NCT02338024

Brief Summary

This study proposes to assess whether a modified Antiretroviral Treatment Access Study intervention, proved to be effective in the U.S. and based on the nurse case management approach, can impact the enrollment in HIV care of recently detected HIV-positive patients in specialized health care clinics in three regions in Ukraine, using the existing local infrastructure. The proposed study addresses a significant public health issue of non-/late enrollment of HIV-positive persons in HIV care and treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 14, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

October 22, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2017

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

2 years

First QC Date

January 9, 2015

Last Update Submit

April 27, 2021

Conditions

HIV

Keywords

Enrollment in HIV careRecently detected HIV-positivespecialized health care clinicsUkraine

Outcome Measures

Primary Outcomes (1)

  • The proportion of referred intervention patients who enroll in HIV care

    Linkage (registration) to HIV care within the 3-month period after study enrollment-both self-reported and confirmed by the medical record.

    3 months

Study Arms (2)

MARTAS intervention

EXPERIMENTAL

Structured motivational sessions and further communication between linkage coordinators and HIV-positive patients focused on engagement in HIV medical care.

Behavioral: Modified Antiretroviral Treatment Access Study intervention

Standard of care

NO INTERVENTION

Oral referrals to a network of government AIDS Centers or their departments ("Trust" offices) located in each study region.

Interventions

Modified Antiretroviral Treatment Access Study interventionBEHAVIORAL
MARTAS intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18+ years;
  • Tested HIV-positive
  • Fluent in Russian or Ukrainian;
  • Able to read/understand and sign an informed consent

You may not qualify if:

  • Enrolled in HIV care;
  • Plan to move out of the study region before the end of their follow-up period
  • Cognitive impairment
  • Have pending legal issues, independent of their lifetime history of incarceration
  • Subject is a part of another intervention or/and research study with similar linkage-to-care objectives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Dermatovenereological dispensary

Dnipropetrovsk, Ukraine

Location

Narcological dispensary

Dnipropetrovsk, Ukraine

Location

Infectious disease clinic

Kryvyi Rih, Ukraine

Location

Ukrainian Institute on Public Health Policy

Kyiv, Ukraine

Location

Dermatovenereological dispensary

Mykolaiv, Ukraine

Location

Infectious disease clinic

Mykolaiv, Ukraine

Location

Narcological dispensary

Mykolaiv, Ukraine

Location

Center of psychical health

Odesa, Ukraine

Location

Dermatovenereological dispensary

Odesa, Ukraine

Location

Infectious disease clinic

Odesa, Ukraine

Location

Related Publications (1)

  • Neduzhko O, Postnov O, Sereda Y, Kulchynska R, Bingham T, Myers JJ, Flanigan T, Kiriazova T. Modified Antiretroviral Treatment Access Study (MARTAS): A Randomized Controlled Trial of the Efficacy of a Linkage-to-Care Intervention Among HIV-Positive Patients in Ukraine. AIDS Behav. 2020 Nov;24(11):3142-3154. doi: 10.1007/s10461-020-02873-7.

    PMID: 32333208DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

January 9, 2015

First Posted

January 14, 2015

Study Start

October 22, 2015

Primary Completion

October 3, 2017

Study Completion

October 3, 2017

Last Updated

April 29, 2021

Record last verified: 2021-04

Locations

UA(10)