Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02921516
• Date of registration: 24/09/2016
• Prospective Registration: No
• Primary sponsor: Florida International University
• Public title: Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings
• Scientific title: Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings
• Date of first enrolment: September 2016
• Target sample size: 278
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02921516
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Haiti

Contacts

• Name: Jessy G. Dévieux, Ph.D.
• Affiliation: Florida International University

Key inclusion & exclusion criteria

Inclusion Criteria:

1. youth aged 15-19 years receiving 1st-line ART for at least 3 months;

2. exhibiting risk factors of detectable Viral Load and/or unprotected vaginal/anal
intercourse in the previous 6 months;

3. fluent in spoken Haitian Creole which is required to complete assessments and to
participate in the intervention groups;

4. willing to a) assent to study participation if under 18, and b) having a parent or
caregiver aged >18 years provide informed consent and participate in the caregiver
workshops.

Exclusion Criteria:

1. cognitively impaired, as determined by the Test of Nonverbal Intelligence (TONI),
since such impairment may compromise the ability to comprehend and participate in the
assessment and intervention;

2. exhibits bipolar disorder, psychosis, or current need for inpatient psychiatric
hospitalization.



Age minimum: 15 Years
Age maximum: 19 Years
Gender: All

Health Condition(s) or Problem(s) studied

HIV Infection

Intervention(s)

Behavioral: Health Promotion - A

Behavioral: N'ap Grandi

Behavioral: N'ap Grandi - A

Primary Outcome(s)

ART Adherence and response [Time Frame: 6 months]

Secondary Outcome(s)

Cost of intervention from the health center perspective [Time Frame: 6 months]

Psychosocial health [Time Frame: 6 months]

HIV sexual transmission risk reduction [Time Frame: 6 months]

Caregiver supportive communication [Time Frame: 6 months]

Secondary ID(s)

NIMH R34MH107335

Source(s) of Monetary Support

Please refer to primary and secondary sponsors