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NCT ID: NCT06285110 Recruiting - Hiv Clinical Trials

HIV-1 Subtype-specific Drug Resistance in Patients Failing Dolutegravir (DTG) Based Regimen

DTG-Resist
Start date: June 13, 2022
Phase:
Study type: Observational

This is a prospective observational study enrolling People Living with HIV (PLHIV) who are on a Dolutegravir-based AntiRetroviral Treatment (ART) regimen and experiencing virologic failure. Virologic failure is defined as two consecutive viral load measurements of >1000 copies/mL of blood. The main aim of the study is to identify the drug-resistance mutations in the viral genome that are associated with this failure. To achieve this goal, patients fulfilling the eligibility criteria will be invited for a single study visit for the collection of blood. The extracted HIV virus will be sequenced through whole genome sequencing methods to identify the drug-resistance mutations. The study is conducted in 15-20 countries within six regions of the IeDEA cohort (International epidemiology Databases to Evaluate AIDS).

NCT ID: NCT06226155 Not yet recruiting - HIV Infections Clinical Trials

Adaptation of an Intervention Addressing Barriers to PrEP Use Among Pregnant Women in Zimbabwe

TENDAI4PrEP
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to develop a multi-level PrEP adherence and persistence intervention as an adaptation of the TENDAI ('grateful' in Shona) program, a problem-solving approach to reduce depression and increase HIV treatment adherence among people living with HIV in Zimbabwe. The new intervention, TENDAI4PrEP, will be designed to improve PrEP uptake and persistence among pregnant persons in Zimbabwe. If feasibility, acceptability, and preliminary efficacy are demonstrated, the intervention will be ready for large-scale effectiveness/implementation testing. This program will has the potential to address a critical public health challenge impacting pregnant and postpartum persons in Zimbabwe: the prevention of HIV acquisition and transmission.

NCT ID: NCT06192160 Not yet recruiting - Clinical trials for Pulmonary Tuberculosis

Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

RAD-TB
Start date: April 15, 2024
Phase: Phase 2
Study type: Interventional

A5409/RAD-TB is an adaptive Phase 2 randomized, controlled, open-label, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary tuberculosis (TB). A5409 hypothesizes that novel regimens for the treatment of pulmonary tuberculosis will result in superior early efficacy, as determined by longitudinal mycobacteria growth indicator tube (MGIT) liquid culture time to positivity (TTP) measurements over the first 6 weeks of treatment, and will have acceptable safety and tolerability over 8 weeks of treatment relative to standard of care [(SOC) isoniazid/rifampicin/pyrazinamide/ethambutol (HRZE)]. The study will run for 52 weeks, inclusive of 26 weeks of TB treatment comprised of 8 weeks of experimental or SOC treatment (based on treatment arm assignment) followed by 18 weeks of SOC treatment with 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm.

NCT ID: NCT06163274 Not yet recruiting - Safety Clinical Trials

Trial to Assess Acceptability and Safety of Two Placebo Intravaginal Rings

MATRIX-003
Start date: March 2024
Phase: Early Phase 1
Study type: Interventional

This research study is being conducted to find out how easy, comfortable, and safe intravaginal rings are for women to use. The two rings used in this study do not dispense any medications, are the same size, but differ in their flexibility and hardness. This study will enroll approximately 100 HIV-negative persons, aged18-45 years, and assigned female sex at birth from sites in the United States, South Africa, and Zimbabwe. Participants will be randomly assigned to use (self-insert) Ring A for 4 weeks and then Ring B for 4 weeks or Ring B first followed by Ring A. There will be a 1-3-week rest period between using the two different rings. The study involves answering questions, undergoing pelvic examinations, and collecting blood and vaginal fluid samples over a total of 7 in-person visits and 2 telephone calls over approximately 9-11 weeks. In addition, both participants and approximately 30 of their sexual partners will be asked to take part in in-depth interviews to further assess acceptability, attitudes, and experiences with ring use to gauge interest in the future use of intravaginal rings as a HIV prevention option.

NCT ID: NCT06135818 Recruiting - Clinical trials for Tuberculosis, Extrapulmonary

Same Day Diagnosis of Extrapulmonary TB (TB Serositis and TB Meningitis).

