NCT07851883

Brief Summary

This study evaluated a six-day Gender-Based Violence (GBV) response training for PCL General Medicine (Health Assistant) students in Nepal. Students at Kantipur College of Medical Sciences (intervention group, n=40) received a facilitator-led training based on the WHO LIVES framework (Listen, Inquire, Validate, Enhance safety, Support) and Nepal's national Health Response to GBV package. Students at Lord Buddha College of Health Science (control group, n=40) received no training during the study period and were offered the same training after data collection. Both groups completed a questionnaire measuring GBV knowledge, attitudes, and self-efficacy before the training (baseline) and after the training (Day 6). The main comparison is the difference between groups in score change from baseline to Day 6. The study was retrospectively registered.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

September 25, 2026

Last Update Submit

September 25, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in GBV Knowledge Score

    Measured with a 25-item single-best-answer multiple-choice questionnaire. Scores range from 0 to 25; higher scores indicate better GBV knowledge. The primary comparison is the between-group difference in gain scores (T2 - T1), analysed with the Mann-Whitney U test, Holm-corrected across the three co-primary outcomes.

    6 Days Training

Secondary Outcomes (1)

  • Change in GBV Attitude Score

    6 Days Training

Other Outcomes (1)

  • Change in Perceived Self-Efficacy Score

    6 Days Training

Study Arms (2)

Intervention Group (Kantipur College of Medical Sciences)

EXPERIMENTAL

Arm description: PCL General Medicine (Health Assistant) students in first and second year (n=40) who received the six-day GBV response training. Intervention: Behavioral: Six-Day GBV Response Training Intervention description: A six-day, facilitator-led training 5 hours per day\] based on the WHO LIVES framework and Nepal's national Health Response to GBV package, covering GBV definitions and types, recognition of red flags, clinical protocols (post-exposure prophylaxis, emergency contraception), relevant Nepali legal frameworks, survivor-centred communication, and referral to One-Stop Crisis Management Centres. Delivery used facilitated lectures, case-study discussions, role-play, and reflective practice. No drug, device, biological product, or procedure was involved.

Behavioral: Six-Day GBV Response Training (WHO LIVES-based)

No Intervention: Control Group (Lord Buddha College of Health Science)

NO INTERVENTION

Arm description: PCL General Medicine (Health Assistant) students in first and second year (n=40) who received no GBV training during the study period and were offered the same training after post-test data collection.

Interventions

Six-day, facilitator-led pre-service training on the health-sector response to gender-based violence (GBV), based on the WHO LIVES framework (Listen, Inquire, Validate, Enhance safety, Support) and Nepal's national Health Response to GBV training package. Content covers GBV definitions and types, recognition of red flags, clinical management protocols (post-exposure prophylaxis and emergency contraception time windows), relevant Nepali legal frameworks, survivor-centred communication, and referral to One-Stop Crisis Management Centres (OCMCs). Delivery methods are facilitated lectures, case-study discussions, role-play exercises, and reflective practice sessions, delivered by trained facilitators over six days. No drug, device, biological product, or procedure is involved; this is a purely educational intervention. If you know the hours per day or the total contact hours, add them after "over six days", for example "over six days (6 hours/day, 36 contact hours)". That still fits withi

Intervention Group (Kantipur College of Medical Sciences)

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Enrolled in the first or second year of the PCL General Medicine (Health Assistant) programme at Kantipur College of Medical Sciences or Lord Buddha College of Health Science.
  • Voluntary written informed consent

You may not qualify if:

  • Previous attendance at a formal GBV training.
  • Absent at baseline assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantipur College of Medical Sciences, Kathmandu, Bagmati, Nepal

Kathmandu, 44800, Nepal

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
No masking was used. Because this was an educational intervention delivered at a separate college, participants, facilitators, and investigators were aware of group allocation. Outcomes were measured with a self-administered questionnaire on KoboToolbox, with automated scoring of the Knowledge items, so no outcome assessor was involved.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Two parallel groups at two colleges: an intervention group receiving six-day GBV response training and a non-equivalent control group receiving delayed training, each assessed at baseline and Day 6
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2026

First Posted

October 1, 2026

Study Start

April 16, 2026

Primary Completion

July 30, 2026

Study Completion

July 30, 2026

Last Updated

October 1, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

Plan Description: De-identified individual participant data underlying the published results will be available from the corresponding author on reasonable request, after publication, for non-commercial academic research, subject to a data-use agreement.

Shared Documents
SAP, ICF
Time Frame
De-identified individual participant data (IPD) and supporting information (study protocol and statistical analysis plan) will be available beginning 3 months after publication of the primary results article and ending 5 years after publication, in line with the data-retention policy of the investigators' institution.
Access Criteria
Access will be granted to researchers affiliated with academic or research institutions who submit a methodologically sound proposal for non-commercial research. Requests should be sent to the corresponding author (Dip Bahadur Singh, dipbdrsingh@gmail.com) and will be reviewed by the study investigators. Approved requesters must sign a data-use agreement that prohibits any attempt to re-identify participants, prohibits sharing the data with third parties, and requires acknowledgement of the original study. Shared data will include de-identified participant-level scores (knowledge, attitude, and self-efficacy at baseline and Day 6) and non-identifying demographic variables; names, college roll numbers, and free-text responses will be excluded. Because some participants were under 18 years of age, age will be provided in grouped categories to reduce re-identification risk. Data will be shared by secure electronic transfer.

Locations