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

Not Applicable

Active, not recruiting

• Conditions: HIV Infections

• Registration Number: NCT05938803
• Lead Sponsor: Harvard University Faculty of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2023-07-07
• Study First Posted: 2023-07-10
• Study Start: 2023-09-29
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2026-11-30
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Unsuccessful transition	24 months	Number of people who experience death, loss to follow-up or unsuppressed viral load \>200 copies/mL

Secondary Outcome Measures

Name	Time	Method
Self-efficacy	6, 9, 12, 24 months	Change in self-efficacy (assessed using the NIH toolbox) from baseline
Social Connectedness	6, 9, 12, 24 months	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
HIV-related death or loss to follow-up	within 12 and 24 months	Time to HIV-related death or loss to follow-up
CD4 cell count	12 and 24 months	Change in CD4 cell count from baseline
Clinic visit attendance	12 and 24 months	Number of scheduled visits attended, among those retained
Transition readiness	6, 9, 12, 24 months	Change in transition readiness (assessed using the Am I on TRAC and Got Transitions questionnaires) from baseline
Sexual Behavior	6, 9, 12, 24 months	Change in sexual behavior of risk (assessed using questions from the Youth Risk Behavior Surveillance System) from baseline
Perceived social support	6, 9, 12, 24 months	Change in social support (assessed using the NIH toolbox) from baseline
HIV-related stigma	6, 9, 12, 24 months	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
ART Adherence	6, 9, 12, 24 months	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.

Trial Locations

Locations (4)

Instituto Nacional de Salud del Nino; 🇵🇪 Breña, Lima, Peru

Hospital Nacional Daniel Alcides Carrión; 🇵🇪 Callao, Lima, Peru

Hospital Nacional Arzobispo Loayza; 🇵🇪 Lima, Peru

Hospital Nacional Hipólito Unanue; 🇵🇪 Lima, Peru