Implementation ScienceNCT06659003
Developing and Testing a Social Network Data Capture Tool to Improve Partner Services: a Preliminary Pilot Implementation
An observational study of Implementation Science and Contact Tracing, run by Northwestern University at 1 site in United States.
Trial summary
This study conducted a preliminary pilot implementation which integrated our existing social network software - Network Canvas - into Chicago Partner Services in order to understand the feasibility and acceptability of this integration, and to gather preliminary evidence of potential efficacy in improving Partner… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implementation Science, Contact Tracing, Public Health System Research
- What is being tested?
- Pilot Implementation of Network Canvas into HBH Partner Services
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 31 May 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will recruit key informants connected to HIV Partner Services, in particular those involved in the implementation of HIV Partner Services at Howard Brown Health (HBH) and/or the Chicago Public Health Department who oversees the administration of HIV Partner Services.
Who may be able to join
- (i) age 18+ years old and (ii) key informant connected to administration or implementation of Partner Services including but not limited to a Partner Services Staff Member (DIS or a DIS Manager), a Surveillance Staff Member, a federally funded STD/HIV Program Director, an Informational Technology Staff Member responsible for the technical systems which support or are connected to Partner Services, and individuals who have in the past been enrolled and interviewed within Partner Services.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
This study conducted a preliminary pilot implementation which integrated our existing social network software - Network Canvas - into Chicago Partner Services in order to understand the feasibility and acceptability of this integration, and to gather preliminary evidence of potential efficacy in improving Partner Services metrics.
All of this work will be conducted through an Active Implementation Framework in which we utilized a staged- approach and strong engagement with local (e.g., Chicago Department of Public Health and Howard Brown Health) and national stakeholders to explore, install, and implement a software pilot into Partner Services.
Read the detailed description
This study conducted a preliminary pilot implementation which integrated our existing social network software - Network Canvas - into Chicago Partner Services in order to understand the feasibility and acceptability of this integration, and to gather preliminary evidence of potential efficacy in improving Partner Services metrics. Specifically, the satisfaction of clients, of DIS, and of public health officials will be assessed. Furthermore, we will track implementation quality and sustainability. Finally, preliminary evidence of efficacy will be captured through a pre-/post-test historical control design evaluating the data quality, the proportion of partners notified, and the timeliness of interviewing, testing and linkage to care.
PRIMARY OUTCOMES Feasibility: We will assessed the feasibility of our initial implementation of Network Canvas. We define feasibility here as satisfaction with and usability of all major areas of our initial reconfiguration of Network Canvas for Howard Brown. For example, we will measured the satisfaction with and usability of our touchscreen interfaces, our procedures for deployment and data management, and important logistical supports such as our training materials, the support provided by our team, and our procedures for evaluation. Data came from KIIs where stakeholders at multiple levels within Howard Brown and CDPH responded to open-ended questions about implementation, usability, and ease of use, as well as complete a modified form of the User Satisfaction and Usability Measure to assess their perspective on the feasibility of Network Canvas. We will further assess feasibility by monitoring program data on uptake.
Acceptability: Our first measure of acceptability will be Fidelity. We will assess the fidelity or quality of implementation of our initial implementation of Network Canvas. We define fidelity here as adherence to interview protocols, deployment protocols, and data workflow protocols. Data will come from a mixture of staff self-ratings of adherence during KIIs and periodic supervision meetings, and researcher ratings of adherence by our staff. The assessment of implementation quality is not just an important outcome in year 3 for us to demonstrate acceptability; it will also serves as a feedback loop to ensure high quality implementation. Further, by beginning assessment in year 2, our team will have the opportunity to adjust and improve our strategy for implementation as well. For example, we may find it necessary to refine our training materials, or the design of our software, or our strategy for coaching and supervision.
Our second measure of acceptability will be Sustainability - or the extent to which our program is able to persist and what ongoing supports would be necessary from our team. Like fidelity, early conversations about sustainability will serve as a feedback loop that will allow our team to first identify the important drivers of implementation in Chicago and other health departments, and then shape our initial design to be sustainable. Conversations about sustainability will occur as early as year 1. Sustainability will primarily be assessed via KIIs with individuals in leadership positions. For those outside of Chicago, we will share Chicago implementation protocols to understand how sustainability may differ across the country.
