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Using Social Media to Improve ART Retention and Treatment Outcomes Among YLHIV in Nigeria (Y-SMART)

Primary Purpose

Human Immunodeficiency Virus

Status
Terminated
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
SMART Connections
Sponsored by
FHI 360
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Human Immunodeficiency Virus focused on measuring HIV, Youth, Social support, Social media, Retention

Eligibility Criteria

15 Years - 24 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • FHI 360

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SMART Connections

Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 24, 2018
Last Updated
April 9, 2020
Sponsor
FHI 360
Collaborators
Center for Population and Reproductive Health, University of Ibadan
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1. Study Identification

Unique Protocol Identification Number
NCT03516318
Brief Title
Using Social Media to Improve ART Retention and Treatment Outcomes Among YLHIV in Nigeria
Acronym
Y-SMART
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
Study funding ended before last round of data collection could be complete.
Study Start Date
September 4, 2018 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FHI 360
Collaborators
Center for Population and Reproductive Health, University of Ibadan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
HIV, Youth, Social support, Social media, Retention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
355 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SMART Connections
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SMART Connections
Intervention Description
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.
Primary Outcome Measure Information:
Title
12-month retention in HIV services
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Social support score
Description
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.
Time Frame
12 months
Title
Adherence to antiretroviral treatment
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa S Dulli, PhD
Organizational Affiliation
FHI 360 (Family Health International)
Official's Role
Principal Investigator
Facility Information:
Facility Name
FHI 360
City
Abuja
Country
Nigeria

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified, quantitative data on study participants will be uploaded to the USAID Development Data Library.
IPD Sharing Time Frame
Data on study participants will be shared once submission of the primary study manuscript has been completed, or no later than the end of project funding.
IPD Sharing Access Criteria
Per the Development Data website: "Data submitted to the Development Data Library (DDL) will first be made available to USAID's (United States Agency for International Development) InfoGov Permanent Working Group (see ADS 579.2.d), the Operating Unit of Origin, and to clearance officials specified in ADS 579.3.2.5. Data sets that are determined (via the clearance process in ADS 579.3.2.5) to be "Public" are listed in the DDL, and the data itself and supporting documentation are made available to the global public. Data sets that are determined via the clearance process to be "Non-Public" or "Restricted Public" (see ADS 579.3.2.4) will be listed in the DDL only. Data sets tagged as Non-Public will remain unavailable to the public. Data sets tagged as Restricted will only be made available under certain use restrictions.
IPD Sharing URL
http://www.usaid.gov/data
Citations:
PubMed Identifier
32484444
Citation
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.
Results Reference
derived

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Using Social Media to Improve ART Retention and Treatment Outcomes Among YLHIV in Nigeria

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