CASI-Plus mHealth for Ukraine's APS Program
- Conditions
- HIV Infections
- Interventions
- Behavioral: CASI-Plus
- Registration Number
- NCT05826977
- Lead Sponsor
- University of Washington
- Brief 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). 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:
1. Aim 1 (R21): Conduct formative research from health worker and client perspectives to design the CASI-Plus mHealth intervention.
2. Aim 2 (R21): In a randomized controlled trial (RCT), assess adoption of CASI-Plus and its impact on contact elicitation.
3. Aim 3 (R33): In an expanded RCT, test CASI-Plus on the HIV testing index.
4. Aim 4 (R33): Assess appropriateness and feasibility of the CASI-Plus intervention and its impact on overall acceptability of APS services.
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.
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.
Aim 3 (R33): In an expanded RCT, test CASI-Plus on the HIV testing index. Approach: The investigators will expand the RCT to three high-volume health facilities and test its effectiveness in improving the HIV testing index (number of partners with unknown HIV status tested per index client; primary outcome, N=888). Secondary outcomes include the percentage of index clients disclosing MSM or PWID partners, HIV case-finding index, and APS-associated adverse events. Hypothesis: The intervention will increase the HIV testing index and participation of PWID and MSM, without increasing adverse events.
Aim 4 (R33): Assess appropriateness and feasibility of the CASI-Plus intervention and its impact on overall acceptability of APS services. Approach: The investigators will use exit surveys of HWs (N=36) and CASI-Plus clients (N=444) to assess appropriateness and feasibility of the intervention. Researchers will assess CASI-Plus impact on overall APS acceptability, via measures of satisfaction and perceived stigma, in an exit survey with clients in both study arms (N=888). Hypothesis: CASI-Plus will be appropriate, feasible, and improve APS acceptability.
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1124
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CASI-Plus CASI-Plus 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).
- Primary Outcome Measures
Name Time Method Contact index 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 Measured at 8 weeks This is the primary outcome for the R33 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.
- Secondary Outcome Measures
Name Time Method Adoption of CASI-Plus Measured between baseline and 8 weeks Percentage of clients responding to \>=1 follow-up survey, based on CASI-Plus paradata and APS case files
CASI-Plus tool system usability Measured at study completion, on average after 8-12 weeks 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".
Level of engagement with CASI-Plus Measured between baseline and 8 weeks Average number of direct engagements between index clients and HW through case closure, based on CASI-Plus paradata and APS case files
Linkage to HIV services Measured at 8 weeks This is a secondary outcome for the R33 phase. Proportion of partners with newly diagnosed HIV who are linked to HIV treatment; Proportion of partners with new HIV-negative results who are linked to HIV pre-exposure prophylaxis (PrEP) services. This outcome will be measured through routine APS program data sources including APS case files and the HIV MIS electronic health record system.
HIV case finding index Measured at 8 weeks This is a secondary outcome for the R33 phase. Number of newly diagnosed HIV cases 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.
IPV risk Measured between baseline and 8 weeks This is a secondary outcome for the R33 phase. Proportion of index clients reporting IPV risk for one or more partners prior to partner notification; proportion partners for whom index clients report IPV concern following partner notification (by client sociodemographic characteristics and risk group type). This outcome will be measured through routine APS program data sources including APS case files and the HIV MIS electronic health record system, and through the client exit survey.
Trial Locations
- Locations (2)
• Municipal Enterprise "Chernihiv Regional Hospital" of the Chernihiv Regional Council "Center for HIV/AIDS and Hepatitis Prevention"
🇺🇦Chernihiv, Ukraine
• Municipal Enterprise "Dnipropetrovsk Regional Medical Center for Socially Significant Diseases" of the Dnipropetrovsk Regional Council
🇺🇦Dnipro, Ukraine