Exploring Feasibility, Acceptability, and Effectiveness of a Digital HIV Onward Disclosure Intervention, in People Living With HIV of Sub-Saharan African Ethnicity.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 9
- 主要终点
- Change from baseline HIV Disclosure Intention after 11 weeks
研究概览
简要总结
Research has shown that people living with HIV struggle to disclose their HIV status to others, (a process known as self-disclosure or onward disclosure) due to associated challenges, including fear of discrimination from others. However, there are a range of potentially positive outcomes associated with self-disclosure, such as increased medication adherence, improved wellbeing, and greater social support. Consequently, people living with HIV should be adequately supported, if they wish to disclose.
This study intends to develop and assess a digital HIV disclosure intervention, based on an existing non-digital intervention, for Sub-Saharan African adults, living with HIV and residing in the U.K. Participants will be followed pre, during and post intervention, with various measures being collected throughout, including HIV disclosure behaviour, HIV disclosure intention, HIV disclosure motivation, general wellbeing and mood. Upon follow up, participants will also be asked to complete a questionnaire regarding their personal experiences of this digital intervention. It is hypothesised that this digital HIV self disclosure intervention may lead to increases in HIV disclosure intention, amongst other secondary variables. Statistical and visual analysis will allow outcomes of this intervention to be summarised and will hopefully lead to implications and suggestions for future digital HIV disclosure interventions, supporting those living with HIV to manage the self-disclosure process effectively.
详细描述
Aims:
This study aims to develop a digital HIV disclosure intervention (based on the HEADS-UP intervention), for Sub-Saharan African adults living in the UK, and to test this through a Single Case Experimental Design (SCED). Research questions include: Is this intervention effective in increasing people's intention to disclose their HIV status? Is this intervention acceptable for Sub Saharan African adults, living in the UK? Is this digital disclosure intervention feasible?
Design:
A single case experimental design (SCED) will be used to explore this digital HIV disclosure intervention. Nine participants will be allocated to a three week baseline phase, four week intervention phase and four week follow up phase.
Morley's assessment, measurement funnel design will be implemented for this research project, whereby measures are taken throughout baseline, intervention and follow up (Morley, 1996). Mood will be measured via a Visual Analogue Scale, daily, for each participant throughout baseline, intervention and follow up, this will be a target measure. Weekly measures will include a 1 item disclosure behaviour question, a 1 item disclosure intention question and 3 items concerning disclosure motivation, being a 1 item question concerning positive cognitions/affect, a 1 item question concerning negative cognitions/affect and a 1 item question concerning self-efficacy, all will be target measures. The full Adolescent HIV Disclosure Cognition and Affect Scale (Evangeli, 2017) and a formal standardised wellbeing measure being the WEMBWBS (Tennant et al, 2007) will be administered twice throughout the study, being pre-baseline and post follow up, these will be the standard/global measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed as HIV positive.
- •Be an adult between the ages of 18 and 65 years old.
- •Identify ethnically as sub-Saharan African.
- •Have a good level of spoken and written English to ensure full engagement with the digital HIV disclosure intervention.
- •Have access to a smart phone or laptop to complete the digital intervention and the associated measures.
排除标准
- •Evidence of significant imminent risk of harm to self, or others, as identified from other professionals and clinical notes.
- •Evidence of acute and very severe mental distress, as identified from other professionals.
- •Significant ongoing safeguarding issues, as identified in participants' clinical notes or by the participant themselves.
- •Have previously participated in the HEADS-UP HIV disclosure intervention trial.
研究组 & 干预措施
Digital HIV self disclosure intervention
This study will develop a digital HIV onward disclosure intervention, drawing from the HEADSUP manual (Evangeli et al., 2020), which consists of four modules, including a HIV disclosure planning component. Participants will be asked to be involved in this study for 11 weeks, consisting of three weeks baseline, four weeks intervention and four weeks follow up.
A single case experimental design will be used to explore HIV disclosure intention, HIV disclosure behaviour, HIV disclosure motivation, general wellbeing and mood via daily and weekly measures throughout baseline, intervention and follow up phases. All these measures will be completed online via a secure qualtrics network.
Participants will further be asked to complete a participant experiences questionnaire to explore how they found this digital intervention. This project will recruit a diverse sample of Sub-Saharan Africa adults living with HIV and residing in the U.K.
干预措施: Digital HIV Self Disclosure Intervention (Other)
结局指标
主要结局
Change from baseline HIV Disclosure Intention after 11 weeks
时间窗: Up to 11 weeks
Measured by a single item disclosure intention question.
Acceptability of Intervention
时间窗: After study completion
Measured by a participant experiences questionnaire, concerning how they found the digital HIV disclosure intervention.
Feasibility of the Intervention
时间窗: Up to 11 weeks
Measured by recruitment and retention rates and adherence rates to the modules of the digital HIV disclosure intervention.
次要结局
- Change from baseline Mental Wellbeing after 11 weeks(Up to 11 weeks)
- Change from baseline HIV Disclosure Cognition and Affect after 11 weeks(Up to 11 weeks)
- Change from baseline mood after 11 weeks(Up to 11 weeks)
- Change from baseline HIV Self Disclosure Behaviour after 11 weeks(Up to 11 weeks)
- Change from baseline HIV Self Disclosure Motivation after 11 weeks(Up to 11 weeks)
研究者
Megan Westhead
Trainee Clinical Psychologist
Royal Holloway University