AIDS, HIV, Medication Adherence
Conditions
Keywords
Antiretroviral Therapy, Adherence, Intervention
Brief 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.
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.
Interventions
BEHAVIORALSituated 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.
Sponsors
National Institute for Health Development, Estonia
University of Tartu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* pregnant * under the influence of alcohol or (illicit)drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure) | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV-1 RNA Count / Viral Load (VL) | 12 months | Undetectable viral load: HIV-1 RNA \<40 copies/mL |
Countries
Estonia
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 254 |
| 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. | 258 |
| Total | 512 |
Baseline characteristics
| Characteristic | Situated Optimal Adherence Intervention | Adherence Counseling, Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 34.08 years STANDARD_DEVIATION 8.02 | 33.92 years STANDARD_DEVIATION 7.65 | 34.00 years STANDARD_DEVIATION 7.83 |
| Region of Enrollment Estonia | 254 participants | 258 participants | 512 participants |
| Sex: Female, Male Female | 113 Participants | 94 Participants | 207 Participants |
| Sex: Female, Male Male | 141 Participants | 164 Participants | 305 Participants |
| Treatment adherence adherent | 190 participants | 189 participants | 379 participants |
| Treatment adherence data not available | 42 participants | 44 participants | 86 participants |
| Treatment adherence non-adherent | 22 participants | 25 participants | 47 participants |
| Viral load data not available | 64 participants | 80 participants | 144 participants |
| Viral load detectable viral load | 81 participants | 91 participants | 172 participants |
| Viral load undetectable viral load | 109 participants | 87 participants | 196 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 254 | 0 / 258 |
| serious Total, serious adverse events | 0 / 254 | 0 / 258 |
Outcome results
Primary
Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure)
Time frame: 12 months
Population: Number of participants who completed the study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Situated Optimal Adherence Intervention | Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure) | >=95% adherent at baseline, but <95% at 12 mo | 6 participants |
| Situated Optimal Adherence Intervention | Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure) | <95% adherent at baseline, but >=95% at 12 mo | 17 participants |
| Situated Optimal Adherence Intervention | Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure) | <95% adherent at baseline and 12 mo | 0 participants |
| Situated Optimal Adherence Intervention | Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure) | data not available (at month 12) | 48 participants |
| Situated Optimal Adherence Intervention | Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure) | >=95% adherent at baseline and 12 mo | 142 participants |
| Adherence Counseling, Standard of Care | Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure) | data not available (at month 12) | 39 participants |
| Adherence Counseling, Standard of Care | Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure) | >=95% adherent at baseline and 12 mo | 139 participants |
| Adherence Counseling, Standard of Care | Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure) | >=95% adherent at baseline, but <95% at 12 mo | 12 participants |
| Adherence Counseling, Standard of Care | Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure) | <95% adherent at baseline and 12 mo | 8 participants |
| Adherence Counseling, Standard of Care | Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure) | <95% adherent at baseline, but >=95% at 12 mo | 8 participants |
Secondary
HIV-1 RNA Count / Viral Load (VL)
Undetectable viral load: HIV-1 RNA \<40 copies/mL
Time frame: 12 months
Population: Number of participants who completed the 12-month study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Situated Optimal Adherence Intervention | HIV-1 RNA Count / Viral Load (VL) | undetectable VL at baseline, detectable at 12 mo | 7 participants |
| Situated Optimal Adherence Intervention | HIV-1 RNA Count / Viral Load (VL) | detectable VL at baseline, undetectable at 12 mo | 18 participants |
| Situated Optimal Adherence Intervention | HIV-1 RNA Count / Viral Load (VL) | detectable VL at baseline and 12 months | 30 participants |
| Situated Optimal Adherence Intervention | HIV-1 RNA Count / Viral Load (VL) | data not available (at month 12) | 96 participants |
| Situated Optimal Adherence Intervention | HIV-1 RNA Count / Viral Load (VL) | undetectable VL at baseline and 12 mo | 62 participants |
| Adherence Counseling, Standard of Care | HIV-1 RNA Count / Viral Load (VL) | data not available (at month 12) | 91 participants |
| Adherence Counseling, Standard of Care | HIV-1 RNA Count / Viral Load (VL) | undetectable VL at baseline and 12 mo | 53 participants |
| Adherence Counseling, Standard of Care | HIV-1 RNA Count / Viral Load (VL) | undetectable VL at baseline, detectable at 12 mo | 6 participants |
| Adherence Counseling, Standard of Care | HIV-1 RNA Count / Viral Load (VL) | detectable VL at baseline and 12 months | 37 participants |
| Adherence Counseling, Standard of Care | HIV-1 RNA Count / Viral Load (VL) | detectable VL at baseline, undetectable at 12 mo | 19 participants |