Soil-transmitted Helminth InfectionsNCT07855978
Community Health Education and Hygiene Promotion Added to Deworming Among Ethnic Khmer Children in Vietnam
A study testing Albendazole 400 mg and Community Health Education and Hygiene Promotion in people with Soil-transmitted Helminth Infections, run by Can Tho University of Medicine and Pharmacy at 4 sites in Vietnam.
Trial summary
This study evaluated whether adding community health education and household hygiene promotion to supervised deworming could improve soil-transmitted helminth (STH) outcomes and related caregiver and household factors among ethnic Khmer children aged 6-10 years in southern Vietnam. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Soil-transmitted Helminth Infections
- What is being tested?
- Albendazole 400 mg and Community Health Education and Hygiene Promotion
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 704 participants
- Where
- 4 sitesVietnam
- Study dates
- 1 Jul 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Ethnic Khmer children aged 6 to 10 years.
- In good general health at enrollment.
- Participation with a primary caregiver.
- Written informed consent provided by a parent or legal guardian.
Who cannot join
- Acute illness at enrollment.
- Serious chronic illness at enrollment.
Trial locations and contacts
4 sites in 1 country.
Vietnam4 sites
Hoa Binh Commune Health Station
Ca Mau, Hoa Binh
Hong Dan Commune Health Station
Ca Mau, Hong Dan
Hung Hoi Commune Health Station
Ca Mau, Hung Hoi
Hiep Thanh Ward Health Station
Hiệp Thành, Ca Mau
About this study
Official title: Effect of Community Health Education and Hygiene Promotion Added to Supervised Deworming Among Ethnic Khmer Children in Vietnam: A Non-Randomized Controlled Before-and-After Study
This study evaluated whether adding community health education and household hygiene promotion to supervised deworming could improve soil-transmitted helminth (STH) outcomes and related caregiver and household factors among ethnic Khmer children aged 6-10 years in southern Vietnam.
The study used a non-randomized controlled before-and-after design in four communes. Two communes received the intervention and two served as controls. Both groups received a single supervised oral dose of albendazole 400 mg at month 3. The intervention group additionally received a 6-month package of community health education sessions, household hygiene guidance visits, and a community handwashing campaign.
The primary outcome was STH positivity at 6 months. Secondary outcomes included species-specific STH positivity, caregiver knowledge, attitudes and practices, and observed household hygiene conditions.
Read the detailed description
This was a non-randomized controlled before-and-after study conducted among ethnic Khmer children and their caregivers in four communes in Ca Mau Province, Vietnam. Communes were selected purposively because of their large ethnic Khmer populations. Two communes were assigned to the intervention condition and two communes to the control condition; allocation was not randomized.
Eligible participants were ethnic Khmer children aged 6-10 years who were in good general health at enrollment and their primary caregivers. A total of 704 children were enrolled, including 365 in the intervention group and 339 in the control group.
Both study groups received a single supervised oral dose of albendazole 400 mg at month 3. In addition, the intervention group received a 6-month community health education and hygiene promotion package. The package included community education sessions for caregivers and children, household hygiene guidance visits, and a community handwashing campaign. Educational content addressed soil-transmitted helminth transmission, consequences of infection, periodic deworming, handwashing with soap, latrine use, safe water, and footwear.
Baseline and 6-month assessments included stool examination for soil-transmitted helminth infection, caregiver knowledge, attitude and practice assessments, and direct observation of selected household hygiene conditions. Stool specimens were examined by direct wet-mount microscopy for Ascaris lumbricoides, Trichuris trichiura, and hookworm.
The intervention was intended to improve caregiver knowledge and household hygiene practices and thereby reduce exposure and reinfection following deworming.
- Conditions
- Soil-transmitted Helminth Infections
- Being tested
- Albendazole 400 mg, Community Health Education and Hygiene Promotion
- Keywords
- soil-transmitted helminths, hookworm, deworming, albendazole, health education, water, sanitation and hygiene, WASH, ethnic Khmer, children, Vietnam, Mekong Delta
- Medical subject headings
- Ancylostomiasis, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albendazole 400 mgDrug
Albendazole 400 mg administered orally as a single supervised dose at month 3 by health staff.
Community Health Education and Hygiene PromotionBehavioural
A 6-month package including at least two community health education sessions for caregivers and children, household hygiene guidance visits during months 2 and 5, and at least one community handwashing campaign. The educational content addressed soil-transmitted helminth transmission, consequences of infection, periodic deworming, handwashing with soap, latrine use, safe water, and footwear.
| Study group | Role | What they receive |
|---|---|---|
| Deworming Plus Community Health Education and Hygiene Promotion | Experimental | Children received a single supervised oral dose of albendazole 400 mg at month 3. In addition, children and their caregivers received a 6-month community health education and hygiene promotion package consisting of community health education sessions, household hygiene guidance visits, and a community handwashing campaign. Receives: Drug: Albendazole 400 mg; Behavioral: Community Health Education and Hygiene Promotion |
| Supervised Deworming Alone | Active comparator | Children received a single supervised oral dose of albendazole 400 mg at month 3. Receives: Drug: Albendazole 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soil-Transmitted Helminth Positivity at 6 Months
Proportion of children with a stool sample positive for at least one soil-transmitted helminth species, including Ascaris lumbricoides, Trichuris trichiura, or hookworm, as detected by direct wet-mount microscopy. A sample was classified as positive when at least one egg or larva of any of these species was observed.
