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Integrating Mental Health Into a HIV Clinic to Improve Outcomes Among Tanzanian Youth

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ClinicalTrials.gov Identifier: NCT02888288
Recruitment Status : Active, not recruiting
First Posted : September 5, 2016
Last Update Posted : December 12, 2017
Sponsor:
Collaborator:
Kilimanjaro Christian Medical Centre, Tanzania
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Health Behavior HIV Mental Health Behavioral: Mental Health Intervention Behavioral: Standard of Care Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Integrating Mental Health Into a HIV Clinic to Improve Outcomes Among Tanzanian Youth
Actual Study Start Date : July 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mental Health Intervention
This 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.
Behavioral: Mental Health Intervention
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.

Active Comparator: Standard of Care
This 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.
Behavioral: Standard of Care
Standard of Care includes enhanced ART adherence based on clinic protocols and monthly HIV teaching sessions prior to adolescent clinic.




Primary Outcome Measures :
  1. Participant attendance [ Time Frame: weekly for 16 weeks during each intervention wave (over 2 years) ]
    Measure the percentage of participants who complete all intervention sessions and ability to interview participants for outcome measures over time.

  2. Caregiver participation as measured by questionnaire [ Time Frame: during 2 caregiver sessions ]
    Record willingness of caregivers to participate (if unwilling, why not) and attendance.

  3. Caregiver participation as measured by attendance sheet [ Time Frame: during 2 caregiver sessions ]
  4. Fidelity as measured by weekly supervisor meeting [ Time Frame: weekly for 16 weeks during the intervention wave (over 2 years) ]
  5. Fidelity as measured by fidelity checklists [ Time Frame: weekly for 16 weeks during the intervention wave (over 2 years) ]

Secondary Outcome Measures :
  1. Change in Mental Health [ Time Frame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention ]
    Compare the change in standard deviation of mental health symptoms on the PHQ-9, between the intervention group versus SOC.

  2. Change in Mental Health [ Time Frame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention ]
    Compare the change in standard deviation of mental health symptoms on the SDQ, between the intervention group versus SOC.

  3. Change in Mental Health [ Time Frame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention ]
    Compare the change in standard deviation of mental health symptoms on the UCLA PTSD-RI, between the intervention group versus SOC.

  4. Change in ART adherence [ Time Frame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention ]
    Compare the change in self-report adherence between the intervention group versus SOC.

  5. Change in virologic outcomes [ Time Frame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention ]
    Describe the proportion of youth with viral suppression (HIV-1 RNA < 400 copies/ml) in the intervention group and SOC.

  6. Compare method of adherence measurement [ Time Frame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention ]
    Compare self-report ART adherence with drug level concentration of hair samples.

  7. Change in mental health (individual) [ Time Frame: baseline to post-intervention, 6-, 12-,18- and 24-months ]
    Compare the change in standard deviation of mental health symptoms on the PHQ-9, SDQ, UCLA PTSD-RI at the individual level.

  8. Change in adherence (individual) [ Time Frame: baseline to post-intervention, 6-, 12-, and 24-months ]
    Compare the change in self-reported adherence and antiretroviral drug concentration in hair.

  9. Change in HIV viral load (individual) [ Time Frame: baseline to post-intervention, 6-, 12-, and 24-months ]
    Compare the change in HIV viral load.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02888288


Locations
Tanzania
Kilimanjaro Christian Medical Centre
Moshi, Tanzania
Sponsors and Collaborators
Duke University
Kilimanjaro Christian Medical Centre, Tanzania
Investigators
Principal Investigator: Dorothy E Dow, MD, MSc-GH Duke University