Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-29 @ 6:22 AM
Study NCT ID:
NCT05022706
Status:
COMPLETED
Last Update Posted:
2021-08-26
First Post:
2021-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of a Transition Intervention for ALWH
Sponsor:
Harvard Medical School (HMS and HSDM)
Organization:
Study Overview
Official Title:
Accompanying HIV-positive Adolescents Through the Transition Into Adult Care: a Feasibility Study
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PASEO
Brief Summary:
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5R21AI143365-02 | NIH | None | https://reporter.nih.gov/quic… | View |