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

NCT02888288 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2022-10-07

No results posted yet for this study

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.

Conditions

Interventions

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.

BEHAVIORAL

Standard of Care

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

Sponsors & Collaborators

  • Kilimanjaro Christian Medical Centre, Tanzania

    collaborator OTHER

  • Duke University

    lead OTHER

Principal Investigators

  • Dorothy E Dow, MD, MSc-GH · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2020-08-28
Completion
2020-08-28

Countries

  • Tanzania

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02888288 on ClinicalTrials.gov