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| ID | Type | Description | Link |
|---|---|---|---|
| R21TW011327 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Fogarty International Center of the National Institute of Health | NIH |
| APIN Public Health Initiatives | UNKNOWN |
| Nigerian Institute of Medical Research | OTHER_GOV |
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The PEERNaija application will feature routine medication reminders, along with individual adherence monitoring with adherence scores, anonymized peer adherence scores (from peers attending the same clinic; social incentive), and a monthly lottery-based prize for youth with the highest adherence scores (financial incentive). The Investigators will recruit a cohort of 50 HIV-infected adolescents and young adults (AYA) to pilot the app and assess feasibility, acceptability, adoption, and preliminary efficacy of important clinical measures (including adherence and virologic suppression). The proposed study will provide important preliminary data for the role of mobile health (mHealth) platforms to harness and deliver social and financial incentives to promote adherence efforts, especially for vulnerable youth, and for a larger intervention trial evaluating this app among HIV-infected AYA in Nigeria.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Social Incentive | Other | 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. |
|
| Social Plus Financial Incentive | Other | 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." |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PeerNaija | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Recruitment rate is measured by the percentage of participants randomized relative to total trial referrals. | Baseline |
| Retention Rate | Retention rate is measured by the percentage of participants who completed the 24-week follow-up. | 24 weeks |
| Feasibility of Intervention | 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. | 24 weeks |
| Acceptability of Intervention | 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. | 24 weeks |
| Appropriateness of Intervention | 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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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aima Ahonkhai, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Martin C Were, MD, MS | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APIN Public Health Initiatives | Abuja | Nigeria | ||||
| Nigerian Institute of Medical Researd |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40776116 | Result | 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. | |
| 39761419 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. PeerNaija: All participants (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 (n=25) or a social plus financial incentive (n=25), PEER+, and be followed for 24 weeks. |
| FG001 | 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." PeerNaija: All participants (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 (n=25) or a social plus financial incentive (n=25), PEER+, and be followed for 24 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. PeerNaija: All participants (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 (n=25) or a social plus financial incentive (n=25), PEER+, and be followed for 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recruitment Rate | Recruitment rate is measured by the percentage of participants randomized relative to total trial referrals. | Posted | Count of Participants | Participants | Baseline |
|
6 months.
All serious and non-serious adverse events were collected systematically during the study period in line with the study's data collection plan. The study's definitions of adverse event and/or serious adverse event were as defined in clinicaltrials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Social Incentive | No breaches in confidentiality or other attributable adverse events occurred in the 'Social Incentive' group over the study period. |
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As a pilot, the trial recruited a small sample size. Otherwise, we have nothing to report.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Martin Were | Vanderbilt University Medical Center | (617) 319-6462 | martin.c.were@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2025 | Oct 27, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 18, 2021 | May 7, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Children's Hospital of Philadelphia |
| OTHER |
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|
| 24 weeks |
| Preliminary Efficacy of Intervention on Viral Load | Preliminary efficacy will be assessed by identifying the number of participants virally suppressed at study end (undetectable < 1000 m/ml). | 24 weeks |
| Lagos |
| Nigeria |
| 35237765 | Result | 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. |
| 37891681 | Result | 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. |
| BG001 | 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." PeerNaija: All participants (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 (n=25) or a social plus financial incentive (n=25), PEER+, and be followed for 24 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Viral Load | Mean | Standard Deviation | copies/mL |
|
| OG001 | 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." PeerNaija: 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. |
|
|
| Primary | Retention Rate | Retention rate is measured by the percentage of participants who completed the 24-week follow-up. | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Primary | Feasibility of Intervention | 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. | FIM is a validated tool; if a participant skipped any single item, their score was counted as missing and they were excluded from data analysis. | Posted | Mean | Standard Deviation | score on a scale | 24 weeks |
|
|
|
| Primary | Acceptability of Intervention | 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. | AIM is a validated tool; if a participant skipped any single item, their score was counted as missing and they were excluded from data analysis. | Posted | Mean | Standard Deviation | score on a scale | 24 weeks |
|
|
|
| Primary | Appropriateness of Intervention | 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. | The IAM is scored on a scale of 1-5 with higher scores indicating higher perceived appropriateness. IAM is a validated tool; if a participant skipped any single item, their score was counted as missing and they were excluded from data analysis. | Posted | Mean | Standard Deviation | score on a scale | 24 weeks |
|
|
|
| Primary | Preliminary Efficacy of Intervention on Viral Load | Preliminary efficacy will be assessed by identifying the number of participants virally suppressed at study end (undetectable < 1000 m/ml). | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Social Plus Financial Incentive | No breaches in confidentiality or other attributable adverse events occurred to the 'Social Plus Financial Incentive' over the study period. | 0 | 28 | 0 | 28 | 0 | 28 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |