HIVMARTASNCT02338024
Enhancing Linkage to HIV Care for Newly Detected HIV-positive Persons in Ukraine
A study testing Modified Antiretroviral Treatment Access Study intervention in people with HIV, run by Ukrainian Institute on Public Health Policy at 10 sites in Ukraine.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Modified Antiretroviral Treatment Access Study intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 10 sitesUkraine
- Study dates
- 22 Oct 2015to 3 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18+ years;
- Tested HIV-positive
- Fluent in Russian or Ukrainian;
- Able to read/understand and sign an informed consent
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Ukraine10 sites
Dermatovenereological dispensary
Dnipropetrovsk
Narcological dispensary
Dnipropetrovsk
Infectious disease clinic
Kryvyi Rih
Ukrainian Institute on Public Health Policy
Kyiv
Dermatovenereological dispensary
Mykolaiv
Infectious disease clinic
Mykolaiv
Narcological dispensary
Mykolaiv
Center of psychical health
Odesa
Dermatovenereological dispensary
Odesa
Infectious disease clinic
Odesa
About this study
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.
Read the 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.
- Conditions
- HIV
- Being tested
- Modified Antiretroviral Treatment Access Study intervention
- Keywords
- Enrollment in HIV care, Recently detected HIV-positive, specialized health care clinics, Ukraine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Antiretroviral Treatment Access Study interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| MARTAS intervention | Experimental | Structured motivational sessions and further communication between linkage coordinators and HIV-positive patients focused on engagement in HIV medical care. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study start22 Oct 2015
- Primary completion3 Oct 2017
- Study completion3 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ukrainian Institute on Public Health Policy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oleksandr Neduzhko, Ukrainian Institute on Public Health Policy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338024
- Sponsor's protocol ID
- 3U01GH000752-01
- Acronym
- MARTAS
- Status last verified
- Apr 2021
- First submitted
- 9 Jan 2015
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32333208
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Linkage to HIV Care for Newly Detected HIV-positive Persons in Ukraine
- ClinicalTrials.gov ID
- NCT02338024
- Acronym / sponsor ID
- MARTAS / 3U01GH000752-01
- Conditions
- HIV
- Keywords
- Enrollment in HIV care, Recently detected HIV-positive, specialized health care clinics, Ukraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Ukrainian Institute on Public Health PolicyUniversity, hospital or other
- Study start
- 22 Oct 2015 (actual)
- Primary completion
- 3 Oct 2017 (actual)
- Study completion
- 3 Oct 2017 (actual)
- First posted
- 14 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MARTAS intervention | Experimental | Behavioral: Modified Antiretroviral Treatment Access Study interventionStructured motivational sessions and further communication between linkage coordinators and HIV-positive patients focused on engagement in HIV medical care. |
| Standard of care | No intervention | –Oral referrals to a network of government AIDS Centers or their departments ("Trust" offices) located in each study region. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18+ years;
- Tested HIV-positive
- Fluent in Russian or Ukrainian;
- Able to read/understand and sign an informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Antiretroviral Treatment Access Study intervention | Behavioural | MARTAS intervention |
Primary outcome
The proportion of referred intervention patients who enroll in HIV care
Time frame: 3 months
Linkage (registration) to HIV care within the 3-month period after study enrollment-both self-reported and confirmed by the medical record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Derived from this study: PubMed 32333208Neduzhko 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Antiretroviral Treatment Access Study intervention in people with HIV, run by Ukrainian Institute on Public Health Policy at 10 sites in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of referred intervention patients who enroll in HIV care (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02338024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.