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NCT ID: NCT05389540 Not yet recruiting - Infections Clinical Trials

Rural South and Southeast Asia Household Health Survey

SEACTN-HHS
Start date: June 2022
Phase:
Study type: Observational

A cross-sectional household survey with two-stage cluster-randomized sampling. This cross-sectional household survey design to recruit a random sample of households that is representative for each of the study sites. From the selected households, all consenting, household members will be included in the study. This study is funded by the UK Wellcome Trust. The grant reference number is 215604/Z/19/Z

NCT ID: NCT05091489 Not yet recruiting - Hiv Clinical Trials

ANRS 12415 - Quali PrEP Cambodia

ANRS 12415
Start date: November 1, 2021
Phase:
Study type: Observational

Hypothesis: - Hypothesis 1 : Regarding the recentness of preexposure prophylaxis (PrEP) implementation with an uptake of 20% and according to the first consultative meeting, awareness and acceptability of PrEP seems to be low in key-populations of Cambodia - Hypothesis 2 : Individual, social and structural barriers and facilitating factors of PrEP implementation as perceived by health workers and community-based organizations would be similar to what was observed worldwide 4,8. - Hypothesis 3: Some subgroups of key-populations are difficult to reach in health facilities. Community organizations can play a critical role to provide PrEP information, initiation and counselling with the support of new technologies. - Hypothesis 4: Community organizations might lack financial, logistical and skill capacities to deliver PrEP in good conditions Main objective: • To qualitatively evaluate the knowledge, awareness, perception, experience and acceptability of PrEP among key populations (entertainment workers (EW), men who have sex with men (MSM), transgender women (TW)), and among healthcare and community workers in charge of key populations Secondary objectives: - To better understand the characteristics, needs and expectations of community-based organizations (CBOs), in order to define the optimal conditions for community-based PrEP implementation - To identify tools that could be useful to increase PrEP awareness and acceptability, especially new technologies (apps, websites) Methodology: Qualitative study Focus groups with key-populations, healthcare and community workers Semi-directive interviews with decision makers and policy makers Estimated enrolment: 10 participants per focus group, 8 focus groups, 80 participants in focus groups, 6 interviewed persons, 86 participants in total Study population: Men who have sex with men (MSM), entertainment workers (EW), transgender women (TGW), healthcare workers, community workers, decision and policy makers

NCT ID: NCT05045547 Recruiting - Febrile Illness Clinical Trials

Village Malaria Worker Expansion

CAM-VMW
Start date: February 17, 2022
Phase:
Study type: Observational

This project will conduct pragmatic operational research in rural communities served by approximately 12 health centres and 120 village malaria workers in Battambang/Pailin, western Cambodia.

NCT ID: NCT04848688 Enrolling by invitation - Clinical trials for Strongyloides Stercoralis Infection

Efficacy, Safety and PK of Moxidectin Versus Ivermectin Against Strongyloides Stercoralis

StrongMoxi_KH
Start date: February 5, 2022
Phase: Phase 3
Study type: Interventional

The study is an extension to the study StrongMoxi NCT04056325 and entails modifications based on the outcome of NCT04056325 part A. The study is a phase 3, double-blinded and randomized clinical trial conducted in Cambodia. It aims at providing evidence on efficacy, safety and pharmacokinetic measures of 8 mg of moxidectin compared to 200 μg/kg ivermectin in adults infected with S. stercoralis. The efficacy of the treatment will be assessed by collecting three stool samples once per-treatment and once 21-28 days post-treatment. The stool samples will be analyzed by a quantitative duplicate Baermann assay.

NCT ID: NCT04829630 Recruiting - Rabies Clinical Trials

Immunity Persistence After Abridged Intradermal Rabies PEP

RESIST-3
Start date: October 20, 2021
Phase: N/A
Study type: Interventional

After exposure, rabies can be prevented in almost 100% of cases by the administration of sufficient and timely post-exposure prophylaxis (PEP). PEP is based on wound cleansing, antisepsis, administration of rabies vaccine as well as rabies immunoglobulin, if reviewed. However, anti-rabies PEP remains too often out of financial and / or geographic access, especially for poor and / or rural populations in endemic countries who remain the most exposed to the risk of contracting rabies. Two major studies planned in Cambodia between 2014 and 2018 - the RESIST 0/1 clinical - epidemiological study and the RESIST-2 study on the antibody response to the vaccine - provided the basis that allowed a change in international recommendations on PPE. Since April 2018, the new "IPC protocol" of three sessions of reduced double doses (0.1 mL x 2) administered intradermally (ID) over one week has replaced the already very effective "TRC protocol" of four sessions over one month which was the reference dose-sparing protocol for endemic countries until 2018. It remains to be determined whether the IPC protocol (3 sessions / 1 week) confers long-term immunity equivalent to that obtained after a TRC ID protocol (4 sessions / 1 month). This question is of importance to public health decision-makers and clinical teams in endemic countries who would hesitate to switch to the abbreviated IPC protocol.

