Clinical trial NCT02338024: Enhancing Linkage to HIV Care for Newly Detected HIV-positive Persons in Ukraine
Official title: Enhancing Linkage to HIV Care for Newly Detected HIV-positive Persons in Ukraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Enrollment in HIV care
Recently detected HIV-positive
specialized health care clinics
Ukraine
Lead sponsor: Ukrainian Institute on Public Health Policy
Sponsor class: OTHER
First posted: 2015-01-14
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Individual, parallel, two-arm, 1:1 RCT. The study participants were recruited between October 2015 and December 2016 at 9 clinics located in Dnipropetrovsk region (Dnipropetrovsk Regional Narcological Dispensary; Dnipropetrovsk Regional Dermatovenereologic Dispensary; Kryvyi Rih Infectious Disease Clinic No. 1), Mykolaiv region (Mykolaiv Regional Narcological Dispensary; Mykolaiv Regional Dermatovenereologic Dispensary; Mykolaiv Regional Infectious Disease Clinic), and Odesa region (Odesa Regional Dermatovenereologic Dispensary; Odesa Infectious Disease Clinic; Odesa Regional Center of Mental Health). These three types of clinical sites (treating addiction, sexually transmitted infections \[STIs\], and infectious diseases \[IDs\]) were located in the regions with the highest HIV prevalence in Ukraine, but were not co-located with HIV care facilities. Participants assigned to the standard of care (SOC) arm and the MARTAS arm received referrals to the local AIDS Centers (Dnipropetrovsk Regional AIDS Center, Kryvyi Rih AIDS Center, Mykolaiv Regional Center for Palliative Care and Integrated Services (former Mykolaiv AIDS Center), and Odesa Regional AIDS Center) or their departments ("Trust" offices) located in each study region. Investigators affiliated with The Ukrainian Institute on Public Health Policy (UIPHP) were responsible for all aspects of study design, management, and analysis.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The proportion of referred intervention patients who enroll in HIV care
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dnipropetrovsk
country: Ukraine
facility: Dermatovenereological dispensary
city: Dnipropetrovsk
country: Ukraine
facility: Narcological dispensary
city: Kryvyi Rih
country: Ukraine
facility: Infectious disease clinic
city: Kyiv
country: Ukraine
facility: Ukrainian Institute on Public Health Policy
city: Mykolaiv
country: Ukraine
facility: Dermatovenereological dispensary
city: Mykolaiv
country: Ukraine
facility: Infectious disease clinic
city: Mykolaiv
country: Ukraine
facility: Narcological dispensary
city: Odesa
country: Ukraine
facility: Center of psychical health
city: Odesa
country: Ukraine
facility: Dermatovenereological dispensary
city: Odesa
country: Ukraine
facility: Infectious disease clinic
Study officials:
References:
citation: 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.