Community Health Education and Hygiene Promotion Added to Deworming Among Ethnic Khmer Children in Vietnam

NCT07855978 | Completed

• 1 other identifier: CTUMP-KHMER-2025.
• Study Type: interventional
• Target: 704
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Soil-transmitted Helminth Infections

Keywords

soil-transmitted helminths; hookworm; deworming; albendazole; health education; water, sanitation and hygiene; WASH; ethnic Khmer; children; Vietnam; Mekong Delta

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months after baseline (approximately 3 months after albendazole administration)

Secondary Outcomes (11)

• Hookworm Positivity at 6 Months

  6 months after baseline

• Ascaris lumbricoides Positivity at 6 Months

  6 months after baseline

• Trichuris trichiura Positivity at 6 Months

  6 months after baseline

• Persistence of STH Positivity Among Baseline-Positive Children

  6 months after baseline

• New STH Positivity Among Baseline-Negative Children

  6 months after baseline

Study Arms (2)

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.

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.

Drug: Albendazole 400 mg

Interventions

Albendazole 400 mg DRUG

Albendazole 400 mg administered orally as a single supervised dose at month 3 by health staff.

Deworming Plus Community Health Education and Hygiene Promotion; Supervised Deworming Alone

Community Health Education and Hygiene Promotion BEHAVIORAL

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.

Deworming Plus Community Health Education and Hygiene Promotion

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Acute illness at enrollment.
• Serious chronic illness at enrollment.

Sponsors & Collaborators

• Can Tho University of Medicine and Pharmacy: lead

Study Sites (4)

Hiep Thanh Ward Health Station

Hiệp Thành, Ca Mau, Vietnam

Location

Hoa Binh Commune Health Station

Ca Mau, Hoa Binh, Vietnam

Location

Hong Dan Commune Health Station

Ca Mau, Hong Dan, Vietnam

Location

Hung Hoi Commune Health Station

Ca Mau, Hung Hoi, Vietnam

Location

MeSH Terms

Conditions

Ancylostomiasis; Health Education

Interventions

Albendazole

Condition Hierarchy (Ancestors)

Hookworm Infections; Strongylida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: July 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication of the main study results and available for 5 years.
• Access Criteria: Data will be available to qualified researchers who submit a scientifically sound proposal. Requests will be reviewed by the study investigators and will require appropriate ethical and institutional approval where applicable. Data will be provided for approved research purposes under a data-use agreement.

Locations

VN (4)