HIVNCT07025109
Assessing Peer Support for Physical Activity in Women With HIV and Hypertension
A study testing Peer support, Exercise Prescription and Blood pressure self monitoring in people with HIV and Hypertension, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- HIV, Hypertension
- What is being tested?
- Peer support, Exercise Prescription and Blood pressure self monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2026to 24 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant
- unable to provide informed consent due to cognitive deficit, serious mental illness, or active substance use
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Family & Community Medicine; University of Alabama at Birmingham
Birmingham, Alabama, 35205
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV, Hypertension
- Being tested
- Peer support, Exercise Prescription, Blood pressure self monitoring
- Keywords
- Women, HIV, Hypertension, Physical Activity, Behavioral clinical trial
- Medical subject headings
- Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer supportBehavioural
Peer support counseling will include phone or text communication to assess goal progress, provide motivational counseling as needed, and to provide social support.
Exercise PrescriptionBehavioural
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 monitoringBehavioural
Women will receive a home blood pressure monitor and encourage to record their readings in a log.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Exercise Prescription; Behavioral: Blood pressure self monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At 6-week (mid-point intervention) and 12-weeks (end of intervention)
Secondary outcomes (6)
Systolic and diastolic blood pressure
Home blood pressure readings taken x3 and averaged.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Collected at baseline, 6-weeks (mid-point), and 12-weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start6 Feb 2026
- Primary completion24 Aug 2026
- Study completion24 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Kaylee Crockett, University of Alabama at Birmingham
- Investigators
- Kaylee B Crockett, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025109
- Sponsor's protocol ID
- 300008025
- Other IDs
- K23HL156758
- Status last verified
- Oct 2026
- First submitted
- 30 May 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pilot trial; Certificate of confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Pilot Testing a Behavioral Physical Activity Intervention With Peer Support for Women With HIV and Co-Occurring Hypertension
- ClinicalTrials.gov ID
- NCT07025109
- Acronym / sponsor ID
- 300008025
- Conditions
- HIV, Hypertension
- Keywords
- Women, HIV, Hypertension, Physical Activity, Behavioral clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- 24 Aug 2026 (actual)
- Study completion
- 24 Aug 2026 (actual)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer support arm | Experimental | Behavioral: Peer support, Behavioral: Exercise Prescription, Behavioral: Blood pressure self monitoringWomen 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. |
| Control arm | Active comparator | Behavioral: Exercise Prescription, Behavioral: Blood pressure self monitoringWomen in the control arm will receive physical activity prescription and home blood pressure monitoring, but will not receive peer support calls. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant
- unable to provide informed consent due to cognitive deficit, serious mental illness, or active substance use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer supportPeer support counseling will include phone or text communication to assess goal progress, provide motivational counseling as needed, and to provide social support. | Behavioural | Peer support arm |
| Exercise PrescriptionWomen 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. | Behavioural | Control arm, Peer support arm |
| Blood pressure self monitoringWomen will receive a home blood pressure monitor and encourage to record their readings in a log. | Behavioural | Control arm, Peer support arm |
Primary outcome
Participant attrition
Time frame: 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
Time frame: 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
Time frame: 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.
6 secondary outcomes
Systolic and diastolic blood pressure
Time frame: Measured at baseline, 6-weeks (mid-point) and 12-weeks (end of intervention)
Daily physical activity: Accelerometer measured
Time frame: Collected at baseline pre-randomization, and at 12-weeks (end of intervention)
Self reported physical activity
Time frame: Collected at baseline, 6 weeks (mid-point), and 12-weeks (post-intervention)
Physical Activity Self Efficacy
Time frame: Collected at baseline, 6-weeks (mid-point) and 12-weeks (post-intervention)
Physical activity enjoyment
Time frame: Collected at baseline, 6-weeks (mid-point), and 12-weeks (post-intervention)
Social support for physical activity
Time frame: Collected at baseline, 6-weeks (mid-point), and 12-weeks (post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No. Pilot trial; Certificate of confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaylee B Crockett, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer support, Exercise Prescription and Blood pressure self monitoring in people with HIV and Hypertension, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant attrition (time frame: From enrollment to end of 12 week intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.