HIVNCT01789138

Adherence Support Intervention for Persons Living With HIV/AIDS (PLWHA) on Antiretroviral Therapy (ART) in Estonia

A study testing Situated Optimal Adherence Intervention in people with HIV and AIDS, run by University of Tartu at 2 sites in Estonia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The specific aim of the study is to assess antiretroviral therapy adherence and evaluate the impact of a situated treatment adherence intervention program among persons living with HIV/AIDS on antiretroviral therapy in Estonia. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV, AIDS, Medication Adherence
What is being tested?: Situated Optimal Adherence Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 519 participants
Where: 2 sitesEstonia
Study dates: Jan 2013to Dec 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

HIV infected
aware of the HIV-positive status for at least 3 months
≥ 18 years of age
speak and read either Estonian or Russian
receive or start (on recruitment date) antiretroviral therapy

Who cannot join

pregnant
under the influence of alcohol or (illicit)drugs

Trial locations and contacts

2 sites in 1 country.

Estonia2 sites

East-Viru Central Hospital
Kohtla-Järve, Ida-Virumaa, 31025
West-Tallinn Central Hospital
Tallinn, Harju, 10617

Other trials in Estonia

About this study

Official title: Randomized Controlled Trial of Situated Optimal Adherence Intervention Estonia (sOAI Estonia) Among Persons Living With HIV/AIDS (PLWHA) on Antiretroviral Therapy (ART) in Estonia

Read the detailed description

Specific antiretroviral therapy (ART) can suppress HIV replication and consequently preserve the functioning of immune system. ART is a lifelong treatment with several different concomitantly administered oral medications. According to studies, low adherence to treatment is directly related to knowledge and beliefs about ART.

Studies have shown the success of different interventions increasing adherence to ART, but additional studies need to be carried out in order to determine the most effective components of the interventions and the methods most suitable considering the local context, that could be easily incorporated into the working routine of an medical institution (clinic) with limited extra resources.

Primary locations to implement activities directed at improving treatment adherence are medical institutions, i.e. the departments of infectious diseases where persons living with HIV/AIDS receive their ART.

The aim of the study is to conduct a small-scale intervention (randomised controlled) study implementing a brief adherence counseling targeting persons receiving ART.

Conditions: HIV, AIDS, Medication Adherence
Being tested: Situated Optimal Adherence Intervention
Keywords: Antiretroviral Therapy, Adherence, Intervention
Medical subject headings: Acquired Immunodeficiency Syndrome, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Situated Optimal Adherence InterventionBehavioural
Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts.

Study groups in NCT01789138
Study group	Role	What they receive
Situated Optimal Adherence Intervention	Experimental	Situated Optimal Adherence Intervention: see 'Interventions' for more details. Receives: Behavioral: Situated Optimal Adherence Intervention
Adherence counseling, standard of care	No intervention	Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.

What is being measured

The primary outcome is the main question the study is designed to answer.

Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure)
Measured: 12 months

Secondary outcomes (1)

HIV-1 RNA Count / Viral Load (VL)
Undetectable viral load: HIV-1 RNA <40 copies/mL
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Dec 2014

First posted11 Feb 2013 (estimated)
Study startJan 2013
Primary completionNov 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)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: 519 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01789138
Sponsor's protocol ID: SARTH12115T
Other IDs: 3.2.1001.11-0020
Status last verified: Feb 2016
First submitted: 8 Feb 2013
Last updated: 10 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided: Currently considering.

Publications

Chesney MA, Ickovics JR, Chambers DB, Gifford AL, Neidig J, Zwickl B, Wu AW. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient Care Committee & Adherence Working Group of the Outcomes Committee of the Adult AIDS Clinical Trials Group (AACTG). AIDS Care. 2000 Jun;12(3):255-66. doi: 10.1080/09540120050042891.
PubMed 10928201
R Amico K, McMahan V, Goicochea P, Vargas L, Marcus JL, Grant RM, Liu A. Supporting study product use and accuracy in self-report in the iPrEx study: next step counseling and neutral assessment. AIDS Behav. 2012 Jul;16(5):1243-59. doi: 10.1007/s10461-012-0182-5.
PubMed 22460228
Fisher JD, Amico KR, Fisher WA, Harman JJ. The information-motivation-behavioral skills model of antiretroviral adherence and its applications. Curr HIV/AIDS Rep. 2008 Nov;5(4):193-203. doi: 10.1007/s11904-008-0028-y.
PubMed 18838059
Fisher JD, Fisher WA, Amico KR, Harman JJ. An information-motivation-behavioral skills model of adherence to antiretroviral therapy. Health Psychol. 2006 Jul;25(4):462-73. doi: 10.1037/0278-6133.25.4.462.
PubMed 16846321
Uuskula A, Laisaar KT, Raag M, Smidt J, Semjonova S, Kogan J, Amico KR, Sharma A, Dehovitz J. Antiretroviral therapy (ART) adherence and correlates to nonadherence among people on ART in Estonia. AIDS Care. 2012;24(12):1470-9. doi: 10.1080/09540121.2012.672724. Epub 2012 Apr 25.
PubMed 22533736
Laisaar KT, Avi R, DeHovitz J, Uuskula A. Estonia at the threshold of the fourth decade of the AIDS era in Europe. AIDS Res Hum Retroviruses. 2011 Aug;27(8):841-51. doi: 10.1089/aid.2010.0223. Epub 2011 Jan 11.
PubMed 21142588

