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

Adaptation and Pilot Testing a Behavioral Physical Activity Intervention With Peer Support for Women With HIV and Co-Occurring Hypertension

This clinical trial will assess the acceptability and feasibility of a peer-supported behavioral physical activity intervention for women living with HIV and Hypertension.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertension; HIV
• Intervention / Treatment: Behavioral: Peer support; Behavioral: Exercise Prescription; Behavioral: Blood pressure self monitoring

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Department of Family & Community Medicine; University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peer support arm; 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; Peer support counseling will include phone or text communication to assess goal progress, provide motivational counseling as needed, and to provide social support.; Behavioral: Exercise 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.; Behavioral: Blood pressure self monitoring; Women will receive a home blood pressure monitor and encourage to record their readings in a log.
Active Comparator: Control arm; 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; 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.; Behavioral: Blood pressure self monitoring; Women will receive a home blood pressure monitor and encourage to record their readings in a log.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	At 6-week (mid-point intervention) and 12-weeks (end of intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic and diastolic blood pressure	Home blood pressure readings taken x3 and averaged.	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	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.	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.	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.	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.	Collected at baseline, 6-weeks (mid-point), and 12-weeks (post-intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Collected at baseline, 6-weeks (mid-point), and 12-weeks (post-intervention)

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Kaylee B Crockett, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: May 30, 2025
• First Submitted That Met QC Criteria: June 9, 2025
• First Posted (Actual): June 17, 2025

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Physical Activity; HIV; Hypertension; Women; Behavioral clinical trial
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Behavior; Hypertension; Motor Activity
• Other Study ID Numbers: 300008025; K23HL156758 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pilot trial; Certificate of confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No