We-INtervention for Chinese male couples where one partner is HIV-positive and the other is HIV-negative

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

This program will test whether a three-session We-INtervention can help Chinese male couples with different HIV status improve relationship support, reduce stigma, and promote healthier behaviors.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 320 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: City University of Hong Kong (Academic / other)
• Locations: 4 sites (Xiamen, Fujian and 3 other locations)
• Trial ID: NCT06639932 on ClinicalTrials.gov

What this trial studies

The randomized trial will enroll 160 Chinese HIV-serodiscordant male couples (320 individuals) and assign them 1:1 to the three-session We-INtervention or to a control condition receiving health information pamphlets. In the intervention arm both partners receive sessions focused on relationship dynamics, coping with stigma, and health-promoting behaviors delivered separately to each partner. Outcomes include stigma perception, quality of life, psychological well-being, relationship satisfaction, HIV-related behaviors, and mediators that may explain any effects. The trial expands on a pilot RCT that showed feasibility, acceptability, cultural sensitivity, and preliminary benefit and will be run at community sites in Xiamen, Guangzhou, and Shenzhen.

Who should consider this trial

Good fit: Ideal candidates are adult (18+) male couples in a committed relationship of at least three months in which one partner is HIV-positive and the other is HIV-negative, both partners have disclosed their status to each other, and both are willing and able to participate in study sessions and assessments.

Not a fit: Couples where either partner cannot complete assessments due to low education or physical/psychological constraints, those with other major chronic diseases, or couples who have not mutually disclosed HIV status are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, the intervention could strengthen partner support, reduce stigma, and improve prevention and care behaviors among serodiscordant male couples.

How similar studies have performed: A preceding pilot randomized trial demonstrated feasibility, acceptability, cultural fit, and preliminary efficacy of the We-INtervention, but larger trials are needed to confirm effects.

Eligibility criteria

Inclusion criteria:

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

Exclusion criteria:

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

Where this trial is running

Xiamen, Fujian and 3 other locations

• Fangzhouai Garden — Xiamen, Fujian, China (Recruiting)
• Guangzhou Yuele Healthcare Service Center — Guangzhou, Guangdong, China (Recruiting)
• Community Always There — Shenzhen, Guangdong, China (Recruiting)
• Jin Tang Six-Color Rainbow Healthcare Center — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Nancy Xiaonan Yu, PhD

Conditions HIV