Department of Medicine, University of California, San Francisco, California, USA.
Department of Medicine, University of California, San Francisco, California, USA
BMJ Open. 2021 Mar 22;11(3):e037468. doi: 10.1136/bmjopen-2020-037468.
Advances in HIV treatment have proven to be effective in increasing virological suppression, thereby decreasing morbidity, and increasing survival. Medication adherence is an important factor in reducing viral load among people living with HIV (PLWH) and in the elimination of transmission of HIV to uninfected partners. Achieving optimal medication adherence involves individuals taking their medications every day or as prescribed by their provider. However, not all PLWH in the USA are engaged in care, and only a minority have achieved suppressed viral load (viral load that is lower than the detectable limit of the assay). Sexual and gender minorities (SGM; those who do not identify as heterosexual or those who do not identify as the sex they were assigned at birth) represent a high-risk population for poor clinical outcomes and increased risk of HIV transmission, as they face barriers that can prevent optimal engagement in HIV care. Research in dyadic support, specifically within primary romantic partnerships, offers a promising avenue to improving engagement in care and treatment outcomes among SGM couples. Dyadic interventions, especially focused on primary romantic partnerships, have the potential to have a sustained impact after the structured intervention ends.
This paper describes the protocol for a randomised control trial of a theory-grounded, piloted intervention (DuoPACT) that cultivates and leverages the inherent sources of support within primary romantic relationships to improve engagement in HIV care and thus clinical outcomes among persons who are living with HIV and who identify as SGM (or their partners). Eligible participants must report being in a primary romantic relationship for at least 3 months, speak English, at least one partner must identify as a sexual or gender minority and at least one partner must be HIV+ with suboptimal engagement in HIV care, defined as less than excellent medication adherence, having not seen a provider in at least the past 8 months, having a detectable or unknown viral load or not currently on antiretroviral therapy. Eligible consenting couples are allocated equally to the two study arms: a structured six-session couples counselling intervention (DuoPACT) or a three-session individually-delivered HIV adherence counselling intervention (LifeSteps). The primary aim is to evaluate the efficacy of DuoPACT on virological suppression among HIV+ members of SGM couples with suboptimal engagement in care. The DuoPACT study began its target enrolment of 150 couples (300 individuals) in August 2017, and will continue to enrol until June 2021.
All procedures are approved by the Institutional Review Board at the University of California, San Francisco. Written informed consent is obtained from all participants at enrolment, and study progress is reviewed twice yearly by an external Safety Monitoring Committee. Dissemination activities will include formal publications and report back sessions with the community.
NCT02925949; Pre-results.
艾滋病毒治疗方面的进展已被证明能有效提高病毒抑制率，从而降低发病率和死亡率，延长患者的生存时间。用药依从性是艾滋病毒感染者（PLWH）降低病毒载量和消除艾滋病毒传播给未感染者的重要因素。实现最佳的用药依从性需要个人每天或按照提供者的规定服药。然而，并非所有美国的 PLWH 都参与治疗，只有少数人达到了抑制病毒载量（低于检测限的病毒载量）。性少数群体（SGM；那些不认同异性恋或不认同出生时被分配的性别的人）代表着临床结局较差和 HIV 传播风险增加的高风险人群，因为他们面临着可能妨碍他们最佳参与 HIV 护理的障碍。在对偶支持方面的研究，特别是在主要浪漫伴侣关系中，为改善 SGM 伴侣的治疗和治疗结果提供了一个有希望的途径。对偶干预措施，特别是针对主要浪漫伴侣关系的干预措施，在结构化干预结束后，有可能产生持续的影响。
本文介绍了一项随机对照试验的方案，该试验是一项基于理论和试点的干预措施（DuoPACT），该干预措施培养和利用主要浪漫关系中的固有支持来源，以改善艾滋病毒感染者的护理参与度，从而改善性少数群体（或其伴侣）的临床结果。符合条件的参与者必须报告至少有 3 个月的主要浪漫关系，会说英语，至少有一名伴侣必须认同性少数群体或性别少数群体，并且至少有一名伴侣必须是 HIV 阳性，并且 HIV 护理参与度不理想，定义为用药依从性不佳、过去至少 8 个月未看过医生、病毒载量可检测或未知或未接受抗逆转录病毒治疗。符合条件的同意夫妇被平均分配到两个研究组：一个是六节结构化的夫妇咨询干预组（DuoPACT），另一个是三节个体提供的 HIV 用药依从性咨询干预组（LifeSteps）。主要目的是评估 DuoPACT 对 HIV 阳性 SGM 夫妇护理参与度不理想者的病毒抑制效果。DuoPACT 研究于 2017 年 8 月开始招募 150 对（300 人）夫妇，预计将于 2021 年 6 月结束招募。
所有程序均经加州大学旧金山分校机构审查委员会批准。在注册时，所有参与者都获得书面知情同意，外部安全监测委员会每年两次审查研究进展。传播活动将包括正式出版物和与社区的反馈会议。
NCT02925949；预结果。
