Evangeli Michael, Foster Caroline, Musiime Victor, Fidler Sarah, Seeley Janet, Gnan Georgina
Royal Holloway University of London, Egham, Surrey, UK.
Imperial College Healthcare NHS Trust, London, UK.
Pilot Feasibility Stud. 2020 Sep 24;6:141. doi: 10.1186/s40814-020-00688-w. eCollection 2020.
Young adults with perinatally acquired HIV (PAH) face several challenges, including adhering to antiretroviral therapy (ART), managing the risk of onward HIV transmission and maintaining positive well-being. Sharing one's HIV status with others (onward HIV disclosure) may assist with these challenges by facilitating emotional and practical support. Rates of HIV status sharing are, however, low in this population. There are no existing interventions focused on sharing one's HIV status for young adults living with PAH. The HEADS-UP study is designed to develop and test the feasibility of an intervention to help the sharing of HIV status for young adults with PAH.
The study is a 30-month multi-site randomised feasibility study across both a high-income/low-HIV prevalence country (UK) and a low-income/high-HIV prevalence country (Uganda). Phase 1 (12 months) will involve developing the intervention using qualitative interviews with 20 young people living with PAH (ten in the UK-18 to 29 years; ten in Uganda-18 to 25 years), 20 of their social network (friends, family, sexual partners as defined by the young person; ten in the UK, ten in Uganda) and ten professionals with experience working with young adults with PAH (five in the UK, five in Uganda). Phase 2 (18 months) involves conducting a randomised feasibility parallel group trial of the intervention alongside current standard of care condition in each country (main study) with 18- to 25-year olds with PAH. A sample size of 94 participants per condition (intervention or standard of care; 188 participants in total: 47 in each condition in each country) with data at both the baseline and 6-month follow-up time points, across UK and Ugandan sites will be recruited. Participants in the intervention condition will also complete measures immediately post-intervention. Face-to-face interviews will be conducted with ten participants in both countries immediately post-intervention and at 6-month follow-up (sub-study).
This study will be the first trial that we are aware of to address important gaps in understanding acceptable and feasible ways of delivering HIV status sharing support for young people living with PAH.
ISRCTN Registry, ISRCTN31852047, Registered on 21 January, 2019. Study sponsor: Royal Holloway University of London. Sponsor contact: alicen.nickson@rhul.ac.uk. Date and version: April 2020. Protocol version 3.5.
围产期感染艾滋病毒（PAH）的年轻人面临诸多挑战，包括坚持抗逆转录病毒治疗（ART）、控制艾滋病毒进一步传播的风险以及保持良好的身心健康。与他人分享自己的艾滋病毒感染状况（艾滋病毒状况披露）可能通过提供情感和实际支持来帮助应对这些挑战。然而，这一人群中艾滋病毒状况披露率较低。目前尚无专门针对感染PAH的年轻成年人分享艾滋病毒感染状况的干预措施。“抬头”研究旨在开发并测试一种干预措施的可行性，以帮助感染PAH的年轻成年人分享艾滋病毒感染状况。
该研究是一项为期30个月的多地点随机可行性研究，涉及一个高收入/低艾滋病毒流行率国家（英国）和一个低收入/高艾滋病毒流行率国家（乌干达）。第一阶段（12个月）将通过对20名感染PAH的年轻人（英国10名，年龄在18至29岁；乌干达10名，年龄在18至25岁）、他们的20名社交网络成员（朋友、家人、年轻人定义的性伴侣；英国10名，乌干达10名）以及10名有与感染PAH的年轻成年人工作经验的专业人员（英国5名，乌干达5名）进行定性访谈来开发干预措施。第二阶段（18个月）包括在每个国家对18至25岁感染PAH的人群进行干预措施与当前标准护理条件的随机可行性平行组试验（主要研究）。将招募每个条件（干预或标准护理）94名参与者的样本量（共188名参与者：每个国家每个条件47名），在英国和乌干达的研究地点收集基线和6个月随访时间点的数据。干预组的参与者还将在干预后立即完成测量。干预后立即以及6个月随访时（子研究）将对两个国家的10名参与者进行面对面访谈。
据我们所知，本研究将是第一项解决在理解为感染PAH的年轻人提供艾滋病毒状况分享支持的可接受和可行方式方面的重要差距的试验。
国际标准随机对照试验编号（ISRCTN）注册库，ISRCTN31852047，于2019年1月21日注册。研究资助者：伦敦大学皇家霍洛威学院。资助者联系方式：alicen.nickson@rhul.ac.uk。日期和版本：2020年4月。方案版本3.5。
