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NCT ID: NCT02776748 Completed - Clinical trials for HIV Pre-exposure Prophylaxis During Breastfeeding

PrEP in Breastfeeding Study

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

The purpose of this study is to quantify the magnitude and extent of infant exposure to daily emtricitabine (FTC) /tenofovir disoproxil fumarate (TDF) via maternal breastmilk when taken pre-exposure prophylaxis (PrEP) by lactating HIV-uninfected women. The primary outcome is the steady state concentrations of emtricitabine and tenofovir in the infant plasma.

NCT ID: NCT02775929 Completed - HIV Infection Clinical Trials

Partners Demonstration Project of PrEP and ART

Start date: November 2012
Phase: Phase 4
Study type: Interventional

The purpose of this protocol is to determine user preferences for antiretroviral therapy (ART) for HIV-1 infected partners and pre-exposure prophylaxis (PrEP) HIV-1 un-infected partners and to optimize targeted delivery and sustained use of these interventions.

NCT ID: NCT02774811 Terminated - Glaucoma Clinical Trials

Primary Glaucoma Treatment Trial in Kenya and South Africa - SLT vs. Medication

SLT/med
Start date: February 2014
Phase: N/A
Study type: Interventional

Multi-centre randomised controlled trial of selective laser trabeculoplasty compared with prostaglandin analogue therapy as primary treatment for high tension open angle glaucoma. Participating centres are: Institute of Ophthalmology, UCL, London, UK McCord Hospital, Durban, South Africa Innovation Eye Centre, Kisii, Kenya

NCT ID: NCT02771132 Completed - Clinical trials for Violence, Non-accidental

A Cluster-randomized Trial to Assess a Sexual Assault Prevention Intervention in Adolescents in Nairobi, Kenya

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

The primary objective of this study is to compare the effectiveness of classroom-based behavioral interventions (12-hour girls program and 12-hour boys program), to a standard-of care intervention, on reducing the incidence of self-reported sexual assault among girls from baseline. Secondary objectives of this study is to determine the impact of the interventions on related physical and mental health status/outcomes, STI-risk behaviors, self-efficacy, and self-esteem.

NCT ID: NCT02764528 Withdrawn - Infection Clinical Trials

Intervention Study to Improve Maternal Handwashing

Start date: February 1, 2016
Phase: N/A
Study type: Interventional

The purpose of the handwashing intervention trial is to determine whether an interactive, storytelling approach to promoting handwashing with soap by health care workers can improve mothers' handwashing behavior during the first month of her child's life.

NCT ID: NCT02762851 Recruiting - Heart Failure Clinical Trials

Influenza Vaccine To Prevent Adverse Vascular Events (RCT-IVVE)

RCT-IVVE
Start date: June 2016
Phase: Phase 4
Study type: Interventional

A multi-centre, randomized, placebo controlled, trial. Participants at high-risk for vascular events from the network of INTER- CHF will be randomized to inactivated influenza vaccine or placebo and followed prospectively over three influenza seasons. 5,000 participants will be enrolled prior to influenza season, randomized to either influenza vaccine or saline placebo, either of which they will receive annually for three years and then followed over each of the influenza seasons.

NCT ID: NCT02762617 Terminated - Healthy Clinical Trials

Safety and Pharmacokinetics (PK) of a Polyurethane Tenofovir Disoproxil Fumarate (TDF) Vaginal Ring (TDF IVR-002)

TDF IVR-002
Start date: February 24, 2017
Phase: Phase 1
Study type: Interventional

This prospective, two-site, two-arm, randomized, single-blind, placebo-controlled trial will examine the safety and pharmacokinetics (PK) of a polyurethane tenofovir disoproxil fumarate (TDF) vaginal ring when used continuously for 84 consecutive days by sexually active women. The primary objective is to assess the safety of TDF vaginal rings when used continuously for 84 days by healthy, HIV-uninfected, sexually active women, as compared with a placebo vaginal ring.

NCT ID: NCT02755350 Recruiting - HIV Clinical Trials

Introducing PrEP Into HIV Combination Prevention - Kenya

IPCP-Kenya
Start date: August 2015
Phase: N/A
Study type: Interventional

Daily oral PrEP will be delivered to men who have sex with men (MSM), female sex workers (FSWs) and young women (YW) as part of a defined package of HIV combination prevention intervention for 12 months in 5 sites in Kenya. The project will assess adherence, adverse events, side effects, user satisfaction, cost, facility preparedness and provider competencies. PrEP eligibility and screening tools for MSM, YW and FSWs will be piloted and validated. Pregnant women will be enrolled in a sub-group and followed through 12 months post- partum to measure mother and infant outcomes that include health status, birth outcomes, birth defects, risk behavior and PrEP adverse effects. With lessons from initial PrEP studies in West and Central Africa, this project will apply good participatory practice guidelines through 1) continuous engagement with communities of FSWs, YW and MSM and 2) development and use of a communication engagement and advocacy strategy that will provide correct information, address attitudes and concerns whilst increasing demand for PrEP uptake. The actual cost of delivering HIV combination prevention which includes PrEP will also be assessed and cost effectiveness modeled.

NCT ID: NCT02746276 Active, not recruiting - Malnutrition Clinical Trials

Optimising Antibiotic Treatment for Sick Malnourished Children

FLACSAM-PK
Start date: April 1, 2016
Phase: Phase 2
Study type: Interventional

Children with severe malnutrition who are admitted sick to hospitals have a high mortality, usually because of infection. All children with severe malnutrition admitted to hospitals are treated with antibiotics. However, policymakers are not sure that the current antibiotics are the most effective. It is possible that the antibiotics that are currently used as second-line should be used first. Finding this out will need a large trial comparing different antibiotics. To prepare for such a trial the investigators first want to make sure that the doses given are correct for malnourished children. The investigators also want to check whether malnourished children more commonly carry resistant bacteria in their feces than well-nourished children. The study is important because the types of antibiotics and the doses needed to fight infection may be different in malnourished children because of the changes in their body due to malnutrition and the types of bacteria present.

NCT ID: NCT02739763 Recruiting - Malaria Clinical Trials

Controlled Human Malaria Infection in Semi-Immune Kenyan Adults. (CHMI-SIKA)

CHMI-SIKA
Start date: May 2016
Phase: Phase 1
Study type: Interventional

The investigators wish to understand how resistance to malaria develops and how this affects the growth rate of malaria in individuals who have past exposure to malaria.