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

Harvard University Faculty of Medicine

Status: Active, not recruiting

Conditions: HIV Infections

Treatments: Behavioral: PASEO

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05938803

R01MH131414 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 14 to 23 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

Control arm

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: PASEO