Antiretroviral Therapy (ART) Adherence Among Adolescents Living With HIVNCT07377760
Adaptive Text Messaging and Non-Monetary Incentives to Sustain ART Adherence Among Adolescents Living With HIV in Ethiopia
A study testing Non-adaptive reminder text messaging and Adaptive interventions in people with Antiretroviral Therapy (ART) Adherence Among Adolescents Living With HIV, run by Arba Minch University at 1 site in Ethiopia.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 19 years
- Conditions the study is for
- Antiretroviral Therapy (ART) Adherence Among Adolescents Living With HIV
- What is being tested?
- Non-adaptive reminder text messaging and Adaptive interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 1 siteEthiopia
- Study dates
- 9 Mar 2026to 15 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Participants outside of the specified age range.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr.Desta G Galcha, MD, plastic surgery contact
Ethiopia1 site
Arba Minch University
Arba Minch, 21
Abayneh Tanga, 0920011972, abaynehtun@yahoo.com
About this study
Official title: Adaptive Text Messaging Reminders Combined With Non-monetary Incentives to Improve Adherence to Antiretroviral Treatment Among Adolescents Living With HIV in Ethiopia: a Hybrid Effectiveness-implementation Trial
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.
- Being tested
- Non-adaptive reminder text messaging, Adaptive interventions, The control arm
- Keywords
- Adolescents with HIV, ART adherence, SMS reminders, habit-based digital intervention, cue-reward system, viral suppression, Ethiopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-adaptive reminder text messagingBehavioural
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 interventionsBehavioural
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.
The control armBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-adaptive reminder text messaging combined with non-monetary incentives | Experimental | Not described Receives: Behavioral: Adaptive interventions; Behavioral: The control arm |
| Adaptive text messaging | Experimental | Not described Receives: Behavioral: Non-adaptive reminder text messaging; Behavioral: The control arm |
| Control (standard care) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (3)
Implementation Outcomes of Adaptive SMS Reminders with Incentives for Adolescents Living with HIV
Implementation Outcomes: The delivery, uptake, and integration of the adaptive SMS reminder and non-monetary incentive intervention will be evaluated by assessing six key implementation outcomes: acceptability, feasibility, fidelity, adoption/uptake, penetration/reach, and sustainability/maintenance.
Description of Outcome Measures:
Acceptability: Measured using the validated Acceptability of Intervention Measure (AIM) and supplemented with in-depth qualitative interviews with participants regarding the intervention's content, timing, and incentives. Assessment timepoints: 3, 6, 9, and 12 months.
Feasibility: Evaluated through digital logs of SMS delivery, records of incentive distribution, and semi-structured interviews with clinic staff to identify barriers, facilitators, and ease of implementation. Formally assessed at 6 and 12 months, with continuous process monitoring.
Fidelity: Assessed by comparing the planned intervention protocol
Measured: 3-12 months
Effect of Adaptive SMS and Incentives on 12-Month Viral Suppression in Adolescents with HIV
The proportion of adolescents living with HIV who maintain a viral load below 1,000 copies/mL at the 12-month study visit, assessed as the primary clinical effectiveness outcome of the adaptive SMS and incentive intervention
Measured: 12 months
Cost-Effectiveness and Cost-Utility of Adaptive SMS Reminders with Non-Monetary Incentives for Improving ART Adherence Among Adolescents with HIV
This study will perform a comprehensive economic evaluation from both healthcare system and societal perspectives. The analysis will compare the incremental costs and health outcomes of the combined adaptive SMS reminder and non-monetary incentive intervention against the standard of care. Cost-effectiveness will be assessed as the incremental cost per additional adolescent achieving sustained ART adherence. Cost-utility will be measured as the incremental cost per Quality-Adjusted Life Year (QALY) gained, with health utilities derived from the EQ-5D-Y/3L instrument administered at baseline, 6, and 12 months. We will calculate Incremental Cost-Effectiveness Ratios (ICERs) and conduct sensitivity analyses to assess uncertainty. A budget impact analysis will model the financial consequences of potential scale-up.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start9 Mar 2026 (estimated)
- Primary completion12 Mar 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Antiretroviral Therapy (ART) Adherence Among Adolescents Living With HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 327 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arba Minch University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abayneh Tunje Tanga, Arba Minch University
- Investigators
- Degu J Dare, MD,PhD, Study director, KNCV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377760
- Sponsor's protocol ID
- CIPHER Research Grant IAS_146
- Status last verified
- Jan 2026
- First submitted
- 1 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 46150Nachega 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 Jan;5(1):70-7. doi: 10.1097/COH.0b013e328333ad61.
PubMed 20046150
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Text Messaging Reminders Combined With Non-monetary Incentives to Improve Adherence to Antiretroviral Treatment Among Adolescents Living With HIV in Ethiopia: a Hybrid Effectiveness-implementation Trial
- ClinicalTrials.gov ID
- NCT07377760
- Acronym / sponsor ID
- CIPHER Research Grant IAS_146
- Keywords
- Adolescents with HIV, ART adherence, SMS reminders, habit-based digital intervention, cue-reward system, viral suppression, Ethiopia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 327 participants (estimated)
- Lead sponsor
- Arba Minch UniversityUniversity, hospital or other
- Study start
- 9 Mar 2026 (estimated)
- Primary completion
- 12 Mar 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants outside of the specified age range.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-adaptive reminder text messagingNon-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. | Behavioural | Adaptive text messaging |
| Adaptive interventionsParticipants 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. | Behavioural | Non-adaptive reminder text messaging combined with non-monetary incentives |
| The control armIn 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. | Behavioural | Adaptive text messaging, Non-adaptive reminder text messaging combined with non-monetary incentives |
Primary outcome
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
Time frame: 12 months
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
3 secondary outcomes
Implementation Outcomes of Adaptive SMS Reminders with Incentives for Adolescents Living with HIV
Time frame: 3-12 months
Effect of Adaptive SMS and Incentives on 12-Month Viral Suppression in Adolescents with HIV
Time frame: 12 months
Cost-Effectiveness and Cost-Utility of Adaptive SMS Reminders with Non-Monetary Incentives for Improving ART Adherence Among Adolescents with HIV
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Results publication: PubMed 46150Hernell 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.
- Results publication: PubMed 20046150Nachega 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 Jan;5(1):70-7. doi: 10.1097/COH.0b013e328333ad61.
- Related InfoLink provided by the sponsor.
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BEYOND Study: Improving HIV Treatment and Well-Being Among Young MSM in Vietnam
HIV Infections, Mental Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr.Desta G Galcha, MD, plastic surgery contact
Degu J Dare, MD,PhD study director
KNCV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-adaptive reminder text messaging and Adaptive interventions in people with Antiretroviral Therapy (ART) Adherence Among Adolescents Living With HIV, run by Arba Minch University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abayneh T Tanga, PhD (+251920011972, abaynehtun@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07377760, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.