HIV InfectionsNCT05826977
CASI-Plus mHealth for Ukraine's APS Program (Aim 2)
A study testing CASI-Plus in people with HIV Infections, run by University of Washington at 2 sites in Ukraine.
Trial summary
The CASI-Plus mHealth intervention seeks to improve partner elicitation and testing as part of assisted partner services (APS) in Ukraine, through a mHealth client engagement tool using computer-assisted self-interview (CASI). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- CASI-Plus
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 2 sitesUkraine
- Study dates
- 7 Aug 2024to 28 Feb 2025
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- consent to participate in APS services and the study;
- are 18 years or older;
- have been diagnosed with HIV and enrolled in care;
- have not previously participated in APS services at another health facility; and
- have access to a personal cell phone and internet.
- Exclusion Criteria Does not meet one or more inclusion criteria
- -
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Ukraine2 sites
• Municipal Enterprise "Chernihiv Regional Hospital" of the Chernihiv Regional Council "Center for HIV/AIDS and Hepatitis Prevention"
Chernihiv, Chernihiv Oblast
• Municipal Enterprise "Dnipropetrovsk Regional Medical Center for Socially Significant Diseases" of the Dnipropetrovsk Regional Council
Dnipro, Dnipro
About this study
Official title: CASI-Plus: A Mobile Health (mHealth) Tool for Client Engagement to Improve Ukraine's Assisted Partner Services (APS) Program Workflow and HIV Testing Outcomes (Aim 2)
The CASI-Plus mHealth intervention seeks to improve partner elicitation and testing as part of assisted partner services (APS) in Ukraine, through a mHealth client engagement tool using computer-assisted self-interview (CASI). APS is a strategy for contact tracing and HIV testing for the high-risk sexual and needle-sharing partners of patients known to be living with HIV. This implementation science research will provide useful evidence on whether CASI-Plus can improve partner elicitation and HIV testing in a routine APS program operating at scale, toward the ultimate goal of linkage to HIV prevention and treatment services among those at highest risk of HIV. The aim of the study is to assess adoption of CASI-Plus and its impact on contact elicitation in a randomized controlled trial (RCT).
Participants will integrate CASI-Plus as part of the APS services workflow to collect information from clients on sexual partners, needle-sharing partners, and biological children with risk of HIV exposure, and on self-reported partner notification and partner HIV testing outcomes.
The investigators will compare APS clients using CASI-Plus to APS clients receiving standard APS services, to see if the contact index (number of partners named per index client enrolled in APS services) and the HIV testing index (number of partners with unknown HIV status tested per index client enrolled in APS services) increase with use of CASI-Plus.
Read the detailed description
In December 2016, the World Health Organization (WHO) recommended scale-up of assisted partner notification services (APS) as a strategy to increase HIV testing among persons living with HIV (PLWH). APS offers PLWH assistance to confidentially notify their sex and needle-sharing partners of their exposure and link them to testing and treatment. Randomized controlled trials (RCTs) have shown that APS increases HIV testing and case-finding, and is cost-effective. APS is scalable in routine practice, but typically with lower HIV case-finding than was observed in RCTs. APS outcomes are sub-optimal when recipients only name their current sex partner, or when partner notification and testing does not occur. There are an estimated 240,000 PLWH in Ukraine, of whom roughly three in four know their HIV status. While population-level HIV prevalence is 1.0%, prevalence among persons who inject drugs (PWID) and men who have sex with men (MSM) is 23% and 8%, respectively.
In 2019, the Ukraine Ministry of Health began scaling APS services. Despite trainings that emphasized the need to elicit >1 partner for each index client, health workers (HW) elicited only 1.14 for sexual and needle-sharing partners per index client, on average.16 Only 5.6% of APS clients identified as MSM or PWID and 45.9% of partners with unknown status had not yet completed HIV testing after 30 days.
The CASI-Plus mHealth intervention seeks to improve partner elicitation and testing, through a mHealth client engagement tool using computer-assisted self-interview (CASI). The CASI-Plus tool supports the initial APS encounter (providing information on how APS works, eliciting names of all sexual or injection partners, screening for risk of intimate partner violence [IPV], and planning for partner notification), and facilitates case management through partner testing (via repeat follow-up surveys to assess for barriers to notification, interest in provider assistance, IPV, and completion of notification). While CASI has reduced social desirability bias in surveys of sexual behavior across diverse settings, it has not yet been used in APS programs in low- or middle-income countries (LMICs). This implementation science research will provide useful evidence on whether CASI-Plus can improve partner elicitation and HIV testing in a routine APS program operating at scale, toward the ultimate goal of linkage to HIV prevention and treatment services among those at highest risk of HIV.
