CASI-Plus mHealth for Ukraine's APS Program

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05826977
• Other study ID #: STUDY00015808
• Secondary ID: 1R21EB032229-01A
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2023
• Est. completion date: January 2025

Study information

• Verified date: June 2024
• Source: University of Washington
• Contact: Olena Nesterova
• Phone: +380-50-606-32-50
• Email: o.nesterova[@]phc.org.ua
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1124
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria for APS Index Clients (R21 Aim 1)

1. age 18 and over;

2. participated in APS services within the past 12 months at the study clinic;

3. willing to come to the clinic to participate in an in-depth interview about the intervention design; and

4. provide informed consent to participate in the study.

Inclusion Criteria for APS Index Clients (R21 Aim 2 and R33 Aim 3)

1. consent to participate in APS services and the study;

2. are 18 years or older;

3. have been diagnosed with HIV and enrolled in care;

4. have not previously participated in APS services at another health facility; and

5. have access to a personal cell phone and internet.

Inclusion Criteria for Health Workers (R21 Aim 1 and R233 Aim 3 and Aim 4)

1. age 18 and over;

2. employed at the study site;

3. have participated in delivery of HIV testing, prevention, care and/or treatment services at the health facility during the past year; and

4. provide informed consent to participate in the study.

Exclusion Criteria Does not meet one or more inclusion criteria

-

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• CASI-Plus
See arm description

Locations

Country	Name	City	State
Ukraine	Chernihiv City Hospital AIDS Center	Chernihiv
Ukraine	Dnipro City Hospital AIDS Center	Dnipro

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	National Institute for Biomedical Imaging and Bioengineering (NIBIB), Public Health Center, Ministry of Health, Ukraine

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline measurement
Primary	Testing index	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.	Measured at 8 weeks
Secondary	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 at study completion, on average after 8-12 weeks
Secondary	Adoption of CASI-Plus	Percentage of clients responding to >=1 follow-up survey, based on CASI-Plus paradata and APS case files	Measured between baseline and 8 weeks
Secondary	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 between baseline and 8 weeks
Secondary	HIV case finding index	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.	Measured at 8 weeks
Secondary	Linkage to HIV services	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.	Measured at 8 weeks
Secondary	IPV risk	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.	Measured between baseline and 8 weeks