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial of Situated Optimal Adherence Intervention Estonia (sOAI Estonia) Among Persons Living With HIV/AIDS (PLWHA) on Antiretroviral Therapy (ART) in Estonia
ClinicalTrials.gov ID: NCT01789138
Acronym / sponsor ID: SARTH12115T
Conditions: HIV, AIDS, Medication Adherence
Keywords: Antiretroviral Therapy, Adherence, Intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 519 participants (actual)
Lead sponsor: University of TartuUniversity, hospital or other
Collaborators: National Institute for Health Development, Estonia
Study start: Jan 2013
Primary completion: Nov 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 11 Feb 2013 (estimated)
Results: Posted 2 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The aim of the study is to conduct a small-scale intervention (randomised controlled) study implementing a brief adherence counseling targeting persons receiving ART.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Situated Optimal Adherence Intervention	Experimental	Behavioral: Situated Optimal Adherence InterventionSituated Optimal Adherence Intervention: see 'Interventions' for more details.
Adherence counseling, standard of care	No intervention	–Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

HIV infected
aware of the HIV-positive status for at least 3 months
≥ 18 years of age
speak and read either Estonian or Russian
receive or start (on recruitment date) antiretroviral therapy

Key exclusion criteria (2 listed)

pregnant
under the influence of alcohol or (illicit)drugs

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
Situated Optimal Adherence InterventionSituated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts.	Behavioural	Situated Optimal Adherence Intervention

Primary outcome

Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure)
Time frame: 12 months

1 secondary outcome

HIV-1 RNA Count / Viral Load (VL)
Time frame: 12 months

Results and safety

Results posted to the registry on 2 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Situated Optimal Adherence Intervention	254	213
Adherence Counseling, Standard of Care	258	206

Primary outcome: Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure)

Time frame: 12 months. Number. Unit: participants

Measure	Situated Optimal Adherence Intervention n = 213	Adherence Counseling, Standard of Care n = 206
>=95% adherent at baseline and 12 mo	142	139
>=95% adherent at baseline, but <95% at 12 mo	6	12
<95% adherent at baseline and 12 mo	0	8
<95% adherent at baseline, but >=95% at 12 mo	17	8
data not available (at month 12)	48	39

Population analysed: Number of participants who completed the study

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Situated Optimal Adherence Intervention	0 of 254 (0%)	0 of 254 (0%)	Not reported
Adherence Counseling, Standard of Care	0 of 258 (0%)	0 of 258 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 10928201Chesney MA, Ickovics JR, Chambers DB, Gifford AL, Neidig J, Zwickl B, Wu AW. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient Care Committee & Adherence Working Group of the Outcomes Committee of the Adult AIDS Clinical Trials Group (AACTG). AIDS Care. 2000 Jun;12(3):255-66. doi: 10.1080/09540120050042891.
Background: PubMed 22460228R Amico K, McMahan V, Goicochea P, Vargas L, Marcus JL, Grant RM, Liu A. Supporting study product use and accuracy in self-report in the iPrEx study: next step counseling and neutral assessment. AIDS Behav. 2012 Jul;16(5):1243-59. doi: 10.1007/s10461-012-0182-5.
Background: PubMed 18838059Fisher JD, Amico KR, Fisher WA, Harman JJ. The information-motivation-behavioral skills model of antiretroviral adherence and its applications. Curr HIV/AIDS Rep. 2008 Nov;5(4):193-203. doi: 10.1007/s11904-008-0028-y.
Background: PubMed 16846321Fisher JD, Fisher WA, Amico KR, Harman JJ. An information-motivation-behavioral skills model of adherence to antiretroviral therapy. Health Psychol. 2006 Jul;25(4):462-73. doi: 10.1037/0278-6133.25.4.462.
Background: PubMed 22533736Uuskula A, Laisaar KT, Raag M, Smidt J, Semjonova S, Kogan J, Amico KR, Sharma A, Dehovitz J. Antiretroviral therapy (ART) adherence and correlates to nonadherence among people on ART in Estonia. AIDS Care. 2012;24(12):1470-9. doi: 10.1080/09540121.2012.672724. Epub 2012 Apr 25.
Background: PubMed 21142588Laisaar KT, Avi R, DeHovitz J, Uuskula A. Estonia at the threshold of the fourth decade of the AIDS era in Europe. AIDS Res Hum Retroviruses. 2011 Aug;27(8):841-51. doi: 10.1089/aid.2010.0223. Epub 2011 Jan 11.
Individual participant dataSharing planned: Undecided. Currently considering.

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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.

Anneli Uusküla, MD, MSc, PhD principal investigator

University of Tartu

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Situated Optimal Adherence Intervention in people with HIV and AIDS, run by University of Tartu at 2 sites in Estonia.

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 5 inclusion and 2 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 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Estonia. 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?

Yes. Results are posted in the registry (first posted 2 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure) (time frame: 12 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 NCT01789138, which also lists 6 linked publications.

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 10 Mar 2016.