Evaluating the Efficacy of Using a Digital Consumption Management Tool for Family Planning in Zambia

Evaluating the Efficacy of Using a Digital Consumption Tracking and Workflow Management Tool to Decrease Unmet Demand and Foster Contraceptive Continuous Use at Last Mile Point of Care in Zambia

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

The investigators will employ mixed-methods for data collection for this two-arm cluster-randomized trial. This effectiveness evaluation will be paired with a concurrent implementation evaluation, making it a Type 2 Hybrid Design.

For the impact evaluation data will be collected from two main sources at both baseline and endline: 1) existing stock management records (eLMIS and paper records, depending on study arm); and 2) Short phone surveys with people of childbearing potential in the community.

Study Overview

• Status: Completed
• Conditions: Family Planning
• Intervention / Treatment: Other: Intervention package

Detailed Description

Rural health facilities catchment areas (HFCAs) and their affiliated CHWs (clusters) will be randomly assigned to the intervention or control arm. The impact evaluation will consist of a cross-sectional baseline assessment of a sample of women living in the catchment areas of both the intervention and control clusters. This will be followed by a six months of implementation phase (mobile device distribution to CHW, CHW training, CHW utilization of the Open SRP). At endline after six months, a new cross-sectional sample of respondents will be assessed in both the intervention and control clusters.

To achieve objective 1, a short questionnaire will be administered over the phone to a cross-sectional sample of last-mile people of childbearing potential living in both the intervention and control clusters. The sample will be drawn from the CHW's client lists and use a short telephone call to reach respondents.

To achieve objective 2, the same quantitative indicators will be abstracted from two different data sources, depending on the study arm: 1) OpenSRP data captured in the CHW tablets among the intervention sites, and 2) data extracted from the paper records maintained by the CHWs or the health facility or the electronic management system in the control sites (and at baseline).

• Study Type: Interventional
• Enrollment (Actual): 2523
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Zambia
  • Kawambwa, Zambia, 730096
    • Kawambwa District Health Office
  • Mansa, Zambia, 710371
    • Mansa District Health Office
  • Samfya, Zambia, 720071
    • Samfya District Health Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; CHWs affiliated with intervention facilities randomized to the intervention arm will be given the intervention package.	Other: Intervention package; 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.
No Intervention: Control arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resupply of family planning of choice	Percentage women whose method required re-supply were re-supplied, or received a referral for information and services specific to their method of choice, during the follow-up or secondary visit	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stock of family planning available at health facility	Percentage of family planning products that are stocked out at the health facility	6 months

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: United States Agency for International Development (USAID); Pharmaceutical Systems Africa (PSA)
• Investigators: Principal Investigator: Veronika J Wirtz, BPharm, PhD, Boston University School of Public Health, Global Health

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2022
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 8, 2023

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Community health workers; Digital consumption management tool; OpenSRP; Rural Zambia
• Other Study ID Numbers: H-43082; MTaPS-19-001 (Other Grant/Funding Number: USAID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No