Couple-based Intervention on Quality of Life in HIV Male Serodiscordant Couples
- Conditions
- HivRelationship, SocialQuality of Life
- Interventions
- Behavioral: Couple-based Dyadic Coping Group
- Registration Number
- NCT06497751
- Lead Sponsor
- City University of Hong Kong
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Couple-based Dyadic Coping Group Couple-based Dyadic Coping Group The investigators will deliver three sessions (we-disease appraisal, communication skills, and dyadic coping skills) once per week. The first two sessions last 30 mins, and the final session lasts one hour.
- Primary Outcome Measures
Name Time Method Perceived Acceptability, Appropriateness, and Feasibility One month (immediately after the last session of intervention) 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.
Change of Health-related Quality of Life Baseline, one month (immediately after the last session of intervention), and two month 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.
Change of Relationship Satisfaction Baseline, one month (immediately after the last session of intervention), and two month 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.
- Secondary Outcome Measures
Name Time Method Change of Well-being Baseline, one month (immediately after the last session of intervention), and two month 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.
Percentage of Couples Agreeing to Participate Baseline The investigators will calculate the percentage of couples agreeing to participate.
Change of We-disease Appraisal Baseline, one month (immediately after the last session of intervention), and two month 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.
Change of Antiretroviral therapy Adherence Baseline, one month (immediately after the last session of intervention), and two month 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.
Change of Dyadic Coping Baseline, one month (immediately after the last session of intervention), and two month 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.
Change of Depressive Symptoms Baseline, one month (immediately after the last session of intervention), and two month 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.
Change of Condom Use with Study Partner Baseline, one month (immediately after the last session of intervention), and two month 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.
Change of Active Listening Baseline, one month (immediately after the last session of intervention), and two month 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.
Change of Self-regulation in Relationship Baseline, one month (immediately after the last session of intervention), and two month 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.
Percentage of Couples Randomized to the Intervention Arm Completed All Three Sessions One month (immediately after the last session of intervention) The investigators will calculate the percentage of couples randomized to the intervention arm completed all three sessions.
Trial Locations
- Locations (4)
Guangzhou Yue Le Health Service Center
🇨🇳Guangzhou, China
Jin Tang Six-color Rainbow Healthcare Service Center
🇨🇳Chengdu, China
Community Always There
🇨🇳Shenzhen, China
Fangzhouai Garden
🇨🇳Xiamen, China