An interventional study of Peer support and Exercise Prescription in HIV and Hypertension, sponsored by University of Alabama at Birmingham. Active, not recruiting at 1 site in United States. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Prevention
This clinical trial will assess the acceptability and feasibility of a peer-supported behavioral physical activity intervention for women living with HIV and Hypertension.
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's planned enrollment of 50 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
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Exclusion Criteria:
Women in the peer support arm will receive weekly peer contacts via phone or text message to assess progress towards study-assigned physical activity goal/prescription and to provide motivational counseling and support.
Behavioral: Peer support · Behavioral: Exercise Prescription · Behavioral: Blood pressure self monitoring
Women in the control arm will receive physical activity prescription and home blood pressure monitoring, but will not receive peer support calls.
Behavioral: Exercise Prescription · Behavioral: Blood pressure self monitoring
Peer support counseling will include phone or text communication to assess goal progress, provide motivational counseling as needed, and to provide social support.
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.
Women will receive a home blood pressure monitor and encourage to record their readings in a log.
Participant attrition
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.
Time frame: From enrollment to end of 12 week intervention
Intervention acceptability: Satisfaction
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.
Time frame: Mid-point (6-week) assessment and end of intervention assessment (12-week)
Intervention Acceptability: Treatment burden
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.
Time frame: At 6-week (mid-point intervention) and 12-weeks (end of intervention)
Systolic and diastolic blood pressure
Home blood pressure readings taken x3 and averaged.
Time frame: Measured at baseline, 6-weeks (mid-point) and 12-weeks (end of intervention)
Daily physical activity: Accelerometer measured
7-day accelerometer observation of daily physical activity
Time frame: Collected at baseline pre-randomization, and at 12-weeks (end of intervention)
Self reported physical activity
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.
Time frame: Collected at baseline, 6 weeks (mid-point), and 12-weeks (post-intervention)
Physical Activity Self Efficacy
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.
Time frame: Collected at baseline, 6-weeks (mid-point) and 12-weeks (post-intervention)
Physical activity enjoyment
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.
Time frame: Collected at baseline, 6-weeks (mid-point), and 12-weeks (post-intervention)
Social support for physical activity
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.
Time frame: Collected at baseline, 6-weeks (mid-point), and 12-weeks (post-intervention)
General Social Support
Medical outcomes study social support scale will be used to assess global social support. The scale includes 19 items and the overall support index is calculated by taking the mean of all of the items resulting in a range from 1-5. Scores can be transformed to a 0-100 score by the following equation: 100\*((observed score-minimum possible score)/(maximum possible score-minimum possible score)). Higher scores mean greater social support.
Time frame: Collected at baseline, 6-weeks (mid-point), and 12-weeks (post-intervention)
Health related quality of life
The Short Form Health Survey-12 (SF-12) will be used to assess Health related quality of life (HRQoL) which asks about physical and emotional health in the past 4 weeks using 12 items. In scoring, all items are coded to yield a total score between 0 and 100 such that higher scores mean better HRQoL.
Time frame: Collected at baseline, 6-weeks (mid-point), and 12-weeks (post-intervention)
Plan to share: No — Pilot trial; Certificate of confidentiality
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This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham