- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05634265
Social Media for ART Adherence and Retention in Adolescents and Young Adults: the Vijana-SMART Study
November 21, 2022 updated by: Keshet Ronen, University of Washington
The goal of this study is to investigate whether a virtual peer support group improves ART knowledge, adherence, and mental health in youth living with HIV in Kenya.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Adolescents and young adults (AYA) living with HIV show lower ART adherence, higher loss to follow-up and higher AIDS-related mortality than other age groups.
Innovative approaches are needed that address AYA's unique needs and improve their adherence and retention in HIV care.
There is evidence that peer support and mobile messaging with healthcare workers (HCW) are two strategies that may be effective in this group, but their evaluation has been limited and no interventions have combined them.
Since 2014, youth-run virtual support groups have spontaneously started at HIV clinics, using the mobile social media application WhatsApp.
These groups present valuable case studies from which the proposed project will develop a structured social media intervention that combines peer and HCW support to improve ART adherence and retention, guided by the preferences of AYA.
The SPECIFIC AIMS are to (1) Characterize the existing WhatsApp groups through in-depth interviews with members and detailed content analysis of the group's communications during a 6-week observation period.
This will define the elements and features desired by AYA in a social media intervention.
(2) Guided by findings from Aim 1, behavioral theory, and the study team's ongoing research on mobile messaging to improve ART adherence, to develop and refine structured content for a reproducible WhatsApp intervention that incorporates peer and HCW interaction.
(3) Pilot the structured intervention for 6 months in another clinic and evaluate its impact on intermediate outcomes ART knowledge, depression and stigma.
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Nairobi, Kenya
- Kayole
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 24 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Living with HIV
- On ART
- Aware of HIV status
- Has access to WhatsApp
- Literate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pilot
Participants will be offered the Vijana-SMART WhatsApp group intervention
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The Vijana-SMART intervention is a facilitated peer group, delivered through WhatsApp.
Intervention messages were developed based on findings from formative interviews and social support theory, which posits that individuals experience social support through informational, instrumental, companionship and emotional forms.
Groups will have approximately 25 members and will be facilitated by a study team member, by sending weekly scheduled messages, answering participant questions, and encouraging group discussion.
Intervention messages were designed based on guidance from formative interviews; topics include ART adherence, medication side effects, nutritional practices, depression, social support, HIV status disclosure, stigma, positive prevention, substance use, and contraception.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ART information, motivation, behavioral skills
Time Frame: 6 months
|
Self-reported score on abbreviated Lifewindows IMB instrument
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6 months
|
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Social support
Time Frame: 6 months
|
Self-reported score on SS-B instrument
|
6 months
|
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Stigma
Time Frame: 6 months
|
Self-reported score on abbreviated ALHIV-SS instrument
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6 months
|
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ART adherence
Time Frame: 6 months
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Self-reported score on Wilson 3-item scale
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6 months
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Depression symptoms
Time Frame: 6 months
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Self-reported score on PHQ-9 scale
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6 months
|
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Resilience
Time Frame: 6 months
|
Self-reported score on abbreviated Connor-Davidson scale
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Keshet Ronen, PhD, MPH, University of Washington
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 31, 2019
Primary Completion (Actual)
December 14, 2019
Study Completion (Actual)
December 14, 2019
Study Registration Dates
First Submitted
November 21, 2022
First Submitted That Met QC Criteria
November 21, 2022
First Posted (Actual)
December 2, 2022
Study Record Updates
Last Update Posted (Actual)
December 2, 2022
Last Update Submitted That Met QC Criteria
November 21, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00002554
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
De-identified participant data will be posted to the Harvard Dataverse
IPD Sharing Time Frame
Upon publication of results
IPD Sharing Access Criteria
Data may not be used for profit
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.