Measured: 6 months after baseline (approximately 3 months after albendazole administration)
Secondary outcomes (11)
Hookworm Positivity at 6 Months
Proportion of children with hookworm eggs or larvae detected in stool by direct wet-mount microscopy.
Measured: 6 months after baseline
Ascaris lumbricoides Positivity at 6 Months
Proportion of children with Ascaris lumbricoides eggs detected in stool by direct wet-mount microscopy.
Measured: 6 months after baseline
Trichuris trichiura Positivity at 6 Months
Proportion of children with Trichuris trichiura eggs detected in stool by direct wet-mount microscopy.
Measured: 6 months after baseline
Persistence of STH Positivity Among Baseline-Positive Children
Proportion of children who were positive for soil-transmitted helminth infection at baseline and remained positive at the 6-month follow-up.
Measured: 6 months after baseline
New STH Positivity Among Baseline-Negative Children
Proportion of children who were negative for soil-transmitted helminth infection at baseline and were positive at the 6-month follow-up.
Measured: 6 months after baseline
Caregiver Knowledge Score
Total caregiver knowledge score ranging from 0 to 21, with higher scores indicating greater knowledge regarding soil-transmitted helminth infection and prevention.
Measured: Baseline and 6 months
Caregiver Attitude Score
Total caregiver attitude score ranging from 0 to 5, with higher scores indicating more favorable attitudes toward prevention of soil-transmitted helminth infection.
Measured: Baseline and 6 months
Caregiver Practice Score
Total caregiver practice score ranging from 0 to 7, with higher scores indicating more recommended preventive practices.
Measured: Baseline and 6 months
Presence of a Household Handwashing Place
Proportion of households with an observed designated handwashing place.
Measured: Baseline and 6 months
Soap Available at the Handwashing Place
Proportion of households with soap observed at the household handwashing place.
Measured: Baseline and 6 months
Clean Household Surroundings
Proportion of households with clean surroundings and no visible waste on direct observation.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Jul 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soil-transmitted Helminth InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Four communes were included in the study. Two communes were assigned to the intervention condition and two communes to the control condition. Allocation was conducted at the commune level and was not randomized. Participants remained in their assigned study condition throughout the 6-month follow-up.
- Masking
- None (open label)
- Enrolment
- 704 participants (actual)
Sponsor and investigators
- Lead sponsor
- Can Tho University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855978
- Sponsor's protocol ID
- CTUMP-KHMER-2025.
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the published article will be available upon reasonable request to the corresponding author, subject to approval by the study investigators and applicable ethical and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Community Health Education and Hygiene Promotion Added to Supervised Deworming Among Ethnic Khmer Children in Vietnam: A Non-Randomized Controlled Before-and-After Study
- ClinicalTrials.gov ID
- NCT07855978
- Acronym / sponsor ID
- CTUMP-KHMER-2025.
- Conditions
- Soil-transmitted Helminth Infections
- Keywords
- soil-transmitted helminths, hookworm, deworming, albendazole, health education, water, sanitation and hygiene, WASH, ethnic Khmer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 704 participants (actual)
- Lead sponsor
- Can Tho University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated whether adding community health education and household hygiene promotion to supervised deworming could improve soil-transmitted helminth (STH) outcomes and related caregiver and household factors among ethnic Khmer children aged 6-10 years in southern Vietnam.
The study used a non-randomized controlled before-and-after design in four communes. Two communes received the intervention and two served as controls. Both groups received a single supervised oral dose of albendazole 400 mg at month 3. The intervention group additionally received a 6-month package of community health education sessions, household hygiene guidance visits, and a community handwashing campaign.
The primary outcome was STH positivity at 6 months. Secondary outcomes included species-specific STH positivity, caregiver knowledge, attitudes and practices, and observed household hygiene conditions.
Detailed description
This was a non-randomized controlled before-and-after study conducted among ethnic Khmer children and their caregivers in four communes in Ca Mau Province, Vietnam. Communes were selected purposively because of their large ethnic Khmer populations. Two communes were assigned to the intervention condition and two communes to the control condition; allocation was not randomized.
Eligible participants were ethnic Khmer children aged 6-10 years who were in good general health at enrollment and their primary caregivers. A total of 704 children were enrolled, including 365 in the intervention group and 339 in the control group.
