Condition category
Infections and Infestations
Date applied
11/10/2013
Date assigned
11/10/2013
Last edited
06/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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+ individual’s 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

Trial website

http://www.ucl.ac.uk/voices

Contact information

Type

Scientific

Primary contact

Miss Meaghan Kall

ORCID ID

Contact details

Centre for Infections
Health Protection Agency
61 Colindale Avenue
London
NW9 5EQ
United Kingdom
meaghan.kall@phe.gov.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14460

Study information

Scientific title

Development and Implementation of Positive Voices: the National Survey of People Living with HIV

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

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=14460

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

London – Harrow Research Ethics Committee, 28/03/2013, ref: 13/LO/0279;

Study design

Observational and interventional two tiered factorial randomised controlled trial; Design type: Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Patient information can be found at: http://www.ucl.ac.uk/silva/voices/pdfs/Patient_Information_Sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

25/07/2013

Overall trial end date

31/10/2014

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 1366

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

United Kingdom

Trial participating centre

Centre for Infections
London
NW9 5EQ
United Kingdom

Sponsor information

Organisation

Public Health England (UK)

Sponsor details

Biosafety Unit
CEPR
Porton Down
Salisbury
SP4 0JQ
United Kingdom
Elizabeth.Coates@phe.gov.uk

Sponsor type

Government

Website

http://www.hpa.org.uk/

Funders

Funder type

Government

Funder name

NIHR (UK) - Public Health Research; Grant Codes: CHPR-2011-006

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes