Acceptability, Feasibility and Effectiveness of Online Peer Support Group for ART Adherence Among Youth

NCT05688709 | Unknown

• 1 other identifier: DRCUganda
• Study Type: interventional
• Target: 488
• Locations: 1 country
• Sites: 3

Brief Summary

In Uganda, Youth living with HIV/AIDS (YLHIVA) enrolled in HIV treatment experience suboptimal treatment adherence and have lower viral load suppression (VLS) rates compared to younger children or adults. VLS is essential in reducing AIDS related morbidity and mortality yet AIDS-related deaths remain high among YLHIVA. To improve these poor outcomes, there has been an effort by Ministry of Health Uganda (MoH) to prioritize and scale up new adolescent and youth-targeted models of service delivery. "Peer support" increasingly forms part of adolescent and youth-responsive service packages as a class of implementation strategies that can support adolescents to access, engage, and sustain treatment. However, peer support activities in Uganda occur face to face at health care settings(2). This approach presents structural limitations such as the need to travel or schedule an appointment, inconvenient working hours and inadequate safe space for peer support activities. Thus, peer support services may not be readily available at the time when youth need them. With the rapid increase in mobile phone availability among Ugandan youth, online peer support groups (PSGs) have the potential to help YLHIVA access regular support without significant effort or cost. The rollout of online PSGs among YLHIVA in Uganda requires evidence on there acceptability feasibility and effectiveness. Aim: The aim of this study is to explore a WhatsApp peer support group as a strategy to improve ART adherence care among youth aged 15-24 years in Kampala district. Methods: The study will use a mixed methods approach. It will be conducted in two phases; first a formative phase to refine the aspects of the WhatsApp peer support group. These findings will then guide the design and implementation of the second phase; an RCT to assess the acceptability, feasibility and effectiveness of WhatsApp PSG as strategy to improve ART adherence among YLHIVA in Kampala. The RCT is a multicentre, open label assessor-blind, with balanced randomisation (1:1) parallel group superiority trial. Study participants randomized to the control arm will remain on the current standard of care only, while those in the intervention arm will be enrolled on a WhatsApp PSG and receive the current standard. Data will be collected using structured questionnaires, Key Informant Interviews, focus group discussions and in-depth interviews. Quantitative data will be analysed using summary statistics, logistic regression models, generalized linear models and Generalized Estimating Equations while for the qualitative verbatim transcription and thematic analysis will be used. Utility: The study findings will help to advance the knowledge on virtual support as a peer support model in Uganda.

Conditions

HIV Disease Progression

Outcome Measures

Primary Outcomes (1)

• ART adherence

  ART adherence defined as an adherence score of ≥ 95% calculated from the number of pills taken divided by the total number of pills expected to have been taken determined using self-reports\[18\]. We will calculate the proportion of youth who adhere to treatment from the number of youth with an adherence score of ≥ 95% divided by the total the number of youth enrolled in the study for each study arm at the specified time points

  Six months

Secondary Outcomes (3)

• Stigma,

  Six months

• adherence self-efficacy

  Six months

• depression

  Six months

Study Arms (2)

Control group

ACTIVE COMPARATOR

Psychosocial services (PSS) are offered by a trained health worker in a designated space within the health facility. They assess youth for PSS needs and depending on the identified needs, health workers determine the relevant approach for providing PSS. Health workers refer PSS they cannot offer to established referral networks. Specifically, for ART adherence, health workers use the 5As principles to offer adherence psychosocial support. These are; * Assess patient psychosocial concerns and needs that may hinder adherence to ART. * Advise on the benefits of disclosure and support systems to adherence. * Assist patients identify the support systems that will enable them to adhere to treatment. * Agree on family and community support systems (expert client in the community). * Arrange for the patient to join psychosocial support groups and use support systems.

Behavioral: WhatsApp peer support group

Intervention

EXPERIMENTAL

In addition to MOH standard care, we will enrol YLHIVA on a WhatsApp PSG and assign them trained peer counsellors. We will allocate YLHIVA to a WhatsApp group depending on their age and the health facility where they seek care (12). YLHIVA will interact with each other and their peer counsellors through one-on-one private communications and on the group chat.

Behavioral: WhatsApp peer support group

Interventions

WhatsApp peer support group BEHAVIORAL

YLHIVA assigned to the WhatsApp group will interact with each other and their peer counsellors through one-on-one private communications and on the group chat. The group chat will allow YLHIVA to ask questions, post comments, and reply to one another at any time. We shall share education videos once a week at a time agreed upon with study participants to optimize assimilation of information. In addition, peer counsellor will engage in private WhatsApp calls with youth once a week, to monitor psychosocial state, medication adherence, identify barriers to adherence and counsel YLHIVA. However, youth may initiate in more private communications' when need arises. The peer counsellor will also engage with YLHIVA daily through WhatsApp messages. We will tailor the messages to young people's treatment schedules, clinic appointments, and psychosocial state. Again, youth may text a peer counsellor whenever they wish to do so.

Control group; Intervention

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• YLHIVA aged 15-24 years seeking services at the study sites during the study period.
• YLHIVA who know their status
• Own a phone with at least android 4.3
• Demonstrated ability to understand basic on-line charts and English

You may not qualify if:

• Currently enrolled in another research study related to HIV service retention or ART adherence.
• Severely ill requiring hospitalization or such that the individual cannot provide informed consent at the time of study recruitment.
• Attending a boarding school where access to phones is prohibited.

Sponsors & Collaborators

• Infectious Diseases Research Collaboration, Uganda: lead
• Makerere University: collaborator

Study Sites (3)

Kiswa HCIV

Kampala, Bugolobi, 256, Uganda

RECRUITING

Komamboga HCIII

Kampala, Kawempe Division, 256, Uganda

RECRUITING

Kawala HCIV

Kampala, Lubaga Division, 256, Uganda

RECRUITING

Study Officials

• Yerusa Ms Kiirya, Masters

  Makerere University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yerusa Ms Kiirya, Masters

CONTACT

773963245; ykiirya@gmail.com

Anne Ms Katahoire, PhD

CONTACT

772723729; anne.ruhweza.katahoire@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is an open-assessor blinded study-we will not blind study participants and staff to treatment arms after the point of randomization except for the outcome assessors.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ms

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 18, 2023
• Study Start: August 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

UG (3)