HIV infection Infections and Infestations Human immunodeficiency virus [HIV] disease
Conditions
Interventions
Current intervention as of 21/02/2022:
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 us
Sponsors
Royal Holloway College and Bedford New College
Eligibility
Sex/Gender
All
Age
18 Years to 29 Years
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 21/02/2022: 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. Aged 16 years or over 2.3. Awareness of the HIV status of the young person with PAH 2.4. 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 29 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 Previous participant inclusion criteria as of 08/04/2020: 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. Aged 16 years or over 2.3. Awareness of the HIV status of the young person with PAH 2.4. 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 Previous 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 a
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 21/02/2022: 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 1.5. Current participation in other psychosocial intervention/support research 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 5. Current participation in other psychosocial intervention/support research 6. Provided feedback about the intervention draft in phase 1 of the study 7. Participation in phase 2 of another individual within the household Previous participant exclusion criteria as of 08/04/2020: 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 1.5. Current participation in other psychosocial intervention/support research 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 5. Current participation in other psychosocial intervention/support research 6. Participation in phase 1 of this st
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 r | — |
Countries
England, Uganda, United Kingdom
Outcome results
None listed