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Behavioral Physical Activity Intervention for Women With HIV and Hypertension

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What is being tested

Peer support

+ Exercise Prescription
+ Blood pressure self monitoring
Behavioral
Who is being recruted

HIV

+ Hypertension
Over 40 Years
+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Interventional
Study Start: October 2025

See protocol details

Summary

Principal SponsorUniversity of Alabama at Birmingham
Study ContactKaylee C Crockett, PhD
Last updated: June 17, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2025Actual date on which the first participant was enrolled.

This study aims to test a special program that encourages women aged 40 and above, who are living with both HIV and high blood pressure, to be more physically active. The program includes guidance on exercise, support from peers, and tools to monitor blood pressure at home. By understanding how well these elements work together, the study seeks to improve the health and quality of life for these women. This research is significant because managing both HIV and hypertension can be challenging, and finding effective ways to help individuals manage these conditions can lead to better overall health outcomes. Participants in the study will be randomly assigned to try the physical activity program. They will receive personalized exercise advice, have access to peer support, and use home devices to track their blood pressure. Researchers will evaluate how feasible and acceptable these strategies are, as well as measure changes in blood pressure, physical activity levels, confidence in exercising, social support, and overall quality of life. The study aims to see if this approach can effectively encourage more physical activity and improve health for the participants.

Official TitleAdaptation and Pilot Testing a Behavioral Physical Activity Intervention With Peer Support for Women With HIV and Co-Occurring Hypertension 
Principal SponsorUniversity of Alabama at Birmingham
Study ContactKaylee C Crockett, PhD
Last updated: June 17, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
50 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 40 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV
Hypertension
Criteria
7 inclusion criteria required to participate
woman living with HIV
age 40 and above
diagnosed with HTN
access to a personal phone for study-related phone calls

Show More Criteria

2 exclusion criteria prevent from participating
Pregnant
unable to provide informed consent due to cognitive deficit, serious mental illness, or active substance use

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
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.
Group II
Active Comparator
Women in the control arm will receive physical activity prescription and home blood pressure monitoring, but will not receive peer support calls.
Study Objectives
Primary Objectives

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.

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.

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.
Secondary Objectives

Home blood pressure readings taken x3 and averaged.

7-day accelerometer observation of daily 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.

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.

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.

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Department of Family & Community Medicine; University of Alabama at BirminghamBirmingham, United StatesSee the location
Recruiting soonOne Study Center