HIV, Hypertension
Conditions
Keywords
Women, HIV, Hypertension, Physical Activity, Behavioral clinical trial
Brief summary
This clinical trial will assess the acceptability and feasibility of a peer-supported behavioral physical activity intervention for women living with HIV and Hypertension.
Detailed description
An individually randomized pilot trial (N=50) of an adapted behavioral physical activity (PA) intervention will be used to assess the feasibility and acceptability of providing exercise prescription, peer support, and home blood pressure monitoring to women ages 40+ living with HIV and Hypertension. Secondary outcomes to be assessed include systolic and diastolic blood pressure, PA time and intensity, PA self-efficacy, perceived social support, and health-related quality of life.
Interventions
BEHAVIORALPeer support
Peer support counseling will include phone or text communication to assess goal progress, provide motivational counseling as needed, and to provide social support.
BEHAVIORALExercise Prescription
Women will be provided with an exercise prescription (Frequency, Intensity, Time, Type) which may be adjusted weekly for 6 weeks to goal of 150min/week of moderate to vigorous physical activity.
BEHAVIORALBlood pressure self monitoring
Women will receive a home blood pressure monitor and encourage to record their readings in a log.
Sponsors
University of Alabama at Birmingham
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* woman living with HIV * age 40 and above * diagnosed with HTN * access to a personal phone for study-related phone calls * willing to wear an accelerometer on their waist or hip for 7 days at beginning and end of 12-week intervention * able to ambulate independently * English speaking
Exclusion criteria
* Pregnant * unable to provide informed consent due to cognitive deficit, serious mental illness, or active substance use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant attrition | From enrollment to end of 12 week intervention | Measure of participants who withdraw from the behavioral trial in the intervention and the control groups to determine feasibility of enrolling and retaining individuals in the trial. Approximately 15% attrition is expected in a behavioral clinical trial. Higher levels of attrition relate to lower feasibility. |
| Intervention acceptability: Satisfaction | Mid-point (6-week) assessment and end of intervention assessment (12-week) | Participant satisfaction with the intervention: Treatment Satisfaction Questionnaire adapted for behavioral treatment. The measure includes 11 items asked on a Likert-type scale from 1=Extremely Dissatisfied to 7=Extremely Satisfied, with 3 items asked on a 1-5 scale. 1 item will be removed that asks about medication side effects. Scores can range from 10 to 64. Higher scores mean higher satisfaction with the treatment/intervention. |
| Intervention Acceptability: Treatment burden | At 6-week (mid-point intervention) and 12-weeks (end of intervention) | The Brief Patient Experiences with Treatment and Self Management will be used. The scale includes 32 items total. Most items use a 5-point Likert-type scale from 1=very easy to 5=very difficult. Some items use a 5-point Likert scale (agreement). And some use a Likert-type frequency/intensity measure from 1=not at all to 5=very much. Does not apply=0. Total scores range from 0 to 150. Higher scores mean higher treatment burden. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic and diastolic blood pressure | Measured at baseline, 6-weeks (mid-point) and 12-weeks (end of intervention) | Home blood pressure readings taken x3 and averaged. |
| Daily physical activity: Accelerometer measured | Collected at baseline pre-randomization, and at 12-weeks (end of intervention) | 7-day accelerometer observation of daily physical activity |
| Self reported physical activity | Collected at baseline, 6 weeks (mid-point), and 12-weeks (post-intervention) | Time and intensity of physical activity via the International Physical Activity Questionnaire - Short Form (IPAQ-SF) which are then computed to a continuous score of MET (metabolic equivalents)-minutes per week. Computed as follows: Total PA METmin/week=\[(3.3\*walking minutes\*walking days)+(4.0\*moderate activity minutes\*moderate activity days)+(8.0\*vigorous activity minutes\*vigorous activity days)\]. Higher scores mean greater physical activity. |
| Physical Activity Self Efficacy | Collected at baseline, 6-weeks (mid-point) and 12-weeks (post-intervention) | Confidence to engage in regular physical activity will be measured using the Exercise Self Efficacy Scale. A total of 9 items are asked using a scale from 0=not at all confident to 10=completely confident. Scores range from 0-90. Higher scores mean higher self efficacy. |
| Physical activity enjoyment | Collected at baseline, 6-weeks (mid-point), and 12-weeks (post-intervention) | Physical activity enjoyment scale will be used. The scale has 18 items and each item is asked on a 1 to 7 scale. Scores may range from 18-126. Higher scores mean higher enjoyment and perceived positive outcomes from exercise/physical activity. |
| Social support for physical activity | Collected at baseline, 6-weeks (mid-point), and 12-weeks (post-intervention) | Social support for exercise behaviors scale will be used that includes 10 items asked on a scale from 1=none to 5=very often, there is also an option for does not apply. Scores range from 10-50. Higher scores mean more social support for physical activity. |
Countries
United States
Contacts
CONTACTKaylee Crockett, PhD
CONTACTMari Katundu, MSc
PRINCIPAL_INVESTIGATORKaylee B Crockett, PhD
University of Alabama at Birmingham
Outcome results
None listed