NCT ID: NCT04766710 Recruiting - HIV Infections Clinical Trials

Community-Based Model for Delivery of Antiretroviral Therapy in Cambodia

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

The community-based ART delivery (CAD) model will build on the existing framework to engage community action, operationalized in the current Global Fund-supported project. Community Action Workers (CAW), who are assigned to ART centers and conduct outreach work, are well-suited to administer CAD scheme. KHANA and the project partners all have implementation roles in the Global Fund-supported project and established working channels with the CAW. While the previous experiences suggest the CAD model's effectiveness, implementing it in Cambodia requires adaptation to its specific local context. The proposed project will be implemented as an implementation study in nine ART sites and supported by a concrete evaluation plan. KHANA Center for Population Health Research will lead the research component. The project has three strategic areas and corresponding deliverables as follows: A. The development of a locally-fitted model: bringing ART closer to the people living with HIV B. The research: formulation, evaluation, documentation, and dissemination of the evidence, knowledge, and lessons learned C. The scale-up: advocacy for the SOP development to replicate/scale-up the CAD model The project will benefit a wide range of stakeholders. The approximately 2,000 ART clients enrolled in the nine selected clinics will face less cost, time, and discrimination, which will also benefit their families. The clinics will have a reduced workload on site, and they would be able to improve the quality of care for the visiting clients. The Cambodian health system will obtain a CAD model tailored to the country's local context and develop Standard Operating Procedures for the scheme with readily involved stakeholders. The scale-up of the model will benefit all other ART clinics and clients in the country. The 36-months project starting from June 1, 2019, will include six months of start-up and baseline assessments, 24-month intervention, and six-month evaluation.

NCT ID: NCT04738812 Recruiting - Tuberculosis Clinical Trials

Determination of Adequate Tuberculosis Regimen in Patients Hospitalized With HIV-associated Severe Immune Suppression

DATURA
Start date: April 21, 2022
Phase: Phase 3
Study type: Interventional

DATURA trial is a phase III, multicenter, two-arm, open-label, randomized superiority trial to compare the efficacy and the safety of an intensified tuberculosis (TB) regimen versus standard TB treatment in HIV-infected adults and adolescents hospitalized for TB with CD4 ≤ 100 cells/μL over 48 weeks: - Intensified TB treatment regimen: increased doses of rifampicin and isoniazid together with standard-dose of pyrazinamide and ethambutol for 8 weeks in addition to prednisone for 6 weeks and albendazole for 3 days - WHO standard TB treatment regimen. The continuation phase of TB treatment will be identical in the two arms: 4 months of rifampicin and isoniazid at standard doses.

NCT ID: NCT04706130 Recruiting - Vivax Malaria Clinical Trials

Rigorous Assessment of P. Vivax Relapses and Primaquine Efficacy for Radical Cure

Start date: April 15, 2021
Phase: Phase 4
Study type: Interventional

The study will be an open-labelled randomized clinical trial to determine therapeutic efficacy. Note that this will not be an Investigational New Drug application, as only World Health Organization (WHO)-approved drugs will be used at dosage and for conditions approved.

NCT ID: NCT04704999 Not yet recruiting - Clinical trials for Plasmodium Vivax Malaria

Southeast Asia Dose Optimization of Tafenoquine

SEADOT
Start date: October 1, 2022
Phase: Phase 4
Study type: Interventional

Tafenoquine was recently approved by regulatory authorities in the USA and Australia. Tafenoquine is an alternative radical curative treatment to primaquine acting against the dormant liver stage of Plasmodium vivax (the hypnozoite). Tafenoquine (an 8-aminoquinoline) has the substantial advantage of single dosing as compared to a 14-day course of primaquine to achieve radical cure. The recommended tafenoquine dose is 300 mg, which was shown to be significantly worse in radical curative efficacy to a total primaquine dose of 3.5 mg/kg in Southeast Asia. The cure rate of tafenoquine 300 mg in Southeast Asian study sites was only 74%. The comparator 3.5 mg/kg total primaquine dose is the standard and most commonly used dose globally, but in Southeast Asia and the Western Pacific, higher doses of primaquine are needed for radical cure. This study aims to determine the optimal dose of tafenoquine in Southeast Asia.

NCT ID: NCT04663620 Recruiting - Neonatal Mortality Clinical Trials

Saving Babies Lives

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

The central hypothesis of this study is that a neonatal healthcare programme that has a significant impact on neonatal mortality and which spans the healthcare journey from village to referral hospital can be developed and implemented in a low-resource rural setting. This study is a five-year stepped-wedge cluster-randomised trial, covering a rural and isolated province in North-Eastern Cambodia. The intervention of this study is the Saving Babies' Lives programme, which is a comprehensive, contextual and iterative neonatal healthcare package. The Saving Babies' Lives programme comprises a training programme for primary care facilities, and participatory action research with community health workers (know in Cambodia as village health support group volunteers). The control is no intervention; standard government service continues. Qualitative and quantitative data collection supports improvements in the iterative programme, and evaluation of the study, with the intention of creating a scalable blueprint.