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NCT ID: NCT03774602 Recruiting - Clinical trials for Knowledge, Attitudes, Practice

Evaluation of the Maternal and Child Survival Program (MCSP) in Mozambique Using Mixed Methods

Start date: November 22, 2018
Phase: N/A
Study type: Interventional

This study evaluates changes in knowledge, attitudes, practices and coverage of key reproductive, maternal, newborn, and child health (RMNCH) areas, including malaria, family planning (FP), nutrition, water, sanitation and hygiene (WASH), and gender equity among the population in Nampula and Sofala provinces targeted by the Maternal and Child Survival Program (MCSP) in Mozambique.

NCT ID: NCT03761836 Not yet recruiting - Circumcision, Male Clinical Trials

Evaluation and Adverse Event Surveillance for Initial Implementation of ShangRing Circumcision in Mozambique

Start date: March 2019
Phase: N/A
Study type: Interventional

This is a single-arm interventional study of 1000 male circumcision procedures using the ShangRing device. The primary objective of the study is to enhance understanding of the potential clinical and operational challenges and opportunities that may be associated with widespread use of ShangRing™ device for circumcision in different settings in Mozambique. Specific objectives are: 1) To monitor the proportion of men who choose circumcision through the WHO-prequalified, FDA-approved ShangRing™ device in routine voluntary medical male circumcision (VMMC) service delivery settings where standard surgical methods of circumcisions are available; and 2) To ensure safety during initial implementation of the ShangRing™ device and confirm that adverse event rates are comparable to those found during implementation in other sub-Saharan countries.

NCT ID: NCT03734172 Not yet recruiting - Tuberculosis Clinical Trials

Rapid and Accurate Diagnosis of Paediatric (RaPaed) TB - An AIDA (Assessment of Innovative Diagnostics and Algorithms for Early and Sensitive Detection of Acute TB) Platform Study

Start date: January 7, 2019
Study type: Observational

This study will serve as a platform to evaluate new diagnostics in children suspected to have TB, to establish diagnostic performance (sensitivity and specificity) and calculation of positive and negative predictive values in a real-life cohort. Finally, this study will comprise results of several tests in its database. This will allow simulation of diagnostic algorithms, that may be composed of screening (i.e. rule-out) tests together with confirmatory tests to maximize sensitivity and specificity.

NCT ID: NCT03671109 Not yet recruiting - Malaria Clinical Trials

Improving Maternal heAlth by Reducing Malaria in African HIV Women

Start date: February 2019
Phase: Phase 3
Study type: Interventional

Trial to evaluate the safety and efficacy of DHA-PPQ for Intermittent Preventive Treatment (IPTp) in HIV-infected pregnant women receiving cotrimoxazole prophylacis (CTXp) and antieretoviral (ARV) drugs and using long lasting insecticide treated nets will be conducted in Mozambique and Gabon where malaria and HIV infection are moderate to highly prevalent. In addition, the possibility for a PK interaction between DHA-PPQ and ARV drugs will be assessed in a sub-sample of participants. Women will receive ARV therapy according to national guidelines and their infants will be followed until one year of age to evaluate the impact of DHA-PPQ on MTCT-HIV.

NCT ID: NCT03618511 Recruiting - Clinical trials for Human Immunodeficiency Virus (HIV) Infection

Interventions to Improve HIV Antiretroviral Therapy Adherence

Start date: August 6, 2018
Phase: N/A
Study type: Interventional

This study will explore whether financial incentives and reminders help improve anti-retroviral therapy (ART) adherence among HIV infected individuals in a resource-limited environment. The interventions will be randomized in the study population in a cross-cutting design, with a control group, a financial incentive treatment group, a reminder phone call treatment group, and a treatment group that receives both reminder calls and a financial incentive. This design allows estimation of complementarities between the two interventions. The primary outcomes of interest for this study will be the adherence to ART, measured by attendance rates at clinic appointments and refill collection rates.

NCT ID: NCT03610815 Not yet recruiting - Clinical trials for SBIRT-CTS - Screening, Brief Intervention, Referral to Treatment Conventional Training and Supervision Strategy

Community I-STAR Mozambique: Community Implementation of SBIRT Using Technology for Alcohol Use Reduction in Mozambique

Start date: July 1, 2019
Phase: Phase 4
Study type: Interventional

Hazardous drinking (HD) is a major public health burden worldwide with significant morbidity and mortality. To reduce HD, the World Health Organization (WHO) recommends using Screening, Brief Intervention, Referral to Treatment (SBIRT). Mobile health technology (mHealth), such as the mSBIRT app, is a promising tool for widespread cost-effective delivery of evidence-based HDS by community health workers (CHWs) because of its potential to increase fidelity, effectiveness, and sustainability. Community I-STAR Mozambique comprises three phases: 1) mSBIRT adaptation, 2) a cluster-randomized trial, and 3) scale-up of the most cost-effective intervention. Community I-STAR Mozambique will scale-up a cost effective, sustainable program and inform policy applicable to Mozambique and other LMICs.

