Couple-based Intervention on Quality of Life in HIV Male Serodiscordant Couples
NCT Number: NCT06497751
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Quality of Life|Hiv|Relationship, Social
Interventions: BEHAVIORAL: Couple-based Dyadic Coping Group
Sponsor: City University of Hong Kong
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07-01
Completion Date: 2024-10-31
Locations: Jin Tang Six-color Rainbow Healthcare Service Center, Chengdu, China|Guangzhou Yue Le Health Service Center, Guangzhou, China|Community Always There, Shenzhen, China|Fangzhouai Garden, Xiamen, China

Summary:
This study aims to provide preliminary evidence of the efficacy of couple-based intervention over usual care in HIV serodiscordant couples in China. The investigators hypothesize that couple-based intervention would be more effective than usual care concerning both partners' quality of life and relationship satisfaction. The investigators also pilot the feasibility, acceptability, and appropriateness of the intervention content and implementation.

HIV serodiscordant couples in the intervention arm will receive three sessions of dyadic intervention. In contrast, couples in the control arm will receive usual care.

Primary Outcome Measures: Change of Health-related Quality of Life, Health-related quality of life will be measured using the 24-item World Health Organization Quality of Life, which contains four domains (i.e., physical, psychological, social relationships, and environment) (WHO, 1998). Both partners will answer this scale. Items are scored on a five-point scale (0-4). The total score for this scale is calculated by summing the scores for the four domains. The score range is 0-96. Higher scores indicate a higher level of quality of life., Baseline, one month (immediately after the last session of intervention), and two month|Change of Relationship Satisfaction, Relationship satisfaction will be assessed using the 4-item Couple Satisfaction Index (Funk \&Rogger, 2007). 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 0-20. Higher scores indicate a higher level of relationship satisfaction., Baseline, one month (immediately after the last session of intervention), and two month|Perceived Acceptability, Appropriateness, and Feasibility, Perceived acceptability, appropriateness, and feasibility will be assessed using the 12-item Implementation Outcome Inventory (Weiner et al., 2017). Only couples in the intervention group will answer this scale. Items are scored on a five-point scale (0-4). The total score for this scale is calculated by summing all items. The score range is 0-48. Higher scores indicate a higher level of acceptability, appropriateness, and feasibility., One month (immediately after the last session of intervention)
Secondary Outcome Measures: Change of We-disease Appraisal, We-disease appraisal will measure the couples' appraisals of HIV ownership using a modified item of the Inclusion of Other in the Self Scale (Aron et al., 1992). 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., Baseline, one month (immediately after the last session of intervention), and two month|Change of Dyadic Coping, Dyadic coping will be assessed using the 35-item Dyadic Coping Inventory (Bodenmann, 2008). Both partners will answer this scale. Items are scored on a five-point scale (0-4). The total score for this scale is calculated by summing all items. The score range is 0-140. Higher scores indicate a higher level of dyadic coping., Baseline, one month (immediately after the last session of intervention), and two month|Change of Active Listening, Active listening will be assessed using the 11-item Active-Empathetic Listening Scale (Bodie, 2011). Both partners will answer this scale. Items are scored on a seven-point scale (0-6). The total score for this scale is calculated by summing all items. The score range is 0-66. Higher scores indicate a higher level of active empathetic listening., Baseline, one month (immediately after the last session of intervention), and two month|Change of Depressive Symptoms, Depressive symptoms will be assessed using the 10-item Center for Epidemiologic Studies Depression Scale (Radloff, 1977). Both partners will answer this scale. Items are scored on a four-point scale (0-3). The total score for this scale is calculated by summing all items. The score range is 0-30. Higher scores indicate a higher level of depressive symptoms., Baseline, one month (immediately after the last session of intervention), and two month|Change of Antiretroviral therapy Adherence, Antiretroviral therapy adherence will be assessed using the 3-item Antiretroviral therapy Adherence Scale (Wilson et al., 2016). Only HIV-positive 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 0-15. Higher scores indicate a higher level of adherence., Baseline, one month (immediately after the last session of intervention), and two month|Change of Condom Use with Study Partner, Condom use with study partner will be assessed using the 2-item condom use scale tailored for serodiscordant couples (Wyatt., 2010). Both partners will answer this scale. Both partners will answer the use of condoms during sex and sexual behaviors they had engaged in with study partners. The score ranges for both items are 0-30. The ratio was calculated by the number of condom use and the number of sexual behaviors in the past 30 days. Higher ratio indicate higher level of protected sex., Baseline, one month (immediately after the last session of intervention), and two month|Change of Self-regulation in Relationship, Self-regulation in relationship will be assessed using the 16-item Behavioral Self-regulation for Effective Relationships Scale (Wilson et al., 2005). Both partners will answer this scale. Items are scored on a five-point scale (0-4). The total score for this scale is calculated by summing all items. The score range is 0-64. Higher scores indicate a higher level of self-regulation., Baseline, one month (immediately after the last session of intervention), and two month|Change of Well-being, Well-being will be assessed using the 5-item WHO Well-being Index (WHO, 2004). 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., Baseline, one month (immediately after the last session of intervention), and two month|Percentage of Couples Agreeing to Participate, The investigators will calculate the percentage of couples agreeing to participate., Baseline|Percentage of Couples Randomized to the Intervention Arm Completed All Three Sessions, The investigators will calculate the percentage of couples randomized to the intervention arm completed all three sessions., One month (immediately after the last session of intervention)