Trial Outcomes & Findings for Adherence Support Intervention for Persons Living With HIV/AIDS (PLWHA) on Antiretroviral Therapy (ART) in Estonia (NCT NCT01789138)
NCT ID: NCT01789138
Last Updated: 2016-03-10
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
519 participants
Primary outcome timeframe
12 months
Results posted on
2016-03-10
Participant Flow
519 participants (259 intervention + 260 control arm) randomized. Written informed consent forms of 2 not available (filed). Post-randomization study site control revealed 5 participants not having met the inclusion criterion 'receive or start (on recruitment date) ART'. Data of 512 participants (254 intervention + 258 control arm) analysed.
Participant milestones
| Measure |
Situated Optimal Adherence Intervention
Situated Optimal Adherence Intervention: see 'Interventions' for more details.
Situated Optimal Adherence Intervention: 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.
|
Adherence Counseling, Standard of Care
Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
|
|---|---|---|
|
Overall Study
STARTED
|
254
|
258
|
|
Overall Study
COMPLETED
|
213
|
206
|
|
Overall Study
NOT COMPLETED
|
41
|
52
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adherence Support Intervention for Persons Living With HIV/AIDS (PLWHA) on Antiretroviral Therapy (ART) in Estonia
Baseline characteristics by cohort
| Measure |
Situated Optimal Adherence Intervention
n=254 Participants
Situated Optimal Adherence Intervention: see 'Interventions' for more details.
Situated Optimal Adherence Intervention: 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.
|
Adherence Counseling, Standard of Care
n=258 Participants
Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
|
Total
n=512 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.08 years
STANDARD_DEVIATION 8.02 • n=5 Participants
|
33.92 years
STANDARD_DEVIATION 7.65 • n=7 Participants
|
34.00 years
STANDARD_DEVIATION 7.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
113 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
141 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
305 Participants
n=5 Participants
|
|
Region of Enrollment
Estonia
|
254 participants
n=5 Participants
|
258 participants
n=7 Participants
|
512 participants
n=5 Participants
|
|
Viral load
undetectable viral load
|
109 participants
n=5 Participants
|
87 participants
n=7 Participants
|
196 participants
n=5 Participants
|
|
Viral load
detectable viral load
|
81 participants
n=5 Participants
|
91 participants
n=7 Participants
|
172 participants
n=5 Participants
|
|
Viral load
data not available
|
64 participants
n=5 Participants
|
80 participants
n=7 Participants
|
144 participants
n=5 Participants
|
|
Treatment adherence
adherent
|
190 participants
n=5 Participants
|
189 participants
n=7 Participants
|
379 participants
n=5 Participants
|
|
Treatment adherence
non-adherent
|
22 participants
n=5 Participants
|
25 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Treatment adherence
data not available
|
42 participants
n=5 Participants
|
44 participants
n=7 Participants
|
86 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Number of participants who completed the study
Outcome measures
| Measure |
Situated Optimal Adherence Intervention
n=213 Participants
Situated Optimal Adherence Intervention: see 'Interventions' for more details.
Situated Optimal Adherence Intervention: 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.
|
Adherence Counseling, Standard of Care
n=206 Participants
Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
|
|---|---|---|
|
Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure)
>=95% adherent at baseline and 12 mo
|
142 participants
|
139 participants
|
|
Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure)
>=95% adherent at baseline, but <95% at 12 mo
|
6 participants
|
12 participants
|
|
Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure)
<95% adherent at baseline and 12 mo
|
0 participants
|
8 participants
|
|
Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure)
<95% adherent at baseline, but >=95% at 12 mo
|
17 participants
|
8 participants
|
|
Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure)
data not available (at month 12)
|
48 participants
|
39 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Number of participants who completed the 12-month study
Undetectable viral load: HIV-1 RNA \<40 copies/mL
Outcome measures
| Measure |
Situated Optimal Adherence Intervention
n=213 Participants
Situated Optimal Adherence Intervention: see 'Interventions' for more details.
Situated Optimal Adherence Intervention: 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.
|
Adherence Counseling, Standard of Care
n=206 Participants
Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
|
|---|---|---|
|
HIV-1 RNA Count / Viral Load (VL)
undetectable VL at baseline and 12 mo
|
62 participants
|
53 participants
|
|
HIV-1 RNA Count / Viral Load (VL)
undetectable VL at baseline, detectable at 12 mo
|
7 participants
|
6 participants
|
|
HIV-1 RNA Count / Viral Load (VL)
detectable VL at baseline and 12 months
|
30 participants
|
37 participants
|
|
HIV-1 RNA Count / Viral Load (VL)
detectable VL at baseline, undetectable at 12 mo
|
18 participants
|
19 participants
|
|
HIV-1 RNA Count / Viral Load (VL)
data not available (at month 12)
|
96 participants
|
91 participants
|
Adverse Events
Situated Optimal Adherence Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Adherence Counseling, Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof. Anneli Uusküla
Department of Public Health, University of Tartu, ESTONIA
Phone: +372 7374195
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place