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NCT ID: NCT05725707 Completed - Mental Health Clinical Trials

Friendship Group Intervention Development in Cambodia

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

A Friendship Group (FG's) (n= 4) will be delivered over an 8-week period (December 2021 - January 2022) to individuals who met the clinical distress threshold as per Kessler-10 score. FG's were offered face-to-face in Phnom Penh (n= 2) and online via Zoom (n= 2). Trained, community support workers and Prosthetists' from the Cambodian School of Prosthetics and Orthotics delivered FG's each week.

NCT ID: NCT05684185 Completed - Clinical trials for Rabies Post-exposure Prophylaxis

Immunogenicity Assessment of Subjects Receiving Rabies Post-exposure Prophylaxis in Cambodia

Start date: July 15, 2020
Phase:
Study type: Observational

A rabies virus neutralizing antibody (RVNA) concentration ≥ 0.5 IU/ml at 14 days after immunization is considered a proxy for protection in vaccine efficacy studies. Abridged and dose-sparing vaccination regimens increase accessibility and reduce both direct and indirect costs, especially in resource-constrained countries where RABV prevalence is highest. Several efficacy studies evaluated safety and immunogenicity of abridged regimens in healthy adult volunteers using either four-site intradermal (ID) or intramuscular (IM) regimens, showing them to be safe and immunogenic. Researchers at the Institut Pasteur du Cambodge (IPC) have previously conducted a retrospective study on clinical outcome at ≥6 months in 3318 Cambodians who received intradermal Vero cell vaccine post-exposure prophylaxis after a bite by a rabid or sick-looking but untested dog in 2003-2014. Here, the investigators could show that there was no significant difference in survival among patients who received 3 versus 4 sessions of the Thai Red Cross (TRC) ID regimen. In a separate study, investigators measured antibody responses in order to evaluate the immunogenicity of the TRC regiment after 3 sessions versus 4 sessions. The investigators did not observe an increase in rabies virus seroneutralization titers 14 days after the fourth immunization compared to 14 days after the third immunization. These results contributed to changes endorsed by the WHO in its April 2018 guidelines. The "Institut Pasteur du Cambodge (IPC) regimen" of three PEP sessions of two-site ID 0.1 mL vaccine doses each at days 0, 3 and 7 is the first one-week PEP regimen to be recommended. In the current research project, the aim is to compare further different PEP vaccination strategies in a real life setting of individuals attending the rabies vaccination center at Institut Pasteur du Cambodge (IPC) in Phom Penh, Cambodia. The antibody kinetics and cellular immune responses in patients following either the one-week, 2-site ID regimen (IPC regimen) or the two-week IM regimen (4-dose regimen) as well as the participants' survival for both protocols after 6 months are evaluated.

NCT ID: NCT05540886 Completed - Infection Control Clinical Trials

CLEAN Frontline: A Stepped Wedge Cluster Trial

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

Environmental hygiene is a key component of infection prevention in healthcare, and a driver of healthcare associated infections. Staff who clean in many low resource countries receive no formal training on cleaning, waste disposal and linen handling. This issue has been execrated by the COVID-19 pandemic. The only recommended training on environmental hygiene for low resourced facilities, TEACH CLEAN, uses a training of trainers model. A selected cadre "champions" which in turn train their peers with responsibilities on environmental hygiene at the facility level. Early pilot data to test its effectiveness of this training package are very promising. The main objective is to evaluate the effectiveness of an environmental cleaning bundle to improve microbiological cleanliness in Cambodian hospitals. The latest TEACH CLEAN will be implemented across all hospitals (13) of three provinces in Cambodia. A stepped wedge randomised trial will be used to evaluate the effectiveness of TEACH CLEAN to improve microbiological cleanliness in Cambodian hospitals. All facilities will receive the intervention. Hospitals are arranged in groups of three or four based on the randomisation with staggered commencement dates of the intervention at four distinct time points. The design will include ten months of data collection. We expect one month gap between the training of champions and the training of staff at the facility level. The main outcome is microbiological cleanliness (<2.5 cfu/cm2 = clean ; ≥2.5 cfu/cm2 = not clean) measured using a non-specific agar on one side for measuring total Aerobic Colony Counts (ACC/cm2). With 30 sampling sites in each hospital and with a pre-training cleanliness proportion ranging from 30% to 50% will give us over 85% power to detect a 10% absolute post-intervention increase in cleanliness. Evidence from this trial will contribute to future policy and practice guidelines about hospital environmental hygiene and ultimately reduce healthcare associated infections. This would be the first randomised trial on environmental hygiene in low resource settings.

