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HIVNCT06639932

We-INtervention Among Chinese HIV-serodiscordant Male Couples

A study testing We-INtervention in people with HIV, run by City University of Hong Kong at 4 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
HIV
What is being tested?
We-INtervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
4 sitesChina
Study dates
1 Sep 2025to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nancy Xiaonan Yu, PhD contact

34429436

nancy.yu@cityu.edu.hk

China4 sites, 4 recruiting
  • Jin Tang Six-Color Rainbow Healthcare Center

    Chengdu, Sichuan

    Shanzhi Feng, 13348854440, owen.feng@outlook.cl

    Recruiting
  • Guangzhou Yuele Healthcare Service Center

    Guangzhou, Guangdong

    Weizan Zhu, 13632346142, 412845528@qq.com

    Recruiting
  • Community Always There

    Shenzhen, Guangdong

    Honglin Liu, 18929303315, 990361066@qq.com

    Recruiting
  • Fangzhouai Garden

    Xiamen, Fujian

    Tianqi Lin, 13043041203, a00886@qq.com

    Recruiting

Other trials in China

About this study

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

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.

Read the 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
Being tested
We-INtervention, Usual Care Group

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • We-INterventionBehavioural

    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 GroupBehavioural

    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 groups in NCT06639932
Study groupRoleWhat they receive
We-INtervention groupExperimentalThe 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.
Receives: Behavioral: We-INtervention
Usual care groupActive comparatorThe participants in the control condition will receive regular care.
Receives: Behavioral: Usual Care Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stigma

    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).

    Measured: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.

  2. Quality of life (WHOQol-HIV for seropositive partners and WHOQol for seronegative partners)

    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.

    Measured: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.

  3. Psychological well-being

    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.

    Measured: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.

  4. Sexual behavior

    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).

    Measured: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.

  5. HIV-seropositive partners' ART adherence

    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).

    Measured: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.

  6. HIV-seronegative partners' PrEP use

    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.

    Measured: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.

Secondary outcomes (3)
  1. We-disease appraisal

    We-disease appraisal will be measured to assess the couples' appraisals of HIV ownership using modified items of the Inclusion of Other in the Self Scale (Aron et al., 1992). The PI previously used these modified items for research on Chinese HIV-serodiscordant couples (Hou et al., 2023). Both partners will answer this scale. The total score is based on this single item. The score range is 0-6. Higher scores indicate a higher level of we-disease appraisal.

    Measured: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.

  2. Communication

    Communication will be measured to assess how the couples handle arguments and communicate about disagreements using 16 items. This measurement was previously conducted by Dr. Darbes in a recent couple-focused intervention (Gamarel et al., 2020) and will be validated for the proposed study.Possible scores range from 0 to 64, with a higher score indicating a higher level of communication.

    Measured: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.

  3. Common dyadic coping

    Common dyadic coping will be assessed using the five-item subscale for common dyadic coping (e.g., coping with the problem together) of the Dyadic Coping Inventory (Bodenmann, 2008). The PI previously used it for research on Chinese HIV-serodiscordant couples (Hou et al., 2023). The total score for this scale is calculated by summing all items. The score range is 0-20. Higher scores indicate a higher level of common dyadic coping.

    Measured: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start1 Sep 2025
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06639932
Sponsor's protocol ID
We-INtervention
Status last verified
Jan 2026
First submitted
9 Oct 2024
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 18843530

Questions about this trial

What is this clinical trial studying?

A study testing We-INtervention in people with HIV, run by City University of Hong Kong at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nancy Xiaonan Yu, PhD (34429436, nancy.yu@cityu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stigma (time frame: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06639932, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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