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

Community-Based Accompaniment for Adolescents Transitioning to Adult HIV Care in Urban Peru: an Evaluation of the "PASEO" Intervention

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 Overview

• Status: Active, not recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: PASEO

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Peru
  • Lima, Peru
    • Hospital Nacional Hipólito Unanue
  • Lima
    • Callao, Lima, Peru
      • Hospital Nacional Daniel Alcides Carrión
  • Lima Province
    • Lima, Lima Province, Peru
      • Hospital Nacional Arzobispo Loayza
  • Lima region
    • Breña, Lima region, Peru
      • Instituto Nacional de Salud del Nino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm; Participants randomized to the control arm of the study will receive a modestly enhanced standard of care. Specifically, they will receive HIV transition information in the form of a paper brochure and/or a video link, and a package of supplies (i.e., a pillbox, a folder to store medical documents). Participants will undergo depression and substance use screening and will be referred as needed.
Experimental: Intervention arm; Participants randomized to the intervention arm of the study will receive a modestly enhanced standard of care. Specifically, they will receive HIV transition information in the form of a paper brochure and/or a video link, and a package of supplies (i.e., a pillbox, a folder to store medical documents). Participants will undergo depression and substance use screening and will be referred as needed. Participants allocated to this group will also receive the PASEO intervention.	Behavioral: PASEO; The intervention consists of community-based accompaniment intervention aimed at facilitating the transition to adult HIV care for adolescents living with HIV in Lima, Peru.The intervention includes the following activities: health systems navigation and accompaniment to clinic visits, monthly check-ins with an entry-level health worker, social support provided through peer support groups, education sessions, resolution of acute needs, and individualized adherence support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unsuccessful transition	Number of people who experience death, loss to follow-up or unsuppressed viral load >200 copies/mL	12 months
Unsuccessful transition	Number of people who experience death, loss to follow-up or unsuppressed viral load >200 copies/mL	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV-related death or loss to follow-up	Time to HIV-related death or loss to follow-up	within 12 and 24 months
Clinic visit attendance	Number of scheduled visits attended, among those retained	12 and 24 months
CD4 cell count	Change in CD4 cell count from baseline	12 and 24 months
Self-efficacy	Change in self-efficacy (assessed using the NIH toolbox) from baseline	6, 9, 12, 24 months
Transition readiness	Change in transition readiness (assessed using the Am I on TRAC and Got Transitions questionnaires) from baseline	6, 9, 12, 24 months
Perceived social support	Change in social support (assessed using the NIH toolbox) from baseline	6, 9, 12, 24 months
HIV-related stigma	Change in HIV-related stigma (assessed using an Abbreviated Berger HIV Stigma Scale: score range 21-84, higher score indicating greater levels of stigma) from baseline	6, 9, 12, 24 months
Social Connectedness	Change in social connectedness (assessed using the Social Connectedness Scale: score range 20-120, higher score indicating greater sense of social connectedness and belongingness) from baseline	6, 9, 12, 24 months
Sexual Behavior	Change in sexual behavior of risk (assessed using questions from the Youth Risk Behavior Surveillance System) from baseline	6, 9, 12, 24 months
ART Adherence	Change in percentage of days, during the last 30, during which at least one dose was missed (assessed using a 30 day-recall) from baseline. Minimum= -100, maximum=100; scores above 0 indicate an improvement relative to baseline, with higher scores indicating greater improvements. Assessed among those on treatment for at least a month at enrollment.	6, 9, 12, 24 months

Collaborators and Investigators

• Sponsor: Harvard University Faculty of Medicine
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Molly Franke, ScD, Harvard Medical School (HMS and HSDM)

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: July 7, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Adherence; Retention; Mental health; Adolescence; Antiretroviral treatment; Social support; Community-based accompaniment; Treatment support
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Behavior; Personal Satisfaction; HIV Infections; Psychological Well-Being
• Other Study ID Numbers: R01MH131414 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No