HIVHIPNCT02886234
Health Improvement Project - Providence
A study testing Mindfulness Training (MT) and Health Coaching (HC) in people with HIV, run by The Miriam Hospital at 1 site in United States.
Trial summary
This study will investigate whether phone-delivered mindfulness training is feasible and acceptable for persons living with HIV and whether it may help them improve adherence to medications and reduce risky sexual behaviors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV
- What is being tested?
- Mindfulness Training (MT) and Health Coaching (HC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Aug 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infection
- Sub-optimal adherence to ART (Less than "always" taking ART medication and/or viral load > 20 copies/mL);
- Psychological distress (PHQ-4 score ≥ 2);
- Recent risky sexual behavior (any unprotected sex OR > 1 sexual partner over the past 6 months)
- Access to a telephone or cell phone
Who cannot join
- Unwilling or unable to provide informed consent
- Cognitive impairment
- Non-English speaking
- Low literacy (i.e., reporting they "often" or "always" need someone to read instructions, pamphlets, or other written material from a doctor or pharmacy to them
- Enrolled in another behavioral trials
- Prior formal mindfulness training or have practiced of mindfulness or related mind-body techniques in the previous year
Show all 10Show fewer
- Severe hearing impairment not allowing phone delivery
- Suicidal ideation
- Planning to move out of the area within the study period
- Clinic provider advising against recruitment in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness Training to Improve ART Adherence and Reduce Risk Behavior Among Persons Living With HIV
This study will investigate whether phone-delivered mindfulness training is feasible and acceptable for persons living with HIV and whether it may help them improve adherence to medications and reduce risky sexual behaviors.
Read the detailed description
Two-thirds of people living with HIV show sub-optimal adherence to antiretroviral therapy (ART) and one-third engages in risky sex. Both non-adherence and risky sex have been associated with emotional distress and impulsivity. In this trial, the investigators will examine the utility of phone-delivered mindfulness training (MT) for people living with HIV. The primary outcomes comprise feasibility and acceptability of phone-delivery; secondary outcomes are estimates of efficacy of MT on adherence to ART and safer sexual practices as well as on their hypothesized antecedents.
Fifty participants will be enrolled in this parallel-group randomized clinical trial (RCT). Outpatients recruited from an HIV treatment clinic will be randomized (1:1 ratio) to either MT or to health coaching intervention; both interventions will be administered during 8 weekly phone calls. ART adherence (self-reported measure and unannounced phone pill counts), sexual behavior (self-reports and biomarkers), mindfulness, depression, stress, and impulsivity will be measured at baseline, post-intervention, and 3 months post-intervention.
- Conditions
- HIV
- Being tested
- Mindfulness Training (MT), Health Coaching (HC)
- Keywords
- HIV, Mindfulness, Adherence behaviors, Stress, Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Training (MT)Behavioural
Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
Health Coaching (HC)Behavioural
The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness training (MT) | Experimental | Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Receives: Behavioral: Mindfulness Training (MT) |
| Health Coaching (HC) | Active comparator | Eight, 30-minute phone delivered HC sessions once a week for 8 weeks Receives: Behavioral: Health Coaching (HC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention
Feasibility - as indicated by the number of patients attending at least 50% of sessions
Measured: post-intervention, 9 to 10 weeks after baseline
Secondary outcomes (7)
Acceptability of the Intervention
Number of patients reporting "very satisfied" or "mostly satisfied" with their intervention
Measured: post-intervention, 9 to 10 weeks after baseline
Antiretroviral Medication Adherence
Self-reported number of missed days of medication
Measured: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
Self-reported Sexual Risk Behavior
Self-reported risky sexual behavior as indicated by the percentage of episodes of condom protected sexual intercourse Higher values are better outcome
Measured: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
Five Facet Mindfulness Questionnaire
Five Facet of Mindfulness Questionnaire (15 items; short form) Construct = Mindfulness Minimum total scale score = 15 Maximum total scale score = 75 Scoring: sum across all 15 items Higher scores represent a better outcome
Measured: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
Perceived Stress Scale
Perceived Stress Scale (4-item version) Construct = perceived stress Minimum total scale score = 0 Maximum total scale score = 16 Scoring: reverse score items 2 and 3, then sum across all 4 items Higher scores represent a worse outcome
Measured: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
Barratt Impulsiveness Scale
Barratt Impulsiveness Scale (short form, 8 items) Construct = Impulsivity Minimum total scale score = 8 Maximum total scale score = 32 Scoring: reverse score items 1, 4, 5, 6, and then sum across all 8 items Higher scores represent a worse outcome
Measured: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
Patient Health Questionnaire
Patient Health Questionnaire (9 item version) Construct measured = depression Minimum total scale score = 0 Maximum total scale score = 27 Scoring: sum across all 9 items Higher scores represent a worse outcome
Measured: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2018
- Study completionAug 2018
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Michael P. Carey, The Miriam Hospital
- Investigators
- MIchael P Carey, PhD, Principal investigator, Centers for Behavioral and Preventive Medicine, The Miriam HospitalElena Salmoirago-Blotcher, MD, PhD, Principal investigator, Centers for Behavioral and Preventive Medicine, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886234
- Sponsor's protocol ID
- R34AT008930
- Other IDs
- R34AT008930
- Acronym
- HIP
- Status last verified
- Dec 2019
- First submitted
- 18 Aug 2016
- Last updated
- 13 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Training to Improve ART Adherence and Reduce Risk Behavior Among Persons Living With HIV
- ClinicalTrials.gov ID
- NCT02886234
- Acronym / sponsor ID
- HIP / R34AT008930
- Conditions
- HIV
- Keywords
- HIV, Mindfulness, Adherence behaviors, Stress, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Aug 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 1 Sep 2016 (estimated)
- Results
- Posted 13 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate whether phone-delivered mindfulness training is feasible and acceptable for persons living with HIV and whether it may help them improve adherence to medications and reduce risky sexual behaviors.
