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NCT ID: NCT05531448 Not yet recruiting - Retention in Care Clinical Trials

Two-way Texting (2wT) to Improve Antiretroviral (ART) Patient Retention in Malawi

Start date: November 2022
Phase: N/A
Study type: Interventional

Investigators aim to demonstrate that interactive, two-way texting (2WT) to remind patients about their clinic visits and engage patients in their health can increase antiretroviral therapy (ART) retention in a routine setting in Lilongwe Malawi.

NCT ID: NCT05510973 Active, not recruiting - Clinical trials for AIDS-related Kaposi Sarcoma

Evaluation of Advanced HIV Disease Differentiated Care Model in Malawi

Start date: June 1, 2021
Phase: N/A
Study type: Interventional

This study will evaluate the implementation of an enhanced package of care, CD4 and tuberculosis lipoarabinomannan (TB-LAM) tests and the initiation of patients on TB prophylaxis [TPT and CPT], on retention in care and viral suppression ((<50 copies/ml) at 6 and 12 months after AHD care and treatment enrollment. The study will also assess the change in AHD screening, management and service uptake indicators among PLHIV clients before and after implementation of the QI collaborative implementation (QICI) project, evaluate the acceptability and feasibility of the AHD package of care among patients and HCWs providing related health services, and conduct a cost analysis of implementing the enhanced AHD package of care in a hub-and-spoke implementation of care model.

NCT ID: NCT05478720 Recruiting - Malaria, Cerebral Clinical Trials

DON in Pediatric Cerebral Malaria

Start date: August 16, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The initial study to be conducted under this IND is a 3-arm dose escalation study. The first two arms will be open-label, dose escalation, and will define the safety of 6-diazo-5-oxo-L-norleucine (DON) in African adults (>18 years old), who are healthy or who have uncomplicated malaria. Each of the two adult arms will enroll 40 participants broken down into 4 dosage groups with safety evaluations before each dose increase. The first 10 participants enrolled will receive 0.1 mg/kg intravenous (IV) DON. If this dose is proven safe, the dose will be increased to 1.0 mg/kg IV DON, and then 5.0 mg/kg IV DON, and then the final group will receive 10.0 mg/kg IV DON. Each adult dosage group contains 10 healthy participants and 10 participants with uncomplicated malaria. The total number of adult participants enrolled is 80 (20 participants at 4 doses). All participants will receive only one dose of DON. Adult participants will receive a premedication dose of the antiemetic ondansetron, 8 mg IV, administered 30 minutes prior to DON, and repeated once 6 hours later. The duration of study participation for all adult participants is six months. Once the safety profile in adults is completed, the third arm will be a randomized, placebo-controlled, dose-escalation study in children ages 6 months to 14 years with cerebral malaria to determine safety. Pediatric enrollments will span a maximum of three years (three malaria seasons, which will be carried out in Study Years 2-4), with a planned interim analysis look at the end of malaria Study Year 3 to determine dosing for malaria Study Year 4. We will first enroll 6 sentinel pediatric patients in malaria season 1 who will receive intravenous artesunate therapy and either adjunctive DON 0.1 mg/kg or placebo randomized 2:1). After review of results by the DSMB, and if approval to move forward is granted, in malaria season 2 (Study Year 3) the next year of pediatric enrollments (n=29, to account for the 6 sentinel subjects) participants will be randomized to receive one of 2 lower doses of adjunctive DON (0.1 mg/kg or 1.0 mg/kg) or placebo (24 subjects will receive DON and 5 will receive placebo) in conjunction with IV artesunate. If DON has a promising risk-benefit profile, the study will continue into a third season of pediatric enrollments (Study Year 4) (n=35) with similar or higher doses of DON (up to 10 mg/kg) or placebo in combination with IV artesunate. pediatric participation in the study will be 6 months.

NCT ID: NCT05452616 Recruiting - Clinical trials for Human Immunodeficiency Virus (HIV) Infection

Same-day Versus Rapid ART Initiation in HIV-positive Individuals Presenting With Symptoms of Tuberculosis

SaDAPT
Start date: October 19, 2022
Phase: N/A
Study type: Interventional

SaDAPT is a pragmatic, randomized, therapeutic-use trial comparing two approaches ("ART first" versus "TB results first") for the timing of ART initiation in PLHIV with presumptive TB, but no signs of central nervous system (CNS) disease, in a routine primary and secondary care setting in southern Africa with regard to HIV viral suppression (VL <400 copies/mL) 26 weeks after enrolment.

