AzTrials
AzTrials

HIV InfectionsPASEONCT05938803

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

A study testing PASEO in people with HIV Infections, run by Harvard University Faculty of Medicine at 4 sites in Peru.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 14 to 23 years
Conditions the study is for
HIV Infections
What is being tested?
PASEO
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
4 sitesPeru
Study dates
22 Sep 2023to 31 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 23 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

4 sites in 1 country.

Peru4 sites

  • Instituto Nacional de Salud del Nino

    Breña, Lima region

  • Hospital Nacional Daniel Alcides Carrión

    Callao, Lima

  • Hospital Nacional Arzobispo Loayza

    Lima, Lima Province

  • Hospital Nacional Hipólito Unanue

    Lima

Other trials in Peru

About this study

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

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
Being tested
PASEO
Keywords
Adolescence, Community-based accompaniment, Retention, Antiretroviral treatment, Social support, Mental health, Treatment support, Adherence
Medical subject headings
HIV Infections, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PASEOBehavioural

    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.

Study groups in NCT05938803
Study groupRoleWhat they receive
Control armNo interventionParticipants 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 armExperimentalParticipants 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.
Receives: Behavioral: PASEO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Unsuccessful transition

    Number of people who experience death, loss to follow-up or unsuppressed viral load >200 copies/mL

    Measured: 12 months

  2. Unsuccessful transition

    Number of people who experience death, loss to follow-up or unsuppressed viral load >200 copies/mL

    Measured: 24 months

Secondary outcomes (10)

  1. HIV-related death or loss to follow-up

    Time to HIV-related death or loss to follow-up

    Measured: within 12 and 24 months

  2. Clinic visit attendance

    Number of scheduled visits attended, among those retained

    Measured: 12 and 24 months

  3. CD4 cell count

    Change in CD4 cell count from baseline

    Measured: 12 and 24 months

  4. Self-efficacy

    Change in self-efficacy (assessed using the NIH toolbox) from baseline

    Measured: 6, 9, 12, 24 months

  5. Transition readiness

    Change in transition readiness (assessed using the Am I on TRAC and Got Transitions questionnaires) from baseline

    Measured: 6, 9, 12, 24 months

  6. Perceived social support

    Change in social support (assessed using the NIH toolbox) from baseline

    Measured: 6, 9, 12, 24 months

  7. 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

    Measured: 6, 9, 12, 24 months

  8. 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

    Measured: 6, 9, 12, 24 months

  9. Sexual Behavior

    Change in sexual behavior of risk (assessed using questions from the Youth Risk Behavior Surveillance System) from baseline

    Measured: 6, 9, 12, 24 months

  10. 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.

    Measured: 6, 9, 12, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2023
  2. Study start22 Sep 2023
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05938803
Sponsor's protocol ID
R01MH131414
Other IDs
R01MH131414
Acronym
PASEO
Status last verified
Apr 2026
First submitted
13 Jun 2023
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing PASEO in people with HIV Infections, run by Harvard University Faculty of Medicine at 4 sites in Peru.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Unsuccessful transition (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05938803.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in