HIV InfectionNCT06971120
CASI-Plus mHealth for Ukraine's APS Program (Aim 1)
An observational study of HIV Infection, 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 Infection
- How many people
- 44 participants
- Where
- 2 sitesUkraine
- Study dates
- 24 May 2023to 28 Feb 2025
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Clients are purposefully selected HIV index testing clients at one of the study sites (Chernihiv). Health workers are purposefully selected employees who are involved in delivering HIV index testing services at the two study sites (Chernihiv and Dnipro).
Who may be able to join
- age 18 and over;
- participated in APS services within the past 12 months at the study clinic;
- willing to come to the clinic to participate in an in-depth interview about the intervention design; and
- provide informed consent to participate in the study.
- age 18 and over;
- employed at the study site;
- have participated in delivery of HIV testing, prevention, care and/or treatment services at the health facility during the past year; and
- provide informed consent to participate in the study.
Who cannot join
- Does not meet one or more inclusion criteria
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, Dnipropetrovsk Oblast
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 1)
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 aims are:
- Aim 1 (R21): Conduct formative research from health worker and client perspectives to design the CASI-Plus mHealth intervention.
- Aim 2 (R21): In a randomized controlled trial (RCT), assess adoption of CASI-Plus and its impact on contact elicitation. [NOTE: Aim 2 is covered under ClinicalTrials.gov record #NCT05826977]
Read more
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=10-15) and focus group discussions with HWs (N=3 groups of 8-15 HWs each) 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 provide feedback on the tool's technical performance, usability, and acceptability. Hypothesis: CASI-Plus will be perceived by both clients and HWs as easy to navigate, acceptable, and technically sound.
- Conditions
- HIV Infection
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Clients living with HIV | Clients living with HIV who participate in HIV index testing services | |
| Healthcare workers | Healthcare workers employed in primary care HIV clinics where HIV index testing services are provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of CASI-Plus tool (client perspective)
The investigators will assess usability through qualitative interviews with clients.
Measured: Usability assessment will take place during months 1-12 (during development and testing of the CASI-Plus tool).
Usability of CASI-Plus tool (health worker perspective)
The investigators will assess usability through qualitative interviews with healthcare workers.
Measured: Qualitative usability assessment will take place during months 1-12 (during development and testing of the CASI-Plus tool).
Usability of CASI-Plus tool (health worker perspective)
The investigators will assess usability through surveys with healthcare workers. The survey includes adapted items from the System Usability Scale (SUS) which assesses dimensions of usability on a Likert scale, as well as customized, project specific items.
Measured: Survey-based usability assessment will take place during the last 3 months of the study.
Secondary outcomes (1)
Heuristic evaluation of CASI-Plus
Health workers at the study sites and Ukrainian study team members will use a custom tool to document usability concerns based on common usability heuristics. The heuristic evaluation tool includes 16 heuristics applied to 12 sub-sections of the CASI-Plus tool. Users can document any issue that arises during prototype testing based on 5 test scripts (sample cases) as well as ad hoc testing. The can rate the severity of the issue identified (low, middle, high severity), and identify recommendations for fixing each issue.
Measured: Heuristic evaluation will take place in months 12-15 of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start24 May 2023
- Primary completion28 Feb 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 InfectionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Puttkammer, University of Washington
- Investigators
- Nancy Puttkammer, PhD, MPH, Principal investigator, International Training and Education Center for Health, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971120
- Sponsor's protocol ID
- STUDY00015808-Aim 1
- Status last verified
- May 2025
- First submitted
- 23 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 the investigators 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 14 May 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 1)
- ClinicalTrials.gov ID
- NCT06971120
- Acronym / sponsor ID
- STUDY00015808-Aim 1
- Conditions
- HIV Infection
- Keywords
- Ukraine, HIV testing, partner notification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 24 May 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 14 May 2025 (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 aims are:
- Aim 1 (R21): Conduct formative research from health worker and client perspectives to design the CASI-Plus mHealth intervention.
- Aim 2 (R21): In a randomized controlled trial (RCT), assess adoption of CASI-Plus and its impact on contact elicitation. [NOTE: Aim 2 is covered under ClinicalTrials.gov record #NCT05826977]
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=10-15) and focus group discussions with HWs (N=3 groups of 8-15 HWs each) 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 provide feedback on the tool's technical performance, usability, and acceptability. Hypothesis: CASI-Plus will be perceived by both clients and HWs as easy to navigate, acceptable, and technically sound.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clients living with HIV | – | –Clients living with HIV who participate in HIV index testing services |
| Healthcare workers | – | –Healthcare workers employed in primary care HIV clinics where HIV index testing services are provided |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Clients are purposefully selected HIV index testing clients at one of the study sites (Chernihiv). Health workers are purposefully selected employees who are involved in delivering HIV index testing services at the two study sites (Chernihiv and Dnipro).
Key inclusion criteria (8 listed)
- age 18 and over;
- participated in APS services within the past 12 months at the study clinic;
- willing to come to the clinic to participate in an in-depth interview about the intervention design; and
- provide informed consent to participate in the study.
- age 18 and over;
Key exclusion criteria (1 listed)
- Does not meet one or more inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Usability of CASI-Plus tool (client perspective)
Time frame: Usability assessment will take place during months 1-12 (during development and testing of the CASI-Plus tool).
The investigators will assess usability through qualitative interviews with clients.
Usability of CASI-Plus tool (health worker perspective)
Time frame: Qualitative usability assessment will take place during months 1-12 (during development and testing of the CASI-Plus tool).
The investigators will assess usability through qualitative interviews with healthcare workers.
Usability of CASI-Plus tool (health worker perspective)
Time frame: Survey-based usability assessment will take place during the last 3 months of the study.
The investigators will assess usability through surveys with healthcare workers. The survey includes adapted items from the System Usability Scale (SUS) which assesses dimensions of usability on a Likert scale, as well as customized, project specific items.
1 secondary outcome
Heuristic evaluation of CASI-Plus
Time frame: Heuristic evaluation will take place in months 12-15 of the study.
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 14 May 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 the investigators 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
International Training and Education Center for Health, University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, 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 8 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 14 May 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?
Usability of CASI-Plus tool (client perspective) (time frame: Usability assessment will take place during months 1-12 (during development and testing of the CASI-Plus tool).). The study lists 3 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 14 May 2025.