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NCT Number: NCT05938803

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

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.

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Key information

Conditions

HIV Infections Behavior Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Personal Satisfaction Psychological Well-Being RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

14 year–23 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Nacional Daniel Alcides Carrión, Callao, Lima, Peru

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PASEO

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Harvard University Faculty of Medicine

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: PASEO

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 10, 2023
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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