HIV-1-infectionNCT05634265
Social Media for ART Adherence and Retention in Adolescents and Young Adults: the Vijana-SMART Study
A study testing Vijana-SMART in people with HIV-1-infection and Adherence, Medication, run by University of Washington at 1 site in Kenya.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 24 years
- Conditions the study is for
- HIV-1-infection, Adherence, Medication, Depression
- What is being tested?
- Vijana-SMART
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteKenya
- Study dates
- 31 Jan 2019to 14 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Living with HIV
- On ART
- Aware of HIV status
- Has access to WhatsApp
- Literate
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- HIV-1-infection, Adherence, Medication, Depression
- Being tested
- Vijana-SMART
- Medical subject headings
- Medication Adherence, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vijana-SMARTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilot | Experimental | Participants will be offered the Vijana-SMART WhatsApp group intervention Receives: Behavioral: Vijana-SMART |
What is being measured
The primary outcome is the main question the study is designed to answer.
ART information, motivation, behavioral skills
Self-reported score on abbreviated Lifewindows IMB instrument
Measured: 6 months
Social support
Self-reported score on SS-B instrument
Measured: 6 months
Stigma
Self-reported score on abbreviated ALHIV-SS instrument
Measured: 6 months
ART adherence
Self-reported score on Wilson 3-item scale
Measured: 6 months
Depression symptoms
Self-reported score on PHQ-9 scale
Measured: 6 months
Resilience
Self-reported score on abbreviated Connor-Davidson scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start31 Jan 2019
- Primary completion14 Dec 2019
- Study completion14 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group pilot
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keshet Ronen, University of Washington
- Investigators
- Keshet Ronen, PhD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634265
- Sponsor's protocol ID
- STUDY00002554
- Status last verified
- Nov 2022
- First submitted
- 21 Nov 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data will be posted to the Harvard Dataverse
Publications
Ronen K, Mugo C, Kaggiah A, Seeh D, Kumar M, Guthrie BL, Moreno MA, John-Stewart G, Inwani I. Facilitated WhatsApp Support Groups for Youth Living With HIV in Nairobi, Kenya: Single-Arm Pilot Intervention Study. JMIR Form Res. 2023 Nov 13;7:e49174. doi: 10.2196/49174.
PubMed 37955957
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Media for ART Adherence and Retention in Adolescents and Young Adults: the Vijana-SMART Study
- ClinicalTrials.gov ID
- NCT05634265
- Acronym / sponsor ID
- STUDY00002554
- Conditions
- HIV-1-infection, Adherence, Medication, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 14 Dec 2019 (actual)
- Study completion
- 14 Dec 2019 (actual)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group pilot
| Arm | Type | Receives |
|---|---|---|
| Pilot | Experimental | Behavioral: Vijana-SMARTParticipants will be offered the Vijana-SMART WhatsApp group intervention |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Living with HIV
- On ART
- Aware of HIV status
- Has access to WhatsApp
- Literate
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vijana-SMARTThe 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. | Behavioural | Pilot |
Primary outcome
ART information, motivation, behavioral skills
Time frame: 6 months
Self-reported score on abbreviated Lifewindows IMB instrument
Social support
Time frame: 6 months
Self-reported score on SS-B instrument
Stigma
Time frame: 6 months
Self-reported score on abbreviated ALHIV-SS instrument
ART adherence
Time frame: 6 months
Self-reported score on Wilson 3-item scale
Depression symptoms
Time frame: 6 months
Self-reported score on PHQ-9 scale
Resilience
Time frame: 6 months
Self-reported score on abbreviated Connor-Davidson scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Derived from this study: PubMed 37955957Ronen K, Mugo C, Kaggiah A, Seeh D, Kumar M, Guthrie BL, Moreno MA, John-Stewart G, Inwani I. Facilitated WhatsApp Support Groups for Youth Living With HIV in Nairobi, Kenya: Single-Arm Pilot Intervention Study. JMIR Form Res. 2023 Nov 13;7:e49174. doi: 10.2196/49174.
- Individual participant dataSharing planned: Yes. De-identified participant data will be posted to the Harvard Dataverse
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keshet Ronen, PhD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vijana-SMART in people with HIV-1-infection and Adherence, Medication, run by University of Washington at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ART information, motivation, behavioral skills (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05634265, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.