Clinical trial NCT05503992: Evaluating the Efficacy of Using a Digital Consumption Management Tool for Family Planning in Zambia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Planning
Keywords: Digital consumption management tool
Community health workers
OpenSRP
Rural Zambia
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: Pharmaceutical Systems Africa (PSA)
First posted: 2022-08-17
Enrollment: 2523
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of women using preferred family planning method
timeFrame: 6 months
Secondary outcomes:
measure: Resupply of family planning of choice
timeFrame: 6 months
Other outcomes:
measure: Stock of family planning available at health facility
timeFrame: 6 months
Locations:
city: Kawambwa
country: Zambia
facility: Kawambwa District Health Office
city: Mansa
country: Zambia
facility: Mansa District Health Office
city: Samfya
country: Zambia
facility: Samfya District Health Office
Study officials:
affiliation: Boston University School of Public Health, Global Health
name: Veronika J Wirtz, BPharm, PhD
role: PRINCIPAL_INVESTIGATOR
References: