Clinical trial NCT02888288: Integrating Mental Health Into a HIV Clinic to Improve Outcomes Among Tanzanian Youth
Official title: Integrating Mental Health Into a HIV Clinic to Improve Outcomes Among Tanzanian Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
HIV
Mental Health
Keywords: adolescent
adolescence
HIV/AIDS
mental health
cognitive behavioral therapy
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Kilimanjaro Christian Medical Centre, Tanzania
First posted: 2016-09-05
Enrollment: 140
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The study will enroll up to approximately 130 participants from the established Kilimanjaro Christian Medical Centre and Mawenzi Saturday Teen Clinics. Participants will be assigned to approximately eight to ten persons per group, based on age and sex. Groups will be matched in pairs as closely as possible (ex. two groups of females 12-16 years of age) and assigned to Wave 1, 2, or 3. Randomization will occur on the individual level and will occur just before the start of mental health intervention for each wave. Individuals will be randomized at this time point to reduce potential drop out of those with delayed start (Wave 2/3). Randomization will occur by a coin flip for two individuals based on alphabetical order: heads will be intervention group (I) and tails the standard of care group (SOC).

This feasibility study is longitudinal with up to 24 month follow-up after intervention. Feasibility measures from lay counselors will be monitored weekly. Outcome measures will be obtained by blinded interviewers using a structured survey to inquire about mental health symptoms, self-report adherence, obtain an ART drug concentration level from a hair sample, and HIV-1 viral load from a blood sample and will be collected by the same research assistants at five to six potential time points: 1) baseline, 2) pre-intervention, 3) post-intervention, 4) 6-months post-intervention, 5) 12-months post-intervention and 6) 24-months post-intervention.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Active psychosis, developmental delay, or cognitive disability that precludes active participation in consent process, intervention, and assessment interviews.

Primary outcomes:
measure: Participant attendance
timeFrame: weekly for 16 weeks during each intervention wave (over 2 years)
measure: Caregiver participation as measured by questionnaire
timeFrame: during 2 caregiver sessions
measure: Caregiver participation as measured by attendance sheet
timeFrame: during 2 caregiver sessions
measure: Fidelity as measured by weekly supervisor meeting
timeFrame: weekly for 16 weeks during the intervention wave (over 2 years)
measure: Fidelity as measured by fidelity checklists
timeFrame: weekly for 16 weeks during the intervention wave (over 2 years)
Secondary outcomes:
measure: Change in Mental Health
timeFrame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
measure: Change in Mental Health
timeFrame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
measure: Change in Mental Health
timeFrame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
measure: Change in ART adherence
timeFrame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
measure: Change in virologic outcomes
timeFrame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
measure: Compare method of adherence measurement
timeFrame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
measure: Change in mental health (individual)
timeFrame: baseline to post-intervention, 6-, 12-,18- and 24-months
measure: Change in adherence (individual)
timeFrame: baseline to post-intervention, 6-, 12-, and 24-months
measure: Change in HIV viral load (individual)
timeFrame: baseline to post-intervention, 6-, 12-, and 24-months
Other outcomes:
Locations:
city: Moshi
country: Tanzania
facility: Kilimanjaro Christian Medical Centre
Study officials:
affiliation: Duke University
name: Dorothy E Dow, MD, MSc-GH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ramaiya 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.
citation: Gichane 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.
citation: Dow 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.