Human Immunodeficiency VirusY-SMARTNCT03516318
Using Social Media to Improve ART Retention and Treatment Outcomes Among YLHIV in Nigeria
A study testing SMART Connections in people with Human Immunodeficiency Virus, run by FHI 360 at 1 site in Nigeria.
Trial summary
A randomized control trial to test the effectiveness of a structured online support group, SMART (Social Media to improve ART Retention in Treatment) Connections, to improve retention in HIV care services among youth living with HIV (YLHIV) in Nigeria. Read more about this study
- Who is it for?
- Ages 15 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- SMART Connections
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 1 siteNigeria
- Study dates
- 4 Sep 2018to 30 Nov 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 15 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- HIV positive and know their status
- Actively on ART for less than 12 months, including newly initiating patients
- Age 15 to 24 years
- Can demonstrate basic literacy necessary to participate in online chats
Who cannot join
- Unable to attend the initial intervention group meeting for treatment participants
- Currently enrolled in another research study related to HIV service retention or ART adherence
- Critically or severely ill requiring hospitalization or such that the individual is unable to provide informed consent at the time of study recruitment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Social Media to Improve ART Retention and Treatment (SMART) Outcomes Among Youth Living With HIV (YLHIV) in Nigeria - The Youth SMART Study
A randomized control trial to test the effectiveness of a structured online support group, SMART (Social Media to improve ART Retention in Treatment) Connections, to improve retention in HIV care services among youth living with HIV (YLHIV) in Nigeria.
Read the detailed description
Study aim is to examine the effect of an online structured support group intervention (SMART Connections) designed to improve retention in HIV care services among youth ages 15-21 years living with HIV enrolled in ART services. A randomized control trial in which youth living with HIV (YLHIV) will be allocated to standard of care (control) or standard of care plus an online support group and followed for 12 months. Structured questionnaires will be administered to participants at baseline, 6 and 12 months. Clinical data will also be extracted on participants. In-depth interviews with a subset of participants and intervention implementers will be completed at the end of the intervention period. Although participants will be recruited from health facilities, the intervention is conducted "virtually," by trained facilitators, not within the health facilities.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- SMART Connections
- Keywords
- HIV, Youth, Social support, Social media, Retention
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART ConnectionsBehavioural
SMART Connections: Trained facilitators will deliver key informational messages and moderate online group discussions. The informational messages have been developed from key messages identified in each of the Positive Connections curriculum sessions. Each SMART Connections group will consist of approximately 15 to 20 YLHIV. Each online support group will begin with one in-person group meeting with the facilitator. During this meeting, participants meet one another and the facilitators. Facilitators will describe the intervention and set ground rules for participation. Ground rules will be discussed and accepted by the group members, but at a minimum, group members will be advised not to talk about what is discussed in the online group with people outside of the group.
| Study group | Role | What they receive |
|---|---|---|
| SMART Connections | Experimental | The intervention components include:
* Informational messages that reflect the content of the structured group counseling curriculum and are posted to the Facebook group wall on a regular basis for approximately 4 to 5 months
* Moderated, closed group chats in a "secret" Facebook group where YLHIV can interact with their peers and with a trained support group facilitator
* Access to a trained facilitator via Facebook Messenger for the duration of the intervention who will be able to provide information or basic counseling on ART/HIV care related issues, with referral to health care services as needed Receives: Behavioral: SMART Connections |
| Control | No intervention | All study participants, in both study arms, will receive standard services currently available to YLHIV in these facilities and communities. The services currently include: routine clinical care for HIV treatment including laboratory testing (CD4, viral load tests); active case management by community volunteers with intensive adherence support during the first 4 weeks of ART; adherence support through phone calls and SMS (short messaging service) reminders; and enhanced adherence counseling for patients with unsuppressed viral loads. |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month retention in HIV services
This main outcome is defined as the proportion of study participants retained in clinical HIV services and on treatment at 12 months after enrollment. We will abstract data from the clinic electronic medical record system on date of all visits, which are typically monthly, to ART services between enrollment and the end-line of this study.
