Integrating Mental Health Into a HIV Clinic to Improve Outcomes Among Tanzanian Youth
1 other identifier
interventional
140
1 country
1
Brief Summary
The purpose of this study is to evaluate if a group-based mental health intervention called Sauti ya Vijana (The Voice of Youth) designed to address mental health challenges faced by adolescents in Tanzania is acceptable and feasible and if it improves mental health, antiretroviral therapy (ART) adherence, and virologic outcomes among HIV-positive adolescents as compared to youth receiving treatment as usual. Mental health intervention sessions will take place three times a month for approximately four months in groups of eight to ten youth based on age and sex. Caregivers will attend two sessions to support the youth and provide the guardian perspective on caring for HIV-positive adolescents. The investigator hypothesizes the mental health intervention will be acceptable, feasible, and will improve mental health and ART adherence among participating youth and this improvement will be sustained over time.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 9, 2016
CompletedFirst Posted
Study publicly available on registry
September 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2020
CompletedOctober 7, 2022
October 1, 2022
4.2 years
August 9, 2016
October 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Participant attendance
Measure the percentage of participants who complete all intervention sessions and ability to interview participants for outcome measures over time.
weekly for 16 weeks during each intervention wave (over 2 years)
Caregiver participation as measured by questionnaire
Record willingness of caregivers to participate (if unwilling, why not) and attendance.
during 2 caregiver sessions
Caregiver participation as measured by attendance sheet
during 2 caregiver sessions
Fidelity as measured by weekly supervisor meeting
weekly for 16 weeks during the intervention wave (over 2 years)
Fidelity as measured by fidelity checklists
weekly for 16 weeks during the intervention wave (over 2 years)
Secondary Outcomes (9)
Change in Mental Health
pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
Change in Mental Health
pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
Change in Mental Health
pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
Change in ART adherence
pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
Change in virologic outcomes
pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
- +4 more secondary outcomes
Study Arms (2)
Mental Health Intervention
EXPERIMENTALThis arm was designed based on mental health needs of HIV-infected youth in Tanzania. It incorporates principles of cognitive behavioral therapy, interpersonal psychotherapy, and motivational interviewing built into 10 group sessions, approximately 90 minutes each (2 sessions with caregiver participation) and 2 individual sessions. Groups are age and gender matched and facilitated by lay counselors with a mix of lived experience and prior mental health research experience.
Standard of Care
ACTIVE COMPARATORThis arm includes standard medical care and adherence counseling with routine education prior to the start of the HIV youth clinic from which participants are recruited.
Interventions
Includes a standard format of greetings, review of last session content, homework discussion, new topic, assigning homework and ends with a fun activity, relaxation or game. First session is a joint session with youth and caregivers. Topics include common stresses and worries experienced by HIV+ youth; relaxation and coping techniques; cognitive behavioral triangle; story of finding out HIV status and if willing, to discuss this in an individual session, peer group session, and with caregiver; identify circles of support; discuss stigma and how to disclose HIV status to others; consider values, hopes and dreams for the future, and how to use this information to live positively with HIV. ART adherence is woven into case examples and discussions.
Standard of Care includes enhanced ART adherence based on clinic protocols and monthly HIV teaching sessions prior to adolescent clinic.
Eligibility Criteria
You may qualify if:
- Youth between the ages of 12 and 24 years of age, attending the Teen Club HIV clinic at Kilimanjaro Christian Medical Centre (KCMC) and/or Mawenzi Hospital and receiving ART
- if \> or =l to 18 years, able to understand the project and provide written, informed consent
- if \< 18 years, a parent or guardian must provide written permission and participant must be able to assent
- all adolescents must also commit to attending 10 weekly CBT (SYV) sessions and 2 individual sessions.
You may not qualify if:
- Active psychosis, developmental delay, or cognitive disability that precludes active participation in consent process, intervention, and assessment interviews.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Kilimanjaro Christian Medical Centre, Tanzaniacollaborator
Study Sites (1)
Kilimanjaro Christian Medical Centre
Moshi, Tanzania
Related Publications (4)
Dow DE, Turner EL, Shayo AM, Mmbaga B, Cunningham CK, O'Donnell K. Evaluating mental health difficulties and associated outcomes among HIV-positive adolescents in Tanzania. AIDS Care. 2016 Jul;28(7):825-33. doi: 10.1080/09540121.2016.1139043. Epub 2016 Feb 3.
PMID: 26837437BACKGROUNDRamaiya MK, Sullivan KA, O' Donnell K, Cunningham CK, Shayo AM, Mmbaga BT, Dow DE. A Qualitative Exploration of the Mental Health and Psychosocial Contexts of HIV-Positive Adolescents in Tanzania. PLoS One. 2016 Nov 16;11(11):e0165936. doi: 10.1371/journal.pone.0165936. eCollection 2016.
PMID: 27851797BACKGROUNDGichane MW, Sullivan KA, Shayo AM, Mmbaga BT, O' Donnell K, Cunningham CK, Dow DE. Caregiver role in HIV medication adherence among HIV-infected orphans in Tanzania. AIDS Care. 2018 Jun;30(6):701-705. doi: 10.1080/09540121.2017.1391986. Epub 2017 Oct 23.
PMID: 29058461BACKGROUNDDow DE, Mmbaga BT, Gallis JA, Turner EL, Gandhi M, Cunningham CK, O'Donnell KE. A group-based mental health intervention for young people living with HIV in Tanzania: results of a pilot individually randomized group treatment trial. BMC Public Health. 2020 Sep 4;20(1):1358. doi: 10.1186/s12889-020-09380-3.
PMID: 32887558DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dorothy E Dow, MD, MSc-GH
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2016
First Posted
September 5, 2016
Study Start
July 1, 2016
Primary Completion
August 28, 2020
Study Completion
August 28, 2020
Last Updated
October 7, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share