Detailed description
Two-thirds of people living with HIV show sub-optimal adherence to antiretroviral therapy (ART) and one-third engages in risky sex. Both non-adherence and risky sex have been associated with emotional distress and impulsivity. In this trial, the investigators will examine the utility of phone-delivered mindfulness training (MT) for people living with HIV. The primary outcomes comprise feasibility and acceptability of phone-delivery; secondary outcomes are estimates of efficacy of MT on adherence to ART and safer sexual practices as well as on their hypothesized antecedents.
Fifty participants will be enrolled in this parallel-group randomized clinical trial (RCT). Outpatients recruited from an HIV treatment clinic will be randomized (1:1 ratio) to either MT or to health coaching intervention; both interventions will be administered during 8 weekly phone calls. ART adherence (self-reported measure and unannounced phone pill counts), sexual behavior (self-reports and biomarkers), mindfulness, depression, stress, and impulsivity will be measured at baseline, post-intervention, and 3 months post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness training (MT) | Experimental | Behavioral: Mindfulness Training (MT)Eight, 30-minute phone delivered MT sessions once a week for 8 weeks |
| Health Coaching (HC) | Active comparator | Behavioral: Health Coaching (HC)Eight, 30-minute phone delivered HC sessions once a week for 8 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV infection
- Sub-optimal adherence to ART (Less than "always" taking ART medication and/or viral load > 20 copies/mL);
- Psychological distress (PHQ-4 score ≥ 2);
- Recent risky sexual behavior (any unprotected sex OR > 1 sexual partner over the past 6 months)
- Access to a telephone or cell phone
Key exclusion criteria (10 listed)
- Unwilling or unable to provide informed consent
- Cognitive impairment
- Non-English speaking
- Low literacy (i.e., reporting they "often" or "always" need someone to read instructions, pamphlets, or other written material from a doctor or pharmacy to them
- Enrolled in another behavioral trials
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 |
|---|---|---|
| Mindfulness Training (MT)Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor. | Behavioural | Mindfulness training (MT) |
| Health Coaching (HC)The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics | Behavioural | Health Coaching (HC) |
Primary outcome
Feasibility of Intervention
Time frame: post-intervention, 9 to 10 weeks after baseline
Feasibility - as indicated by the number of patients attending at least 50% of sessions
7 secondary outcomes
Acceptability of the Intervention
Time frame: post-intervention, 9 to 10 weeks after baseline
Antiretroviral Medication Adherence
Time frame: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
Self-reported Sexual Risk Behavior
Time frame: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
Five Facet Mindfulness Questionnaire
Time frame: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
Perceived Stress Scale
Time frame: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
Barratt Impulsiveness Scale
Time frame: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
Patient Health Questionnaire
Time frame: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
MIchael P Carey, PhD principal investigator
Centers for Behavioral and Preventive Medicine, The Miriam Hospital
Elena Salmoirago-Blotcher, MD, PhD principal investigator
Centers for Behavioral and Preventive Medicine, The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Training (MT) and Health Coaching (HC) in people with HIV, run by The Miriam Hospital at 1 site in United States.
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 10 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 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 13 Jan 2020). 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?
Feasibility of Intervention (time frame: post-intervention, 9 to 10 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2020.