PASEO Intervention for Adolescents Transitioning to Adult HIV Care in Urban Peru

N/AActive Not RecruitingNCT05938803

Harvard University Faculty of Medicine160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Enrollment

160

Conditions

HIV Infections

Interventions

Eligibility

Sex: ALLMin age: 14 YearsMax age: 23 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Unsuccessful transition

Number of people who experience death, loss to follow-up or unsuppressed viral load \>200 copies/mL

Time frame: 12 months

Unsuccessful transition

Number of people who experience death, loss to follow-up or unsuppressed viral load \>200 copies/mL

Time frame: 24 months

Secondary Outcomes

HIV-related death or loss to follow-up

Time to HIV-related death or loss to follow-up

Time frame: within 12 and 24 months

Clinic visit attendance

Number of scheduled visits attended, among those retained

Time frame: 12 and 24 months

CD4 cell count

Change in CD4 cell count from baseline

Time frame: 12 and 24 months

Self-efficacy

Change in self-efficacy (assessed using the NIH toolbox) from baseline