Clinical trial NCT06639932: We-INtervention Among Chinese HIV-serodiscordant Male Couples
Official title: Evaluating the Effects of the We-INtervention Among Chinese HIV-serodiscordant Male Couples in a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV
Lead sponsor: City University of Hong Kong
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 320
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion criteria:

1. both partners are male,
2. both partners are aged 18 or above,
3. both partners report being in a committed relationship for at least 3 months,
4. one partner is HIV-seropositive and the other partner is HIV-seronegative (i.e., serodiscordant couple),
5. both partners have disclosed their serostatus to each other, and
6. both partners are willing to participate in this study.

Exclusion criteria:

1. either partner is unable to complete the assessment due to a low education level or to physical or psychological constraints and
2. either partner has been diagnosed with another chronic disease (e.g., cancer and coronary heart disease).

Primary outcomes:
measure: Stigma
timeFrame: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.
measure: Quality of life
timeFrame: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.
measure: Psychological well-being
timeFrame: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.
measure: Sexual behavior
timeFrame: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.
measure: HIV-seropositive partners' ART adherence
timeFrame: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.
measure: HIV-seronegative partners' PrEP use
timeFrame: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.
Secondary outcomes:
measure: We-disease appraisal
timeFrame: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.
measure: Communication
timeFrame: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.
measure: Common dyadic coping
timeFrame: pre-intervention, post-intervention (upon the completion of intervention), 1-month follow-up, and 3-month follow-up.
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Fangzhouai Garden
state: Fujian
city: Guangzhou
country: China
facility: Guangzhou Yuele Healthcare Service Center
state: Guangdong
city: Shenzhen
country: China
facility: Community Always There
state: Guangdong
city: Chengdu
country: China
facility: Jin Tang Six-Color Rainbow Healthcare Center
state: Sichuan
Study officials:
References:
citation: Shiu CS, Chen WT, Simoni J, Fredriksen-Goldsen K, Zhang F, Zhou H. The Chinese Life-Steps Program: A Cultural Adaptation of a Cognitive-Behavioral Intervention to Enhance HIV Medication Adherence. Cogn Behav Pract. 2013 May;20(2):202-212. doi: 10.1016/j.cbpra.2012.05.005.
citation: Pan S, Sun S, Li X, Chen J, Xiong Y, He Y, Pachankis JE. A pilot cultural adaptation of LGB-affirmative CBT for young Chinese sexual minority men's mental and sexual health. Psychotherapy (Chic). 2021 Mar;58(1):12-24. doi: 10.1037/pst0000318. Epub 2020 Jun 15.
citation: Gamarel KE, Sevelius JM, Neilands TB, Kaplan RL, Johnson MO, Nemoto T, Darbes LA, Operario D. Couples-based approach to HIV prevention for transgender women and their partners: study protocol for a randomised controlled trial testing the efficacy of the 'It Takes Two' intervention. BMJ Open. 2020 Oct 15;10(10):e038723. doi: 10.1136/bmjopen-2020-038723.
citation: Burton J, Darbes LA, Operario D. Couples-focused behavioral interventions for prevention of HIV: systematic review of the state of evidence. AIDS Behav. 2010 Feb;14(1):1-10. doi: 10.1007/s10461-008-9471-4.