Clinical trial NCT07025109: Assessing Peer Support for Physical Activity in Women With HIV and Hypertension
Official title: Adaptation and Pilot Testing a Behavioral Physical Activity Intervention With Peer Support for Women With HIV and Co-Occurring Hypertension
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV
Hypertension
Keywords: Women
HIV
Hypertension
Physical Activity
Behavioral clinical trial
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-06-17
Enrollment: 50
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Participant attrition
timeFrame: From enrollment to end of 12 week intervention
measure: Intervention acceptability: Satisfaction
timeFrame: Mid-point (6-week) assessment and end of intervention assessment (12-week)
measure: Intervention Acceptability: Treatment burden
timeFrame: At 6-week (mid-point intervention) and 12-weeks (end of intervention)
Secondary outcomes:
measure: Systolic and diastolic blood pressure
timeFrame: Measured at baseline, 6-weeks (mid-point) and 12-weeks (end of intervention)
measure: Daily physical activity: Accelerometer measured
timeFrame: Collected at baseline pre-randomization, and at 12-weeks (end of intervention)
measure: Self reported physical activity
timeFrame: Collected at baseline, 6 weeks (mid-point), and 12-weeks (post-intervention)
measure: Physical Activity Self Efficacy
timeFrame: Collected at baseline, 6-weeks (mid-point) and 12-weeks (post-intervention)
measure: Physical activity enjoyment
timeFrame: Collected at baseline, 6-weeks (mid-point), and 12-weeks (post-intervention)
measure: Social support for physical activity
timeFrame: Collected at baseline, 6-weeks (mid-point), and 12-weeks (post-intervention)
Other outcomes:
measure: General Social Support
timeFrame: Collected at baseline, 6-weeks (mid-point), and 12-weeks (post-intervention)
measure: Health related quality of life
timeFrame: Collected at baseline, 6-weeks (mid-point), and 12-weeks (post-intervention)
Locations:
city: Birmingham
country: United States
facility: Department of Family & Community Medicine; University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Kaylee B Crockett, PhD
role: PRINCIPAL_INVESTIGATOR
References: