We-INtervention Among Chinese HIV-serodiscordant Male Couples
- Conditions
- HIV
- Registration Number
- NCT06639932
- Lead Sponsor
- City University of Hong Kong
- 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 320
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 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.
- Secondary Outcome Measures
Name Time Method We-disease appraisal pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up. 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.
Communication pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up. 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.
Common dyadic coping pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up. 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.
Trial Locations
- Locations (4)
Fangzhouai Garden
🇨🇳Xiamen, Fujian, China
Guangzhou Yuele Healthcare Service Center
🇨🇳Guangzhou, Guangdong, China
Community Always There
🇨🇳Shenzhen, Guangdong, China
Jin Tang Six-Color Rainbow Healthcare Center
🇨🇳Chengdu, Sichuan, China