Pilot Study of a Transition Intervention for ALWH

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

October 7, 2019

Primary Completion Date

January 31, 2021

Study Completion Date

January 31, 2021

Conditions
Treatment Adherence
Interventions
OTHER

Community-based accompaniment and home visits

"Trained health promoters will accompany adolescents to their first appointments; facilitate enrollment in public health insurance and completion of other administrative requisites (e.g. obtaining a foreign identification card for migrants; transferring to a different health facility); help troubleshoot new logistical and/or social challenges; and will foster communication between the adult care providers and the patient.~Health promoters will visit the participant's home or another mutually-agreed upon location at least monthly, to review ART adherence, identify barriers to care and adherence, remind patients of upcoming medical encounters, screen and follow-up for clinical and social problems, and offer social support."

BEHAVIORAL

Directly Observed Therapy

Among adolescents who have already initiated combination antiretroviral therapy (cART), directly observed therapy (DOT) will be provided to the subset of adolescents identified as being at high risk of non-adherence, defined by meeting at least one of the following criteria: 1) identified by the pediatric health provider as having unstable adherence; or 2) having a detectable viral load at one of their two previous measurements. In adolescents newly initiating cART, there will not be an adherence precedent. This group will choose whether they wish to receive DOT. As part of this research, trained community health workers (CHWs) will deliver DOT in participant's homes or in a mutually agreed upon location. CHWs will observe ingestion of cART daily, ensure it is taken as prescribed and record each dose as DOT, self-administered, not taken or not prescribed.

BEHAVIORAL

Monthly Peer Support Groups

The investigators will assign ALWH to a social support group with 9 to 11 other adolescents also participating in the research. The goal of the social support groups is to provide a venue for participants to share experiences and resources and provide encouragement and support to one another. Each group will last approximately 3 to 4 hours. Support groups will be led by adult peers or trained community health workers. The final group session will incorporate a discussion about the group experience, how it may change behavior, recommendations for improvement, and unmet needs that should be considered for a future intervention.

Trial Locations (3)

15007

Hospital Nacional Hipólito Unanue, El Agustino

15037

Instituto Nacional de Salud del Nino, San Borja

15082

Hospital Nacional Arzobispo Loayza, Lima Cercado

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University of South Florida

OTHER

collaborator

Partners HealthCare

OTHER

collaborator

Socios En Salud Sucursal, Peru

OTHER

collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Harvard Medical School (HMS and HSDM)

OTHER

NCT05022706 - Pilot Study of a Transition Intervention for ALWH | Biotech Hunter | Biotech Hunter