Clinical trial NCT06497751: Couple-based Intervention on Quality of Life in HIV Male Serodiscordant Couples
Official title: Pilot Randomized Controlled Trial of Couple-based Intervention on Relationship Satisfaction and Quality of Life in HIV Male Serodiscordant Couples
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Quality of Life
Hiv
Relationship, Social
Keywords: Dyadic Coping
Serodiscordant Couples
Randomized Controlled Trial
China
Lead sponsor: City University of Hong Kong
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change of Health-related Quality of Life
timeFrame: Baseline, one month (immediately after the last session of intervention), and two month
measure: Change of Relationship Satisfaction
timeFrame: Baseline, one month (immediately after the last session of intervention), and two month
measure: Perceived Acceptability, Appropriateness, and Feasibility
timeFrame: One month (immediately after the last session of intervention)
Secondary outcomes:
measure: Change of We-disease Appraisal
timeFrame: Baseline, one month (immediately after the last session of intervention), and two month
measure: Change of Dyadic Coping
timeFrame: Baseline, one month (immediately after the last session of intervention), and two month
measure: Change of Active Listening
timeFrame: Baseline, one month (immediately after the last session of intervention), and two month
measure: Change of Depressive Symptoms
timeFrame: Baseline, one month (immediately after the last session of intervention), and two month
measure: Change of Antiretroviral therapy Adherence
timeFrame: Baseline, one month (immediately after the last session of intervention), and two month
measure: Change of Condom Use with Study Partner
timeFrame: Baseline, one month (immediately after the last session of intervention), and two month
measure: Change of Self-regulation in Relationship
timeFrame: Baseline, one month (immediately after the last session of intervention), and two month
measure: Change of Well-being
timeFrame: Baseline, one month (immediately after the last session of intervention), and two month
measure: Percentage of Couples Agreeing to Participate
timeFrame: Baseline
measure: Percentage of Couples Randomized to the Intervention Arm Completed All Three Sessions
timeFrame: One month (immediately after the last session of intervention)
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Jin Tang Six-color Rainbow Healthcare Service Center
city: Guangzhou
country: China
facility: Guangzhou Yue Le Health Service Center
city: Shenzhen
country: China
facility: Community Always There
city: Xiamen
country: China
facility: Fangzhouai Garden
Study officials:
affiliation: City University of Hong Kong
name: Nancy Xiaonan Yu, PhD
role: PRINCIPAL_INVESTIGATOR
References: