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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2022
• Main ID: NCT02888288
• Date of registration: 09/08/2016
• Prospective Registration: No
• Primary sponsor: Duke University
• Public title: Integrating Mental Health Into a HIV Clinic to Improve Outcomes Among Tanzanian Youth
• Scientific title: Integrating Mental Health Into a HIV Clinic to Improve Outcomes Among Tanzanian Youth
• Date of first enrolment: July 2016
• Target sample size: 140
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02888288
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Tanzania

Contacts

• Name: Dorothy E Dow, MD, MSc-GH
• Affiliation: Duke University

Key inclusion & exclusion 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.



Age minimum: 12 Years
Age maximum: 24 Years
Gender: All

Health Condition(s) or Problem(s) studied

Health Behavior

HIV

Mental Health

Intervention(s)

Behavioral: Mental Health Intervention

Behavioral: Standard of Care

Primary Outcome(s)

Fidelity as measured by fidelity checklists [Time Frame: weekly for 16 weeks during the intervention wave (over 2 years)]

Participant attendance [Time Frame: weekly for 16 weeks during each intervention wave (over 2 years)]

Caregiver participation as measured by attendance sheet [Time Frame: during 2 caregiver sessions]

Fidelity as measured by weekly supervisor meeting [Time Frame: weekly for 16 weeks during the intervention wave (over 2 years)]

Caregiver participation as measured by questionnaire [Time Frame: during 2 caregiver sessions]

Secondary Outcome(s)

Change in ART adherence [Time Frame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention]

Change in adherence (individual) [Time Frame: baseline to post-intervention, 6-, 12-, and 24-months]

Change in mental health (individual) [Time Frame: baseline to post-intervention, 6-, 12-,18- and 24-months]

Compare method of adherence measurement [Time Frame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention]

Change in Mental Health [Time Frame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention]

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

Change in virologic outcomes [Time Frame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention]

Secondary ID(s)

Pro00069892

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Kilimanjaro Christian Medical Centre, Tanzania