NCT05938803Active, not recruiting
PASEO Intervention for Adolescents Transitioning to Adult HIV Care in Urban Peru
Community-Based Accompaniment for Adolescents Transitioning to Adult HIV Care in Urban Peru: an Evaluation of the "PASEO" Intervention
Source: ClinicalTrials.gov · Last updated 14 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 160 (actual)
- First submitted
- 13 Jun 2023
- Start date
- Sept 2023
- Primary completion date
- Nov 2026
- Lead sponsor
- Harvard University Faculty of Medicine
- Diseases
- HIV
- NCT number
- NCT05938803
What you commit to
- Study type: Interventional
- Participants enrolled: 160
- From Sept 2023 to the primary completion date, Nov 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Having any condition (social or medical) which the study team considers would make participation unsafe
Other
- Living outside of Lima province
- Participation in the PASEO pilot study
- Current enrollment in another research study
Who the study is looking for
- 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
Age in the registry: 14 years to 23 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Nacional de Salud del Nino Coordinator of this site? Confirm its status | Breña | Peru | Unknown status |
| Hospital Nacional Daniel Alcides Carrión Coordinator of this site? Confirm its status | Callao | Peru | Unknown status |
| Hospital Nacional Arzobispo Loayza Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| Hospital Nacional Hipolito Unanue Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.