be optimised and utilized in a point-of-care format (TransDot) to rapidly test for TB disease in symptomatic people. Hypothesis: The TransDot test will achieve a sensitivity of > 90% for TB disease, in a training set of people suspected of having TB disease, and be validated (achieve similarly high sensitivity) subsequently in a prospective test set of people suspected of having TB disease, when compared to a composite gold standard of sputum culture, smear, GeneXpert, chest X-ray, TB symptoms and TB treatment response. Objectives: The overall objective of the study is to incorporate a six-marker serum signature into a multiplex UCP-LFA format, referred to as TransDot, for finger-prick blood testing. The end point of the study is the accuracy (sensitivity and specificity) of the UCP-LFA TransDot test on finger-prick blood for active TB and will be prospectively compared against gold standard composite diagnostic criteria (GeneXpert, MGIT culture, TB sputum smear, CXR, TB symptom screen and response to TB treatment). Primary: The primary outcome of interest will be accuracy, sensitivity and specificity of the TransDot finger-prick test when compared with the composite gold standard tests.

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: NCT03315962 Recruiting - Tuberculosis Clinical Trials

Simplified Isoniazid Preventive Therapy Strategy to Reduce TB Burden

SEARCH-IPT
Start date: November 15, 2017
Phase: N/A
Study type: Interventional

The failure to use isoniazid (INH) preventative therapy (IPT) in HIV-infected individuals in Sub-Saharan Africa represents one of the single biggest implementation gaps between evidence and practice in today's response to the HIV epidemic. The proposed study will evaluate the effectiveness of a multi-component intervention to improve IPT uptake across the country of Uganda. The overall objective of this study is to determine if a multi-component implementation intervention (SPIRIT) that targets District Health Officers (DHOs) can increase IPT initiation and completion among HIV-infected persons, and decrease tuberculosis (TB) incidence, as compared to country standard practices, in a cluster randomized trial in Uganda.

NCT ID: NCT03307226 Not yet recruiting - HIV/AIDS Clinical Trials

Suubi4Her: A Combination Intervention Addressing HIV Risk Behaviors Among Older Adolescent Girls Transitioning Into Adulthood in Uganda

Start date: October 15, 2017
Phase: N/A
Study type: Interventional

This study examines the impact and cost associated with Suubi4Her, an innovative combination intervention that aims to prevent HIV risk behaviors among 15-17 year-old girls living in communities heavily affected by poverty and HIV/AIDS in Uganda. Participants will be randomly assigned at the school level into one of three study conditions: 1) Savings (Youth Development Accounts - YDA) - with a 1:1 incentive match rate - for education and microenterprise development; 2) Savings (YDA) + Multiple Family Groups intervention; 3) Control condition receiving standard health and sex education provided in schools. The intervention will last for 24 months. Assessments will be conducted at baseline, 12, 24 and 36 months. Assessments will include biologically confirmed STIs, proportion of HIV infections during the study period, and for HIV+ participants markers for ART adherence. The study aims to examine the impact of the Suubi4Her intervention on behavioral health functioning, and protecting adolescent girls against known HIV risk factors. The study will also examine the cost-effectiveness of each intervention condition.

NCT ID: NCT03302299 Recruiting - Tuberculosis Clinical Trials

Alcohol Drinkers' Exposure to Preventive Therapy for TB (ADEPTT)

ADEPTT
Start date: April 7, 2017
Phase: Phase 4
Study type: Interventional

The Alcohol Drinkers' Exposure to Preventive Therapy for TB (ADEPTT) will examine the safety and tolerability of, and adherence to, 6 months of daily INH (6H) in 300 TB and HIV-infected persons (200 drinkers and 100 non-drinkers) in Uganda. The first aim is to evaluate the safety and tolerability of 6H overall and by level of alcohol use. The second aim is to estimate adherence and compare adherence by level of alcohol use and at 3 and 6 months. Self-reported measures of alcohol use will be augmented by phosphatidylethanol (PEth), an established biomarker of alcohol use. Objective measures of adherence will include electronic pill bottle monitoring and a novel measure of INH exposure, INH concentration in hair. The study will actively monitor for hepatotoxicity using the U.S. standard of care for TB preventive therapy for heavy drinkers and discontinue if any Grade 3/4 toxicities are detected. The investigators will use the safety, tolerability, and adherence results, together with the known efficacy and mortality benefit of TB preventive therapy in HIV-infected persons in SSA, and an established decision analytic model of TB preventive therapy to conduct the third aim: to determine whether the benefits of TB preventive therapy outweigh the toxicity risks for HIV-infected drinkers in resource limited settings. The study will additionally follow the cohort every 6 months after completing INH to monitor drinking and the development of active TB.

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.