Condition category
Infections and Infestations
Date applied
08/01/2019
Date assigned
21/01/2019
Last edited
21/01/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
There are large numbers of young people with HIV globally, many with HIV acquired around the time of birth or through breastfeeding (perinatally acquired HIV [PAH]). Young people with PAH face challenges in adhering to antiretroviral therapy (ART), managing onward HIV transmission risk, and maintaining wellbeing. Onward HIV disclosure (sharing one’s HIV status with others) may facilitate positive outcomes in the above areas. Sharing of one’s HIV status with sexual partners may decrease HIV transmission risk through more consistent condom use, or the use of pre and post-exposure prophylaxis (preventative treatment), if virally non-suppressed. Onward disclosure may also facilitate ART adherence and improve wellbeing. Despite the public health and individual benefits of onward disclosure, there are low rates of onward disclosure in young people with PAH. No interventions have been developed to support this population to make decisions about sharing their status, and there is a lack of onward disclosure guidance for this population or for professionals working with them. This study aims to develop and test the feasibility of a behavioural intervention to increase onward disclosure levels and support onward disclosure decision-making in perinatally infected 18-25 year olds in the UK and Uganda.

Who can participate?
Perinatally infected 18-25 year olds in the UK and Uganda

What does the study involve?
The study involves developing a programme (an intervention) for 18-25 year olds who have grown up with HIV in the UK and Uganda, to help with decision-making about sharing an HIV-positive status with others (onward HIV disclosure). In particular, the researchers want to know whether people will take part in the study, stay in the study until the end, and whether the programme is acceptable. Participants are randomly allocated to receive the intervention or standard care. The intervention consists of four sessions (90 minutes per session) delivered in a mixed group/individual format (3 group and 1 individual session). Face to face interviews with ten participants in the UK and ten participants in Uganda are also conducted.

What are the possible benefits and risks of participating?
Being part of this study may help participants to think about sharing their status. By being part of this study, participants are helping to develop new ways to help support other young people with HIV to make decisions about whether and how to share their status. The researchers do not think there are risks with taking part. It may be difficult, however, to talk about some aspects of living with HIV if participants are assigned to the intervention group.

Where is the study run from?
1. St. Mary's Hospital (UK)
2. King's College Hospital (UK)
3. Guy's Hospital (UK)
4. Heartlands Hospital (UK)
5. Joint Clinical Research Centre (Uganda)

When is the study starting and how long is it expected to run for?
June 2019 to December 2021

Who is funding the study?
ViiV Healthcare

Who is the main contact?
Dr Michael Evangeli
michael.evangeli@rhul.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michael Evangeli

ORCID ID

http://orcid.org/0000-0002-9783-2625

Contact details

Department of Psychology
RHUL
Egham
TW20 0EX
United Kingdom
+44 (0)7801543681
michael.evangeli@rhul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

39850

Study information

Scientific title

Randomised feasibility trial of an onward HIV disclosure intervention for 18-25 year olds living with perinatally acquired HIV

Acronym

Study hypothesis

1. The intervention will be feasible, in relation to recruitment, retention and acceptability.
2. Participants in the intervention group will have a higher rate of onward HIV disclosure in the previous 6 months at follow-up than participants in the SOC group.

Ethics approval

London - Brent Research Ethics Committee, 80 London Road, Skipton House, London, SE1 6LH, Tel: +44 (0)2071048129, contact: Nicole Curtis - nrescommittee.london-brent@nhs.net, 09/01/ 2019, REC ref: 18/LO/1810

Study design

Randomised; Interventional; Design type: Treatment, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: Infection, Primary sub-specialty: HIV; Health Category: Infection; Disease/Condition: Human immunodeficiency virus [HIV] disease

Intervention

The trialists plan a 30 month project to:
1. Develop the planned intervention for each context (Phase 1) with 50 participants (20 young people with PAH; 20 partners, friends and family of young people with PAH; 10 professionals working with young people with PAH).
2. Conduct a randomised feasibility parallel group trial of the intervention alongside a standard of care condition (Phase 2 - main study). The use of standard of care as the comparison condition reflects the fact that onward disclosure is likely to be discussed in an unstructured way in standard practice (Kazdin, 2015). The primary outcome relates to the feasibility of the intervention, in particular recruitment, retention and acceptability (Bowen et al., 2009). The main secondary outcome is the level of onward disclosure. A sample size of 64 per condition (intervention or standard of care) (128 participants in total: 32 in each condition in each country) with data at both the baseline and follow-up time points, across UK and Ugandan sites will be recruited, consistent with existing guidance (Craig et al., 2008). The median retention rate in comparable disclosure interventions reported in the Kennedy et al systematic review was 68% (Kennedy et al., 2015). Therefore we will aim to recruit additional participants at baseline to allow for attrition (approximately 30 per country).
3. Conduct face to face interviews with ten participants in the UK and ten participants in Uganda post-intervention (Phase 2 - sub-study).

