Clinical trial NCT05938803: PASEO Intervention for Adolescents Transitioning to Adult HIV Care in Urban Peru
Official title: Community-Based Accompaniment for Adolescents Transitioning to Adult HIV Care in Urban Peru: an Evaluation of the "PASEO" Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV Infections
Keywords: Adolescence
Community-based accompaniment
Retention
Antiretroviral treatment
Social support
Mental health
Treatment support
Adherence
Lead sponsor: Harvard University Faculty of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-07-10
Enrollment: 160
Sex: ALL
Minimum age (years): 14
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is an evaluation of an intervention (nicknamed "PASEO") that aims to facilitate the transition to adult HIV care for adolescents living with HIV in Lima, Peru. The intervention consists of health systems navigation and accompaniment, monthly check-ins with a lay health worker, enhanced social support provided through peer support groups, education sessions, mental health screening and referral, resolution of acute needs, and individualized adherence support.

The study is a two-arm 1:1 randomized evaluation to determine the short- and long-term (i.e., post-intervention) efficacy of the PASEO intervention with regard to retention with viral load suppression as well as other indicators of well-being. The cumulative incidence of unsuccessful transition at 12- and 24-months will be compared. The cost and cost-effectiveness of the study intervention in terms of cost per additional successful transition achieved will be estimated. Data on implementation considerations essential for uptake, sustainability, and successful adoption by the public sector will be provided.


Eligibility criteria: Inclusion Criteria:

* Adolescent or young person living with HIV and aware of diagnosis
* 14 to 21 years of age (may be increased to 23 to meet recruitment targets)
* Currently taking or eligible for ART at a participating facility
* Scheduled to transition to adult care or previous unsuccessful transition to adult care
* Willing to participate regardless of the study arm to which they will be assigned
* Able and willing to provide written informed consent

Exclusion Criteria:

* Living outside of Lima province
* Participation in the PASEO pilot study
* Current enrollment in another research study
* Having any condition (social or medical) which the study team considers would make participation unsafe

Primary outcomes:
measure: Unsuccessful transition
timeFrame: 12 months
measure: Unsuccessful transition
timeFrame: 24 months
Secondary outcomes:
measure: HIV-related death or loss to follow-up
timeFrame: within 12 and 24 months
measure: Clinic visit attendance
timeFrame: 12 and 24 months
measure: CD4 cell count
timeFrame: 12 and 24 months
measure: Self-efficacy
timeFrame: 6, 9, 12, 24 months
measure: Transition readiness
timeFrame: 6, 9, 12, 24 months
measure: Perceived social support
timeFrame: 6, 9, 12, 24 months
measure: HIV-related stigma
timeFrame: 6, 9, 12, 24 months
measure: Social Connectedness
timeFrame: 6, 9, 12, 24 months
measure: Sexual Behavior
timeFrame: 6, 9, 12, 24 months
measure: ART Adherence
timeFrame: 6, 9, 12, 24 months
Other outcomes:
Locations:
city: Breña
country: Peru
facility: Instituto Nacional de Salud del Nino
state: Lima
city: Callao
country: Peru
facility: Hospital Nacional Daniel Alcides Carrión
state: Lima
city: Lima
country: Peru
facility: Hospital Nacional Arzobispo Loayza
city: Lima
country: Peru
facility: Hospital Nacional Hipólito Unanue
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Molly Franke, ScD
role: PRINCIPAL_INVESTIGATOR
References: