Adaptive Text Messaging and Non-Monetary Incentives to Sustain ART Adherence Among Adolescents Living With HIV in Ethiopia

NCT07377760 | Not Yet Recruiting DMC

• 1 other identifier: CIPHER Research Grant IAS_146
• Study Type: interventional
• Target: 327
• Locations: 1 country
• Sites: 1

Brief Summary

Many adolescents living with HIV have difficulty taking their medicine on time, which can make it less effective and affect their health. This study will test whether sending reminder text messages, combined with small rewards like school supplies, hygiene kits, or sports items, can help adolescents take their HIV medicine regularly and stay in care. Each adolescent will choose a daily habit or routine to link to their medication. We will compare two groups receiving messages and rewards to a group receiving standard care to see which approach works best. We will also ask participants about their experience with the messages and rewards. The aim is to find a simple and effective way to help adolescents living with HIV stay healthy and in care.

Conditions

Antiretroviral Therapy (ART) Adherence Among Adolescents Living With HIV

Keywords

Adolescents with HIV; ART adherence; SMS reminders; habit-based digital intervention; cue-reward system; viral suppression; Ethiopia

Outcome Measures

Primary Outcomes (1)

• Adaptive text messaging reminders combined with non-monetary incentives to improve sustained adherence to antiretroviral treatment among adolescents in Ethiopia: a hybrid effectiveness-implementation trial

  ART adherence will be measured using a multi-method composite adherence assessment tool based on previously validated measures, including self-reported adherence, pill count (PC), and retention in care (missed appointments). Self-reported adherence will be assessed through four validated yes/no questions addressing difficulties remembering medication, intentional discontinuation when feeling better or worse, and missed doses over the preceding four days. Participants will also rate their adherence over the past 30 days using a visual analogue scale (VAS) ranging from 0 (no adherence) to 10 (perfect adherence). Each adherence component will be dichotomized using established thresholds (≥95% adherence for self-report, pill count, and VAS; no missed appointments for retention in care) and assigned a score of 1 (adherent) or 0 (non-adherent). Component scores will be summed to generate a composite adherence index ranging from 0 to 3, which will be reported as a single adherence measure ca

  12 months

Secondary Outcomes (3)

• Implementation Outcomes of Adaptive SMS Reminders with Incentives for Adolescents Living with HIV

  3-12 months

• Effect of Adaptive SMS and Incentives on 12-Month Viral Suppression in Adolescents with HIV

  12 months

• Cost-Effectiveness and Cost-Utility of Adaptive SMS Reminders with Non-Monetary Incentives for Improving ART Adherence Among Adolescents with HIV

  12 months

Other Outcomes (2)

• Patient-Level Psychosocial and Behavioral Determinants of ART Adherence

  Measurement Time Points: Baseline, 3, 6, 9, and 12 months post-enrollment.

• Patient-Level Determinants and Contextual Factors

  From baseline to 12-months

Study Arms (3)

Non-adaptive reminder text messaging combined with non-monetary incentives

EXPERIMENTAL

Behavioral: Adaptive interventions; Behavioral: The control arm

Adaptive text messaging

EXPERIMENTAL

Behavioral: Non-adaptive reminder text messaging; Behavioral: The control arm

Control (standard care)

NO INTERVENTION

Interventions

The control arm BEHAVIORAL

In the control arm, all adolescents will receive the standard care as per the national guidelines (25). The standard care provided encompasses counseling, mental health support, nutritional assessment, and social and emotional support given by family, friends, and healthcare providers to adolescents diagnosed with HIV.

Adaptive text messaging; Non-adaptive reminder text messaging combined with non-monetary incentives

Non-adaptive reminder text messaging BEHAVIORAL

Non-adaptive reminder text messaging combined with non-monetary incentives versus the standard of care. Under this sub-aim, we will compare adherence levels between those who receive continuous text messaging combined with participant-preferences of daily cue and medication time.

Adaptive text messaging

Adaptive interventions BEHAVIORAL

Participants will choose a lifestyle 'cue,' as in arm 1, and receive daily, personalized text message reminders tailored to their selected cues for the first three months. After three months, adherence will be evaluated, and a non-monetary reward will be provided to both adherent and non-adherent participants. Following this, the cue reminder text messages will be discontinued for participants who achieved 95% ART adherence over the next 12-month period. However, they will receive a non-monetary reward for achieving 95% ART adherence over six months of follow-up.

Non-adaptive reminder text messaging combined with non-monetary incentives

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Consenting adolescents aged 15 to 19 who have been on ART for at least a year and want to continue treatment at the selected facility during the trial period are eligible.

You may not qualify if:

• Participants outside of the specified age range.

Sponsors & Collaborators

• Arba Minch University: lead

Study Sites (1)

Arba Minch University

Arba Minch, 21, Ethiopia

Location

Related Publications (2)

• Hernell O, Egelrud T, Olivecrona T. Serum-stimulated lipases (lipoprotein lipases). Immunological crossreaction between the bovine and the human enzymes. Biochim Biophys Acta. 1975 Feb 13;381(2):233-41.

  PMID: 46150 RESULT

• Nachega JB, Mills EJ, Schechter M. Antiretroviral therapy adherence and retention in care in middle-income and low-income countries: current status of knowledge and research priorities. Curr Opin HIV AIDS. 2010;5(1):70-7.

  RESULT

Related Links

• Related Info

Study Officials

• Degu J Dare, MD,PhD

  KNCV

  STUDY DIRECTOR

Central Study Contacts

Abayneh T Tanga, PhD

CONTACT

+251920011972; abaynehtun@yahoo.com

Dr.Desta G Galcha, MD, plastic surgery

CONTACT

kingdomfirst6@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adaptive text messaging reminders combined with non-monetary incentives to improve adherence to antiretroviral treatment among adolescents in Ethiopia: a hybrid effectiveness-implementation trial

Model Details: Adolescents living with HIV are randomly assigned to two SMS-based habit-reward interventions or a standard care control group to evaluate ART adherence, retention, and health outcomes.

Study Record Dates

• First Submitted: January 1, 2026
• First Posted: January 30, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): March 12, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

ET (1)