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NCT ID: NCT03529409 Not yet recruiting - Clinical trials for Human Immunodeficiency Virus

Effectiveness & Implementation of a Behavioral Intervention for Adherence and Substance Use in HIV Care in South Africa

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

The purpose of this study is to test the effectiveness and implementation of a brief, integrated behavioral intervention for HIV medication adherence and substance use in the HIV care setting in South Africa. The intervention is specifically designed to be implemented by non-specialist counselors using a task sharing model in local HIV clinics. The behavioral intervention will be compared to usual care, enhanced with referral to a local outpatient substance use treatment program (Enhanced Standard of Care - ESOC) on study endpoints (as described in study endpoint section below).

NCT ID: NCT03519503 Recruiting - Clinical trials for Growth and Development

Infant Peri-Exposure Prophylaxis to Prevent HIV-1 Transmission by Breastfeeding: Mechanisms & Safety

Start date: February 27, 2017
Study type: Observational

General objective - To assess the long-term safety and efficacy of one-year infant prophylaxis using lamivudine (3TC) or lopinavir/ritonavir (LPV/r) to prevent post-natal transmission through breastfeeding. - To investigate the biological mechanisms involved in postnatal HIV transmission. Specific objectives - To compare the long-term safety of infant prophylaxis using either 3TC versus LPV/r on child development (growth, somatic and mental health), mortality, adrenal function, liver function, full blood count and mitochondrial toxicity. - To estimate the final efficacy data of 50 weeks of infant prophylaxis using either LPV/r or 3TC, since some mothers may have resumed breastfeeding after the trial. - To profile miRNA in breast milk according to maternal HIV status and HIV transmission. - To determine the influence of maternal milk on infant gut inflammation in an in vitro 3D-intestinal model (CACO-2 cells). The study population will comprise all ANRS 12174 PROMISE-PEP trial participants who completed the 50 week follow-up and are not HIV infected. An estimate of 881 mother-child pairs from the ANRS 12174 PROMISE- PEP will be recruited. This study is structured in two parts. The 'clinical & biological safety' component involves a cross sectional survey. A clinical and neuropsychological examination of participants will be conducted. In addition one venous blood sample will be collected to evaluate children HIV status, full blood count, liver & adrenal function and mitochondrial toxicity. Capillary hair follicles will be collected from 100 children in Zambia to study their genome integrity. The 'mechanisms' component includes biological assays to be conducted on breast milk samples previously collected from HIV infected, transmitting or non-infected mothers enrolled at ANRS 12174 PROMISE-PEP trial. Primary endpoint: Long term survival, mortality rate, measurements of infant growth (length and weight), somatic and neuropsychological development of the 5 year old children enrolled in the ANRS 12174 PROMISE- PEP trial. Secondary endpoints: HIV seroconversion since last PROMISE PEP trial visit, full blood count, liver function, adrenal function, serum lactate. Number of mitochondrial DNA copies per cell & percentage of mitochondrial DNA deletion for mitochondrial toxicity. Number of micronuclei & number of Ɣ-tubulin spot per cell to study genomic toxicity.

NCT ID: NCT03517878 Active, not recruiting - HIV Infections Clinical Trials

Evaluation of a Home-based Community Health Worker Program in Rural Eastern Cape, South Africa

Start date: August 11, 2014
Study type: Observational

The purpose of this early Phase 2 comparison trial is to evaluate the impact of community health worker (CHW) home visitors on pregnant women and their children in a rural setting in the rural Eastern Cape of South Africa. The intervention provided by the CHWs targets underweight children, mothers living with HIV (MLH), mothers using alcohol, and depressed mothers with the goal of supporting pregnant women to improve birth outcomes, decrease the number of children born with a low birthweight, and develop child caretaking skills over time. UCLA has identified and matched four areas surrounding primary health care clinics: two intervention areas in which this CHW program has been running for one year, and two control areas without the program. Mothers in the research area are followed for one year after giving birth.

NCT ID: NCT03517722 Recruiting - Clinical trials for Lupus Erythematosus, Systemic

A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus

Start date: April 16, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard of care treatments.

