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NCT Number: NCT06497751

Couple-based Intervention on 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.

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Key information

Conditions

Quality of Life Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Relationship, Social Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Jin Tang Six-color Rainbow Healthcare Service Center, Chengdu, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Change of Health-related Quality of Life

    Time frame: 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.

  2. Change of Relationship Satisfaction

    Time frame: 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.

  3. Perceived Acceptability, Appropriateness, and Feasibility

    Time frame: 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.

Secondary outcomes

  1. Change of We-disease Appraisal

    Time frame: 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.

  2. Change of Dyadic Coping

    Time frame: 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.

  3. Change of Active Listening

    Time frame: 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.

  4. Change of Depressive Symptoms

    Time frame: 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.

  5. Change of Antiretroviral therapy Adherence

    Time frame: 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.

  6. Change of Condom Use with Study Partner

    Time frame: 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.

  7. Change of Self-regulation in Relationship

    Time frame: 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.

  8. Change of Well-being

    Time frame: 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.

  9. Percentage of Couples Agreeing to Participate

    Time frame: Baseline

    The investigators will calculate the percentage of couples agreeing to participate.

  10. Percentage of Couples Randomized to the Intervention Arm Completed All Three Sessions

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

City University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 12, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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