Study settings
1. UK – the trialists will recruit participants mainly from Imperial Healthcare NHS Trust in St. Mary’s Hospital, London’s 900 Clinic, a service for HIV+ young people (16+ years) with a caseload of approximately 120 individuals with PAH within the 18-25 years age range. They will recruit from a further three NHS clinics (Guy’s Hospital, London; King’s College Hospital, London, and Heartlands Hospital, Birmingham).
2. Uganda – the trialists will recruit participants from the Joint Clinical Research Centre, Lubowa, Kampala. The JCRC is a not-for-profit organization that provides HIV care to approximately 300 young people with PAH ≥18 years.

Phase 1 – Intervention Development and Adaptation
This phase will involve: assessing barriers and facilitators to onward disclosure; developing a theory of onward disclosure relevant to the study contexts using an intervention development framework (Michie, van Stralen, & West, 2011), developing intervention and recruitment strategies; carrying out formative assessment of intervention components for feasibility, understanding and acceptability; manualising the intervention; developing semi-structured interview guides; developing and adapting measures of primary and secondary outcomes and other variables (e.g., ART adherence self-efficacy); developing a fidelity measure for the intervention; developing a measure to describe standard of care; and training therapists. The following methods will be used: individual assessments, focus groups and surveys.

Phase 2 Main study – Feasibility trial
Design
This phase will use a pilot randomised feasibility parallel group design. Participants will be randomised to either the intervention or standard of care. Assessments will be carried out at three timepoints – pre-intervention/baseline (for both conditions), post-intervention (at the end of the final session, only for the intervention condition), and six month follow-up (six months from baseline, both conditions).

Intervention condition
The intervention condition will consist of four sessions (90 minutes per session) delivered in a mixed group/individual format (3 group and 1 individual session for all participants in the intervention condition); professionally-led; mixed gender; face-to-face; with peer mentor involvement and follow-up emotional, informational and problem-solving support (in the 6 months from baseline to the follow-up data point) from a peer worker for both young people in the intervention condition and people whom they have disclosed to. This will involve the use of both phone and online/social media options (Henwood et al., 2016). In total, participants in the intervention condition will be asked to attend for seven main study visits (consent, enrollment, baseline assessment/intervention session 1 (group session), intervention session 2 (group session), intervention session 3 (group session), intervention session 4 (individual session)/post assessment, and 6 month follow-up assessment). During the enrolment session, a study id will be provided, personal information will recorded, and randomisation will take place. During assessment sessions, questionnaires will be administered (see below). We will try to combine study visits with routine clinic appointments where possible.

Standard of Care condition
The nature of psychosocial support provided (in particular relating to onward HIV disclosure) and the age of transition from paediatric care during the study period at all sites will be recorded. Both the main UK site and the Uganda site have a dedicated clinic for young people who have previously been in paediatric care, with peer support and professional psychosocial support available. In these clinics, young people can discuss HIV disclosure with their multidisciplinary team, attend with their partner, and have access to a range of other services (e.g., HIV testing and condom provision). Standard of care in both countries, however, is for there to be no routine or structured psychosocial intervention to facilitate HIV disclosure or disclosure decision-making, and it has been reported that discussions between professionals and young people with HIV about more affectively-laden sexual health issues (e.g., discussing disclosure within intimate relationships) is infrequent (Fair, Albright, & Houpt, 2016). In total, participants in the standard of care condition will be asked to attend for three study visits (consent, enrollment/baseline assessment, 6 month follow-up assessment). During the enrolment session, a study id will be provided, personal information will recorded, and randomisation will take place. During assessment sessions, questionnaires will be administered (see below). We will try to combine study visits with routine clinic appointments where possible.

Phase 2 Sub-study - Process Evaluation
Face to face one-off interviews with ten participants in the UK and ten participants in Uganda will be conducted post-intervention (immediately after the final intervention session, and at the six month follow-up) by the study coordinators to aid in the assessment of feasibility and to clarify potential causal mechanisms of the intervention. Individuals will be sampled purposively from both conditions (interventions and standard of care) to ensure that a range of participant characteristics are represented. They will be contacted by phone after the baseline assessment if they have been selected for the sub-study (if they have consented to take part in this aspect of the research). If they agree to be interviewed, participants will be asked to attend the clinic site for this to take place. We will try to combine this visit with routine clinic appointments where possible.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

The feasibility of the intervention will be assessed in relation to:
1. Recruitment rates calculated for each site and for each condition at baseline
2. Retention rates calculated for each site and for each condition at 6 months
3. Acceptability measured using rating scales for participants in the intervention condition (satisfaction, intention to continue to use, and perceived appropriateness of the intervention) (Bowen et al., 2009) post intervention

