Clinical trial NCT05022706: Pilot Study of a Transition Intervention for ALWH
Official title: Accompanying HIV-positive Adolescents Through the Transition Into Adult Care: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment Adherence
Keywords: adolescents
social support
differentiated care
HIV care continuum
key and vulnerable populations
Lead sponsor: Harvard Medical School (HMS and HSDM)
Sponsor class: OTHER
Collaborators: name: University of South Florida
name: Partners HealthCare
name: Socios En Salud Sucursal, Peru
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2021-08-26
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of the intervention: Study refusal rates
timeFrame: Baseline
measure: Acceptability and demand of the intervention: Intervention retention rates
timeFrame: 12 months
measure: Acceptability of the intervention: Focus groups and in-depth interviews
timeFrame: 10 months, 11 months, and 12 months
measure: Demand of the intervention: Group attendance rates
timeFrame: 12 months
measure: Evidence of effectiveness of the intervention: combined antiretroviral therapy (cART) adherence
timeFrame: Baseline, 6 months, 9 months, and 12 months
measure: Evidence of effectiveness of the intervention: Psychosocial outcomes
timeFrame: Baseline, 6 months, 9 months, and 12 months
measure: Evidence of effectiveness of the intervention: Transition readiness through "Am I on Trac?"
timeFrame: Baseline, 6 months, 9 months, and 12 months
measure: Evidence of effectiveness of the intervention: Transition readiness through Got transition checklist
timeFrame: Baseline, 6 months, 9 months, and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: El Agustino
country: Peru
facility: Hospital Nacional Hipólito Unanue
state: Lima
city: Lima Cercado
country: Peru
facility: Hospital Nacional Arzobispo Loayza
state: Lima
city: San Borja
country: Peru
facility: Instituto Nacional de Salud del Nino
state: Lima
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Molly F Franke, ScD
role: PRINCIPAL_INVESTIGATOR
References: