Positive Voices: National Survey of People with HIV
| ISRCTN | ISRCTN63267760 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63267760 |
| Secondary identifying numbers | 14460 |
- Submission date
- 11/10/2013
- Registration date
- 11/10/2013
- Last edited
- 16/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
The number of people living with human immunodeficiency virus (HIV) [PLHIV] in the UK is estimated at 100,000 in 2012, due to effective HIV treatment and ongoing new HIV diagnoses. There is a need to better understand the patterns of risk behaviour in PLHIV, the prevalence of HIV-associated co-morbidities, and attitudes and satisfaction with current models of care, in order to plan HIV prevention, treatment and care services.
Who can participate?
HIV+ individuals aged 18+ attending NHS HIV specialist services will be eligible to take part.
What does the study involve?
The project will utilise the national census of HIV positive individuals in care [SOPHID] as a national sampling frame to invite a random sample of PLHIV to complete an online questionnaire. Topics covered will include: sexual and drug taking behaviours; co-morbidities and risk behaviours associated with chronic disease; use of health services; quality of life; satisfaction with care; and attitudes and experiences toward living with HIV.
The project will be carried out in two phases. In Phase 1, we will use mainly qualitative methods with patients, clinic staff, and other key informants to develop and validate the survey tool and explore the acceptability and feasibility of a variety of incentives targeting clinics and patients to improve survey response rates. In Phase 2, the survey will be conducted in twenty clinics. In the initial small study, two interventions will be studied (incentive and recruitment method).
Incentive method: Patients will be randomly allocated to one of four incentives:
1. Control - no incentive
2. Offer of health information
3. A prize draw for gift vouchers
4. Offer of health information plus a prize draw for gift vouchers
Recruitment method, Clinic level randomisation - clinics will be randomised to recruit either : a) a pre-defined randomly selected list of patients sent from Health Protection Agency OR b) all patients attending clinic during a specified time period.
What are the possible benefits and risks of participating?
There are no direct benefits for patients who participate, unless the patient is randomly allocated to receive health information or entry into a prize draw. The indirect benefits are contributing to the evaluation and improvement of their HIV services. The risks of participating are minimal, but the survey includes questions of a sensitive nature and therefore patients may feel some distress or discomfort. Patients are free to quit the survey at any time, and details of local HIV support organisations will be provided.
Where is the study run from?
The study is run from Public Health England in London.
When is the study starting and how long is it expected to run for?
The qualitative work of Phase 1 will recruit from July - October 2013. Phase 2 (the initial small study) will start recruitment in November 2013 until October 2014.
Who is funding the study?
National Institute for Health Research (UK).
Who is the main contact?
Meaghan Kall, Survey Coordinator
meaghan.kall@phe.gov.uk
Contact information
Scientific
Centre for Infections
Health Protection Agency
61 Colindale Avenue
London
NW9 5EQ
United Kingdom
| meaghan.kall@phe.gov.uk |
Study information
| Study design | Observational and interventional two tiered factorial randomised controlled trial; Design type: Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Patient information can be found at: http://www.ucl.ac.uk/silva/voices/pdfs/Patient_Information_Sheet |
| Scientific title | Development and Implementation of Positive Voices: the National Survey of People Living with HIV |
| Study acronym | Positive Voices |
| Study hypothesis | The main objectives of the study are to: 1. Evaluate the method of delivering the survey with the highest response rate 2. Identify differences between survey respondents and non-respondents Protocol can be found at: http://www.ucl.ac.uk/silva/voices/pdfs/protocol On 06/06/2014 the anticipated end date was changed from 01/04/2014 to 31/10/2014. |
| Ethics approval(s) | London Harrow Research Ethics Committee, 28/03/2013, ref: 13/LO/0279 |
| Condition | Topic: Infection; Subtopic: Infection (all Subtopics); Disease: Infectious diseases and microbiology |
| Intervention | Incentive, Patients will be randomised to one of four incentive packages in a factorial design: 1. Control - no incentive 2. Offer of health information 3. A prize draw for gift vouchers, or 4. Offer of health information plus a prize draw for gift vouchers Recruitment method, Clinic level randomisation - clinics will be randomised to recruit either : a) a pre-defined randomly selected list of patients sent from Health Protection Agency OR b) all patients attending clinic during a specified time period The total duration of intervention varies by clinic recruitment method. Clinics assigned to recruit from a pre-selected list of patients will run the study for 4 months. Clinics assigned to recruit sequential attendees, will run the study for 2 months. There will be no follow up with patients after this time. |
| Intervention type | Other |
| Primary outcome measure | Response rates; Timepoints: Which method of incentivising clinics and participants achieves the highest response rate. Assessed at the end of the study. For example, response rates will be calculated by counting the total number of survey responses, the total number of survey invitation slips returned by the clinics, and retrospectively counting the actual number of HIV+ patients who attended during the study period. |
| Secondary outcome measures | 1. Assess whether response rates among the various risk groups and age groups are representative of the national HIV population (+/10%). 2. Assess key determinants of variation in response rates by risk group, age group, geography, and clinic size. Assessed at the end of the study. |
| Overall study start date | 25/07/2013 |
| Overall study end date | 31/10/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 1366 |
| Participant inclusion criteria | Phase 1: Focus Group Discussion & Cognitive Interviews: 1. HIV positive 2. Male and female, aged 18 and over 3. Accessing care at an NHS HIV clinic Phases 2 & 3: Pilot and Full Survey: 1. HIV positive 2. Male and female, aged 18 and over 3. Accessing care at an NHS HIV clinic 4. Reported to SOPHID in the previous calendar year |
| Participant exclusion criteria | Phase 1: Focus Group Discussion & Cognitive Interviews: 1. Unable to speak English 2. Participant declines audio recording of the discussion (for focus group discussions only) Phases 2 & 3: Pilot and Full Survey: Unable to complete online questionnaire due to language or literacy |
| Recruitment start date | 25/07/2013 |
| Recruitment end date | 31/10/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NW9 5EQ
United Kingdom
Sponsor information
Government
Biosafety Unit
CEPR, Porton Down
Salisbury
SP4 0JQ
United Kingdom
| Elizabeth.Coates@phe.gov.uk | |
| Website | http://www.hpa.org.uk/ |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
16/03/2017: No publications found in PubMed, verifying study status with principal investigator. Removed a broken link.
