Pilot Study of a Transition Intervention for ALWH

NCT ID: NCT05022706

Last Updated: 2021-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-07
• Study Completion Date: 2021-01-31

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.

Conditions

Treatment Adherence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Community-based accompaniment and home visits

Intervention Type: OTHER

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.

Directly Observed Therapy

Intervention Type: BEHAVIORAL

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.

Monthly Peer Support Groups

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of South Florida

OTHER

Sponsor Role: collaborator

Partners HealthCare

OTHER

Sponsor Role: collaborator

Socios En Salud Sucursal, Peru

OTHER

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: lead

Responsible Party

Molly Franke

Associate Professor of Global Health and Social Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Molly F Franke, ScD

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School (HMS and HSDM)

Locations

Hospital Nacional Hipólito Unanue

El Agustino, Lima region, Peru

Hospital Nacional Arzobispo Loayza

Lima Cercado, Lima region, Peru

Instituto Nacional de Salud del Nino

San Borja, Lima region, Peru

Countries

Peru

Other Identifiers

5R21AI143365-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB19-0086

Identifier Type: -

Identifier Source: org_study_id