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NCT ID: NCT03088410 Recruiting - Diabetes Mellitus Clinical Trials

Study of HIV-Infected and Uninfected Pregnant Woman/Child Dyads in Gabarone, Botawana

MOCHA
Start date: April 1, 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the early longitudinal metabolic effects including insulin sensitivity in HIV-exposed uninfected (HEU) children compared to HIV-unexposed uninfected (HUU) children; as well as to determine differences in the effects of neonatal zidovudine (AZT) vs. nevirapine (NVP) prophylaxis on early longitudinal changes in insulin sensitivity in the first 3 years of life.

NCT ID: NCT03048422 Not yet recruiting - HIV Infections Clinical Trials

Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants

VESTED
Start date: November 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the virologic efficacy and safety of three antiretroviral (ARV) regimens in HIV-1-infected pregnant women and to compare the safety of these regimens for their infants.

NCT ID: NCT02803827 Recruiting - Clinical trials for Acute Gastroenteritis

Optimizing the Management of Acute Diarrhoeal Disease

Start date: June 2016
Phase: Phase 3
Study type: Interventional

Many children admitted to hospital in Botswana without bloody diarrhoea are presumed to have viral gastroenteritis and so not treated with antibiotics - but they may indeed have a treatable cause for their illness. The investigators will conduct a randomized trial to see if rapid testing using novel methods to identify potentially treatable causes of diarrhoea leads to improved outcomes. The investigators will also be randomizing children to Lactobacillus reuteri DSM (daughter strain) 17938 therapy versus placebo (the standard of care) to see if this treatment decreases the duration of diarrhoea. The proposed study is a large multi-centre trial following the previous pilot trial.

NCT ID: NCT02752061 Enrolling by invitation - HIV Clinical Trials

Potlako: A Programmatic Intervention to Improve Access to Timely Oncology Care

Start date: April 2016
Phase: N/A
Study type: Interventional

Diagnostic and treatment delays contribute substantially to disparities in cancer morbidity and mortality between low- and middle- income countries (LMICs) and high-income countries. Individuals present with advanced stage disease resulting in minimal chance for cure or long-term survival. The Potlako project will implement and evaluate a multifaceted intervention to test the hypothesis that a package of enhanced coordination of care including an electronic messaging, transportation support, and training targeted at generalist clinicians at primary and secondary level facilities, can reduce time to diagnosis and stage at diagnosis for HIV-infected individuals with cancer.

NCT ID: NCT02581527 Recruiting - Clinical trials for Pulmonary Tuberculosis

A Randomised Trial to Evaluate Toxicity and Efficacy of 1200mg and 1800mg Rifampicin Daily for 4 Months for Pulmonary Tuberculosis

RIFASHORT
Start date: February 1, 2017
Phase: Phase 3
Study type: Interventional

In this trial, the investigators are assessing whether giving an increased dose of rifampicin to patients receiving the standard treatment for tuberculosis is safe and, when given for 4 months only, will also result in greater and faster killing of the tubercle bacillus in the lungs and result in relapse rates similar to those found in the World Health Organisation (WHO) recommended standard 6 month regimen.

NCT ID: NCT02568215 Recruiting - HIV Infections Clinical Trials

Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection in Women

Start date: May 2016
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection in high-risk, HIV-uninfected women.

NCT ID: NCT02538952 Active, not recruiting - Tuberculosis Clinical Trials

Evaluating Accuracy, Impact, and Operational Challenges of GeneXpert Use for TB Case Finding Among HIV-infected Persons

XPRES
Start date: July 2012
Phase: Phase 4
Study type: Interventional

Background: In Botswana, as in the rest of sub-Saharan Africa, undiagnosed TB or TB diagnosed late in the course of disease is thought to be the most common cause of death among HIV-infected persons. Interventions for Evaluation: The Xpert MTB/RIF assay for the GeneXpert platform (Xpert) has a TB diagnostic sensitivity of 82.4%, significantly superior to that of smear microscopy (44.6%). In line with WHO guidelines, the Botswana Ministry of Health (MOH) and CDC rapidly rolled out the Xpert device and a new Xpert-based diagnostic algorithm in service of 22 HIV care and treatment clinics. To maximize impact of the Xpert device in improving detection of active TB, Xpert rollout was preceded by strengthening of TB screening procedures by: (1) adopting the WHO-recommended 4-symptom TB screen for adults; (2) situating trained TB case-finding nurses in facilities; and (3) training health facility personnel in TB diagnostic algorithms. The combination of these strengthened TB screening procedures and rollout of the Xpert device is referred to as the "Xpert package" in this protocol. Key Evaluation Objectives: The protocol has two key objectives: (1) to evaluate whether the new MOH-recommended Xpert-based TB diagnostic algorithm for new adult HIV clinic enrollees is more sensitive than the pre-Xpert smear-microscopy-based algorithm in diagnosing culture-positive TB disease; and (2) to evaluate the impact of the whole "Xpert package" on all-cause mortality during the first 6 months of ART, among adult patients. Design: Stepped-wedge cluster randomized trial. Sample Size: 6,136 patients were prospectively enrolled to meet the first primary objective. A retrospective cohort of 10,131 persons was also enrolled to meet the second objective. Projected power to meet both objectives is >80%. Time line: Prospective cohort enrollment started in July 2012 and was complete by March 2014. Retrospective cohort enrollment was complete by March 2015. Patient follow-up and data entry will be complete in March 2016 at which time analysis to answer the first two primary study questions will be possible.

NCT ID: NCT02455583 Active, not recruiting - HIV Clinical Trials

An Assessment of an HIV Prevention Intervention (Project AIM) Among Junior Secondary School Students in Eastern Botswana

AIM
Start date: August 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the effectiveness of an HIV prevention intervention called Project AIM (Adult Identity Mentoring) to delay onset of sexual activity and reduce sexual risk behaviors among students (approximate ages 12- 17 years) in junior secondary schools (Form 1 - 3) in Eastern Botswana.

NCT ID: NCT02412436 Recruiting - Tuberculosis Clinical Trials

PK Study of Rifampicin Interactions With DMPA and Efaviranz in TB

PRIDE-HT
Start date: September 2015
Phase: Phase 2
Study type: Interventional

This study is being done to evaluate the effect of HIV and TB treatment on a commonly used birth control method. This study is being done on women who are infected with HIV and TB and are taking efavirenz (EFV; Sustiva®; an anti-HIV medication), rifampicin (RIF; an anti-TB medication) and isoniazid (INH; an anti-TB medication). The purpose of this study is to find out the best schedule to give depot medroxyprogesterone acetate (DMPA; a hormonal birth control method that is given as a shot every 3 months) in women with HIV and TB who are also taking EFV and RIF. This study will also try to find out if a 150 mg injection of DMPA is effective in preventing ovulation, the process by which the ovaries (the ovaries are part of the female reproductive system) release an egg for fertilization, for 12 weeks in women who are taking EFV and RIF. Another purpose of this study is to find out if it is safe to take RIF, EFV and DMPA at the same time.

NCT ID: NCT02369406 Recruiting - HIV Clinical Trials

Early Infant HIV Treatment in Botswana

EIT
Start date: February 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The overall objective of this study is to determine whether very early antiretroviral treatment (ART) initiation in HIV-infected infants limits the seeding of viral reservoirs and maintains immune responses, potentially allowing future periods off ART.