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

NCT ID: NCT06497751

Last Updated: 2024-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2024-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Quality of Life Hiv Relationship, Social

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Couple-based Dyadic Coping Group

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.

Group Type EXPERIMENTAL

Couple-based Dyadic Coping Group

Intervention Type 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.

Usual Care Group

Participants received routine care from health providers.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Couple-based Dyadic Coping Group

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion 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).
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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City University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Nancy Xiaonan Yu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nancy Xiaonan Yu, PhD

Role: PRINCIPAL_INVESTIGATOR

City University of Hong Kong

Locations

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Jin Tang Six-color Rainbow Healthcare Service Center

Chengdu, , China

Site Status RECRUITING

Guangzhou Yue Le Health Service Center

Guangzhou, , China

Site Status RECRUITING

Community Always There

Shenzhen, , China

Site Status RECRUITING

Fangzhouai Garden

Xiamen, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Nancy Xiaonan Yu, PhD

Role: CONTACT

Jianhua Hou, MS

Role: CONTACT

Facility Contacts

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Shanzhi Feng, BS

Role: primary

13348854440

Weizan Zhu, BS

Role: primary

13632346142

Honglin Liu, BS

Role: primary

18929303315

Tianqi Lin, BS

Role: primary

13043041203

Other Identifiers

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United together

Identifier Type: -

Identifier Source: org_study_id

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