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

NCT ID: NCT07025109

Last Updated: 2025-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-16

Study Completion Date

2026-07-31

Brief Summary

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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

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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.

Conditions

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HIV Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Peer support

Intervention Type BEHAVIORAL

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

Exercise Prescription

Intervention Type 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.

Blood pressure self monitoring

Intervention Type BEHAVIORAL

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

Control arm

Women in the control arm will receive physical activity prescription and home blood pressure monitoring, but will not receive peer support calls.

Group Type ACTIVE_COMPARATOR

Exercise Prescription

Intervention Type 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.

Blood pressure self monitoring

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Blood pressure self monitoring

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Kaylee Crockett

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kaylee B Crockett, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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

Birmingham, Alabama, United States

Site Status

Countries

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United States

Central Contacts

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Kaylee C Crockett, PhD

Role: CONTACT

205-934-5167

Mari Katundu, MSc

Role: CONTACT

205-864-8510

Facility Contacts

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Kaylee Crockett, PhD

Role: primary

205-934-5167

Mari Katundu, MSc

Role: backup

205-864-8510

Other Identifiers

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K23HL156758

Identifier Type: NIH

Identifier Source: secondary_id

View Link

300008025

Identifier Type: -

Identifier Source: org_study_id

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