Health Improvement Project - Providence
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 8/17/2018 |
| Start Date: | August 2016 |
| End Date: | August 2018 |
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.
acceptable for persons living with HIV and whether it may help them improve adherence to
medications and reduce risky sexual behaviors.
Two-thirds of people living with HIV (PLWH) 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 PWLH. 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.
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 PWLH. 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.
Inclusion Criteria:
- HIV infection
- Sub-optimal adherence to ART (Less than "always" taking ART medication and/or VL >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.
We found this trial at
1
site
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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