Pilot Study of a Transition Intervention for ALWH (PASEO)

Harvard Medical School (HMS and HSDM)

Status: Completed

Conditions: Treatment Adherence

Treatments: Other: Community-based accompaniment and home visits; Behavioral: Monthly Peer Support Groups; Behavioral: Directly Observed Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05022706

IRB19-0086

5R21AI143365-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 15 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Adolescents living with HIV

Experimental group

Description:

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

Treatment:

Behavioral: Directly Observed Therapy

Behavioral: Monthly Peer Support Groups

Other: Community-based accompaniment and home visits