- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04930198
PeerNaija: A Mobile Health Platform Incentivizing Medication Adherence Among Youth Living With HIV in Nigeria
Study Overview
Detailed Description
The use of digital health solutions, especially medication reminders delivered via mHealth platforms, have shown promise as adherence support tools in sub-Saharan Africa (SSA). Importantly, the proliferation of mobile phones in resource-limited settings and the early adoption of communication technologies by young people make mHealth technologies an ideal platform for this age group. The Investigators propose to pilot a novel, mHealth peer-based intervention for AYA living with HIV in Nigeria that will utilize social and financial incentives to promote medication adherence. In addition to medication reminders and peer support, the proposed intervention will innovate within the mHealth arena to leverage the currency of social incentives through daily adherence monitoring with the provision of adherence scores for individual users in relation to their peers, and financial incentives through a monthly lottery for youth with the highest adherence scores with the prize delivered through the mHealth application itself. This proposal builds on the Investigator's successful research collaborations in Nigeria with APIN Public Health Initiatives, (APIN, a multi-site non-governmental organization with solid President's Emergency Plan For AIDS Relief-funded HIV infrastructure), the investigators expertise in building capacity for implementation research, and proficiency in developing and deploying mHealth-based interventions in SSA. This will be accomplished through the following specific aim:
To establish the feasibility, acceptability, and preliminary efficacy of PEERNaija, an mHealth intervention designed to harness peer influence as an incentive to promote medication adherence among a pilot cohort of 50 AYA living with HIV in Nigeria. Hypothesis: PEERNaija will be feasible, acceptable, and show preliminary efficacy in improving antiretroviral (ART) adherence.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Abuja, Nigeria
- APIN Public Health Initiatives
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Lagos, Nigeria
- Nigerian Institute of Medical Researd
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Own a smartphone (on which they are willing to download PEERNaija),
- 16-27 years of age,
- on ART, and
- demonstrate the ability read simple text language in English.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Social Incentive
For the social incentive, the mHealth application will track the participant's individual adherence score (% of doses taken), track the top scorers (leaderboard), and provide a figure highlighting the proportion of their peers with poor (<80%), medium (80-94%), or high (>94%) adherence scores.
The display of the individual's adherence score relative to peer scores is considered a descriptive norm and is meant to portray "what most people are doing," as young people often inaccurately estimate behaviors for their peer groups.
Participants will also receive an injunctive norm, or an indication of what they ought to be doing.
This will come in the form of an emoji or congratulatory vs. motivating text for those with high or low adherence scores, respectively.
When coupled with descriptive norms, injunctive norms have counteracted regression to the mean for individuals who demonstrate desirable behaviors relative to their peers.
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All participants (anticipated N=50) will receive daily medication reminders and access to the virtual support group on the PEERNaija app.
Participants will be randomized to receive a social incentive (anticipated n=25) or a social plus financial incentive (anticipated n=25), PEER+, and be followed for 24 weeks.
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Other: Social Plus Financial Incentive
For the financial incentive, the top 5 scorers in the PEER+ arm will be eligible win a lottery prize each month of the 24 week pilot of 1000 Nigerian Naira (NGN) of "data" that can be directly loaded onto the winner's phone.
Behavioral economics theory tells us that individuals are more averse to losses than rewarded by gains, so that even incentives/prizes should be framed in terms of losses.
Accordingly, participants in the financial incentive arm will receive weekly motivating messages such as "take your dose today or you lose the chance of winning the lottery."
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All participants (anticipated N=50) will receive daily medication reminders and access to the virtual support group on the PEERNaija app.
Participants will be randomized to receive a social incentive (anticipated n=25) or a social plus financial incentive (anticipated n=25), PEER+, and be followed for 24 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Recruitment Rate
Time Frame: Baseline
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Recruitment rate is measured by the percentage of participants randomized relative to total trial referrals.
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Baseline
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Retention Rate
Time Frame: 24 weeks
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Retention rate is measured by the percentage of participants who completed the 24-week follow-up.
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24 weeks
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Feasibility of Intervention
Time Frame: 24 weeks
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Feasibility will be assessed with the Feasibility of Intervention Measure (FIM), a validated, four-item measure to determine the extent to which stakeholders believe an intervention is feasible to implement.
The FIM will assess participant's likes/dislikes of the mobile health platform, privacy/security concerns, technology barriers, usage preferences, medication compliance and reasons for non-compliance.
The FIM is scored on a scale of 1-5 with higher scores indicating higher perceived feasibility.
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24 weeks
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Acceptability of Intervention
Time Frame: 24 weeks
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Acceptability will be assessed with the Acceptability of Intervention Measure (AIM), a validated, four-item measure to determine the extent to which stakeholders believe an intervention is feasible to implement.
The AIM will assess participant's likes/dislikes of the mobile health platform, privacy/security concerns, technology barriers, usage preferences, medication compliance and reasons for non-compliance.
The AIM is scored on a scale of 1-5 with higher scores indicating higher perceived acceptability.
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24 weeks
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Appropriateness of Intervention
Time Frame: 24 weeks
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Appropriateness will be assessed with the Intervention Appropriateness Measure (IAM), a validated, four-item measure to determine the extent to which stakeholders believe an intervention is feasible to implement.
The IAM will assess participant's likes/dislikes of the mobile health platform, privacy/security concerns, technology barriers, usage preferences, medication compliance and reasons for non-compliance.
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24 weeks
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Preliminary Efficacy of Intervention on Viral Load
Time Frame: 24 weeks
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Preliminary efficacy will be assessed by identifying the number of participants virally suppressed at study end (undetectable < 1000 m/ml).
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24 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Aima Ahonkhai, MD, MPH, Massachusetts General Hospital
- Principal Investigator: Martin C Were, MD, MS, Vanderbilt University Medical Center
Publications and helpful links
General Publications
- Were MC, Pierce LJ, Idigbe I, Okonkwo P, Mbugua S, Savai S, Eliazer CL, Ahonkhai AA. Applying Gamification Principles to a Mhealth App to Support Adherence to Hiv Medication in a Resource-Limited Setting. Stud Health Technol Inform. 2025 Aug 7;329:1545-1549. doi: 10.3233/SHTI251098.
- Idigbe I, Were M, Pierce LJ, Ekelem C, Nmoh A, Gbaja-Biamila T, David A, Ejiga Q, Ogunwale J, Adetoye D, Okonkwo P, Musa Z, Downshen N, Ezechi O, Audet C, Ahonkhai AA. User-centered adaption of PEERNaija, A novel mhealth application integrating medication reminders with virtual peer support and social/financial incentives to improve medication adherence. AIDS Care. 2025 Feb;37(2):263-278. doi: 10.1080/09540121.2024.2445789. Epub 2025 Jan 6.
- Ahonkhai AA, Pierce LJ, Mbugua S, Wasula B, Owino S, Nmoh A, Idigbe I, Ezechi O, Amaral S, David A, Okonkwo P, Dowshen N, Were MC. PEERNaija: A Gamified mHealth Behavioral Intervention to Improve Adherence to Antiretroviral Treatment Among Adolescents and Young Adults in Nigeria. Front Reprod Health. 2021;3:656507. doi: 10.3389/frph.2021.656507. Epub 2021 Jul 30.
- Pierce LJ, Were MC, Amaral S, Aliyu MH, Ezechi O, David A, Idigbe I, Musa AZ, Okonkwo P, Dowshen N, Ahonkhai AA. PEERNaija-a mobile health platform incentivizing medication adherence among youth living with HIV in Nigeria: study protocol for a randomized controlled trial. Pilot Feasibility Stud. 2023 Oct 27;9(1):179. doi: 10.1186/s40814-023-01404-0.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Blood-Borne Infections
- Urogenital Diseases
- Genital Diseases
- Immune System Diseases
- Infections
- RNA Virus Infections
- Virus Diseases
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- 200116
- R21TW011327 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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