Quality of LifeNCT06497751
Couple-based Intervention on Quality of Life in HIV Male Serodiscordant Couples
A study testing Couple-based Dyadic Coping Group in people with Quality of Life and Hiv, run by City University of Hong Kong at 4 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Hiv, Relationship, Social
- What is being tested?
- Couple-based Dyadic Coping Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jul 2024to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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).
Trial locations and contacts
4 sites in 1 country.
China4 sites
Jin Tang Six-color Rainbow Healthcare Service Center
Chengdu
Guangzhou Yue Le Health Service Center
Guangzhou
Community Always There
Shenzhen
Fangzhouai Garden
Xiamen
About this study
Official title: 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.
- Conditions
- Quality of Life, Hiv, Relationship, Social
- Being tested
- Couple-based Dyadic Coping Group
- Keywords
- Dyadic Coping, Serodiscordant Couples, Randomized Controlled Trial, China
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couple-based Dyadic Coping GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Couple-based Dyadic Coping Group |
| Usual Care Group | No intervention | Participants received routine care from health providers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: One month (immediately after the last session of intervention)
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One month (immediately after the last session of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Jul 2024
- Primary completion30 Sep 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- City University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nancy Xiaonan Yu, City University of Hong Kong
- Investigators
- Nancy Xiaonan Yu, PhD, Principal investigator, City University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497751
- Sponsor's protocol ID
- United together
- Status last verified
- Feb 2026
- First submitted
- 3 Jul 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial of Couple-based Intervention on Relationship Satisfaction and Quality of Life in HIV Male Serodiscordant Couples
- ClinicalTrials.gov ID
- NCT06497751
- Acronym / sponsor ID
- United together
- Conditions
- Quality of Life, Hiv, Relationship, Social
- Keywords
- Dyadic Coping, Serodiscordant Couples, Randomized Controlled Trial, China
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- City University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Couple-based Dyadic Coping Group | Experimental | Behavioral: Couple-based Dyadic Coping GroupThe 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. |
| Usual Care Group | No intervention | –Participants received routine care from health providers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Couple-based Dyadic Coping GroupSession 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. | Behavioural | Couple-based Dyadic Coping Group |
Primary outcome
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.
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.
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.
10 secondary outcomes
Change of We-disease Appraisal
Time frame: Baseline, one month (immediately after the last session of intervention), and two month
Change of Dyadic Coping
Time frame: Baseline, one month (immediately after the last session of intervention), and two month
Change of Active Listening
Time frame: Baseline, one month (immediately after the last session of intervention), and two month
Change of Depressive Symptoms
Time frame: Baseline, one month (immediately after the last session of intervention), and two month
Change of Antiretroviral therapy Adherence
Time frame: Baseline, one month (immediately after the last session of intervention), and two month
Change of Condom Use with Study Partner
Time frame: Baseline, one month (immediately after the last session of intervention), and two month
Change of Self-regulation in Relationship
Time frame: Baseline, one month (immediately after the last session of intervention), and two month
Change of Well-being
Time frame: Baseline, one month (immediately after the last session of intervention), and two month
Percentage of Couples Agreeing to Participate
Time frame: Baseline
Percentage of Couples Randomized to the Intervention Arm Completed All Three Sessions
Time frame: One month (immediately after the last session of intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Xiaonan Yu, PhD principal investigator
City University of Hong Kong
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Couple-based Dyadic Coping Group in people with Quality of Life and Hiv, run by City University of Hong Kong at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Health-related Quality of Life (time frame: Baseline, one month (immediately after the last session of intervention), and two month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.