Using Social Media to Improve ART Retention and Treatment Outcomes Among YLHIV in Nigeria (Y-SMART)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03516318|
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : September 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus||Behavioral: SMART Connections||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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|
|Actual Study Start Date :||September 4, 2018|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||November 30, 2020|
Experimental: SMART Connections
The intervention components include:
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.
No Intervention: Control
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.
- 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.
- Social support score [ Time Frame: 12 months ]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 [ Time Frame: 12 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516318
|Contact: Lisa S Dulli, PhD||+1-919-544-7040 ext firstname.lastname@example.org|
|Contact: Catherine Packer, MSPH||+ 1-919-544-7040 ext email@example.com|
|Contact: Tosin Idaboh, MD + 234-08023282165 firstname.lastname@example.org|
|Contact: Nnamdi Ike, BS + 234-08067800424 email@example.com|
|Principal Investigator:||Lisa S Dulli, PhD||FHI 360 (Family Health International)|