Aim 1 (R21): Conduct formative research from health worker and client perspectives to design the CASI-Plus mHealth intervention. Approach: The investigators will complete in-depth interviews with APS clients (N=10) and focus group discussions with HWs (N=2 groups of 8 HWs) to elicit barriers to partner elicitation and testing, use this information to design the CASI-Plus tool and its integration within the APS workflow, and test the tool for technical performance, usability, and acceptability. Hypothesis: CASI-Plus will be perceived by both clients and HWs as easy to navigate, acceptable, and technically sound. [NOTE: Aim 1 is covered under a separate submission to ClinicalTrials.gov]
Aim 2 (R21): In a RCT, assess adoption of CASI-Plus and its impact on contact elicitation. Approach: In one high-volume health facility, the investigators will randomize PLWH (N=154) to either the CASI-Plus or standard care (SC) APS workflow, and measure the use of the tool and contact index using routinely-collected data. Hypothesis: Clients will complete initial and follow-up surveys, and will report more partners when using the tool.
The proposed research team brings together experienced researchers, APS program specialists, and digital health specialists from the University of Washington (UW) and the Ministry of Health's Public Health Center (PHC). The project builds upon the existing national platform for APS within public-sector HIV clinics, and lays the foundation for a simple intervention to optimize APS delivery which could be evaluated for implementation outcomes and effectiveness at scale in a future cluster-randomized controlled clinical trial.
- Conditions
- HIV Infections
- Being tested
- CASI-Plus
- Keywords
- Ukraine, HIV testing, partner notification
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CASI-PlusBehavioural
See arm description
| Study group | Role | What they receive |
|---|---|---|
| CASI-Plus | Experimental | The CASI-Plus arm involves use of a tablet-based computerized self-interview tool. This mHealth tool supports the initial assisted partner services (APS) encounter (providing information on how APS works, eliciting names of all sexual or injection partners, screening for risk of intimate partner violence [IPV], and planning for partner notification), and facilitates case management through partner testing (via repeat follow-up surveys to assess for barriers to notification, interest in provider assistance, IPV, and completion of notification). Receives: Behavioral: CASI-Plus |
| Standard of care | No intervention | Standard APS services involve: 1) Nurses, social workers or doctors introduce APS services to clients during routine health care visits and complete partner elicitation and intimate partner violence (IPV) screening via in-person counseling. 3) HWs discuss options for partner notification. 4) If index clients opts for a HW to notify the partner, the HW makes multiple contact attempts to contact partners by phone. When index clients return for their regular healthcare services, HW follow up with index clients to check if exposed partners have completed the testing process. 5) If partners have an unknown HIV status, they are encouraged to complete HIV testing. 6) Partners who test negative for HIV are referred to HIV prevention services, while those with confirmed HIV diagnoses are linked to HIV care and treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contact index
This is the primary outcome for the R21 study, measured during the initial APS encounter, at client enrollment into the study. Number of partners named per index client. This outcome will be measured through routine APS program data sources including APS case files and the HIV management information system (MIS) electronic health record system.
Measured: Baseline measurement
Testing index
This is a secondary outcome for the Aim 2 Study. Number of partners with unknown HIV status tested per index client. This outcome will be measured through routine APS program data sources including APS case files and the HIV MIS electronic health record system.
Measured: Measured at 8 weeks
Secondary outcomes (3)
CASI-Plus tool system usability
System Usability Scale (Bangor, 2008). This is a 10-item instrument with 5-point Likert scale response options, such as "I found the tool unnecessarily complex" or "I would imagine that most people would learn to use this tool very quickly".
Measured: Measured at study completion, on average after 8-12 weeks
Adoption of CASI-Plus
Percentage of clients responding to >=1 follow-up survey, based on CASI-Plus paradata and APS case files
Measured: Measured between baseline and 8 weeks
Level of engagement with CASI-Plus
Average number of direct engagements between index clients and HW through case closure, based on CASI-Plus paradata and APS case files
Measured: Measured between baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start7 Aug 2024
- Primary completion31 Jan 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the R21 trial, in one high-volume health facility, researchers will randomize PLWH (N=178) to either the CASI-Plus or standard care (SC) APS workflow, and measure the use of the tool and contact index using routinely-collected data.
