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

HIV Infections Clinical Trial

— PASEO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05938803
• Other study ID #: R01MH131414
• Secondary ID: R01MH131414
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2023
• Est. completion date: January 31, 2027

Study information

• Verified date: May 2024
• Source: Harvard University Faculty of Medicine
• Contact: Alyson Nunez
• Phone: 617-432-5224
• Email: alyson_nunez[@]hms.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: January 31, 2027
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 23 Years

Eligibility

Inclusion Criteria:

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

• 15 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

Related Conditions & MeSH terms

• HIV Infections

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.

Locations

Country	Name	City	State
Peru	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

Sponsors (2)

Lead Sponsor	Collaborator
Harvard University Faculty of Medicine	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unsuccessful transition	Number of people who experience death, loss to follow-up or unsuppressed viral load >200 copies/mL	12 months
Primary	Unsuccessful transition	Number of people who experience death, loss to follow-up or unsuppressed viral load >200 copies/mL	24 months
Secondary	HIV-related death or loss to follow-up	Time to HIV-related death or loss to follow-up	within 12 and 24 months
Secondary	Clinic visit attendance	Number of scheduled visits attended, among those retained	12 and 24 months
Secondary	CD4 cell count	Change in CD4 cell count from baseline	12 and 24 months
Secondary	Self-efficacy	Change in self-efficacy (assessed using the NIH toolbox) from baseline	6, 9, 12, 24 months
Secondary	Transition readiness	Change in transition readiness (assessed using the Am I on TRAC and Got Transitions questionnaires) from baseline	6, 9, 12, 24 months
Secondary	Perceived social support	Change in social support (assessed using the NIH toolbox) from baseline	6, 9, 12, 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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