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

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ClinicalTrials.gov Identifier: NCT05938803
Recruitment Status : Recruiting
First Posted : July 10, 2023
Last Update Posted : May 14, 2024
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Molly Franke, Harvard University Faculty of Medicine

Study Description
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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.


Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: PASEO Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Community-Based Accompaniment for Adolescents Transitioning to Adult HIV Care in Urban Peru: an Evaluation of the "PASEO" Intervention
Actual Study Start Date : September 22, 2023
Estimated Primary Completion Date : November 30, 2026
Estimated Study Completion Date : January 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Unsuccessful transition [ Time Frame: 12 months ]
    Number of people who experience death, loss to follow-up or unsuppressed viral load >200 copies/mL

  2. Unsuccessful transition [ Time Frame: 24 months ]
    Number of people who experience death, loss to follow-up or unsuppressed viral load >200 copies/mL


Secondary Outcome Measures :
  1. HIV-related death or loss to follow-up [ Time Frame: within 12 and 24 months ]
    Time to HIV-related death or loss to follow-up

  2. Clinic visit attendance [ Time Frame: 12 and 24 months ]
    Number of scheduled visits attended, among those retained

  3. CD4 cell count [ Time Frame: 12 and 24 months ]
    Change in CD4 cell count from baseline

  4. Self-efficacy [ Time Frame: 6, 9, 12, 24 months ]
    Change in self-efficacy (assessed using the NIH toolbox) from baseline

  5. Transition readiness [ Time Frame: 6, 9, 12, 24 months ]
    Change in transition readiness (assessed using the Am I on TRAC and Got Transitions questionnaires) from baseline

  6. Perceived social support [ Time Frame: 6, 9, 12, 24 months ]
    Change in social support (assessed using the NIH toolbox) from baseline

  7. HIV-related stigma [ Time Frame: 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

  8. Social Connectedness [ Time Frame: 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

  9. Sexual Behavior [ Time Frame: 6, 9, 12, 24 months ]
    Change in sexual behavior of risk (assessed using questions from the Youth Risk Behavior Surveillance System) from baseline

  10. ART Adherence [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05938803


Contacts
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Contact: Alyson Nunez 617-432-5224 alyson_nunez@hms.harvard.edu
Contact: Molly Franke, ScD 617-432-5224 molly_franke@hms.harvard.edu

Locations
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Peru
Instituto Nacional de Salud del Nino Recruiting
Breña, Lima, Peru
Contact: Lenka Kolevic, MD         
Hospital Nacional Daniel Alcides Carrión Recruiting
Callao, Lima, Peru
Contact: Juan Castro, MD         
Hospital Nacional Arzobispo Loayza Recruiting
Lima, Peru
Contact: Eduardo Matos, MD         
Hospital Nacional Hipólito Unanue Recruiting
Lima, Peru
Contact: Luis Vásquez, MD         
Sponsors and Collaborators
Harvard University Faculty of Medicine
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Molly Franke, ScD Harvard Medical School (HMS and HSDM)
More Information
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Responsible Party: Molly Franke, Associate Professor of Global Health and Social Medicine, Harvard University Faculty of Medicine
ClinicalTrials.gov Identifier: NCT05938803    
Other Study ID Numbers: R01MH131414 ( U.S. NIH Grant/Contract )
R01MH131414 ( U.S. NIH Grant/Contract )
First Posted: July 10, 2023    Key Record Dates
Last Update Posted: May 14, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Molly Franke, Harvard University Faculty of Medicine:
Adolescence
Community-based accompaniment
Retention
Antiretroviral treatment
 Social support
Mental health
Treatment support
Adherence
Additional relevant MeSH terms:
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HIV Infections
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