NCT06639932

We-INtervention Among Chinese HIV-serodiscordant Male Couples

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: City University of Hong Kong · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• HIV

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-04-30
• Completion: 2027-06-30
• First posted: 2024-10-15
• Last updated: 2026-01-21

Locations

4 sites across 1 country: China