Retention is defined as having attended a scheduled HIV clinic visit within three months of the visit date. For our primary analysis, using a survival analysis approach, we will record the dates for all scheduled clinic visits for each participant, then follow the data up to three months from the date of the last visit attended. If a participant fails to return after a scheduled visit for more than three months, the date of the missed visit will be the date of loss to follow-up recorded, unless a death or transfer of service is documented.
Measured: 12 months
Secondary outcomes (2)
Social support score
To measure social support, we will use the Medical Outcomes Study - Social Support Survey (MOS-SSS).The MOS-SSS is a 19-item scale that covers the dimensions of emotional/informational (8 items), affectionate (3 items) and tangible (4 items) social support in addition to positive social interaction (3 items), and one additional item. Each item is measured on a 4 point Likert-type scale.From the scale a total SS score is calculated by summing the items. A transformed score can be calculated for total SS or each dimension by taking the raw score (total summed score), subtracting the number of items for the score and dividing by the total possible score for those items.
Measured: 12 months
Adherence to antiretroviral treatment
Proportion of participants who are adherent to ART will be measured through self-reported measures in the structured questionnaire of treatment adherence and challenges with taking medication as prescribed. We will measure self-reported adherence using the AIDS Clinical Trials Group adherence measure (AACTG baseline: http://caps.ucsf.edu/uploads/tools/surveys/pdf/2098.4186.pdf). We will also extract viral load cell data from patient medical records to triangulate self-reported adherence. For this secondary outcome, a dichotomous variable will be created defined as adherent or not adherent (missed any doses of medication) in the prior 30 days.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start4 Sep 2018
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Why it stopped: Study funding ended before last round of data collection could be complete.
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 Human Immunodeficiency VirusStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Population and Reproductive Health, University of Ibadan
- Responsible party
- Sponsor
- Investigators
- Lisa S Dulli, PhD, Principal investigator, FHI 360 (Family Health International)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516318
- Sponsor's protocol ID
- 1151489
- Acronym
- Y-SMART
- Status last verified
- Apr 2020
- First submitted
- 24 Apr 2018
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified, quantitative data on study participants will be uploaded to the USAID Development Data Library.
Publications
Dulli L, Ridgeway K, Packer C, Murray KR, Mumuni T, Plourde KF, Chen M, Olumide A, Ojengbede O, McCarraher DR. A Social Media-Based Support Group for Youth Living With HIV in Nigeria (SMART Connections): Randomized Controlled Trial. J Med Internet Res. 2020 Jun 2;22(6):e18343. doi: 10.2196/18343.
PubMed 32484444
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Social Media to Improve ART Retention and Treatment (SMART) Outcomes Among Youth Living With HIV (YLHIV) in Nigeria - The Youth SMART Study
- ClinicalTrials.gov ID
- NCT03516318
- Acronym / sponsor ID
- Y-SMART / 1151489
- Conditions
- Human Immunodeficiency Virus
- Keywords
- HIV, Youth, Social support, Social media, Retention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study funding ended before last round of data collection could be complete.
- Enrolment
- 355 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- Center for Population and Reproductive Health, University of Ibadan
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 4 May 2018 (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.
A randomized control trial to test the effectiveness of a structured online support group, SMART (Social Media to improve ART Retention in Treatment) Connections, to improve retention in HIV care services among youth living with HIV (YLHIV) in Nigeria.
