Randomised feasibility trial of an onward HIV disclosure intervention
Research type
Research Study
Full title
Randomised feasibility trial of an onward HIV disclosure intervention for 18-25 year olds living with perinatally acquired HIV
IRAS ID
252582
Contact name
Michael Evangeli
Contact email
Sponsor organisation
Royal Holloway University of London
ISRCTN Number
ISRCTN31852047
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
There are large numbers of young people with HIV globally, many with 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, if virally non-suppressed. Onward disclosure may also facilitate ART adherence and improve well-being. 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. We will:
• Develop the planned intervention for each context (Phase 1: 12 months, n=50).
• Conduct a randomised feasibility parallel group trial of the intervention alongside a standard of care condition (Phase 2 main study: 18 months). 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. We will recruit additional participants at baseline to allow for attrition (30 per country, i.e., a total of 188 participants). Face to face interviews with ten participants in the UK and ten participants in Uganda will also be conducted(Phase 2 sub-study).REC name
London - Brent Research Ethics Committee
REC reference
18/LO/1810
Date of REC Opinion
9 Jan 2019
REC opinion
Further Information Favourable Opinion