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

NCT07025109 | Recruiting

• 2 other identifiers: 300008025K23HL156758
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; HIV

Keywords

Women; HIV; Hypertension; Physical Activity; Behavioral clinical trial

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Systolic and diastolic blood pressure

  Measured at baseline, 6-weeks (mid-point) and 12-weeks (end of intervention)

• Daily physical activity: Accelerometer measured

  Collected at baseline pre-randomization, and at 12-weeks (end of intervention)

• Self reported physical activity

  Collected at baseline, 6 weeks (mid-point), and 12-weeks (post-intervention)

• Physical Activity Self Efficacy

  Collected at baseline, 6-weeks (mid-point) and 12-weeks (post-intervention)

• Physical activity enjoyment

  Collected at baseline, 6-weeks (mid-point), and 12-weeks (post-intervention)

Other Outcomes (2)

• General Social Support

  Collected at baseline, 6-weeks (mid-point), and 12-weeks (post-intervention)

• Health related quality of life

  Collected at baseline, 6-weeks (mid-point), and 12-weeks (post-intervention)

Study Arms (2)

Peer support arm

EXPERIMENTAL

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

Control arm

ACTIVE COMPARATOR

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

Interventions

Exercise Prescription BEHAVIORAL

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.

Control arm; Peer support arm

Blood pressure self monitoring BEHAVIORAL

Women will receive a home blood pressure monitor and encourage to record their readings in a log.

Control arm; Peer support arm

Peer support BEHAVIORAL

Peer support counseling will include phone or text communication to assess goal progress, provide motivational counseling as needed, and to provide social support.

Peer support arm

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Women are eligible to participate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant
• unable to provide informed consent due to cognitive deficit, serious mental illness, or active substance use

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Department of Family & Community Medicine; University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

RECRUITING

MeSH Terms

Conditions

Hypertension; Motor Activity

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Kaylee B Crockett, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaylee Crockett, PhD

CONTACT

205-934-5167; kcrockett@uabmc.edu

Mari Katundu, MSc

CONTACT

205-864-8510; marikatundu@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 17, 2025
• Study Start: February 6, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)