Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-03 @ 5:53 AM
Study NCT ID:
NCT06639932
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-15
First Post:
2024-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
We-INtervention Among Chinese HIV-serodiscordant Male Couples
Sponsor:
City University of Hong Kong
Organization:
Study Overview
Official Title:
Evaluating the Effects of the We-INtervention Among Chinese HIV-serodiscordant Male Couples in a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
HIV-serodiscordant male couples, in which one male partner is HIV-seropositive and the other is HIV-seronegative, experience multiple risks in HIV care and prevention. As stigma often hinders such couples' access to support and services, leveraging their relational resources is crucial for optimizing their outcomes. The proposed study will assess the efficacy of the three-session We-INtervention focusing on their relationship dynamics to enhance Chinese HIV-serodiscordant male couples' health and well-being.
A total of 160 Chinese HIV-serodiscordant male couples (320 individuals: 160 HIV-seropositive and 160 HIV-seronegative) will be randomized at a 1:1 ratio to either the intervention or control arm. In the intervention arm, the We-INtervention will be delivered to both partners of each couple separately. In the control arm, each couple will receive health information pamphlets.
A total of 160 Chinese HIV-serodiscordant male couples (320 individuals: 160 HIV-seropositive and 160 HIV-seronegative) will be randomized at a 1:1 ratio to either the intervention or control arm. In the intervention arm, the We-INtervention will be delivered to both partners of each couple separately. In the control arm, each couple will receive health information pamphlets.
Detailed Description:
A pilot randomized controlled trial has already demonstrated the feasibility, acceptability, cultural sensitivity, and preliminary efficacy of the We-INtervention in improving the quality of life, psychological well-being, relationship satisfaction, and health behaviors of both partners in HIV-serodiscordant male couples. The proposed randomized controlled trial will extend the pilot study to examine the effects of the We-INtervention on stigma perception and other HIV-related behavioral outcomes, the mediators that account for the intervention effects, and the conditions under which the intervention is most effective.
The We-INtervention, if found to be effective, will be a valuable supplement to existing medical care modules.
The We-INtervention, if found to be effective, will be a valuable supplement to existing medical care modules.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: