We-INtervention Among Chinese HIV-serodiscordant Male Couples

NCT06639932 | Recruiting

• 1 other identifier: We-INtervention
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

HIV

Outcome Measures

Primary Outcomes (6)

• 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).

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

• 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.

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

• 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.

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

• 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).

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

• 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).

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

• 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.

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

Secondary Outcomes (3)

• 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.

Study Arms (2)

We-INtervention group

EXPERIMENTAL

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.

Behavioral: We-INtervention

Usual care group

ACTIVE COMPARATOR

The participants in the control condition will receive regular care.

Behavioral: Usual Care Group

Interventions

We-INtervention BEHAVIORAL

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.

We-INtervention group

Usual Care Group BEHAVIORAL

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.

Usual care group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only male couples will be recruited.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• City University of Hong Kong: lead

Study Sites (4)

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

Related Publications (4)

• 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.

  PMID: 23667305 RESULT

• 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.

  PMID: 32538644 RESULT

• 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.

  PMID: 33060086 RESULT

• 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.

  PMID: 18843530 RESULT

Central Study Contacts

Nancy Xiaonan Yu, PhD

CONTACT

34429436; nancy.yu@cityu.edu.hk

Jianhua Hou, MS

CONTACT

34429436; jianhuhou2-c@my.cityu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)