Couple-based Intervention on Quality of Life in HIV Male Serodiscordant Couples

Pilot Randomized Controlled Trial of Couple-based Intervention on Relationship Satisfaction and Quality of Life in HIV Male Serodiscordant Couples

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Hiv; Relationship, Social
• Intervention / Treatment: Behavioral: Couple-based Dyadic Coping Group

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chengdu, China
    • Jin Tang Six-color Rainbow Healthcare Service Center
  • Guangzhou, China
    • Guangzhou Yue Le Health Service Center
  • Shenzhen, China
    • Community Always There
  • Xiamen, China
    • Fangzhouai Garden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

The inclusion criteria for couples will be: (a) both partners are males, (b) both partners age over 18, (c) both partners report being a couple for at least three months, (d) one partner is HIV positive and the other partner is HIV-negative (i.e., serodiscordant couples), and (e) both partners are willing to participate.

The exclusion criteria for couples will be: (a) either partner cannot complete the assessment due to a low education level or physical or psychological constraint, and (b) either partner has been diagnosed with another life-threatening disease (e.g., cancer).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Couple-based Dyadic Coping Group; Session one: We-disease appraisal (30 minutes). Couples will work toward a congruent perception of HIV as a shared disease, enhancing illness control. Session two: Couple communication (30 minutes). Couples will learn basic knowledge of effective communication and undertake skill-building exercises focusing on effective communication techniques. Session three: Dyadic coping (60 minutes). Couples will learn basic knowledge of dyadic coping and work on skill-building exercises (e.g., three-phase dyadic coping exercise) to enhance support mobilization.
No Intervention: Usual Care Group; Participants received routine care from health providers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: City University of Hong Kong
• Investigators: Principal Investigator: Nancy Xiaonan Yu, PhD, City University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: China; Randomized Controlled Trial; Dyadic Coping; Serodiscordant Couples
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: United together

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No