We-INtervention Among Chinese HIV-serodiscordant Male Couples

Condition(s) studied

Investigational drug(s) / intervention(s)

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 shared disease, enhancing illness control. Session 2: Couple communication. Couples undertake skill-building exercises on effective communication techniques to strengthen their relationship. Session 3: Dyadic coping. Couples learn to optimize preference and value assessments in HIV management. A few skill-building exercises help them mobilize and maintain mutual support and develop joint problem-solving skills.

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Stigma — 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 (WHOQol-HIV for seropositive partners and WHOQol for seronegative partners) — 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 — 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 — 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 — 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 — 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.

Trial sites (4)

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