Assessing Peer Support for Physical Activity in Women With HIV and Hypertension

Not Applicable

Not yet recruiting

• Conditions: HIV; Hypertension

• Registration Number: NCT07025109
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study First Submitted: 2025-05-30
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-09
• Last Update Submitted: 2025-06-09
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17
• Study Start: 2025-10-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Family & Community Medicine; University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States