Secondary outcome measures

1. HIV disclosure - Self-reported HIV disclosure events assessed through recording the frequency of new disclosures (full or partial; first hand or second hand with consent) in last six months to partners, friends and family. For each disclosure, recipient and relationship characteristics, perceived satisfaction with disclosure decision, and the nature of the recipient’s response will be assessed. In addition, for those individuals in a participant’s social network not disclosed to, satisfaction with disclosure decisions and disclosure intention will be measured. Any social harms occurring as a result of disclosure will be recorded. The trialists will develop this measure with reference to existing relevant measures (O'Connor, 1995; Serovich, Craft, & Reed, 2012; Serovich, Craft, & Yoon, 2007; Teti et al., 2010). At the follow-up time point for those in the both conditions, they will also ask about whether any disclosure support was sought from therapists or peers during the previous six months. Measured at baseline and 6 months.
2. ART adherence behaviour assessed by the CASE adherence index (Mannheimer et al., 2006). Biological correlates of ART adherence (most recent viral load and CD4 count, if available) will be collected from participants’ clinical records. Measured at baseline and 6 months.
3. Psychological wellbeing, assessed using the six-item psychological domain from the WHOQOL BREF (Skevington, Lotfy, O'Connell, & Group, 2004) at baseline, post intervention (just for intervention condition), and 6 months
4. Social support, assessed using the six-item Social Support Questionnaire Short form – SSQ6 (Sarason, Sarason, Shearin, & Pierce, 1987) at baseline, post intervention (just for intervention condition), and 6 months
5. Hope, assessed using the State Hope Scale (C. R. Snyder et al., 1996) at baseline, post intervention (just for intervention condition), and 6 months
6. The frequency and rate of unprotected sexual intercourse calculated for casual and regular partners with self-report data. Partner status will also be recorded. Measured at baseline and 6 months.

Overall trial start date

01/06/2019

Overall trial end date

01/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Phase 1:
1. Ten young people with PAH in the UK and ten in Uganda (recruited purposively with a range of levels of onward disclosure):
1.1. Aged 18 to 25 years inclusive
1.2. Living with PAH. PAH status will be ascertained using the following criteria if information is available: HIV diagnosis before 15 years, evidence of parental HIV+ diagnosis/maternal death consistent with HIV, no other risk factors for behavioural acquisition
1.3. Knowledge of own HIV status
1.4. Able to give informed consent

2. Friends, family and partners of young people with PAH in the UK (ten individuals in total) and in Uganda (a further ten in total)
2.1. Friends, family or partners of people currently or recently aged 18-25 with PAH
2.2. Awareness of the HIV status of the young person with PAH
2.3. Able to give informed consent

3. Five professionals working with young people with PAH in the UK and five in Uganda
3.1. Current or recent involvement in the care of the people aged 18-25 with PAH

Phase 2 – Feasibility trial:
1. Aged 18 to 25 years inclusive
2. Living with PAH. PAH status will be ascertained using the following criteria: HIV diagnosis before 15 years, evidence of parental HIV+ diagnosis/maternal death consistent with HIV, no other risk factors for behavioural acquisition
3. Receiving HIV care at study sites
4. Knowledge of own HIV status
5. Able to give informed consent

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 119; UK Sample Size: 119

Participant exclusion criteria

Phase 1:
1. Young people with PAH:
1.1. Current serious mental health problems. Professional opinion will be sought regarding the assessment of any mental health difficulties that might render young people unsuitable for the study
1.2. Moderate to severe learning disability/executive functioning difficulties. Individuals with clinically documented moderate to severe cognitive difficulties will be excluded
1.3. Current serious physical health problems with life expectancy < 12 months, according to professional opinion
1.4. Inability to understand or communicate in English (UK) or either English or Luganda (Uganda) according to professional opinion

2. Friends, family and partners of young people with PAH:
2.1. Inability to understand or communicate in English (UK) or either English or Luganda (Uganda)

Phase 2 – Feasibility trial:
1. Current serious mental health problems. Clinician opinion will be sought regarding the assessment of any mental health difficulties that might render young people unsuitable for the study
2. Moderate to severe learning disability/executive functioning difficulties. Individuals with clinically documented moderate to severe cognitive difficulties will be excluded
3. Current serious physical health problems with life expectancy < 12 months, according to clinician opinion
4. Inability to understand or communicate in English (UK) or either English or Luganda (Uganda) according to clinician opinion

Recruitment start date

01/07/2019

Recruitment end date

01/03/2021

Locations

Countries of recruitment

Uganda, United Kingdom

Trial participating centre

St Mary's Hospital
Praed Street
London
W2 1NY
United Kingdom

Trial participating centre

King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

Trial participating centre

Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

Trial participating centre

Heartlands Hospital
Bordesley Green East
Birmingham
B9 5ST
United Kingdom

Trial participating centre

Joint Clinical Research Centre
Lubuwa
-
Uganda

Sponsor information

Organisation

Royal Holloway College and Bedford New College

Sponsor details

c/o Alicen Nickson
RHUL
Director of Research and Enterprise
Egham
TW20 0EX
United Kingdom
+44 (0)1784414691
alicen.nickson@rhul.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

ViiV Healthcare

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The trialists aim to publish the study protocol in a peer review journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a publically available repository. Anonymised electronic data from the study will be transferred to a data repository (e.g., Figshare or RHUL Research Data Archive) at the end of the study. This will be freely accessible under Creative Commons CC BY licence and will be retained for 10 years.

Intention to publish date

01/09/2022

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes