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

NCT05938803 | Active Not Recruiting

• 1 other identifier: R01MH131414
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 4

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.

Conditions

HIV Infections

Keywords

Adolescence; Community-based accompaniment; Retention; Antiretroviral treatment; Social support; Mental health; Treatment support; Adherence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• HIV-related death or loss to follow-up

  within 12 and 24 months

• Clinic visit attendance

  12 and 24 months

• CD4 cell count

  12 and 24 months

• Self-efficacy

  6, 9, 12, 24 months

• Transition readiness

  6, 9, 12, 24 months

Study Arms (2)

Control arm

NO INTERVENTION

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.

Intervention arm

EXPERIMENTAL

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

Interventions

PASEO BEHAVIORAL

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.

Intervention arm

Eligibility Criteria

• Age: 14 Years - 23 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescent or young person living with HIV and aware of diagnosis
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvard University Faculty of Medicine: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (4)

Hospital Nacional Arzobispo Loayza

Lima, Lima Province, Peru

Location

Instituto Nacional de Salud del Nino

Breña, Lima region, Peru

Location

Hospital Nacional Daniel Alcides Carrión

Callao, Lima, Peru

Location

Hospital Nacional Hipólito Unanue

Lima, Peru

Location

MeSH Terms

Conditions

HIV Infections; Psychological Well-Being

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; Personal Satisfaction; Behavior

Study Officials

• Molly Franke, ScD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Global Health and Social Medicine

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: July 10, 2023
• Study Start: September 22, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations

PE (4)