SECONDARY OUTCOME Preliminary Evidence of Efficacy: To provide us with preliminary evidence of the efficacy of Network Canvas on Partner Service Program outcomes, we will work closely with Howard Brown and CDPH to analyze anonymized administrative data. While we anticipate that our requested metrics will be largely standard for CDPH's analysts, as the majority are tracked for yearly reporting to the Centers for Disease Control and Prevention (CDC), our team may need to run analyses ourselves. If that occurs, as data received by our team will be completely stripped of identifiers, this work will not be considered human subjects research. All analyses of efficacy will utilize a pre-/post-test measurement - specifically a historical control design - where we will compare program data obtained in the years prior (excluding 2020 due to COVID-19) to program data obtained during the one-year period during full implementation. We have chosen a number of metrics based primarily on the CDC's 18-1802 Evaluation and Performance Measurement Plan for Partner Services, as well as two other important studies which contributed to defining important process and outcome measures of Partner Services (Bernstein 2014 \& Marcus 2009). These HIV and program metrics span data quality, the proportion of partners that are notified, and timeliness.
- Being tested
- Pilot Implementation of Network Canvas into HBH Partner Services
- Keywords
- Network Canvas, Partner Services, Implementation, Software Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilot Implementation of Network Canvas into HBH Partner ServicesOther
Our team deployed our network data capture software - Network Canvas - into Partner Services at HBH to examine feasibility and acceptability and to provide initial evidence of efficacy (examining impacts on data quality, number of partners notified, and timeliness). Further, our team worked closely with HBH on developing implementation strategies, a Network Canvas interview protocol, evaluation measures, and training materials for their staff. Finally, we provided the HBH team technical support, and regular coaching, supervision, and evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Pilot Implementation | In order to understand feasibility and acceptability of the pilot implementation, we had key informants complete structured assessments - the majority of these key informants were Partner Services Staff Members (DIS or DIS Managers) from Chicago who reported on their experiences of the initial installation and pilot activities and the feasibility and acceptability of Network Canvas. Key informants also included directors of STD/HIV Prevention Programs, Informational Technology Staff responsible for deploying and maintaining the technical systems which support or are connected to Partner Services, and local Chicago Public Health Surveillance Staff Members.
To evaluate our secondary outcome (Preliminary Efficacy), we worked with Howard Brown and CDPH to obtain anonymized program-level administrative metrics. As data received by our team was completely stripped of identifiers, this work was considered 'exempt' human subjects research. Receives: Other: Pilot Implementation of Network Canvas into HBH Partner Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
We will assess the feasibility of our initial implementation of Network Canvas. We define feasibility here as satisfaction with and usability of all major areas of our initial reconfiguration of Network Canvas for CDPH. For example, we will measure the satisfaction with and usability of our touchscreen interfaces, our procedures for deployment and data management, and important logistical supports such as our training materials, the support provided by our team, and our procedures for evaluation. Data will come from KIIs where stakeholders at multiple levels will respond to open-ended questions about implementation, usability, and ease of use, as well as complete a modified form of the User Satisfaction and Usability Measure to assess their perspective on the feasibility of Network Canvas.
Measured: 12 months
Acceptability
Our first measure of acceptability will be Fidelity. We will assess the fidelity or quality of implementation of our initial implementation of Network Canvas. We define fidelity here as adherence to interview protocols, deployment protocols, and data workflow protocols. Data will come from a mixture of staff self-ratings of adherence and periodic supervision meetings, and researcher ratings of adherence by our staff. The assessment of implementation quality serves as a feedback loop to ensure high quality implementation, so our team has the opportunity to adjust and improve our strategy for implementation. Our second measure of acceptability will be Sustainability - or the extent to which our program is able to persist and what ongoing supports would be necessary from our team.
