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| ID | Type | Description | Link |
|---|---|---|---|
| R21TW013174 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Fogarty International Center of the National Institute of Health | NIH |
| Johns Hopkins University | OTHER |
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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.
The specific aims of this proposal are to (1) adapt Project YES+ to create To-Hieu (I understand) to improve mental health and internalized HIV stigma for AYMSM living with HIV in Vietnam and (2) examine acceptability and feasibility of To-Hieu among AYMSM living with HIV in Vietnam through a pilot randomized controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| To-Hieu | Experimental | The participants will receive the To Hieu intervention for 4 months |
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| Standard of care | No Intervention | The participants will receive standard of care at their clinics. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| To-Hieu (I understand) | Behavioral | Project 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the end of the intervention at 4 months. |
| Feasibility: intervention attendance | Percentage of participants who complete at least 80% of the required sessions of To-Hieu | From enrollment to the end of the intervention at 4 months |
| Acceptability: perception of implementation | Acceptability will be assessed qualitatively with exit interviews with AYMSMLH and youth peer mentors | At the end of the intervention at 4 months. |
| Feasibility: Perception of implementation | Feasibility will be assessed qualitatively in exit interviews with AYMSMLH and youth peer mentors. | At the end of the intervention at 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and at the end of the intervention at 4 months |
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Inclusion Criteria:
Exclusion Criteria:
This study focuses on adolescent and young men who have sex with men.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trang T. Nguyen, PhD | Contact | +84988424871 | trangthu@hmu.edu.vn | |
| Julie Denison, PhD, MHS | Contact | jdenison@jhu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanoi Medical University | Hanoi | Hanoi | 100000 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36452380 | Background | Li Z, Shang W, Wang C, Yang K, Guo J. Characteristics and trends in acceptance and commitment therapy research: A bibliometric analysis. Front Psychol. 2022 Nov 14;13:980848. doi: 10.3389/fpsyg.2022.980848. eCollection 2022. | |
| 32871505 | Background | Nguyen MX, Dowdy D, Latkin CA, Hutton HE, Chander G, Frangakis C, Lancaster KE, Sripaipan T, Bui QX, Tran HV, Go VF. Social support modifies the association between hazardous drinking and depression symptoms among ART clients in Vietnam. Drug Alcohol Depend. 2020 Oct 1;215:108249. doi: 10.1016/j.drugalcdep.2020.108249. Epub 2020 Aug 25. |
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De-identified individual participant data underlying the primary and secondary outcomes reported in publications will be shared, including baseline characteristics, intervention allocation, and follow-up outcome measures. Identifiable information and sensitive qualitative data will not be shared.
De-identified IPD and supporting information will be available beginning 12 months after publication of the main trial results and ending 5 years after publication.
De-identified IPD and supporting information will be made available upon reasonable request to qualified researchers with a methodologically sound proposal. Requests will be reviewed by the study investigators, and approved researchers may be required to sign a data use agreement. Data and supporting documents will be shared through a secure data-sharing platform or another secure transfer method.
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| 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. | Baseline and at the end of the intervention at 4 months |
| 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) | Baseline and at the end of the intervention at 4 months |
| 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. | Baseline and at the end of the intervention at 4 months |
| Preliminary effectiveness: changes in sexual minority stigma | Changes in sexual minority stigma will be assessed using the 7-item, 3-factor Reactions to Homosexuality Scale. Total scores range from 7 to 49, with higher scores indicate lower levels of internalized stigma. | Baseline and at the end of the intervention at 4 months |
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