NCT ID: NCT03610750 Not yet recruiting - Clinical trials for Severe Mental Disorder

Training Providers to Conduct PRIDES-sSA

Start date: December 1, 2018
Phase: Phase 4
Study type: Interventional

Global mental health (MH) and substance use disorders prevention, treatment and research gaps require that efficacious treatments be scaled-up, leveraging existing platforms. In tandem, participation of Ministries ready to apply evidence-inform policies must sustain them over time. PRIDE SSA may generate templates for other low- and middle-income countries (LMICs) by conducting a state of the art scale up study in Mozambique and by establishing a collaborative research network of nascent research "Seed Teams." Such "Seed Teams," trained by the capacity building component, may work across the region to build capacity and conduct implementation research to sustainably scale-up MH services. Scale Up Research (Mozambique) in MH and substance use disorders will evaluate strategies and costs of scaling up an innovative, integrated, sustainable, stepped-care community approach. The scale up study will leverage: (1) Mozambique's task-shifting strategy of training psychiatric technicians (PsyTs) to provide MH care, (2) the WHO-funded epilepsy community care program successfully implemented in 5 Provinces, now primed for scale-up by the Health Ministry. The cost-effective approach redefines work roles without requiring new human resources. Importantly, it comports with the Health Ministry's plan to implement prevention and treatment for all MH conditions, rather than single disorders. The model employs evidence-based practices (EBPs; e.g. Psychopharmacology; Interpersonal Therapy), already in use by PsyTs to: a) establish a sustainable program delivered and supervised by non-MH professionals, overseen by MH specialists; b) provide community screening, care and/or referrals for all MH disorders; and c) use implementation tools to monitor sustainability. This collaborative network will scale-up a cost-effective, sustainable program and inform policy.

NCT ID: NCT03600844 Recruiting - Clinical trials for Malaria in Pregnancy

Evaluating the Effects of Community Delivery of Malaria Intermittent Preventive Treatment on Pregnant Women and Babies

Start date: April 2, 2018
Phase: N/A
Study type: Interventional

This study evaluates the effectiveness of community delivery of sulfadoxine-pyrimetamine (SP) for intermittent preventive treatment of malaria in pregnancy (IPTp) in increasing the coverage of IPTp among pregnant women in selected districts in Democratic Republic of Congo (DRC), Madagascar, Mozambique and Nigeria, compared to comparison districts where SP for IPTp is distributed as usual in facilities through routine antenatal care (ANC).

NCT ID: NCT03425136 Recruiting - HIV Clinical Trials

Systems Analysis and Improvement Approach for Prevention of MTC HIV Transmission

Start date: February 1, 2018
Phase: N/A
Study type: Interventional

Optimizing the prevention of mother-to-child HIV transmission cascade minimizes drop offs from one step to the next to maximize the benefits of antiretroviral therapy on maternal health and pediatric survival, growth, and development. This proposal scales-up a health systems intervention (the systems analysis and improvement approach - SAIA) that packages systems engineering methods (including cascade analysis, flow mapping, and continuous quality improvement) and was previously shown to be effective in improving the prevention of mother-to-child HIV transmission cascade. By spreading the SAIA through routine district management structures, and studying the implementation process, this study will build evidence on how to achieve rapid, sustainable and scalable improvements in services that can dramatically improve population health in resource limited countries.

NCT ID: NCT03313128 Recruiting - Clinical trials for Rotavirus Infections

SaniVac Trial - Sanitation and Oral Rotavirus Vaccine Performance

Start date: October 1, 2017
Phase: N/A
Study type: Observational

This is a controlled cohort study to assess the effect of improved sanitation on oral rotavirus vaccine performance in low-income urban neighbourhoods of Maputo, Mozambique. The specific hypotheses are that: (1) access to improved sanitation is associated with increased oral rotavirus vaccine immunogenicity; (2) enteric infection concurrent to oral rotavirus vaccination is associated with reduced oral rotavirus vaccine immunogenicity; and (3) Environmental Enteric Dysfunction is associated with reduced oral rotavirus vaccine immunogenicity. Pregnant women will be enrolled from the intervention and control arms of a previous sanitation trial (NCT02362932) post-intervention and will be enrolled at no later than eight months' gestation and then followed to 4 months of age of the infant. Blood samples and faeces will be taken from the infant at the time of administration of the first dose of the oral rotavirus vaccine and four weeks after the second dose of the vaccine. The primary outcome of interest in the study is oral rotavirus vaccine immunogenicity among participating vaccinated infants. Seroconversion is defined as a ≥ fourfold rise in serum anti-rotavirus IgA titers between first dose of oral RV vaccine and 4 weeks (+/- 1 week) after second dose of oral RV vaccine. Enteric infections are defined as the presence of ≥ 1 of the following enteric infections in stool: adenovirus 40/41, rotavirus A, norovirus GI/GII, Salmonella spp. (including serovars Typhi and Paratyphi), Campylobacter spp. (C. jejuni, C. coli, C. lari), Shigella spp. (S. boydii, S. sonnei, S. flexneri, S. dysenteriae), Clostridium difficile Toxin A/B, enterotoxigenic Escherichia coli (ETEC) LT/ST, E. coli O157, Shiga-like toxin-producing E. coli (STEC) stx1/stx2, Yersinia enterocolitica, Vibrio cholerae, Giardia lamblia, Entamoeba histolytica, and Cryptosporidium spp. (C. parvum, C. hominis). Environmental Enteric Dysfunction is measured via a combined disease activity score including faecal markers of intestinal inflammation and permeability: neopterin, α-1 antitrypsin, and myeloperoxidase in stool.