We-INtervention Among Chinese HIV-serodiscordant Male Couples

Официальное название

Evaluating the Effects of the We-INtervention Among Chinese HIV-serodiscordant Male Couples in a Randomized Controlled Trial

Обзор

HIV-serodiscordant male couples, in which one male partner is HIV-seropositive and the other is HIV-seronegative, experience multiple risks in HIV care and prevention. As stigma often hinders such couples' access to support and services, leveraging their relational resources is crucial for optimizing their outcomes. The proposed study will assess the efficacy of the three-session We-INtervention focusing on their relationship dynamics to enhance Chinese HIV-serodiscordant male couples' health and well-being. A total of 160 Chinese HIV-serodiscordant male couples (320 individuals: 160 HIV-seropositive and 160 HIV-seronegative) will be randomized at a 1:1 ratio to either the intervention or control arm. In the intervention arm, the We-INtervention will be delivered to both partners of each couple separately. In the control arm, each couple will receive health information pamphlets.

Подробное описание

A pilot randomized controlled trial has already demonstrated the feasibility, acceptability, cultural sensitivity, and preliminary efficacy of the We-INtervention in improving the quality of life, psychological well-being, relationship satisfaction, and health behaviors of both partners in HIV-serodiscordant male couples. The proposed randomized controlled trial will extend the pilot study to examine the effects of the We-INtervention on stigma perception and other HIV-related behavioral outcomes, the mediators that account for the intervention effects, and the conditions under which the intervention is most effective.

The We-INtervention, if found to be effective, will be a valuable supplement to existing medical care modules.

Вмешательства

• Поведенческое We-INtervention
  The We-INtervention focuses on the relationship dynamics of HIV-serodiscordant male couples. In developing the intervention, we reviewed relevant theories and frameworks, such as the cognitive transactional model, the systemic transactional model, the dyadic illness management model, and the intersectional framework of stigma. The three weekly 60-minute sessions are Session 1: We-disease appraisal. Despite stigma related to their dual minority identities, couples develop a perception of HIV as a
• Поведенческое Usual Care Group
  The participants in the control condition will receive health information pamphlets. The HIV-seropositive partners will receive information on HIV-related knowledge (e.g., symptoms, comorbidity, stages, and opportunistic infection), treatment (e.g., ART and side effects), and management (e.g., nutrition and mental health). The HIV-seronegative partner will receive information on HIV transmission (e.g., risk factors), prevention (e.g., safe sex and PrEP), and testing.

Первичные конечные точки

• Stigma [Срок оценки: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.]
• Quality of life (WHOQol-HIV for seropositive partners and WHOQol for seronegative partners) [Срок оценки: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.]
• Psychological well-being [Срок оценки: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.]
• Sexual behavior [Срок оценки: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.]
• HIV-seropositive partners' ART adherence [Срок оценки: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.]
• HIV-seronegative partners' PrEP use [Срок оценки: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.]

Вторичные конечные точки (3)

• We-disease appraisal [Срок оценки: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.]
• Communication [Срок оценки: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.]
• Common dyadic coping [Срок оценки: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.]

Критерии участия

Критерии включения

• both partners are male,
• both partners are aged 18 or above,
• both partners report being in a committed relationship for at least 3 months,
• one partner is HIV-seropositive and the other partner is HIV-seronegative (i.e., serodiscordant couple),
• both partners have disclosed their serostatus to each other, and
• both partners are willing to participate in this study.

Критерии исключения

• either partner is unable to complete the assessment due to a low education level or to physical or psychological constraints and
• either partner has been diagnosed with another chronic disease (e.g., cancer and coronary heart disease).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 4 центра

• Fangzhouai Garden — Xiamen
• Guangzhou Yuele Healthcare Service Center — Гуанчжоу
• Community Always There — Шэньчжэнь
• Jin Tang Six-Color Rainbow Healthcare Center — Чэнду

Публикации

• Shiu CS, Chen WT, Simoni J, Fredriksen-Goldsen K, Zhang F, Zhou H. The Chinese Life-Steps Program: A Cultural Adaptation of a Cognitive-Behavioral Intervention to Enhance HIV Medication Adherence. Cogn Behav Pract. 2013 May;20(2):202-212. doi: 10.1016/j.cbpra.2012.05.005. PMID 23667305
• Pan S, Sun S, Li X, Chen J, Xiong Y, He Y, Pachankis JE. A pilot cultural adaptation of LGB-affirmative CBT for young Chinese sexual minority men's mental and sexual health. Psychotherapy (Chic). 2021 Mar;58(1):12-24. doi: 10.1037/pst0000318. Epub 2020 Jun 15. PMID 32538644
• Gamarel KE, Sevelius JM, Neilands TB, Kaplan RL, Johnson MO, Nemoto T, Darbes LA, Operario D. Couples-based approach to HIV prevention for transgender women and their partners: study protocol for a randomised controlled trial testing the efficacy of the 'It Takes Two' intervention. BMJ Open. 2020 Oct 15;10(10):e038723. doi: 10.1136/bmjopen-2020-038723. PMID 33060086
• Burton J, Darbes LA, Operario D. Couples-focused behavioral interventions for prevention of HIV: systematic review of the state of evidence. AIDS Behav. 2010 Feb;14(1):1-10. doi: 10.1007/s10461-008-9471-4. PMID 18843530

Идентификаторы

NCT: NCT06639932 · We-INtervention

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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