NCT06654505

Brief Summary

The study aims to assess the effectiveness of male-female VHV/Ws working in pairs on women's uptake of second PNC visits in rural Sepone, Lao PDR. Methods A quasi-experimental cluster study will be conducted between July 2024 and October 2026 in 37 selected sites from two districts in southern Lao PDR. In 19 selected intervention villages in the Sepone district, female-male VHV/Ws pairs will promote postpartum services, whereas, in 18 similar control villages in the Vilabuly district, VHV/Ws will work as individuals.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
302

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Aug 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress78%
Aug 2024Oct 2026

Study Start

First participant enrolled

August 10, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 23, 2024

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Expected
Last Updated

October 28, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

October 15, 2024

Last Update Submit

October 23, 2024

Conditions

Pregnant WomenLactating Mother

Outcome Measures

Primary Outcomes (1)

  • Uptake of second postnatal care visit

    Second postnatal visit within 6 weeks after delivery in a health facility reported in maternal and child health handbook

    6 weeks after delivery

Secondary Outcomes (1)

  • Lenght of facility-based postpartum stay

    cutoff is 12 hours

Study Arms (2)

Villages where Village Health Volunteers/Workers work as individuals

NO INTERVENTION

Villages where Community Health Workers work in pairs

EXPERIMENTAL
Behavioral: Paired Community Health Workers

Interventions

Paired Community Health WorkersBEHAVIORAL

Community Health Workers will promote maternal and child health services as paired female and male

Villages where Community Health Workers work in pairs

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women who delivered a baby within a define period
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Women who gave birth within six weeks and twelve months before the study's baseline and end-line surveys.

You may not qualify if:

  • Women whose births resulted in a loss,
  • Women who do consent to participate in the surveys
  • Women who face a language barrier with surveyors will not be enrolled.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sepon and Vilabouly districts

Savannakhet, Laos

RECRUITING

Central Study Contacts

Credo Ahissou, PhD

CONTACT

+818064827518Adelphahiss@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research fellow and Assistant Investigator

Study Record Dates

First Submitted

October 15, 2024

First Posted

October 23, 2024

Study Start

August 10, 2024

Primary Completion

October 30, 2024

Study Completion (Estimated)

October 31, 2026

Last Updated

October 28, 2024

Record last verified: 2024-10

Locations

LA(1)