NCT ID: NCT05409274 Active, not recruiting - Covid19 Clinical Trials

Understanding COVID-19 Infections in Pregnant Women and Their Babies in 5 African Nations (periCOVID Africa)

Start date: November 1, 2020
Phase:
Study type: Observational

Develop coronavirus disease 2019 (COVID-19) surveillance in pregnancy in The Gambia, Kenya, Malawi, Mozambique and Uganda Estimate the seroepidemiology of COVID-19 infection among pregnant women in these countries Define the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in pregnant women and their babies and determine the presence of antibodies in cord blood Work with communities to develop understanding of infection prevention and control techniques to reduce the spread of COVID-19 amongst the pregnant population

NCT ID: NCT05383742 Not yet recruiting - Clinical trials for Tuberculous Meningitis

Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide Versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents With Tuberculous Meningitis

Start date: March 1, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare a 6-month regimen of high-dose rifampicin (RIF), high-dose isoniazid (INH), linezolid (LZD), and pyrazinamide (PZA) versus the World Health Organization (WHO) standard of care (SOC) treatment for tuberculosis meningitis (TBM).

NCT ID: NCT05362955 Not yet recruiting - HIV Infections Clinical Trials

5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa

Start date: February 20, 2023
Phase: Phase 1
Study type: Interventional

This is a single arm study on the safety, feasibility, and acceptability of adjuvant, self-administered, intravaginal 5-Fluorouracil (5-FU) following treatment for high-grade cervical precancer (CIN2/3) among women living with human immunodeficiency virus (HIV).

NCT ID: NCT05343390 Recruiting - Clinical trials for Human Immunodeficiency Virus

Package of Resources for Assisted Contact Tracing: Implementation, Costs, and Effectiveness

PRACTICE
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Having health workers assist HIV-infected persons with the recruitment and testing of their sexual contacts and biological children is an effective and efficient way of identifying additional HIV-infected persons in need of HIV treatment and HIV-uninfected persons in need of HIV prevention. However, in Malawi, a country with a generalized HIV epidemic, health workers lack the counseling and coordination skills to routinely assist their HIV-infected clients with these services. This study will determine how to help health workers to effectively and efficiently provide these services to their patients through a set of digital capacity-building tools.

NCT ID: NCT05323396 Recruiting - HIV Coinfection Clinical Trials

HIV And Parasitic Infection (HAPI) Study

HAPI
Start date: May 2, 2022
Phase: N/A
Study type: Interventional

The overall goal of this study is to determine if periodic de-worming of persons living with HIV in intestinal parasite-endemic regions will lead to decreased morbidity and mortality associated with HIV by reducing immune activation and intestinal damage associated with these diseases. The hypothesis for this project is that intestinal parasitic infections contribute to a modifiable pro-inflammatory state in persons living with HIV (PLWH). Aim 1: Determine the prevalence of intestinal parasitic infections in PLWH receiving care at an HIV-treatment center in Lilongwe, Malawi using a highly sensitive multi-parallel stool PCR test. Hypothesis: highly sensitive stool PCR testing will demonstrate that disease burden of parasitic infection in PLWH in Malawi is higher than historically reported based on stool microscopy. Aim 2: Determine the impact of parasitic infection on intestinal damage and immune activation by measuring sCD14, sCD163, and intestinal fatty acid binding protein (I-FABP) in PLWH. Hypothesis: plasma biomarkers reflecting intestinal damage and immune activation are elevated in those with HIV and parasitic co-infection compared with parasite-negative participants with HIV. Aim 3: Determine the impact of eradication of parasitic infection on intestinal damage and immune activation by measuring sCD14, sCD163, and intestinal fatty acid binding protein (I-FABP) in PLWH before and after treatment of parasitic co-infection. Hypothesis: plasma biomarkers reflecting intestinal damage and immune activation are elevated in those with HIV and parasitic co-infection, and these biomarkers decrease with anti-parasitic treatment.

NCT ID: NCT05307991 Recruiting - HIV Infections Clinical Trials

Integrating Enhanced HIV PrEP Into a STI Clinic in Lilongwe

Start date: March 9, 2022
Phase:
Study type: Observational

This is a prospective cohort study evaluating acceptability, feasibility, and effectiveness of integrating HIV pre-exposure prophylaxis (PrEP) into a sexually transmitted infection (STI) clinic alongside assisted partner notification and etiologic STI testing in Lilongwe, Malawi.