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Completed

NCT Number: NCT02886234

Health Improvement Project - Providence

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.

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Key information

Conditions

HIV Behavior Behavioral Symptoms Depression

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

Mindfulness Training (MT)

Behavioral

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)

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Acceptability of the Intervention

    Time frame: post-intervention, 9 to 10 weeks after baseline

    Number of patients reporting "very satisfied" or "mostly satisfied" with their intervention

  2. Antiretroviral Medication Adherence

    Time frame: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline

    Self-reported number of missed days of medication

  3. Self-reported Sexual Risk Behavior

    Time frame: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline

    Self-reported risky sexual behavior as indicated by the percentage of episodes of condom protected sexual intercourse Higher values are better outcome

  4. Five Facet Mindfulness Questionnaire

    Time frame: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline

    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

  5. Perceived Stress Scale

    Time frame: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline

    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

  6. Barratt Impulsiveness Scale

    Time frame: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline

    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

  7. Patient Health Questionnaire

    Time frame: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline

    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

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Mindfulness Training to Improve ART Adherence and Reduce Risk Behavior Among Persons Living With HIV

Acronym: HIP

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 1, 2016
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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