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NCT ID: NCT02589678 Completed - High Risk for HIV Clinical Trials

Zambia SiVET MMR Tdap-IPV

SiVET
Start date: August 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Participants will receive vaccination for measles, mumps, and rubella (MMR) and tetanus, diphtheria, pertussis, and inactivated polio (Tdap-IPV). The study schedule design is to simulate a vaccine efficacy trial to see if single women can participate in studies that mimic actual HIV vaccine studies.

NCT ID: NCT02550067 Completed - HIV Clinical Trials

The Evidence for Contraceptive Options and HIV Outcomes Trial

ECHO
Start date: December 14, 2015
Phase: N/A
Study type: Interventional

The ECHO Study is an open-label randomized clinical trial that will compare three highly effective, reversible methods of contraception (including a non-hormonal method) to evaluate whether there is a link between use of any of these methods and increased risk of acquiring HIV infection. A randomized clinical trial among about 7,800 women in four countries, ECHO will deliver evidence to support and guide individual, policy and programmatic decisions on contraception for women at risk of acquiring HIV infection.

NCT ID: NCT02516852 Completed - Malnutrition, Child Clinical Trials

Assessing the Effect of Sustainable Small-scale Egg Production on Maternal and Child Nutrition in Rural Zambia

Start date: June 2014
Phase: N/A
Study type: Interventional

Animal source foods (ASF), such as meat and eggs, are rich in nutrients critical for growth and development. Yet, for poor children in developing countries, ASF consumption is limited by cost, inadequate caregiver knowledge, and lack of local production and physical availability. The impact of HH- and village-level livestock interventions on household dietary diversity and nutritional status in resource-poor communities is not well established. The objective of this study is to test the effectiveness of local egg production intervention on maternal and child diets and child nutrition status. This project takes place in the Luangwa Valley, Zambia in partnership with a local non-governmental organization, COMACO. Twenty communities will be assigned to the intervention, and 20 matched communities will be selected as controls. In each intervention community, an egg production facility will be built, owned, and operated by trained COMACO farmers. Households (HHs) in each community will be sampled twice annually for 1 year pre-intervention (baseline) and 1 year post-intervention to assess dietary diversity and nutritional status. Data analysis will test for a change in these outcomes from baseline in each intervention community compared to the matched control community.

NCT ID: NCT02459678 Completed - Clinical trials for Human Immunodeficiency Virus

ART Readiness in HIV-infected Pregnant Women

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

This study seeks to evaluate the readiness of HIV-infected pregnant women in Zambia to initiate, adhere to, and be retained in care under the Ministry of Health's Option B+ policy. Under a 3-phased research study the investigators will: (1) conduct formative research regarding readiness to start lifelong ART in the pregnant population; (2) translate the results of formative research into a readiness assessment tool and an enhanced adherence package for pregnant women eligible for Option B+ and (3) conduct an individual randomized trial of the enhanced adherence package.

NCT ID: NCT02445846 Completed - HIV Clinical Trials

Dual Rapid HIV & Syphilis Tests in Zambia

Start date: May 2014
Phase: N/A
Study type: Observational

The purpose of this study is to provide evidence on the performance and operational characteristics of commercially available dual HIV/syphilis Rapid Diagnostic Tests (RDTs) in Zambia for their introduction into antenatal care and other settings.

NCT ID: NCT02409680 Completed - Premature Birth Clinical Trials

Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN)

ASPIRIN
Start date: March 23, 2016
Phase: N/A
Study type: Interventional

Available data suggest that low dose aspirin may be a safe, widely available and inexpensive intervention that may significantly reduce the risk of preterm birth. However, this possibility needs to be proven in a properly designed randomized controlled trial (RCT) with preterm birth as the primary outcome. Such a clinical trial in a racially, ethnically and geographically diverse population could best be accomplished by the established infrastructure of the Global Network for Women's and Children's Health Research (GN).

NCT ID: NCT02386592 Completed - Neonatal Sepsis Clinical Trials

Prevention of Nosocomial Bacteremia Among Zambian Neonates

Start date: September 1, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to estimate the burden of disease, identify risk factors associated with nosocomial bacteremia among neonates and assess the efficacy of low-cost measures targeted to known and suspected nosocomial BSI (bloodstream) risk factors, the investigators propose to study the impact of a novel package of infection control interventions on nosocomial bacteremia and mortality among neonates at a tertiary care center in sub-Saharan Africa.

NCT ID: NCT02353117 Completed - Congenital Syphilis Clinical Trials

Preventing Congenital Syphilis

PCS
Start date: January 11, 2016
Phase: N/A
Study type: Interventional

Nearly 1.5 million pregnant women are infected with syphilis each year, and it is estimated that half of them will have adverse birth outcomes. Congenital syphilis remains a major public health issue, despite the fact that maternal syphilis is easy to detect and treat. Multiple barriers impair the elimination of congenital syphilis. Syphilis is often stigmatized and of low priority, and even women attending prenatal care early are potentially facing multiple clinical barriers. The study objective is to use implementation research methods to evaluate a multifaceted intervention to increase the use of evidence-based clinical procedures to prevent congenital syphilis. The investigators will perform a facility-based, two-arm parallel cluster randomized implementation trial in the Democratic Republic of the Congo and Zambia. The intervention will be multifaceted, tailored by formative research, and include: opinion leaders, reminders, monitoring, and feedback; point-of-care rapid tests; and treatment kits to be used immediately if the rapid test is positive. Improving syphilis screening and treatment will be promoted as a key step toward improving the quality of all components of prenatal care.

NCT ID: NCT02342886 Completed - Clinical trials for Tuberculosis, Pulmonary, Multi Drug-resistant

Shortening Treatment by Advancing Novel Drugs

STAND
Start date: February 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy, safety and tolerability of a combination of moxifloxacin, PA-824, and pyrazinamide treatments with varying doses and treatment lengths from 4 to 6 months in subjects with drug-sensitive (DS) pulmonary TB compared to standard HRZE treatment. This study will also assess the efficacy, safety and tolerability of a combination of moxifloxacin, PA-824, and pyrazinamide treatments after 6 months of treatment in subjects with multi drug-resistant (MDR) pulmonary TB compared to a combination of moxifloxacin, PA-824, and pyrazinamide treatments in DS-TB subjects.

NCT ID: NCT02329301 Completed - Malaria Clinical Trials

Mass Drug Administration With Dihydroartemisinin + Piperaquine for Reducing Malaria in Southern Zambia

Start date: September 2014
Phase: N/A
Study type: Interventional

To quantify the relative effectiveness, cost, and cost-effectiveness of fMDA and MDA with DHAp against no mass treatment for reducing P. falciparum parasite prevalence, confirmed OPD malaria case incidence and cohort infection incidence in areas of high and low malaria transmission and in a program-relevant manner that will permit adoption and adaptation for wider-scale deployment.