Detailed description
Study aim is to examine the effect of an online structured support group intervention (SMART Connections) designed to improve retention in HIV care services among youth ages 15-21 years living with HIV enrolled in ART services. A randomized control trial in which youth living with HIV (YLHIV) will be allocated to standard of care (control) or standard of care plus an online support group and followed for 12 months. Structured questionnaires will be administered to participants at baseline, 6 and 12 months. Clinical data will also be extracted on participants. In-depth interviews with a subset of participants and intervention implementers will be completed at the end of the intervention period. Although participants will be recruited from health facilities, the intervention is conducted "virtually," by trained facilitators, not within the health facilities.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMART Connections | Experimental | Behavioral: SMART ConnectionsThe intervention components include: * Informational messages that reflect the content of the structured group counseling curriculum and are posted to the Facebook group wall on a regular basis for approximately 4 to 5 months * Moderated, closed group chats in a "secret" Facebook group where YLHIV can interact with their peers and with a trained support group facilitator * Access to a trained facilitator via Facebook Messenger for the duration of the intervention who will be able to provide information or basic counseling on ART/HIV care related issues, with referral to health care services as needed |
| Control | No intervention | –All study participants, in both study arms, will receive standard services currently available to YLHIV in these facilities and communities. The services currently include: routine clinical care for HIV treatment including laboratory testing (CD4, viral load tests); active case management by community volunteers with intensive adherence support during the first 4 weeks of ART; adherence support through phone calls and SMS (short messaging service) reminders; and enhanced adherence counseling for patients with unsuppressed viral loads. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- HIV positive and know their status
- Actively on ART for less than 12 months, including newly initiating patients
- Age 15 to 24 years
- Can demonstrate basic literacy necessary to participate in online chats
Key exclusion criteria (3 listed)
- Unable to attend the initial intervention group meeting for treatment participants
- Currently enrolled in another research study related to HIV service retention or ART adherence
- Critically or severely ill requiring hospitalization or such that the individual is unable to provide informed consent at the time of study recruitment
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 |
|---|---|---|
| SMART ConnectionsSMART Connections: Trained facilitators will deliver key informational messages and moderate online group discussions. The informational messages have been developed from key messages identified in each of the Positive Connections curriculum sessions. Each SMART Connections group will consist of approximately 15 to 20 YLHIV. Each online support group will begin with one in-person group meeting with the facilitator. During this meeting, participants meet one another and the facilitators. Facilitators will describe the intervention and set ground rules for participation. Ground rules will be discussed and accepted by the group members, but at a minimum, group members will be advised not to talk about what is discussed in the online group with people outside of the group. | Behavioural | SMART Connections |
Primary outcome
12-month retention in HIV services
Time frame: 12 months
This main outcome is defined as the proportion of study participants retained in clinical HIV services and on treatment at 12 months after enrollment. We will abstract data from the clinic electronic medical record system on date of all visits, which are typically monthly, to ART services between enrollment and the end-line of this study. Retention is defined as having attended a scheduled HIV clinic visit within three months of the visit date. For our primary analysis, using a survival analysis approach, we will record the dates for all scheduled clinic visits for each participant, then follow the data up to three months from the date of the last visit attended. If a participant fails to return after a scheduled visit for more than three months, the date of the missed visit will be the date of loss to follow-up recorded, unless a death or transfer of service is documented.
2 secondary outcomes
Social support score
Time frame: 12 months
Adherence to antiretroviral treatment
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Study funding ended before last round of data collection could be complete.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Derived from this study: PubMed 32484444Dulli L, Ridgeway K, Packer C, Murray KR, Mumuni T, Plourde KF, Chen M, Olumide A, Ojengbede O, McCarraher DR. A Social Media-Based Support Group for Youth Living With HIV in Nigeria (SMART Connections): Randomized Controlled Trial. J Med Internet Res. 2020 Jun 2;22(6):e18343. doi: 10.2196/18343.
- Individual participant dataSharing planned: Yes. De-identified, quantitative data on study participants will be uploaded to the USAID Development Data Library.
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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.
Lisa S Dulli, PhD principal investigator
FHI 360 (Family Health International)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART Connections in people with Human Immunodeficiency Virus, run by FHI 360 at 1 site in Nigeria.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 13 Apr 2020. 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 Nigeria. 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 was stopped early (reason given: Study funding ended before last round of data collection could be complete.). Results are not available in the source record.
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?
12-month retention in HIV services (time frame: 12 months). 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 NCT03516318, 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 13 Apr 2020.