An interventional study of PeerNaija in HIV/AIDS, sponsored by Vanderbilt University Medical Center. Completed at 2 sites in Nigeria. Open to participants aged 16 Years to 27 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Supportive care
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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Inclusion Criteria:
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.
Behavioral: PeerNaija
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."
Behavioral: 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.
Recruitment Rate
Recruitment rate is measured by the percentage of participants randomized relative to total trial referrals.
Time frame: Baseline
Retention Rate
Retention rate is measured by the percentage of participants who completed the 24-week follow-up.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 24 weeks
| Milestone | Social Incentive | Social Plus Financial Incentive |
|---|---|---|
| Started | 26 | 28 |
| Completed | 19 | 23 |
| Not completed | 7 | 5 |
Recruitment rate is measured by the percentage of participants randomized relative to total trial referrals.
| Participants | Social Incentive | Social Plus Financial Incentive |
|---|---|---|
| Recruitment Rate | 26 | 28 |
Retention rate is measured by the percentage of participants who completed the 24-week follow-up.
| Participants | Social Incentive | Social Plus Financial Incentive |
|---|---|---|
| Retention Rate | 19 | 23 |
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.
| score on a scale | Social Incentive | Social Plus Financial Incentive |
|---|---|---|
| Feasibility of Intervention | 4.0 ± 0.7 | 4.0 ± 0.7 |
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.
| score on a scale | Social Incentive | Social Plus Financial Incentive |
|---|---|---|
| Acceptability of Intervention | 4.2 ± 0.6 | 4.0 ± 0.7 |
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.
| score on a scale | Social Incentive | Social Plus Financial Incentive |
|---|---|---|
| Appropriateness of Intervention | 4.2 ± 0.6 | 4.0 ± 0.8 |
Preliminary efficacy will be assessed by identifying the number of participants virally suppressed at study end (undetectable \< 1000 m/ml).
| Participants | Social Incentive | Social Plus Financial Incentive |
|---|---|---|
| Preliminary Efficacy of Intervention on Viral Load | 16 | 18 |
Collected over 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Social Incentive | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Social Plus Financial Incentive | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
| Age, Continuous(years) | Social Incentive | Social Plus Financial Incentive | Total |
|---|---|---|---|
| Mean | 18.3 ± 2.8 | 19.2 ± 3.9 | 18.8 ± 3.4 |
| Sex/Gender, Customized(Participants) | Social Incentive | Social Plus Financial Incentive | Total |
|---|---|---|---|
| Male | 14 | 13 | 27 |
| Female | 10 | 14 | 24 |
| Unknown | 2 | 1 | 3 |
| Race (NIH/OMB)(Participants) | Social Incentive | Social Plus Financial Incentive | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 26 | 28 | 54 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Social Incentive | Social Plus Financial Incentive | Total |
|---|---|---|---|
| Nigeria | 26 | 28 | 54 |
| Baseline Viral Load(copies/mL) | Social Incentive | Social Plus Financial Incentive | Total |
|---|---|---|---|
| Mean | 14327.1 ± 41822.3 | 6010.2 ± 27266.1 | 9422.3 ± 33734.7 |
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Acquired Immunodeficiency Syndrome→
Vanderbilt University Medical Center