Improving the assessment of overweight and obesity in people living with HIV and/or chronic hepatitis B
| ISRCTN | ISRCTN13394880 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13394880 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 341062 |
| Protocol serial number | 179908 |
| Sponsor | University College London |
| Funders | Naughton/Clift-Matthews Global Health Fund, NIHR HPRU BBSTI Pre-Application Support Fund |
- Submission date
- 01/11/2025
- Registration date
- 03/11/2025
- Last edited
- 03/11/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
People living with HIV and/or chronic hepatitis B (HBV) are at higher risk of developing health problems related to how fat and muscle are distributed in the body, such as heart disease, diabetes, and liver damage. These risks may be linked to long-term inflammation caused by the viruses and the effects of some treatments.
Current NHS tools like Body Mass Index (BMI) do not give enough information about where fat is stored or how much muscle someone has. This is important because fat stored deep inside the body (such as around the organs) can be more harmful than fat just under the skin. Better tools are needed to assess body composition in people living with HIV and/or HBV.
This study aims to find out how acceptable three different body composition tools are for people in this group:
-Bioelectrical Impedance Analysis (BIA)
-3D Body Scanning
-Stunkard Figure Rating Scale (a visual body shape scale)
The goal is to understand whether these tools could be used more widely in clinics to support better care.
Who can participate?
Adults aged 18 or over who are living with HIV (with a stable, undetectable viral load) and/or chronic hepatitis B infection can take part. People with certain medical devices (such as pacemakers), those who use wheelchairs, or those recently treated for hepatitis C or taking weight-loss injections will not be eligible for safety or technical reasons.
What does the study involve?
Participants will be asked to attend one study visit at the Mortimer Market Centre in London, which will take about 2 hours. During the visit, they will:
Have their height, weight, blood pressure, and body shape measured
Give a fasting blood sample (for cholesterol and blood sugar)
Complete physical function tests (such as grip strength and walking balance)
Complete the three body composition assessments (BIA, 3D scan, and body shape scale)
Fill in a short questionnaire about how acceptable they found each assessment
Some participants (20 people) will also be invited to take part in a short interview (about 30 minutes, either in person or by phone) to share their experiences in more detail.
All data will be anonymised and handled confidentially. Participants will receive a £20 voucher as a thank you, and an additional £15 if they take part in the interview.
What are the possible benefits and risks of participating?
There is no direct medical benefit to participants, but the results may help improve how body composition is measured and monitored in future clinical care for people living with HIV and/or HBV. Participants may also gain insights into their own body shape and health risks.
The procedures are safe and non-invasive. Some people may feel uncomfortable discussing weight or body shape, but the research team is trained to be sensitive and supportive. Any participant who becomes upset will be offered information about further support. People with implanted medical devices or limited mobility will not be able to participate due to equipment limitations.
Where is the study run from?
University College London (UK)
When is the study starting and how long is it expected to run for?
The study aims to start recruitment in September 2025 and close recruitment in April 2026.
Who is funding the study?
The study is funded through the UCL Naughton/Clift-Matthews Global Health Fund 2024.
Who is the main contact?
Florence Bascombe - florence.bascombe@nhs.net / cnwl.behive@nhs.net
Contact information
Public, Scientific, Principal investigator
Mortimer Market Centre, off Capper Street
London
WC1E 6JD
United Kingdom
 ORCID ID |
0000-0003-1005-6190 |
|---|---|
| Phone | +44 7554411752 |
| f.bascombe@ucl.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre cross-sectional cohort study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | Improving the assessment of overweight and oBEsity in people living with HIV and/or chronic hepatitis B |
| Study acronym | BEHIVe |
| Study objectives | Primary objective: To assess the acceptability of BIA, 3D Scan and the SFRs in people living with HIV and/or chronic HBV using a validated framework for assessing acceptability of healthcare interventions, and to capture additional process outcomes such as completion rates and time required for assessments. Secondary objectives: 1. To describe body composition using BIA, 3D Scan, anthropometry, and to assess cardiometabolic risk through metabolic profiling, functional assessments and risk scores. 2. To compare the participants assessment of their own body shape using the SFRS to characteristics of the participants avatar created through 3D body imaging 3. To compare the patient and clinicians’ assessment of body shape through the SFRS |
| Ethics approval(s) |
Approved 23/09/2025, East of England - Cambridge East Research Ethics Committee (2 Redman Place, London, EC20 1JQ, United Kingdom; +44 2071048000; cambridgeeast.rec@hra.nhs.uk), ref: 22/EE/0198 |
| Health condition(s) or problem(s) studied | People living with Human Immunodeficiency Virus (HIV) and/or chronic Hepatitis B Virus (HBV) |
| Intervention | This cross-sectional study will recruit 100 people living with HIV and/or chronic HBV from the Mortimer Market Centre in London. Participants will undergo body composition assessments using BIA, 3D scanning, and the Stunkard Figure Rating Scale, anthropometric and sarcopenia measurements, alongside validated questionnaires to evaluate the acceptability of these interventions. A subset of participants will take part in qualitative interviews to explore their perceptions of weight and health, their preferences for body composition assessment methods and experiences with these tools. Quantitative data will assess acceptability as well as any potential correlation between measurement methods, while qualitative data will provide insights into patient perspectives. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Acceptability of three body composition assessment tools measured using a validated questionnaire (based on the Theoretical Framework of Acceptability) immediately after each assessment. Completion rates and time taken to complete each assessment will also be recorded. |
| Key secondary outcome measure(s) |
1. Body composition and cardiometabolic risk profiling using data from BIA, 3D scans, and standard anthropometric measures (e.g. BMI, waist circumference). We will also assess cardiometabolic risk using blood tests (lipids, HbA1c), blood pressure, QRISK3 score, liver fat (CAP score), and sarcopenia risk (Short Physical Performance Battery and grip strength) |
| Completion date | 30/04/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Age ≥18 years 2. HIV-1 positive with viral load <200 copies/ml at time of enrolment AND/OR Chronic Hepatitis B Virus diagnosed as presence of Hepatitis B surface antigen (HBsAG) in the blood for ≥6 months 3. Provision of written informed consent 4. Able to stand unaided for >30 seconds |
| Key exclusion criteria | 1. Wheelchair users 2. People with artificial electrical implants, such as pacemakers or defibrillators 3. People who have had bariatric surgery or are currently taking/recently completed a course (within <6 months) of GLP-1 receptor agonist therapies 4. Person living with HIV and/or chronic HBV and active Hepatitis C co-infection or who has completed HCV treatment within the previous 6 months |
| Date of first enrolment | 27/09/2025 |
| Date of final enrolment | 30/04/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
London
WC1E 6JD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
03/11/2025: Trial's existence confirmed by NHS HRA.
