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

NCT ID: NCT05938803

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-29
• Study Completion Date: 2027-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

PASEO

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 23 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Harvard University Faculty of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Molly Franke

Professor of Global Health and Social Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Molly Franke, ScD

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School (HMS and HSDM)

Locations

Hospital Nacional Arzobispo Loayza

Lima, Lima Province, Peru

Instituto Nacional de Salud del Nino

Breña, Lima region, Peru

Hospital Nacional Daniel Alcides Carrión

Callao, Lima, Peru

Hospital Nacional Hipólito Unanue

Lima, , Peru

Countries

Peru

Other Identifiers

R01MH131414

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH131414

Identifier Type: NIH

Identifier Source: org_study_id

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