NCT ID: NCT05389540 Completed - Infections Clinical Trials

Rural South and Southeast Asia Household Health Survey

SEACTN-HHS
Start date: October 3, 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 Completed - Hiv Clinical Trials

ANRS 12415 - Quali PrEP Cambodia

ANRS 12415
Start date: January 1, 2022
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: NCT04848688 Completed - Clinical trials for Strongyloides Stercoralis Infection

Efficacy and Safety 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 Completed - 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: NCT04663620 Completed - Perinatal 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 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 (known 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. Wellcome Trust grant number 220211.

NCT ID: NCT04594122 Completed - Food Safety Clinical Trials

Good Hygiene Practice Interventions for Safer Pork at Traditional Markets in Cambodia

SFFF Cambodia
Start date: June 30, 2020
Phase: N/A
Study type: Interventional

Safe Food Fair Food for Cambodia (SFFF) is a Feed the Future Innovation Lab project funded by USAID. This 3-year project aims to improve food safety of animal source food (ASF) in Cambodia. SFFF was awarded to the International Livestock Research Institute (ILRI), National Animal Health and Production Research Institute (NAHPRI) and Livestock Development for Community Livelihood Organization (LDC) and in collaboration with Cambodian Ministry of Health CDC and NIPH. Based on the findings and consultations with food safety stakeholders in Cambodia, we have developed a set of interventions to improve hygienic practice and pork safety at the traditional markets in Cambodia. Those interventions will be introduced and tested at retail in six selected provinces using Randomized Controlled Trials (RCT). To ensure compliance of targeted actors (e.g. retailers), participatory methods (e.g. FGD) were used to validate intervention packages. There are two steps of intervention which contain of part 1) Retailer formative research for SFFF Cambodia and 2) Interventions for Good Hygiene Practices for Safer Pork at Traditional Markets. Part 1. Retailer formative research for SFFF Cambodia: We will implement an intervention package to this trial group and collect biological sampling to determine the hygienic status before and after the intervention. The intervention packages will be developed for SFFF Cambodia in consultation with partners and based on findings of SFFF Cambodia project. Part 2. Intervention for Good Hygiene Practices for Safer Pork at Traditional Markets: A randomized controlled trial (RCT) intervention will be conducted in 12 markets in 6 provinces. Those provinces were selected based on the prevalence of Salmonella in a market survey study, namely Kampot, Kampong Cham, Kampong Speu, Takeo, Siem Reap, and Phnom Penh. Another 12 markets, in the same provinces, will be used as a control group. In total 24 traditional wet markets will be included in the sampling, by selecting the 4 largest traditional markets in the six provinces with at least 15 pork shops. At each market, 15 pork shops were selected for sampling. The intervention package includes 5 keys actions (Handbook) and provision of equipment incentive (e.g. inox tray, easy-clean surface material), and training on good hygiene practices.

NCT ID: NCT04434846 Completed - Dengue Fever Clinical Trials

Sylvatic Transmission of Zika, Dengue, and Chikungunya Viruses in Thailand and Cambodia

Start date: February 8, 2021
Phase:
Study type: Observational

Background: Zika, dengue, and chikungunya are spread by mosquitos. These diseases have a major impact on public health. This is especially true in in Southeast Asia. Non-human primates (such as macaques) could play an essential role in spreading these diseases. Researchers want to further understand the relationship between humans and these primates. They want to see how this affects how mosquito-borne viruses are spread in Southeast Asia. Objective: To describe the prevalence of Zika virus, dengue virus, and chikungunya virus in the blood of people who live close to long-tailed macaques in Thailand and Cambodia. Eligibility: Healthy people aged 18-55 who have lived or worked within approximately 10 kilometers of the Wat Amphae Phnom monkey habitat in Kampong Speu, Cambodia, for a minimum of 2 years Design: Participation will last 1 day. Participants will be screened in person through an interview. Their medical history will be reviewed. Participants will give information about themselves. This will include sex, age, and behaviors related to the spread of mosquito-borne disease. For example, they will be asked about the number of water containers at their home. They will be asked about recent travel. They will be asked about the extent of their contact with the macaques. Participants will give a blood sample....