NCT05503992

Brief Summary

The primary objective of this evaluation is to understand the effectiveness of the OpenSRP platform on unmet family planning (FP) demand in rural Zambia. The specific objectives are to:

  1. 1.assess the impact of the intervention on satisfaction and use of modern family planning methods among last-mile people of childbearing potential; and
  2. 2.understand the impact of the intervention on FP inventory management and dispensing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,523

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

November 5, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2023

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

August 15, 2022

Last Update Submit

December 14, 2023

Conditions

Keywords

Digital consumption management toolCommunity health workersOpenSRPRural Zambia

Outcome Measures

Primary Outcomes (1)

  • Percentage of women using preferred family planning method

    Percentage of women who are still using a FP method they had obtained through the CHW or as result of referral by the CHW at the index visit.

    6 months

Secondary Outcomes (1)

  • Resupply of family planning of choice

    6 months

Other Outcomes (1)

  • Stock of family planning available at health facility

    6 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

CHWs affiliated with intervention facilities randomized to the intervention arm will be given the intervention package.

Other: Intervention package

Control arm

NO INTERVENTION

CHWs affiliated with control sites randomized to the control arm will continue to implement the current standard of care which includes using paper records for inventory management and dispensing.

Interventions

The intervention package will include a mobile device configured with OpenSRP configured to facilitate clinical/service provision and stock management. The intervention also incorporates a training component on OpenSRP with accompanying follow-up supervisory visits for a limited period. Per the theory of changes, these activities will improve CHWs' knowledge and ability to use the platform for clinical care, dispensing, and workflow management, leading to an improved stock of commodities to meet preferred FP needs among last mile women.

Intervention arm

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Resident in a study health facility catchment area (HFCA)
  • Family planning (FP) client of community health worker (CHW) affiliated with one of the study sites
  • Access to a mobile phone

You may not qualify if:

  • Unwilling or unable to consent
  • Currently pregnant
  • Currently breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kawambwa District Health Office

Kawambwa, 730096, Zambia

Location

Mansa District Health Office

Mansa, 710371, Zambia

Location

Samfya District Health Office

Samfya, 720071, Zambia

Location

Study Officials

  • Veronika J Wirtz, BPharm, PhD

    Boston University School of Public Health, Global Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study design is a two-arm cluster-randomized trial. The unit of randomization is the health facility catchment areas (HFCAs) which will be matched in pairs on 1) ruralness as defined by distance/time to the nearest tertiary clinic or district capital; 2) supply chain performance as defined by number of family planning commodities stockouts in the nearest preceding three to six month period for which data are available (for baseline: August to October, 2022; for endline: February to June 2023); 3) catchment area size and; 4) number of CHW affiliates. This effectiveness evaluation will be paired with a concurrent implementation evaluation, making it a Type 2 Hybrid Design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2022

First Posted

August 17, 2022

Study Start

November 5, 2022

Primary Completion

December 1, 2023

Study Completion

December 8, 2023

Last Updated

December 20, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations