Pilot Study of a Transition Intervention for ALWH (PASEO)

August 23, 2021 updated by: Molly Franke, Harvard Medical School (HMS and HSDM)

Accompanying HIV-positive Adolescents Through the Transition Into Adult Care: a Feasibility Study

The investigators will conduct a pilot study of a community-based intervention designed to improve outcomes among adolescents living with HIV (ALWH) transitioning to adult HIV care in Lima, Peru. The investigators will enroll adolescents transitioning to adult HIV care, either due to a recent diagnosis or having aged out of their pediatric clinic. ALWH previously lost from care during the transition process will also be invited to participate. The nine-month intervention will consist of (1) logistical, adherence and social support delivered by entry-level health workers who will accompany adolescents during their transition to adult HIV care and (2) group sessions to improve health-related knowledge, skills, and social support. The investigators will assess intervention feasibility and effectiveness in improving medication adherence, psycho-social outcomes, and transition readiness after 6, 9, and 12 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Adolescents living with HIV (ALWH) face an elevated risk of poor health outcomes when transitioning into adult-oriented care. Evidence-based interventions to support ALWH during this high-risk period are lacking, especially in Latin America.

The investigators will prospectively enroll adolescents living with HIV into a community-based accompaniment (CBA) intervention to assess the feasibility of the intervention to improve retention with viral load suppression. The intervention will include (a) combined antiretroviral therapy (cART) directly observed therapy (DOT) for participants at risk of or with a history of non-adherence, (b) monthly home visits by trained health promoters to assess adherence and barriers to care and provide social support, (c) ongoing support in navigating the health system, such as accompaniment to appointments and assistance enrolling in public health insurance, and (d) monthly peer support groups. The intervention activities will be delivered more frequently in an intensive phase for 6 months followed by a taper phase for 3 months. The investigators also aim to pilot study procedures relevant to a future trial, including an evaluation of new data collection tools, intervention fidelity assessments, and consent procedures.

Data collection will consist of the use of self-administered questionnaires using RedCap, focus groups with participants, and in-depth interviews with a subset of participants. To examine changes in outcomes throughout the intervention, the investigators will calculate within-person changes from baseline to 6, 9, and 12 months and will use paired t-tests or Wilcoxon signed-rank tests to test whether these quantities differ from zero. The investigators will stratify analyses by early childhood versus recent diagnosis of HIV to understand any differences in effectiveness among subgroups. Data will be analyzed using SAS version 9.4.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Peru
    • Lima
      • El Agustino, Lima, Peru, 15007
        • Hospital Nacional Hipólito Unanue
      • Lima Cercado, Lima, Peru, 15082
        • Hospital Nacional Arzobispo Loayza
      • San Borja, Lima, Peru, 15037
        • Instituto Nacional de Salud del Nino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 15 to 21
  • HIV-infected and aware of diagnosis
  • Currently on or eligible for antiretroviral therapy for HIV, including patients that are lost to treatment follow-up
  • Enrolled in HIV care at a participating public sector clinic
  • Able to provide informed assent or consent

Exclusion Criteria:

  • Living outside of Lima Province

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Adolescents living with HIV
  1. cART directly observed therapy (DOT) for participants at risk of or with a history of non-adherence
  2. monthly home visits by trained health promoters
  3. ongoing support in navigating the health system, including accompaniment to appointments and assistance enrolling in public health insurance
  4. monthly peer support groups
Other: Community-based accompaniment and home visits

Trained health promoters will accompany adolescents to their first appointments; facilitate enrollment in public health insurance and completion of other administrative requisites (e.g. obtaining a foreign identification card for migrants; transferring to a different health facility); help troubleshoot new logistical and/or social challenges; and will foster communication between the adult care providers and the patient.

Health promoters will visit the participant's home or another mutually-agreed upon location at least monthly, to review ART adherence, identify barriers to care and adherence, remind patients of upcoming medical encounters, screen and follow-up for clinical and social problems, and offer social support.

Behavioral: Directly Observed Therapy
Among adolescents who have already initiated combination antiretroviral therapy (cART), directly observed therapy (DOT) will be provided to the subset of adolescents identified as being at high risk of non-adherence, defined by meeting at least one of the following criteria: 1) identified by the pediatric health provider as having unstable adherence; or 2) having a detectable viral load at one of their two previous measurements. In adolescents newly initiating cART, there will not be an adherence precedent. This group will choose whether they wish to receive DOT. As part of this research, trained community health workers (CHWs) will deliver DOT in participant's homes or in a mutually agreed upon location. CHWs will observe ingestion of cART daily, ensure it is taken as prescribed and record each dose as DOT, self-administered, not taken or not prescribed.
Behavioral: Monthly Peer Support Groups
The investigators will assign ALWH to a social support group with 9 to 11 other adolescents also participating in the research. The goal of the social support groups is to provide a venue for participants to share experiences and resources and provide encouragement and support to one another. Each group will last approximately 3 to 4 hours. Support groups will be led by adult peers or trained community health workers. The final group session will incorporate a discussion about the group experience, how it may change behavior, recommendations for improvement, and unmet needs that should be considered for a future intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acceptability of the intervention: Study refusal rates
Time Frame: Baseline
The investigators will measure the feasibility of the intervention through acceptability quantitative analyses. These include the study refusal rates (i.e. the proportion of potentially eligible individuals for the study who chose not to participate).
Baseline
Acceptability and demand of the intervention: Intervention retention rates
Time Frame: 12 months
The investigators will calculate the intervention retention rates (i.e. the proportion of individuals who were retained in the study) to measure the acceptability and demand of the intervention.
12 months
Acceptability of the intervention: Focus groups and in-depth interviews
Time Frame: 10 months, 11 months, and 12 months
The investigators will also measure the acceptability of the intervention through qualitative analyses including focus groups and in-depth interviews. Focus groups will be conducted with the participants between month 10 and month 12 of their participation in the intervention. These discussions will explore the perception and acceptance of each component of the intervention and potential future adaptations of the study. The in-depth interviews will be carried out to complement and extend the data collected in focus groups. Open-ended questions will be asked to assess 1) how the CBA intervention was perceived and accepted in each group; 2) any adaptations that would need to be made in future studies, and 3) the varying roles of the treatment supporter during the transition.
10 months, 11 months, and 12 months
Demand of the intervention: Group attendance rates
Time Frame: 12 months
The investigators will assess demand to describe the extent to which the intervention is likely to be used. The investigators will calculate group attendance for study activities. Group attendance will be measured by the proportion of individuals who attended activities, the number of participants who attended at least one session, the median number of groups attended by participants who attended at least one session, the median number of participants per session, and the number of engagements (comments) during virtual sessions.
12 months
Evidence of effectiveness of the intervention: combined antiretroviral therapy (cART) adherence
Time Frame: Baseline, 6 months, 9 months, and 12 months
The investigators will assess the evidence of effectiveness through cART adherence. (i.e. three questions to record self-adherence). The three questions will include, "How many days did you miss at least one dose of any of your ART medications?"; "How often did you take your ART medications correctly?" (5-point scale with 5 representing "always" and 1 representing "never"); and "How well would you say you took your HIV medications, as directed by your doctor?" (6-point scale with 6 representing "excellent" and 1 representing "very bad"). The investigators will calculate the within-person change from baseline to 6, 9, and 12 months to examine changes in outcome and determine if the intervention shows promise of success.
Baseline, 6 months, 9 months, and 12 months
Evidence of effectiveness of the intervention: Psychosocial outcomes
Time Frame: Baseline, 6 months, 9 months, and 12 months
The investigators will assess the evidence of effectiveness through psychosocial outcomes including self-efficacy, quality of life, and perceived social and instrumental support. These outcomes will be measured using the NIH toolbox (version 2.0) for ages 18-85 on a 5-point ordinal scale ranging from "never" to "always", with higher scores indicating higher levels. The investigators will calculate the within-person change from baseline to 6, 9, and 12 months to examine changes in outcome and determine if the intervention shows promise of success.
Baseline, 6 months, 9 months, and 12 months
Evidence of effectiveness of the intervention: Transition readiness through "Am I on Trac?"
Time Frame: Baseline, 6 months, 9 months, and 12 months
The investigators will assess transition readiness through "Am I On TRAC?" scales, which consist of knowledge and behavior indices adapted to the local context. The knowledge scale will assess the health condition and general medical self-care of the participant. The behavior scale will measure the frequency with which participants engage in individual health-related behaviors related to transition. The investigators will report the summed score of the subscales. The investigators will calculate the within-person change from baseline to 6, 9, and 12 months to examine changes in outcome and determine if the intervention shows promise of success.
Baseline, 6 months, 9 months, and 12 months
Evidence of effectiveness of the intervention: Transition readiness through Got transition checklist
Time Frame: Baseline, 6 months, 9 months, and 12 months
The investigators will also assess transition readiness through the "Got Transition?" checklist (version 2.0). This checklist will analyze personal health knowledge and use of medical services. The questionnaire has a 3-point scale ranging from "not my responsibility" to "yes, I know this." The investigators will calculate the within-person change from baseline to 6, 9, and 12 months to examine changes in outcome and determine if the intervention shows promise of success.
Baseline, 6 months, 9 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Harvard Medical School (HMS and HSDM)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Allergy and Infectious Diseases (NIAID)
University of South Florida
Partners HealthCare
Socios En Salud Sucursal, Peru

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Molly F Franke, ScD, Harvard Medical School (HMS and HSDM)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB19-0086
  • 5R21AI143365-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The investigators will not release personal information because the small number of patients consecutively enrolled at each facility, could potentially make them identifiable, even in the absence of direct identifiers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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