Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Single-blind, Randomized, Parallel Design Study to Assess the Effectiveness of SMS Reminders in Improving ART Adherence Among Adolescents Living With HIV in Nigeria (STARTA Trial-Adolescents)
Brief Summary: The non-maintenance of ART adherence is a major barrier to the achievement of optimal treatment outcomes among adolescents living with HIV. ART adherence is a challenge among adolescents living with HIV because of lack of appropriate information, their unique emotional state and lifestyles but the most commonly quoted challenge to adherence is forgetting to take antiretroviral drugs. There is evidence to suggest that short message service (SMS) reminder- interventions may enhance drug compliance among adolescents living with other chronic diseases such as asthma and diabetes. Available literature underscores the need for randomized controlled trials (RCTs) of effective interventions to promote ART adherence among adolescents with HIV.

The aim of this study is to evaluate the feasibility, acceptability, and efficacy of interactive and tailored SMS reminders on ART adherence among adolescents (15-19 years) living with HIV in Ogun State, Nigeria. The study hypothesizes that the use of personal mobile phones and SMS reminders for the improvement of ART adherence among adolescents living with HIV are feasible, acceptable, and effective.

A single-blind, parallel-design (ratio 1:1), and multi-center RCT of 230 adolescent living with HIV who are non-adherent to medications will be conducted over a one-year period in Southwest Nigeria. All the participants will receive routine adherence counseling during clinic visits and one SMS reminder each for follow-up appointments 48 hours and 24 hours before the follow-up visit date. The intervention group will also receive daily ART adherence reminder SMS. Participants will be assessed at baseline and during follow-up visits at 4, 8, 12, 16 and 20 weeks after the baseline. Baseline assessment of participants will include socio-demographic characteristics; HIV/AIDS risk behaviour assessment, Alcohol and Drug abuse assessment, Client Satisfaction Survey, ART adherence assessment, CD4count and viral load assessments. ART adherence and client satisfaction will be assessed at each follow-up visit while CD4count and viral load assessments will be done at baseline and at 20th week.

It is possible that tailored SMS reminders will mitigate the barrier of forgetfulness in ART-adherence and lead to improved drug compliance, viral suppression, and quality of life among adolescents living with HIV.


Options:
A: Arm Label: Control Arm; Type: ACTIVE_COMPARATOR; Interventions: Other: Standard of Care Treatment | Arm Label: Mobile Health Messaging Arm; Type: EXPERIMENTAL; Interventions: Behavioral: Mobile Health Messaging application, Other: Standard of Care Treatment | Arm Label: Focus Group Arm; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Mobile Health Messaging application; Assigned to Arm(s): Mobile Health Messaging Arm | Intervention Type: OTHER; Name: Standard of Care Treatment; Assigned to Arm(s): Control Arm, Mobile Health Messaging Arm
B: Arm Label: Intervention Group; Type: EXPERIMENTAL; Interventions: Other: Automated text and voice messages | Arm Label: Control Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Automated text and voice messages; Assigned to Arm(s): Intervention Group
C: Arm Label: Standard of Care (SoC); Type: NO_INTERVENTION; Interventions: N/A | Arm Label: SoC + iTab; Type: ACTIVE_COMPARATOR; Interventions: Device: SoC + iTab | Intervention Type: DEVICE; Name: SoC + iTab; Assigned to Arm(s): SoC + iTab
D: Arm Label: Intervention group; Type: EXPERIMENTAL; Interventions: Behavioral: Daily ART-adherence SMS reminder, Behavioral: Standard Adherence Counselling/Patient experience group chat | Arm Label: Control group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard Adherence Counselling/Patient experience group chat | Intervention Type: BEHAVIORAL; Name: Daily ART-adherence SMS reminder; Assigned to Arm(s): Intervention group | Intervention Type: BEHAVIORAL; Name: Standard Adherence Counselling/Patient experience group chat; Assigned to Arm(s): Control group, Intervention group

Answer: D