Measured: 12 months
Secondary outcomes (1)
Preliminary Evidence of Efficacy
To provide us with preliminary evidence of the efficacy of Network Canvas on Partner Service Program outcomes, we worked closely with Howard Brown and CDPH to obtain anonymized administrative data. These metrics are largely standard for CDPH's analysts, as the majority are tracked for yearly reporting to the Centers for Disease Control and Prevention (CDC). All obtained data will be completely stripped of identifiers, therefore this work will be considered exempt. All analyses of efficacy will utilize a pre-/post-test measurement - specifically a historical control design - where we will compare program data obtained in the years prior 2019 - 2022 (excluding 2020 due to COVID-19) to program data obtained during the one-year period of implementation. Specific program metrics include data quality, number of partners notified, and timeliness.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start1 Jul 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implementation ScienceStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Michelle Birkett, Northwestern University
- Investigators
- Michelle Birkett, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659003
- Sponsor's protocol ID
- STU00214870
- Other IDs
- R34DA052216
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Our study obtained aggregated non-identifiable program-level data in order to assess preliminary evidence of efficacy.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing a Social Network Data Capture Tool to Improve Partner Services: a Preliminary Pilot Implementation
- ClinicalTrials.gov ID
- NCT06659003
- Acronym / sponsor ID
- STU00214870
- Keywords
- Network Canvas, Partner Services, Implementation, Software Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 26 Oct 2024 (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.
This study conducted a preliminary pilot implementation which integrated our existing social network software - Network Canvas - into Chicago Partner Services in order to understand the feasibility and acceptability of this integration, and to gather preliminary evidence of potential efficacy in improving Partner Services metrics.
All of this work will be conducted through an Active Implementation Framework in which we utilized a staged- approach and strong engagement with local (e.g., Chicago Department of Public Health and Howard Brown Health) and national stakeholders to explore, install, and implement a software pilot into Partner Services.
Detailed description
This study conducted a preliminary pilot implementation which integrated our existing social network software - Network Canvas - into Chicago Partner Services in order to understand the feasibility and acceptability of this integration, and to gather preliminary evidence of potential efficacy in improving Partner Services metrics. Specifically, the satisfaction of clients, of DIS, and of public health officials will be assessed. Furthermore, we will track implementation quality and sustainability. Finally, preliminary evidence of efficacy will be captured through a pre-/post-test historical control design evaluating the data quality, the proportion of partners notified, and the timeliness of interviewing, testing and linkage to care.
PRIMARY OUTCOMES Feasibility: We will assessed the feasibility of our initial implementation of Network Canvas. We define feasibility here as satisfaction with and usability of all major areas of our initial reconfiguration of Network Canvas for Howard Brown. For example, we will measured the satisfaction with and usability of our touchscreen interfaces, our procedures for deployment and data management, and important logistical supports such as our training materials, the support provided by our team, and our procedures for evaluation. Data came from KIIs where stakeholders at multiple levels within Howard Brown and CDPH responded to open-ended questions about implementation, usability, and ease of use, as well as complete a modified form of the User Satisfaction and Usability Measure to assess their perspective on the feasibility of Network Canvas. We will further assess feasibility by monitoring program data on uptake.
Acceptability: Our first measure of acceptability will be Fidelity. We will assess the fidelity or quality of implementation of our initial implementation of Network Canvas. We define fidelity here as adherence to interview protocols, deployment protocols, and data workflow protocols. Data will come from a mixture of staff self-ratings of adherence during KIIs and periodic supervision meetings, and researcher ratings of adherence by our staff. The assessment of implementation quality is not just an important outcome in year 3 for us to demonstrate acceptability; it will also serves as a feedback loop to ensure high quality implementation. Further, by beginning assessment in year 2, our team will have the opportunity to adjust and improve our strategy for implementation as well. For example, we may find it necessary to refine our training materials, or the design of our software, or our strategy for coaching and supervision.
Our second measure of acceptability will be Sustainability - or the extent to which our program is able to persist and what ongoing supports would be necessary from our team. Like fidelity, early conversations about sustainability will serve as a feedback loop that will allow our team to first identify the important drivers of implementation in Chicago and other health departments, and then shape our initial design to be sustainable. Conversations about sustainability will occur as early as year 1. Sustainability will primarily be assessed via KIIs with individuals in leadership positions. For those outside of Chicago, we will share Chicago implementation protocols to understand how sustainability may differ across the country.
