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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Duke University
Sponsor:
Collaborator:
Kilimanjaro Christian Medical Centre, Tanzania
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02888288
First received: August 9, 2016
Last updated: September 7, 2016
Last verified: September 2016
  Purpose
The purpose of this study is to evaluate if implementing an adapted Human Immunodeficiency Virus (HIV) curriculum plus mental health intervention versus HIV curriculum alone is acceptable and feasible and if it improves mental health, antiretroviral therapy (ART) adherence, and virologic outcomes among HIV-positive adolescents. HIV curriculum will continue to take place prior to the start of the monthly Saturday youth clinic. Mental health intervention sessions will take place three times a month for four months in groups of eight based on age and gender. 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 Intervention
Health Behavior
HIV
Mental Health
Behavioral: Mental Health Intervention
Behavioral: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Integrating Mental Health Into a HIV Clinic to Improve Outcomes Among Tanzanian Youth

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Participant attendance [ Time Frame: weekly for 40 weeks per year (over 2 years) ]
    Measure the percentage of participants who complete all intervention sessions and ability to interview participants for outcome measures over time.

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

  • Caregiver participation as measured by attendance sheet [ Time Frame: during 2 caregiver sessions ]
  • Fidelity as measured by weekly supervisor meeting [ Time Frame: weekly for 40 weeks per year (over 2 years) ]
  • Fidelity as measured by fidelity checklists [ Time Frame: weekly for 40 weeks per year (over 2 years) ]

Secondary Outcome Measures:
  • Change in Mental Health [ Time Frame: baseline, within 1 month post-intervention, 6 months, 12 months, 24 months ]
    .Compare the change in standard deviation of mental health symptoms on the PHQ-9, between the intervention group versus SOC from baseline to post-intervention, 6-, 12-, and 24-month completion.

  • Change in Mental Health [ Time Frame: baseline, within 1 month post-intervention, 6 months, 12 months, 24 months ]
    Compare the change in standard deviation of mental health symptoms on the SDQ, between the intervention group versus SOC from baseline to post-intervention, 6-, 12-, and 24-month completion.

  • Change in Mental Health [ Time Frame: baseline, within 1 month post-intervention, 6 months, 12 months, 24 months ]
    Compare the change in standard deviation of mental health symptoms on the UCLA PTSD-RI, between the intervention group versus SOC from baseline to post-intervention, 6-, 12-, and 24-month completion.

  • Change in ART adherence [ Time Frame: baseline, within 1 month post-intervention, 6 months, 12 months, 24 months ]
    Compare the change in self-report adherence between the intervention group versus SOC from baseline to post-intervention, 6-, 12-, and 24-month completion.

  • Change in virologic outcomes [ Time Frame: baseline, within 1 month post-intervention, 6 months, 12 months, 24 months ]
    Describe the proportion of youth with viral suppression (HIV-1 RNA < 400 copies/ml) in the intervention group and SOC baseline to post-intervention, 6-, 12-, and 24-month completion.

  • Compare method of adherence measurement [ Time Frame: Baseline ]
    Compare self-report ART adherence with drug level concentration of hair samples at baseline.


Estimated Enrollment: 100
Study Start Date: September 2016
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 an enhanced HIV curriculum led by youth participating in the HIV youth clinic from which participants are recruited.
Behavioral: Standard of Care
Standard of Care is enhanced with a 12 session HIV curriculum taught by youth leaders which is integrated into the HIV youth clinic. ART adherence is discussed in all sessions.

Detailed Description:

The study will enroll 100 participants from the established Kilimanjaro Christian Medical Centre and Mawenzi Saturday Teen Clinics. Participants will be assigned to eight persons per group, based on age and gender. 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 just before the start of mental health intervention for each wave. Matched groups 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 the matched groups: 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 will be collected by the same research assistants at 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

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 > 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 mental health intervention 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02888288

Contacts
Contact: Dorothy E Dow, MD, MSc-GH +255-762-431-127 dorothy.dow@duke.edu

Locations
Tanzania
Kilimanjaro Christian Medical Centre Recruiting
Moshi, Tanzania
Contact: Dorothy E Dow, MD, Msc-GH    +255-762-431-127    dorothy.dow@duke.edu   
Sponsors and Collaborators
Duke University
Kilimanjaro Christian Medical Centre, Tanzania
Investigators
Principal Investigator: Dorothy E Dow, MD, MSc-GH Duke University
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02888288     History of Changes
Other Study ID Numbers: Pro00069892
Study First Received: August 9, 2016
Last Updated: September 7, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Duke University:
adolescent
adolescence
HIV/AIDS
mental health
cognitive behavioral therapy

ClinicalTrials.gov processed this record on April 24, 2017