Evaluating the Effects of the We-INtervention Among Chinese HIV-serodiscordant Male Couples in a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 320
- 试验地点
- 4
- 主要终点
- Stigma
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
We-INtervention group
The interventionists at each study site will be either healthcare providers (e.g., nurses), social workers, or psychologists with at least 3 years of experience serving HIV-serodiscordant male couples.
干预措施: We-INtervention (Behavioral)
Usual care group
The participants in the control condition will receive regular care.
干预措施: Usual Care Group (Behavioral)
结局指标
主要结局
Stigma
时间窗: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.
Stigma related to HIV status and homosexual identity will be assessed using the modified version of Negative Self-image Subscale of Berger's HIV Stigma Scale (Berger, Ferrans, \& Lashley, 2001) with parallel items related to "being HIV seropositive" (HIV-seronegative partners will respond to "being a partner to someone who is HIV seropositive") and "being homosexual." This dual stigma assessment was used in the PI's previous study (Chen et al., 2020). Possible scores range from 0 (no stigma) to 39 (most stigma).
Quality of life
时间窗: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.
Quality of life will be measured using the 29-item World Health Organization Quality of Life-HIV for the HIV-seropositive partners and the 24-item World Health Organization Quality of Life for the HIV-seronegative partners (WHO, 1998). These two measures were previously used in the PI's study of Chinese HIV-serodiscordant couples (Hou et al., 2023). Possible scores range from 0 (worst quality of life) to 108 (Best quality of life) for HIV-seropositive partners , and from 0 (worst quality of life) to 96 (Best quality of life) for HIV-seronegative partners.
Psychological well-being
时间窗: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.
Psychological well-being will be measured using the five-item WHO Well-Being Index (Topp et al., 2015). This scale was used in the PI's study of Chinese HIV-seropositive partners (Huang et al., 2018). Both partners will answer this scale. Items are scored on a six-point scale (0-5). The total score for this scale is calculated by summing all items. The score range is 0-25. Higher scores indicate a higher level of well-being.
Sexual behavior
时间窗: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.
Sexual behavior will be assessed via the participants' self-reports of condomless sex with their primary partner or any outside partner and of their partners' HIV status. Sexual agreement on the monogamous relationship will also be assessed. These items were previously used in Dr. Darbes's couple-focused interventions (e.g., Gamarel et al., 2020).
HIV-seropositive partners' ART adherence
时间窗: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.
HIV-seropositive partners' ART adherence will be measured using a visual analog scale to indicate missing doses (Zhang et al., 2020), previously used by the PI in an HIV-related RCT (GRF 11606221). Possible scores range from 0 (never adhere) to 10 (always adhere); and (b) single-item questions asking about missing and delayed doses in the last three days, seven days (one week) and 30 days (one month).
HIV-seronegative partners' PrEP use
时间窗: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.
HIV-seronegative partners' PrEP use will assess their knowledge of PrEP, their lifetime and current use of PrEP, and their willingness to use PrEP in their current relationship. These items were previously used in Dr. Darbes's couple-focused interventions (e.g., Gamarel et al., 2020). Self-report history of any lifetime PrEP use (yes/no), reason for taking PrEP (if relevant), PrEP use during the past month (yes/no), current PrEP use (yes/no), reasons for PrEP discontinuation (if relevant), number of PrEP pills taken every week during the past month (if relevant), frequency of missing PrEP pills during the past month (if relevant; 0=never to 3=often), strategic PrEP dosing (yes/no), type of strategic dosing schedule (if relevant), date of last dose of PrEP.
次要结局
- We-disease appraisal(pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.)
- Communication(pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.)
- Common dyadic coping(pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.)
研究者
Dr. Nancy Xiaonan Yu
Associate Professor
City University of Hong Kong