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

NCT06497751 | Completed

• 1 other identifier: United together
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 4

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.

Conditions

Quality of Life; Hiv; Relationship, Social

Keywords

Dyadic Coping; Serodiscordant Couples; Randomized Controlled Trial; China

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Change of We-disease Appraisal

  Baseline, one month (immediately after the last session of intervention), and two month

• Change of Dyadic Coping

  Baseline, one month (immediately after the last session of intervention), and two month

• Change of Active Listening

  Baseline, one month (immediately after the last session of intervention), and two month

• Change of Depressive Symptoms

  Baseline, one month (immediately after the last session of intervention), and two month

• Change of Antiretroviral therapy Adherence

  Baseline, one month (immediately after the last session of intervention), and two month

Study Arms (2)

Couple-based Dyadic Coping Group

EXPERIMENTAL

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

Usual Care Group

NO INTERVENTION

Participants received routine care from health providers.

Interventions

Couple-based Dyadic Coping Group BEHAVIORAL

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.

Couple-based Dyadic Coping Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• City University of Hong Kong: lead

Study Sites (4)

Jin Tang Six-color Rainbow Healthcare Service Center

Chengdu, China

Location

Guangzhou Yue Le Health Service Center

Guangzhou, China

Location

Community Always There

Shenzhen, China

Location

Fangzhouai Garden

Xiamen, China

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Nancy Xiaonan Yu, PhD

  City University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 12, 2024
• Study Start: July 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: October 31, 2024
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)