Project Yes+ for Young MSM Living With HIV in Vietnam
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age16-24
SponsorHanoi Medical University
About this trial
In Vietnam, adolescent and young men who have sex with men (AYMSM) are among those most affected by HIV, and they also experience significant HIV-related mental health and stigma challenges. The study team proposes to adapt Project YES+ to address both mental health and internalized HIV stigma among AYMSM living with HIV in Vietnam. This research will build local capacity and develop networks for collaborative research on mental health and stigma in this population between Vietnam, Zambia and the United States.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
16-24 years old Vietnamese;
assigned male sex at birth and identifying as male;
anal intercourse with another man in the last 12 months;
HIV positive status and currently receiving ART at the study sites;
Disqualifiers
Being currently enrolled in another HIV intervention;
Severe psychotic disorders or other interfering problems that require specialty care
Trial design
Design model
Parallel
Treatments tested in this trial
To-Hieu (I understand)
BehavioralProject YES+ was developed from two evidence-based interventions - Project Yes! and Self-Help Plus, based on Social Cognitive Theory (Project Yes!) and Acceptance and Commitment Therapy (Self-Help Plus). The youth-focused intervention component comprises 6 individual sessions with a youth peer mentor, 3 youth group sessions facilitated by a youth peer mentor and 5 group sessions to learn stress management skills. The original intervention was designed for 4 months and involves caregivers. The adaptation of Project YES+ for adolescents and young men who have sex with men living with HIV in Vietnam will make revisions on the content, frequency and delivery format of the intervention.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: To-HieuExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Acceptability: Client satisfaction
Scores on the Client Satisfaction Questionnaire (CSQ-8). Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Time frame
At the end of the intervention at 4 months.2
Feasibility: intervention attendance
Percentage of participants who complete at least 80% of the required sessions of To-Hieu
Time frame
From enrollment to the end of the intervention at 4 months3
Acceptability: perception of implementation
Acceptability will be assessed qualitatively with exit interviews with AYMSMLH and youth peer mentors
Time frame
At the end of the intervention at 4 months.4
Feasibility: Perception of implementation
Feasibility will be assessed qualitatively in exit interviews with AYMSMLH and youth peer mentors.
Time frame
At the end of the intervention at 4 monthsSecondary outcomes
1
Preliminary effectiveness: changes in mental health symptom severity
Depression and anxiety symptoms over the past two weeks will be assessed using the 9-item Patient Health Questionnaire (PHQ-9) and the 7-item Generalized Anxiety Disorder (GAD-7) questionnaire. PHQ-9 scores range from 0 to 27 and GAD-7 scores range from 0 to 21, with higher scores indicate greater symptom severity.
Time frame
Baseline and at the end of the intervention at 4 months2
Preliminary effectiveness: Change in percentage of ART adherence
ART adherence will be assessed as the percentage of prescribed doses taken over the past 4 days, calculated using the self-reported number of missed doses and the total number of prescribed doses during that period.
Time frame
Baseline and at the end of the intervention at 4 months3
Preliminary effectiveness: HIV viral load
HIV viral load will be assessed with a test provided by the study or through participants' medical records (if available)
Time frame
Baseline and at the end of the intervention at 4 months4
Preliminary effectiveness: changes in internalized HIV stigma scores
Changes in internalized HIV stigma scores will be measured using the 6-item Internalized AIDS-Related Stigma Scale. Scores range from 6 to 24, with higher scores indicate greater internalized stigma.
Time frame
Baseline and at the end of the intervention at 4 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hanoi Medical University
Lead sponsor
Fogarty International Center of the National Institute of Health
Collaborator
Johns Hopkins University
Collaborator
Source ClinicalTrials.gov
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