Couple-based Intervention on Quality of Life in HIV Male Serodiscordant Couples (NCT06497751) | Clinical Trial Compass
CompletedNot Applicable
Couple-based Intervention on Quality of Life in HIV Male Serodiscordant Couples
China88 participantsStarted 2024-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of Health-related Quality of Life
Timeframe: Baseline, one month (immediately after the last session of intervention), and two month
2
Change of Relationship Satisfaction
Timeframe: Baseline, one month (immediately after the last session of intervention), and two month
3
Perceived Acceptability, Appropriateness, and Feasibility
Timeframe: One month (immediately after the last session of intervention)