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

Family Planning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05503992
• Other study ID #: H-43082
• Secondary ID: MTaPS-19-001
• Status: Completed
• Phase: N/A
• Start date: November 5, 2022
• Est. completion date: December 8, 2023

Study information

• Verified date: December 2023
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2523
• Est. completion date: December 8, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Family Planning

Intervention

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.

Locations

Country	Name	City	State
Zambia	Kawambwa District Health Office	Kawambwa
Zambia	Mansa District Health Office	Mansa
Zambia	Samfya District Health Office	Samfya

Sponsors (3)

Lead Sponsor	Collaborator
Boston University	Pharmaceutical Systems Africa (PSA), United States Agency for International Development (USAID)

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stock of family planning available at health facility	Percentage of family planning products that are stocked out at the health facility	6 months
Primary	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	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