Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-28 @ 6:02 PM
Study NCT ID:
NCT05503992
Status:
COMPLETED
Last Update Posted:
2023-12-20
First Post:
2022-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Efficacy of Using a Digital Consumption Management Tool for Family Planning in Zambia
Sponsor:
Boston University
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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. 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.
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.
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MTaPS-19-001 | OTHER_GRANT | USAID | View |