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

NCT02921516 | Completed

• 1 other identifier: NIMH R34MH107335
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

Brief Summary

Despite overall declines in HIV incidence and mortality since ART scale-up in low and middle income countries, both have risen among youth. In addition, HIV-infected youth achieve inferior treatment outcomes compared to their adult counterparts in both high- and low-income countries, and these poorer outcomes are generally attributed to suboptimal adherence. Thus, there is a critical need for the development of adherence and risk reduction interventions for the growing cohort of these youth, and the proposed cognitive behavioral N'ap Grandi is one such intervention.

Conditions

HIV Infection

Keywords

Adolescence; Adherence

Outcome Measures

Primary Outcomes (1)

• ART Adherence and response

  Data from self report questionnaire (percent medications taken), medication possession ratio (percent completed), and virologic suppression (percent improvement) will be aggregated into a composite measure of adherence.

  6 months

Secondary Outcomes (4)

• HIV sexual transmission risk reduction

  6 months

• Caregiver supportive communication

  6 months

• Psychosocial health

  6 months

• Cost of intervention from the health center perspective

  6 months

Study Arms (3)

N'ap Grandi

EXPERIMENTAL

Both Adolescent and Caregiver participate in assessment and intervention groups. Adolescent assessments will be administered at baseline, 3 months- and 6 months-post intervention. Caregiver assessments will be administered at baseline and 6 months-post intervention.

Behavioral: N'ap Grandi

N'ap Grandi - A

ACTIVE COMPARATOR

Adolescents participate in assessment and intervention groups, Caregivers participate in assessment only. Adolescent assessments will be administered at baseline, 3 months- and 6 months-post intervention. Caregiver assessments will be administered at baseline and 6 months-post intervention.

Behavioral: N'ap Grandi - A

Health Promotion - A

PLACEBO COMPARATOR

Adolescents participate in assessment and intervention groups, Caregivers participate in assessment only. Adolescent assessments will be administered at baseline, 3 months- and 6 months-post intervention. Caregiver assessments will be administered at baseline and 6 months-post intervention.

Behavioral: Health Promotion - A

Interventions

N'ap Grandi BEHAVIORAL

Eight 90-minute adolescent cognitive behavioral modules and four 90-minute caregiver cognitive behavioral modules, delivered in weekend workshops over a 1 month period, with the last two modules for joint participation of adolescents and caregivers.

N'ap Grandi

N'ap Grandi - A BEHAVIORAL

Eight 90-minute adolescent cognitive behavioral modules delivered in weekend workshops over a 1 month period.

N'ap Grandi - A

Health Promotion - A BEHAVIORAL

Eight 90-minute adolescent health promotion modules delivered in weekend workshops over a 1 month period.

Health Promotion - A

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• youth aged 15-19 years receiving 1st-line ART for at least 3 months;
• exhibiting risk factors of detectable Viral Load and/or unprotected vaginal/anal intercourse in the previous 6 months;
• fluent in spoken Haitian Creole which is required to complete assessments and to participate in the intervention groups;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Florida International University: lead

Study Sites (1)

GHESKIO Centers

Port-au-Prince, Haiti

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jessy G. Dévieux, Ph.D.

  Florida International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 24, 2016
• First Posted: October 3, 2016
• Study Start: September 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: July 11, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

HA (1)