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

Human Immunodeficiency Virus Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03516318
• Other study ID #: 1151489
• Status: Terminated
• Phase: N/A
• Start date: September 4, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: April 2020
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 355
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Intervention

Behavioral:
• SMART Connections
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.

Locations

Country	Name	City	State
Nigeria	FHI 360	Abuja

Sponsors (2)

Lead Sponsor	Collaborator
FHI 360	Center for Population and Reproductive Health, University of Ibadan

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12 months
Secondary	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.	12 months