Trial Outcomes & Findings for The Effectiveness of SMS in Improving Antiretroviral Medication Adherence Among Adolescents Living With HIV in Nigeria (NCT NCT03394391)

Participants were recruited while attending routine clinic visits across five (5) high patient-density ART sites in 2 States in South West, Nigeria over a 13 week period.

There was no significant event.

The Effectiveness of SMS in Improving Antiretroviral Medication Adherence Among Adolescents Living With HIV in Nigeria

ART adherence is assessed by different well-validated methods. In this study, ART adherence will be measured, primarily, using the self-report visual analog scale. The scale is well-validated, self-report of the level of ART adherence with a range from 0 to 100%. While higher values indicate better levels of adherence, patients with adherence levels of 95% and above are regarded as ART-adherent while those with values less than 95% are not adherent to ART medications. Viral load is the number of copies of viral RNA detected in participants' blood. Participants with viral load \</=20 copies per ml are regarded to have optimal viral suppression indicative of optimal adherence to medications.

AIDS Clinical Trials Group Scale scores range from 0 to 1. The higher scores reflect better ART adherence Pill count scores also range from 0 to 1 and the higher scores also reflect better adherence. Visual analog scale \[VAS\] adherence ranges between 0 and 100%. Higher scores reflect better ART adherence

Viral load count is measured in copies per ml. The minimum value is 0. There is no maximum value. The higher values reflect poor adherence

log of viral load count is log 10 transformation of the viral load values

Patient satisfaction will be assessed using a 22-item adaptation of the SERVQUAL tool. It is a multi-dimensional service quality assessment tool that uses a 5-point likert scale scored from 1 to 5 points to assess 5 domains of client satisfaction. The domains are tangibility (4 items; scores from 4 to 20), reliability (5 items; scores from 5 to 25), responsiveness (4 items; scores from 4 to 20), assurance (4 items; scores from 4 to 20), and empathy (5 items; scores from 5 to 25). Patient satisfaction is measured by the total score which will range between 22 and 110. Higher scores indicate better client satisfaction.

The General Health Questionnaire 12 (GHQ12) will be used to assess the mental health status of all the participants. It is a well-validated and widely used instrument for screening for mental health distress. It is a 12-item questionnaire that is based on a 4-point likert scale scored from 0 to 3 points. The scores will range between 0 and 36. A score of 12 or more is suggestive of mental distress while scores less than 12 suggest that mental distress is absent.