Both study groups received a single supervised oral dose of albendazole 400 mg at month 3. In addition, the intervention group received a 6-month community health education and hygiene promotion package. The package included community education sessions for caregivers and children, household hygiene guidance visits, and a community handwashing campaign. Educational content addressed soil-transmitted helminth transmission, consequences of infection, periodic deworming, handwashing with soap, latrine use, safe water, and footwear.
Baseline and 6-month assessments included stool examination for soil-transmitted helminth infection, caregiver knowledge, attitude and practice assessments, and direct observation of selected household hygiene conditions. Stool specimens were examined by direct wet-mount microscopy for Ascaris lumbricoides, Trichuris trichiura, and hookworm.
The intervention was intended to improve caregiver knowledge and household hygiene practices and thereby reduce exposure and reinfection following deworming.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Four communes were included in the study. Two communes were assigned to the intervention condition and two communes to the control condition. Allocation was conducted at the commune level and was not randomized. Participants remained in their assigned study condition throughout the 6-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Deworming Plus Community Health Education and Hygiene Promotion | Experimental | Drug: Albendazole 400 mg, Behavioral: Community Health Education and Hygiene PromotionChildren received a single supervised oral dose of albendazole 400 mg at month 3. In addition, children and their caregivers received a 6-month community health education and hygiene promotion package consisting of community health education sessions, household hygiene guidance visits, and a community handwashing campaign. |
| Supervised Deworming Alone | Active comparator | Drug: Albendazole 400 mgChildren received a single supervised oral dose of albendazole 400 mg at month 3. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Ethnic Khmer children aged 6 to 10 years.
- In good general health at enrollment.
- Participation with a primary caregiver.
- Written informed consent provided by a parent or legal guardian.
Key exclusion criteria (2 listed)
- Acute illness at enrollment.
- Serious chronic illness at enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albendazole 400 mgAlbendazole 400 mg administered orally as a single supervised dose at month 3 by health staff. | Drug | Deworming Plus Community Health Education and Hygiene Promotion, Supervised Deworming Alone |
| Community Health Education and Hygiene PromotionA 6-month package including at least two community health education sessions for caregivers and children, household hygiene guidance visits during months 2 and 5, and at least one community handwashing campaign. The educational content addressed soil-transmitted helminth transmission, consequences of infection, periodic deworming, handwashing with soap, latrine use, safe water, and footwear. | Behavioural | Deworming Plus Community Health Education and Hygiene Promotion |
Primary outcome
Soil-Transmitted Helminth Positivity at 6 Months
Time frame: 6 months after baseline (approximately 3 months after albendazole administration)
Proportion of children with a stool sample positive for at least one soil-transmitted helminth species, including Ascaris lumbricoides, Trichuris trichiura, or hookworm, as detected by direct wet-mount microscopy. A sample was classified as positive when at least one egg or larva of any of these species was observed.
11 secondary outcomes
Hookworm Positivity at 6 Months
Time frame: 6 months after baseline
Ascaris lumbricoides Positivity at 6 Months
Time frame: 6 months after baseline
Trichuris trichiura Positivity at 6 Months
Time frame: 6 months after baseline
Persistence of STH Positivity Among Baseline-Positive Children
Time frame: 6 months after baseline
New STH Positivity Among Baseline-Negative Children
Time frame: 6 months after baseline
Caregiver Knowledge Score
Time frame: Baseline and 6 months
Caregiver Attitude Score
Time frame: Baseline and 6 months
Caregiver Practice Score
Time frame: Baseline and 6 months
Presence of a Household Handwashing Place
Time frame: Baseline and 6 months
Soap Available at the Handwashing Place
Time frame: Baseline and 6 months
Clean Household Surroundings
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the published article will be available upon reasonable request to the corresponding author, subject to approval by the study investigators and applicable ethical and institutional requirements.
Related trials for Soil-transmitted Helminth Infections
Not yet recruitingPhase 3
Follow-up Assessment of Change in Soil-transmitted Helminths Infection Intensity in Uganda
Ascariasis
RecruitingPhase 3
Phase 3, Multi-center, Prospective, Randomized, Double-blind, Placebo- Controlled Study to Evaluate the Effectiveness and Safety of ZP5-9676 for the Treatment of Soil Transmitted Helminthiasis (STH)
Soil-Transmitted Helminthiasis (STH)
Not yet recruitingPhase 2
Efficacy and Safety of a Single Dose of Emodepside Compared to a Single Dose of Albendazole in Adolescents and Adults Infected With Trichuris Incognita
Trichuris Infection
Not yet recruitingPhase 3
Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth Infections
Trichuris Trichiura; Infection, Hookworm Infection
Recruiting
Expanding Access to Preventive Chemotherapy Among Mobile and Migrant Populations
Onchocerciasis (River Blindness), Schistosomiasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albendazole 400 mg and Community Health Education and Hygiene Promotion in people with Soil-transmitted Helminth Infections, run by Can Tho University of Medicine and Pharmacy at 4 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soil-Transmitted Helminth Positivity at 6 Months (time frame: 6 months after baseline (approximately 3 months after albendazole administration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.