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB), Public Health Center, Ministry of Health, Ukraine
- Responsible party
- Principal investigator, Nancy Puttkammer, University of Washington
- Investigators
- Nancy Puttkammer, PhD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826977
- Sponsor's protocol ID
- STUDY00015808
- Other IDs
- 1R21EB032229-01A1
- Status last verified
- Jun 2025
- First submitted
- 24 Mar 2023
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Shared individual participant data (IPD) will include IPD that underlie the results reported in published articles, after deidentification (text, tables, figures, and appendices). Anyone who wishes to access the data and who provides a methodologically sound proposal, may request access IPD. Researchers will be asked to submit a request in writing describing their qualifications including their certification by their local institutional review board (IRB), analytic plans and other uses of the data/resources, and plans to secure the confidentiality and safety of the data. They will be required to agree in writing that they will not share the data with others, will use it only for the research purpose(s) delineated, and will return or destroy the data upon completion. Proposals should be directed to Nancy Puttkammer (nputt@uw.edu). Given the sensitive nature of the data we are collecting, including HIV diagnosis, the data will not be shared in a public access file.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CASI-Plus: A Mobile Health (mHealth) Tool for Client Engagement to Improve Ukraine's Assisted Partner Services (APS) Program Workflow and HIV Testing Outcomes (Aim 2)
- ClinicalTrials.gov ID
- NCT05826977
- Acronym / sponsor ID
- STUDY00015808
- Conditions
- HIV Infections
- Keywords
- Ukraine, HIV testing, partner notification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB), Public Health Center, Ministry of Health, Ukraine
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 24 Apr 2023 (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 CASI-Plus mHealth intervention seeks to improve partner elicitation and testing as part of assisted partner services (APS) in Ukraine, through a mHealth client engagement tool using computer-assisted self-interview (CASI). APS is a strategy for contact tracing and HIV testing for the high-risk sexual and needle-sharing partners of patients known to be living with HIV. This implementation science research will provide useful evidence on whether CASI-Plus can improve partner elicitation and HIV testing in a routine APS program operating at scale, toward the ultimate goal of linkage to HIV prevention and treatment services among those at highest risk of HIV. The aim of the study is to assess adoption of CASI-Plus and its impact on contact elicitation in a randomized controlled trial (RCT).
Participants will integrate CASI-Plus as part of the APS services workflow to collect information from clients on sexual partners, needle-sharing partners, and biological children with risk of HIV exposure, and on self-reported partner notification and partner HIV testing outcomes.
The investigators will compare APS clients using CASI-Plus to APS clients receiving standard APS services, to see if the contact index (number of partners named per index client enrolled in APS services) and the HIV testing index (number of partners with unknown HIV status tested per index client enrolled in APS services) increase with use of CASI-Plus.
Detailed description
In December 2016, the World Health Organization (WHO) recommended scale-up of assisted partner notification services (APS) as a strategy to increase HIV testing among persons living with HIV (PLWH). APS offers PLWH assistance to confidentially notify their sex and needle-sharing partners of their exposure and link them to testing and treatment. Randomized controlled trials (RCTs) have shown that APS increases HIV testing and case-finding, and is cost-effective. APS is scalable in routine practice, but typically with lower HIV case-finding than was observed in RCTs. APS outcomes are sub-optimal when recipients only name their current sex partner, or when partner notification and testing does not occur. There are an estimated 240,000 PLWH in Ukraine, of whom roughly three in four know their HIV status. While population-level HIV prevalence is 1.0%, prevalence among persons who inject drugs (PWID) and men who have sex with men (MSM) is 23% and 8%, respectively.
In 2019, the Ukraine Ministry of Health began scaling APS services. Despite trainings that emphasized the need to elicit >1 partner for each index client, health workers (HW) elicited only 1.14 for sexual and needle-sharing partners per index client, on average.16 Only 5.6% of APS clients identified as MSM or PWID and 45.9% of partners with unknown status had not yet completed HIV testing after 30 days.
The CASI-Plus mHealth intervention seeks to improve partner elicitation and testing, through a mHealth client engagement tool using computer-assisted self-interview (CASI). The CASI-Plus tool supports the initial APS encounter (providing information on how APS works, eliciting names of all sexual or injection partners, screening for risk of intimate partner violence [IPV], and planning for partner notification), and facilitates case management through partner testing (via repeat follow-up surveys to assess for barriers to notification, interest in provider assistance, IPV, and completion of notification). While CASI has reduced social desirability bias in surveys of sexual behavior across diverse settings, it has not yet been used in APS programs in low- or middle-income countries (LMICs). This implementation science research will provide useful evidence on whether CASI-Plus can improve partner elicitation and HIV testing in a routine APS program operating at scale, toward the ultimate goal of linkage to HIV prevention and treatment services among those at highest risk of HIV.