NCT ID: NCT03512249 Not yet recruiting - Clinical trials for Tuberculosis, Pulmonary

A Phase 2, Double-blind, Randomized, Placebo-Controlled Study to Evaluate Prevention of Recurrence (POR)

Start date: September 30, 2018
Phase: Phase 2
Study type: Interventional

This is a phase 2, double-blind, randomized (1:1), placebo-controlled trial with two parallel groups. - H56:IC31 (investigational vaccine) - Placebo 900 HIV-negative adults with a diagnosis of drug susceptible pulmonary TB are planned to be included, recruited from TB clinics with established relationships to the trial sites at the start of their TB treatment. 4 trial sites are planned in South Africa (ZA): 1 site in Klerksdorp at the Aurum Institute and 3 sites in Cape Town at TASK, UCT Lung Institute and SATVI. 1 trial site is planned in Tanzania (TZ): 1 site in Mbeya at NIMR.

NCT ID: NCT03512080 Not yet recruiting - Clinical trials for Cardiovascular Diseases

Warfarin Anticoagulation in Patients in Sub-Saharan Africa

Start date: May 2018
Study type: Observational

This research programme aims to translate expertise in warfarin anticoagulation from resource-rich to low and middle income countries (LMIC)settings with the goal of improving patient health outcomes. An observational study which will be used to develop warfarin dosing algorithms - the ultimate aim will be to ascertain whether these algorithms increase time in the therapeutic range, reduce bleeding and thrombotic risks, and clinic visits for International Normalised ratio (INR) monitoring. Two algorithms will be developed: the first will take into account clinical and geographical factors ("clinical algorithm"), while the second will also incorporate genetic factors in addition to the clinical and geographical factors ("genetic algorithm"). Patients will be recruited from sites in rural and urban Uganda, and in Cape Town, South Africa, to develop a clinical dosing algorithm. It is important to note that there is a wealth of literature data which will be used to define the clinical data that needs to be collected from these patients. To identify genetic factors in African patients, Genome-wide Association Study (GWAS) will be undertaken and any novel factors incorporated into the genetic algorithm - the percentage variation in warfarin dosing explained by the genetic algorithm will be compared with the clinical algorithm.

NCT ID: NCT03507738 Not yet recruiting - Healthy Clinical Trials

Safety and Immunogenicity of MT-5625 in Healthy Adults, Toddlers and Infants

Start date: July 2018
Phase: Phase 1
Study type: Interventional

A study to investigate the safety and reactogenicity of MT-5625 independently in adults aged 18-35 years, toddlers ages 12-24 months, and infants aged 6-10 weeks

NCT ID: NCT03505047 Not yet recruiting - Contraception Clinical Trials

Immediate Versus Delayed IUD Insertion After Second Trimester Medical Abortion

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

The main objective of the study is to compare use, in a randomised controlled trial, of the the copper IUD if inserted immediately after completion of a second trimester medical abortion, to standard care with insertion 3-4 or more weeks after abortion at community health centres.

NCT ID: NCT03496493 Recruiting - Anesthesia Clinical Trials

COMparison of Portable Fingertip Versus Conventional Pulse OximeteRs Trial

Start date: April 15, 2018
Study type: Observational

Perioperative non-invasive measurement of a patient's peripheral arterial oxygen saturation has become an accepted standard of care endorsed by anaesthesiologists and their regulatory bodies throughout the world. Pulse oximeters are an integral item on the World Health Organisation's Surgical Safety Checklist which is performed prior to the commencement of every surgical procedure. They are also utilised by other medical professionals and patients in various scenarios. When compared to conventional bedside pulse oximeters, portable fingertip devices have the advantages of cost-effectiveness, high portability, ease of use and battery operation. A review of recent literature reveals a paucity of accuracy studies in adult patients with various comorbidities in the clinical setting. Most data has been obtained under ideal laboratory conditions utilizing healthy adult volunteers. This study aims to pragmatically investigate the performance of a portable fingertip pulse oximeter in adult patients in a hospital setting.

NCT ID: NCT03490058 Recruiting - HIV/AIDS Clinical Trials

The Prevention Options for Women Evaluation Research (POWER) Cohort

Start date: June 14, 2017
Study type: Observational

The POWER Cohort study is a PrEP implementation project to demonstrate Pre-exposure prophylaxis (PrEP) delivery for young women in Cape Town and Johannesburg, South Africa and Kisumu, Kenya.