Study Information

Scientific title

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

Acronym

HEADS-UP  (HIV Empowering Adults’ Decisions to Share – UK/Uganda Project)

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

HIV infection

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 29 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 18-29 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 18-29 with PAH

Phase 2 – Feasibility trial:
1. Aged 18 to 25 years inclusive in Uganda, and aged 18-29 inclusive in the UK
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