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Africa clinical trials

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NCT ID: NCT05358795 Recruiting - HIV Clinical Trials

Family Connections Cluster RCT in Zambia

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

This study will evaluate the impact of Family Connections, a family-based group intervention for adolescents and young adults (AYA) living with HIV and their family caregivers, on AYA viral status. The intervention seeks to increase social and family support and decrease self-stigma among AYA, so they may improve their medication adherence and achieve an undetectable viral load. Findings will fill a critical gap in available evidence-based intervention options for improving the HIV-related outcomes and wellbeing of HIV-positive AYA in sub-Saharan Africa.

NCT ID: NCT04847817 Completed - Clinical trials for Coronavirus Infection

Important Data on COVID-19 Profile in Africa

AIDCO
Start date: August 1, 2020
Phase:
Study type: Observational

The purpose of this study is to Understand the natural history of Coronavirus 2019 (COVID-19) infection to better define the period of infectiousness and transmissibility and to establish biobanks of COVID-19 blood and mucosal samples.

NCT ID: NCT04442399 Completed - HIV Clinical Trials

Family Connection: Pilot of Family-based Self-management for HIV-infected Adolescents

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

The study design has two phases. The first phase is the refinement of intervention manual for an adolescent living with HIV (ALHIV)and their caregiver intervention, followed by a second phase feasibility pilot study. The study goals are to refine and pilot a feasible intervention that fosters resiliency and draws upon the strengths of adolescents and their families. Specific aims include to: (1) Refine activities and an intervention manual for a family-focused group intervention for adolescents and their caregivers to improve HIV self-management among adolescents living with HIV; (2) conduct a pilot study to assess the acceptability and feasibility of the group intervention among 50 adolescent/caregiver pairs that are randomly assigned to the intervention or the comparison arms, and (sub aim 2a) examine preliminary trends in outcome measures, including Anti-Retroviral Therapy (ART) adherence, safer sex behaviors and stigma, comparing the intervention and comparison study arms.

NCT ID: NCT04029207 Enrolling by invitation - Cesarean Section Clinical Trials

The ASOS-2 Trial Maternal Mortality Sub-study

Start date: May 6, 2019
Phase:
Study type: Observational

This sub-study is a mixed-methods analysis of a prospective case-series of maternal deaths within the African Surgical OutcomeS-2 trial cohort. The aims of the sub-study are i) to describe the contextual factors that contribute towards maternal deaths after caesarean delivery in Africa using a conceptual framework of "transport-treatment-training" and ii) to classify the maternal deaths in the ASOS-2 trial according to the WHO ICD-10 maternal mortality reporting standard. Data will be extracted from the ASOS-2 trial database. A sub-study case report form (CRF) and semi-structured telephonic interviews will be used to gather additional information from clinicians who were experienced a maternal death during the trial.

NCT ID: NCT03751475 Completed - Clinical trials for Severe Acute Malnutrition

Optimizing Acute Malnutrition Management in Children Aged 6 to 59 Months in Democratic Republic of Congo

OptiMA-DRC
Start date: July 22, 2019
Phase: N/A
Study type: Interventional

Acute malnutrition affects 51 million children under the age of 5 worldwide. Malnutrition contributes to nearly half of all child deaths each year, with the forms characterized by wasting or oedema (acute malnutrition) associated with the highest risk of death. Although acute malnutrition is a continuum condition, it is arbitrarily divided into severe and moderate acute malnutrition (SAM, MAM) which are managed separately, with programs overseen by different UN agencies, and using different protocols and products. Such separation complicates delivery of care, contributes to high default and low coverage, and creates confusion among caregivers. Often treatment is only available for SAM children resulting in lives lost and costly hospitalisation that could be averted if nutritional support were available earlier in the wasting process. If we are to reduce the health and mortality burden from malnutrition, the effectiveness and cost-effectiveness of current protocols need dramatic improvements. The dosage of Ready to Use Therapeutic Food (RUTF) for SAM (130-200 kcal/kg/d) has not changed since introduction of out-patient protocols in the mid-2000s. Children classified as SAM in these protocols are determined by three independent criteria: the presence of nutritional oedema or MUAC < 115 mm or weight-height Z score <-3. The RUTF dosage in these protocols is paradoxical in that the absolute amount of RUTF prescribed in the initial phases of treatment is often less than that given as the child nears recovery, because the number of packets in the weekly ration is determined by weight. However, rate of weight gain (g/kg/day) is highest in the first two weeks of treatment, and then plateaus - suggesting no benefit of increased RUTF amounts in the later phases of treatment. Progressive reduction seems to be a more rational use of RUTF. The Optimizing treatment for acute MAlnutrition (OptiMA) strategy consists in simplifying management of acute malnutrition through the use of a single anthropometric admission criterion (mid upper arm circumference [MUAC] < 125 mm or nutritional oedema) - one that best captures children's anthropometry related mortality risk- and by optimizing the use of RUTF by adapting doses to the nutritional recovery of the child. RUTF doses begin at 170 kcal/kg/d for the most severely wasted (MUAC < 115 mm or oedema) and reduce to 75 kcal/kg/d as oedema resolves and MUAC increases > 120 mm. The investigators hypothesize that this strategy could double the number of children in care compared to current SAM programs without substantially increasing the amount of RUTF or staffing required while maintaining a recovery rate in line with current programs. OptiMA may also improve coverage and reduce the need for hospitalization through early identification of malnourished children. The investigators propose to conduct a community-based non-inferiority clinical trial with individual randomization comparing the OptiMA strategy to the Democratic Republic of Congo standard nutritional protocol for SAM. Study children will be randomly assigned to the intervention arm or control arm - with children at MUAC < 125 mm or oedema eligible for RUTF in the intervention arm and those meeting current WHO SAM definition eligible in the control group. All participants will be followed for 9 months post-randomization to assess non-inferiority as defined by a composite of three endpoints : alive, acceptable nutritional status (MUAC ≥ 125 mm and WHZ >-3, no oedema) and no relapse to acute malnutrition for those who were treated with RUTF. The main secondary outcome will assess the non-inferiority of OptiMA RUTF dosing (170 kcal/kg/d) in children meeting current WHO SAM criteria compared to children with the same criteria in the control arm who will receive 130-200 kcal/kg/d.

NCT ID: NCT02060162 Completed - HIV Clinical Trials

Antiretroviral Treatment Outcomes in HIV-HBV Co-infected Patients in Southern Africa

Start date: October 2013
Phase:
Study type: Observational

This is a prospective HIV cohort that aims to establish causes of liver disease among HIV-infected individuals in Zambia, including viral hepatitis and alcohol.

NCT ID: NCT01175161 Completed - Contraception Clinical Trials

Postpartum Intrauterine Device Study

PPIUD
Start date: October 2010
Phase: N/A
Study type: Interventional

The purpose of this non-blinded randomized clinical trial is to pilot the design of a randomized clinical trial to be conducted in Malawi to investigate immediate postpartum insertion of the Copper T380 intrauterine contraceptive device (CuT380A-IUCD) compared to placement at the 6-week postpartum visit. The investigators hypothesize that it will be feasible to enroll 140 women into this study, and that women will find the 10 minute to 48 hour time frame for IUCD placement acceptable.