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

NCT03516318 | Terminated

• 1 other identifier: 1151489
• Study Type: interventional
• Target: 355
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus

Keywords

HIV; Youth; Social support; Social media; Retention

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (2)

• Social support score

  12 months

• Adherence to antiretroviral treatment

  12 months

Study Arms (2)

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

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.

Interventions

SMART Connections BEHAVIORAL

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.

SMART Connections

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• FHI 360: lead
• Center for Population and Reproductive Health, University of Ibadan: collaborator

Study Sites (1)

FHI 360

Abuja, Nigeria

Location

Related Publications (1)

• 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.

  PMID: 32484444 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Lisa S Dulli, PhD

  FHI 360 (Family Health International)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 4, 2018
• Study Start: September 4, 2018
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: April 13, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

NG (1)