CASI-Plus mHealth for Ukraine's APS Program (Aim 1)

NCT06971120 | Completed

• 1 other identifier: STUDY00015808-Aim 1
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 2

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. 1.Aim 1 (R21): Conduct formative research from health worker and client perspectives to design the CASI-Plus mHealth intervention.
2. 2.Aim 2 (R21): In a randomized controlled trial (RCT), assess adoption of CASI-Plus and its impact on contact elicitation. \[NOTE: Aim 2 is covered under ClinicalTrials.gov record #NCT05826977\]

Conditions

HIV Infection

Keywords

Ukraine; HIV testing; partner notification

Outcome Measures

Primary Outcomes (3)

• Usability of CASI-Plus tool (client perspective)

  The investigators will assess usability through qualitative interviews with clients.

  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.

  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.

  Survey-based usability assessment will take place during the last 3 months of the study.

Secondary Outcomes (1)

• Heuristic evaluation of CASI-Plus

  Heuristic evaluation will take place in months 12-15 of the study.

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (2)

Municipal Enterprise "Chernihiv Regional Hospital" of the Chernihiv Regional Council "Center for HIV/AIDS and Hepatitis Prevention"

Chernihiv, Chernihiv Oblast, Ukraine

Location

Municipal Enterprise "Dnipropetrovsk Regional Medical Center for Socially Significant Diseases" of the Dnipropetrovsk Regional Council

Dnipro, Dnipropetrovsk Oblast, Ukraine

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Nancy Puttkammer, PhD, MPH

  International Training and Education Center for Health, University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Global Health

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 14, 2025
• Study Start: May 24, 2023
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Beginning 9 months and ending 36 months following article publication.

Locations

UA (2)