Family PlanningNCT05503992
Evaluating the Efficacy of Using a Digital Consumption Management Tool for Family Planning in Zambia
A study testing Intervention package in people with Family Planning, run by Boston University at 3 sites in Zambia.
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Family Planning
- What is being tested?
- Intervention package
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,523 participants
- Where
- 3 sitesZambia
- Study dates
- 5 Nov 2022to 8 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Unwilling or unable to consent
- Currently pregnant
- Currently breastfeeding
Trial locations and contacts
3 sites in 1 country.
Zambia3 sites
Kawambwa District Health Office
Kawambwa, 730096
Mansa District Health Office
Mansa, 710371
Samfya District Health Office
Samfya, 720071
About this study
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
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:
- assess the impact of the intervention on satisfaction and use of modern family planning methods among last-mile people of childbearing potential; and
- understand the impact of the intervention on FP inventory management and dispensing.
Read more
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.
Read the 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).
- Conditions
- Family Planning
- Being tested
- Intervention package
- Keywords
- Digital consumption management tool, Community health workers, OpenSRP, Rural Zambia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention packageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | CHWs affiliated with intervention facilities randomized to the intervention arm will be given the intervention package. Receives: Other: Intervention package |
| Control arm | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start5 Nov 2022
- Primary completion1 Dec 2023
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family PlanningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 2,523 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Pharmaceutical Systems Africa (PSA)
- Responsible party
- Sponsor
- Investigators
- Veronika J Wirtz, BPharm, PhD, Principal investigator, Boston University School of Public Health, Global Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503992
- Sponsor's protocol ID
- H-43082
- Other IDs
- MTaPS-19-001
- Status last verified
- Dec 2023
- First submitted
- 15 Aug 2022
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05503992
- Acronym / sponsor ID
- H-43082
- Conditions
- Family Planning
- Keywords
- Digital consumption management tool, Community health workers, OpenSRP, Rural Zambia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,523 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Pharmaceutical Systems Africa (PSA)
- Study start
- 5 Nov 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- assess the impact of the intervention on satisfaction and use of modern family planning methods among last-mile people of childbearing potential; and
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Intervention packageCHWs affiliated with intervention facilities randomized to the intervention arm will be given the intervention package. |
| Control arm | No intervention | –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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Unwilling or unable to consent
- Currently pregnant
- Currently breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention packageThe 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. | Other | Intervention arm |
Primary outcome
Percentage of women using preferred family planning method
Time frame: 6 months
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.
1 secondary outcome
Resupply of family planning of choice
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronika J Wirtz, BPharm, PhD principal investigator
Boston University School of Public Health, Global Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention package in people with Family Planning, run by Boston University at 3 sites in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of women using preferred family planning method (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.