Epi-TB
Start date: March 16, 2021
Phase: N/A
Study type: Interventional

Extrapulmonary TB (EPTB) accounts for nearly 30% of TB cases in HIV endemic settings, such as South Africa. The diagnosis of extrapulmonary TB is complicated by the poor performance of Gene Xpert and TB Culture in extrapulmonary fluid (30-50% sensitive), as well as the poor specificity of ADA. We can therefore not reliably use these tests to diagnose EPTB as effectively as we use them in sputum samples. The current best practice for diagnosing pleural TB is to perform a pleural biopsy, which is both invasive and costly. A rapid, easy to use test is needed to allow accurate and fast diagnosis of EPTB. Interferon-gamma is released at high concentrations in extrapulmonary fluid in active EPTB. Antrum Biotech has developed the IRISA-TB assay (validated and SAHPRA licenced) for the diagnosis of EPTB. The study will assess the real-world performance of IRISA-TB compared to ADA, Gene Xpert, and TB Culture when used to diagnose EPTB. We will evaluate IRISA-TB's performance in the following patient groups: - Suspected TB pleural effusion (n= 650) - Suspected TB pericardial effusion (n= 280) - Suspected TB peritonitis (n= 200) - Suspected TB meningitis (n = 1040) As part of our evaluation, we will ask clinicians who treat these patients to provide their feedback on IRISA-TB. We will ask them to indicate to what extent the IRISA-TB test helped them to make treatment decisions. Finally, we will conduct an economic assessment to determine the true cost of diagnosing and treating EPTB to the health system and patients, and we will determine how IRISA-TB could potentially result in cost savings.

NCT ID: NCT06134362 Not yet recruiting - HIV Infections Clinical Trials

Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)

PALISADE
Start date: April 1, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is long-term evaluation of long-acting injectable cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in eligible participants who have completed DAIDS (Division of AIDS) sponsored studies HPTN 083 and HPTN 084 and associated sub-studies. Participants will continue receiving CAB LA and be followed for new HIV diagnosis, SAEs (serious adverse events), Grade 3 and Grade 4 ISRs (injection site reactions), and AEs (adverse events) leading to withdrawal.

NCT ID: NCT06090006 Recruiting - Adolescent Behavior Clinical Trials

An Adolescent Health and Wellbeing Check-up Programme in Three African Cities (Y-Check)

Y-Check
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

This is a multi-country prospective intervention study, with a mixed-method process evaluation to assess the implementation, effects and short-term cost-effectiveness of Y-Check. The intervention involves screening, on-the-spot care and, if needed, referral of adolescents through health and wellbeing check-up visits in early adolescence (10-14 years) and older adolescence (15-19 years old). In each city, the intervention will be delivered to 2000 adolescents recruited in schools (both age groups) or community venues (older adolescents only).

NCT ID: NCT06046053 Recruiting - Safety Clinical Trials

MATRIX-002: Trial to Assess Acceptability and Safety of Two Placebo Vaginal Films

Start date: October 18, 2023
Phase: Early Phase 1
Study type: Interventional

This study will enroll approximately 100 HIV-negative persons, aged18-45 years, and assigned female sex at birth from sites in the United States, Kenya, South Africa, and Zimbabwe. The study will assess the acceptability and safety of two placebo vaginal films. The placebo films do not contain any active medication, are the same size, but differ by shape (square versus rounded corners). Participants will be randomly assigned to one of the two films and asked to use (self-insert) the assigned film two times (approximately one month apart). Participants will be asked to refrain from sexual activity during the first month of use and may resume usual sexual activity during the second month of use. The study involves answering questions, undergoing pelvic examinations, and collecting blood and vaginal fluid samples. The study involves a total of 10 visits/contacts, including in person visits and telephone calls over approximately 9 weeks. In addition, both participants and approximately 30 of their sexual partners will be asked to take part in in depth interviews to further assess acceptability, attitudes, and experiences with film use to gauge interest in the future use of vaginal films as a HIV prevention option.

NCT ID: NCT06042543 Not yet recruiting - Cervical Cancer Clinical Trials

Novel, One Stop, Affordable, Point of Care and AI Supported System of Screening, Triage and Treatment Selection for Cervical Cancer in LMICs

EASTER
Start date: September 30, 2023
Phase:
Study type: Observational

Artificial intelligence (AI) is fast gaining reputation as a highly promising solution for cervical cancer screening. AI-based detection of cervical neoplasias is named automated visual exam (AVE) by the National Cancer Institute, USA. The investigators propose to develop and evaluate the performance characteristics of a novel AI system to both screen and triage women as well as help in treatment decision making. AI will analyse infrared spectroscopic signals derived from urine samples of unscreened women for the presence of high-risk human papillomavirus (hr-HPV). Our preliminary study has shown that spectroscopy can detect hr-HPV in urine. For screen-positive women the AI will interpret a set of cervical images captured with a high-quality devoted camera to detect high grade cervical precancers and cancers and to determine the type of transformation zone (TZ) (helps in treatment decision). The prototype device for image capture and the AI algorithms are already developed by us. The technologies will be further improved in part 1 (initial 2 years) and validated in part 2 (subsequent 3 years). During Part 1, the investigators will analyse urine samples collected from 1100 women at multiple screening clinics in Zimbabwe for the presence of hr-HPV using spectroscopy and use the signals generated to improve the AI algorithm. In this part the investigators will also assess the concordance between hr-HPV detection in urine samples using spectroscopy and cervical human papillomavirus (HPV) detection using a validated HPV test. The cervical image recognition device and the AI algorithm will be further improved during part 1 by collecting more images from hr-HPV positive and negative women. AI will also be trained to interpret the cervical images to determine the TZ type. In part 2 total 2100 women will be screened in Zimbabwe with AI-supported spectroscopic analysis of urine to detect hr-HPV and a validated HPV test to evaluate and compare their sensitivity and specificity to detect histology-proved high grade cervical precancers and cancers. The sensitivity and specificity of AI-supported detection of cervical neoplasias on cervical images will be evaluated to triage the HPV positive women. The accuracy of AI to determine TZ type will be compared with expert opinion. During the field validation part (part 2), the investigators will also conduct a cost analysis and compare cost of our approach to current standard Zimbabwean practice. The International Agency for Research on Cancer- World Health Organization WHO (IARC-WHO) has partnered with The Neo Sense Vector Company (NSV), Delaware, USA (industry), The Engineering Department, Lancaster University, Lancaster, UK and The University of Zimbabwe, College of Health Sciences, Harare, Zimbabwe to implement this study focusing on innovation that will greatly contribute to the global elimination of cervical cancer, a WHO priority.

NCT ID: NCT06007105 Recruiting - Schizophrenia Clinical Trials

SUCCEED Africa: Support, Comprehensive Care and Empowerment of People With Psychosocial Disabilities

SUCCEED
Start date: July 18, 2023
Phase: N/A
Study type: Interventional

Although psychotic disorders typically affect less than 1% of the population, they are a significant cause of disability worldwide. Psychotic symptoms such as hallucinations, delusions and suicidal ideation can be profoundly disturbing, and negatively impact daily living. However, the social consequences of psychosis are often even more troubling than the symptoms. For example, people with psychosis have a high risk of experiencing violence, poverty, homelessness, incarceration, and unemployment, among other adverse outcomes. There is a need for a range of accessible, appropriate interventions for people with psychosis to be delivered to those in the most vulnerable situations, including in low-resource settings in sub-Saharan Africa. A systematic review recently carried out as part of the formative research for SUCCEED identified 10 studies evaluating the impact of interventions for people with psychosis in Africa, most of which had a strongly clinical focus. The review concluded that there was a need for further research involving people with lived experience of psychosis in designing and evaluating holistic interventions that meet their diverse needs, within and beyond the health sector. SUCCEED Africa is a six-year Health Research Programme Consortium (RPC) that has brought together people with lived experience of psychosis and people with professional experience (researchers, clinicians) from four African countries (Malawi, Nigeria, Sierra Leone, Zimbabwe) to co-produce a community-based intervention for psychosis, using a Theory of Change-driven approach. The SUCCEED intervention takes the World Health Organisation's (WHO's) CBR Matrix as a point of departure to consider the multifaceted needs of people living with psychosis and other psychosocial disabilities, and how best to meet these needs by mobilising the resources of individuals and families affected, as well as their broader communities. This protocol describes a pilot study in which the SUCCEED intervention will be delivered and evaluated on a small scale, in preparation for a larger multi-country research evaluation using more rigorous methods, including randomised controlled trials in Nigeria and Zimbabwe and observational studies in Malawi and Sierra Leone, respectively. The main outcome of interest is change in subjective quality of life among participants with lived experience of psychosis who are offered the intervention over a four-month follow up period.