Aim 1 (R21): Conduct formative research from health worker and client perspectives to design the CASI-Plus mHealth intervention. Approach: The investigators will complete in-depth interviews with APS clients (N=10) and focus group discussions with HWs (N=2 groups of 8 HWs) to elicit barriers to partner elicitation and testing, use this information to design the CASI-Plus tool and its integration within the APS workflow, and test the tool for technical performance, usability, and acceptability. Hypothesis: CASI-Plus will be perceived by both clients and HWs as easy to navigate, acceptable, and technically sound. [NOTE: Aim 1 is covered under a separate submission to ClinicalTrials.gov]
Aim 2 (R21): In a RCT, assess adoption of CASI-Plus and its impact on contact elicitation. Approach: In one high-volume health facility, the investigators will randomize PLWH (N=154) to either the CASI-Plus or standard care (SC) APS workflow, and measure the use of the tool and contact index using routinely-collected data. Hypothesis: Clients will complete initial and follow-up surveys, and will report more partners when using the tool.
The proposed research team brings together experienced researchers, APS program specialists, and digital health specialists from the University of Washington (UW) and the Ministry of Health's Public Health Center (PHC). The project builds upon the existing national platform for APS within public-sector HIV clinics, and lays the foundation for a simple intervention to optimize APS delivery which could be evaluated for implementation outcomes and effectiveness at scale in a future cluster-randomized controlled clinical trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In the R21 trial, in one high-volume health facility, researchers will randomize PLWH (N=178) to either the CASI-Plus or standard care (SC) APS workflow, and measure the use of the tool and contact index using routinely-collected data.
| Arm | Type | Receives |
|---|---|---|
| CASI-Plus | Experimental | Behavioral: CASI-PlusThe CASI-Plus arm involves use of a tablet-based computerized self-interview tool. This mHealth tool supports the initial assisted partner services (APS) encounter (providing information on how APS works, eliciting names of all sexual or injection partners, screening for risk of intimate partner violence [IPV], and planning for partner notification), and facilitates case management through partner testing (via repeat follow-up surveys to assess for barriers to notification, interest in provider assistance, IPV, and completion of notification). |
| Standard of care | No intervention | –Standard APS services involve: 1) Nurses, social workers or doctors introduce APS services to clients during routine health care visits and complete partner elicitation and intimate partner violence (IPV) screening via in-person counseling. 3) HWs discuss options for partner notification. 4) If index clients opts for a HW to notify the partner, the HW makes multiple contact attempts to contact partners by phone. When index clients return for their regular healthcare services, HW follow up with index clients to check if exposed partners have completed the testing process. 5) If partners have an unknown HIV status, they are encouraged to complete HIV testing. 6) Partners who test negative for HIV are referred to HIV prevention services, while those with confirmed HIV diagnoses are linked to HIV care and treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- consent to participate in APS services and the study;
- are 18 years or older;
- have been diagnosed with HIV and enrolled in care;
- have not previously participated in APS services at another health facility; and
- have access to a personal cell phone and internet.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CASI-PlusSee arm description | Behavioural | CASI-Plus |
Primary outcome
Contact index
Time frame: Baseline measurement
This is the primary outcome for the R21 study, measured during the initial APS encounter, at client enrollment into the study. Number of partners named per index client. This outcome will be measured through routine APS program data sources including APS case files and the HIV management information system (MIS) electronic health record system.
Testing index
Time frame: Measured at 8 weeks
This is a secondary outcome for the Aim 2 Study. Number of partners with unknown HIV status tested per index client. This outcome will be measured through routine APS program data sources including APS case files and the HIV MIS electronic health record system.
3 secondary outcomes
CASI-Plus tool system usability
Time frame: Measured at study completion, on average after 8-12 weeks
Adoption of CASI-Plus
Time frame: Measured between baseline and 8 weeks
Level of engagement with CASI-Plus
Time frame: Measured between baseline and 8 weeks
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 10 Jun 2025.
- Individual participant dataSharing planned: Yes. Shared individual participant data (IPD) will include IPD that underlie the results reported in published articles, after deidentification (text, tables, figures, and appendices). Anyone who wishes to access the data and who provides a methodologically sound proposal, may request access IPD. Researchers will be asked to submit a request in writing describing their qualifications including their certification by their local institutional review board (IRB), analytic plans and other uses of the data/resources, and plans to secure the confidentiality and safety of the data. They will be required to agree in writing that they will not share the data with others, will use it only for the research purpose(s) delineated, and will return or destroy the data upon completion. Proposals should be directed to Nancy Puttkammer (nputt@uw.edu). Given the sensitive nature of the data we are collecting, including HIV diagnosis, the data will not be shared in a public access file.
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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.
Nancy Puttkammer, PhD, MPH principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CASI-Plus in people with HIV Infections, run by University of Washington at 2 sites in Ukraine.
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 7 inclusion and 0 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 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ukraine. 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?
Contact index (time frame: Baseline measurement). 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 10 Jun 2025.