SECONDARY OUTCOME Preliminary Evidence of Efficacy: To provide us with preliminary evidence of the efficacy of Network Canvas on Partner Service Program outcomes, we will work closely with Howard Brown and CDPH to analyze anonymized administrative data. While we anticipate that our requested metrics will be largely standard for CDPH's analysts, as the majority are tracked for yearly reporting to the Centers for Disease Control and Prevention (CDC), our team may need to run analyses ourselves. If that occurs, as data received by our team will be completely stripped of identifiers, this work will not be considered human subjects research. All analyses of efficacy will utilize a pre-/post-test measurement - specifically a historical control design - where we will compare program data obtained in the years prior (excluding 2020 due to COVID-19) to program data obtained during the one-year period during full implementation. We have chosen a number of metrics based primarily on the CDC's 18-1802 Evaluation and Performance Measurement Plan for Partner Services, as well as two other important studies which contributed to defining important process and outcome measures of Partner Services (Bernstein 2014 \& Marcus 2009). These HIV and program metrics span data quality, the proportion of partners that are notified, and timeliness.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot Implementation | – | Other: Pilot Implementation of Network Canvas into HBH Partner ServicesIn order to understand feasibility and acceptability of the pilot implementation, we had key informants complete structured assessments - the majority of these key informants were Partner Services Staff Members (DIS or DIS Managers) from Chicago who reported on their experiences of the initial installation and pilot activities and the feasibility and acceptability of Network Canvas. Key informants also included directors of STD/HIV Prevention Programs, Informational Technology Staff responsible for deploying and maintaining the technical systems which support or are connected to Partner Services, and local Chicago Public Health Surveillance Staff Members. To evaluate our secondary outcome (Preliminary Efficacy), we worked with Howard Brown and CDPH to obtain anonymized program-level administrative metrics. As data received by our team was completely stripped of identifiers, this work was considered 'exempt' human subjects research. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will recruit key informants connected to HIV Partner Services, in particular those involved in the implementation of HIV Partner Services at Howard Brown Health (HBH) and/or the Chicago Public Health Department who oversees the administration of HIV Partner Services.
Key inclusion criteria (1 listed)
- (i) age 18+ years old and (ii) key informant connected to administration or implementation of Partner Services including but not limited to a Partner Services Staff Member (DIS or a DIS Manager), a Surveillance Staff Member, a federally funded STD/HIV Program Director, an Informational Technology Staff Member responsible for the technical systems which support or are connected to Partner Services, and individuals who have in the past been enrolled and interviewed within Partner Services.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Pilot Implementation of Network Canvas into HBH Partner ServicesOur team deployed our network data capture software - Network Canvas - into Partner Services at HBH to examine feasibility and acceptability and to provide initial evidence of efficacy (examining impacts on data quality, number of partners notified, and timeliness). Further, our team worked closely with HBH on developing implementation strategies, a Network Canvas interview protocol, evaluation measures, and training materials for their staff. Finally, we provided the HBH team technical support, and regular coaching, supervision, and evaluation. | Other | Pilot Implementation |
Primary outcome
Feasibility
Time frame: 12 months
We will assess the feasibility of our initial implementation of Network Canvas. We define feasibility here as satisfaction with and usability of all major areas of our initial reconfiguration of Network Canvas for CDPH. For example, we will measure the satisfaction with and usability of our touchscreen interfaces, our procedures for deployment and data management, and important logistical supports such as our training materials, the support provided by our team, and our procedures for evaluation. Data will come from KIIs where stakeholders at multiple levels will respond to open-ended questions about implementation, usability, and ease of use, as well as complete a modified form of the User Satisfaction and Usability Measure to assess their perspective on the feasibility of Network Canvas.
Acceptability
Time frame: 12 months
Our first measure of acceptability will be Fidelity. We will assess the fidelity or quality of implementation of our initial implementation of Network Canvas. We define fidelity here as adherence to interview protocols, deployment protocols, and data workflow protocols. Data will come from a mixture of staff self-ratings of adherence and periodic supervision meetings, and researcher ratings of adherence by our staff. The assessment of implementation quality serves as a feedback loop to ensure high quality implementation, so our team has the opportunity to adjust and improve our strategy for implementation. Our second measure of acceptability will be Sustainability - or the extent to which our program is able to persist and what ongoing supports would be necessary from our team.
1 secondary outcome
Preliminary Evidence of Efficacy
Time frame: 12 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 26 Oct 2024.
- Project WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Our study obtained aggregated non-identifiable program-level data in order to assess preliminary evidence of efficacy.
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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.
Michelle Birkett, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Implementation Science and Contact Tracing, run by Northwestern University at 1 site in United States.
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 1 inclusion and 1 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 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Feasibility (time frame: 12 months). The study lists 2 primary outcomes in all. 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 26 Oct 2024.