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

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Boston University

Status

Completed

Conditions

Family Planning

Treatments

Other: Intervention package

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT05503992
MTaPS-19-001 (Other Grant/Funding Number)
H-43082

Details and patient eligibility

About

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.

Full 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).

Enrollment

2,523 patients

Sex

Female

Ages

18 to 49 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2,523 participants in 2 patient groups

Intervention arm
Experimental group
Description:
CHWs affiliated with intervention facilities randomized to the intervention arm will be given the intervention package.
Treatment:
Other: Intervention package
Control arm
No Intervention group
Description:
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.

Trial documents
1

Trial contacts and locations

3

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Central trial contact

Jeanette Kaiser, MPH; Veronika J Wirtz, BPharm, PhD

Data sourced from clinicaltrials.gov

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