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

Primary Purpose

HIV Infections

Status
Recruiting
Phase
Not Applicable
Locations
Peru
Study Type
Interventional
Intervention
PASEO
Sponsored by
Harvard University Faculty of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV Infections focused on measuring Adolescence, Community-based accompaniment, Retention, Antiretroviral treatment, Social support, Mental health, Treatment support, Adherence

Eligibility Criteria

15 Years - 23 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adolescent or young person living with HIV and aware of diagnosis 15 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

Sites / Locations

  • Instituto Nacional de Salud del NinoRecruiting
  • Hospital Nacional Daniel Alcides CarriónRecruiting
  • Hospital Nacional Arzobispo LoayzaRecruiting
  • Hospital Nacional Hipólito UnanueRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control arm

Intervention arm

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

HIV-related death or loss to follow-up
Time to HIV-related death or loss to follow-up
Clinic visit attendance
Number of scheduled visits attended, among those retained
CD4 cell count
Change in CD4 cell count from baseline
Self-efficacy
Change in self-efficacy (assessed using the NIH toolbox) from baseline
Transition readiness
Change in transition readiness (assessed using the Am I on TRAC and Got Transitions questionnaires) from baseline
Perceived social support
Change in social support (assessed using the NIH toolbox) from baseline
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
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
Sexual Behavior
Change in sexual behavior of risk (assessed using questions from the Youth Risk Behavior Surveillance System) from baseline
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.

Full Information

First Posted
June 13, 2023
Last Updated
October 7, 2023
Sponsor
Harvard University Faculty of Medicine
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05938803
Brief Title
PASEO Intervention for Adolescents Transitioning to Adult HIV Care in Urban Peru
Acronym
PASEO
Official Title
Community-Based Accompaniment for Adolescents Transitioning to Adult HIV Care in Urban Peru: an Evaluation of the "PASEO" Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard University Faculty of Medicine
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Adolescence, Community-based accompaniment, Retention, Antiretroviral treatment, Social support, Mental health, Treatment support, Adherence

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
No Intervention
Arm 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.
Arm Title
Intervention arm
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
PASEO
Intervention Description
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 Outcome Measure Information:
Title
Unsuccessful transition
Description
Number of people who experience death, loss to follow-up or unsuppressed viral load >200 copies/mL
Time Frame
12 months
Title
Unsuccessful transition
Description
Number of people who experience death, loss to follow-up or unsuppressed viral load >200 copies/mL
Time Frame
24 months
Secondary Outcome Measure Information:
Title
HIV-related death or loss to follow-up
Description
Time to HIV-related death or loss to follow-up
Time Frame
within 12 and 24 months
Title
Clinic visit attendance
Description
Number of scheduled visits attended, among those retained
Time Frame
12 and 24 months
Title
CD4 cell count
Description
Change in CD4 cell count from baseline
Time Frame
12 and 24 months
Title
Self-efficacy
Description
Change in self-efficacy (assessed using the NIH toolbox) from baseline
Time Frame
6, 9, 12, 24 months
Title
Transition readiness
Description
Change in transition readiness (assessed using the Am I on TRAC and Got Transitions questionnaires) from baseline
Time Frame
6, 9, 12, 24 months
Title
Perceived social support
Description
Change in social support (assessed using the NIH toolbox) from baseline
Time Frame
6, 9, 12, 24 months
Title
HIV-related stigma
Description
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
Time Frame
6, 9, 12, 24 months
Title
Social Connectedness
Description
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
Time Frame
6, 9, 12, 24 months
Title
Sexual Behavior
Description
Change in sexual behavior of risk (assessed using questions from the Youth Risk Behavior Surveillance System) from baseline
Time Frame
6, 9, 12, 24 months
Title
ART Adherence
Description
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.
Time Frame
6, 9, 12, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adolescent or young person living with HIV and aware of diagnosis 15 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alyson Nunez
Phone
617-432-5224
Email
alyson_nunez@hms.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Molly Franke, ScD
Phone
617-432-5224
Email
molly_franke@hms.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Molly Franke, ScD
Organizational Affiliation
Harvard Medical School (HMS and HSDM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Salud del Nino
City
Breña
State/Province
Lima
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lenka Kolevic, MD
Facility Name
Hospital Nacional Daniel Alcides Carrión
City
Callao
State/Province
Lima
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Castro, MD
Facility Name
Hospital Nacional Arzobispo Loayza
City
Lima
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Matos, MD
Facility Name
Hospital Nacional Hipólito Unanue
City
Lima
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Vásquez, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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