HIV/AIDS
Conditions
Keywords
HIV/AIDS, Sub-Saharan Africa
Brief summary
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.
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.
Interventions
BEHAVIORALPeerNaija
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.
Sponsors
Fogarty International Center of the National Institute of Health
APIN Public Health Initiatives
Nigerian Institute of Medical Research
Children's Hospital of Philadelphia
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 27 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | Baseline | Recruitment rate is measured by the percentage of participants randomized relative to total trial referrals. |
| Retention Rate | 24 weeks | Retention rate is measured by the percentage of participants who completed the 24-week follow-up. |
| Feasibility of Intervention | 24 weeks | 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. |
| Acceptability of Intervention | 24 weeks | 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. |
| Appropriateness of Intervention | 24 weeks | 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. |
| Preliminary Efficacy of Intervention on Viral Load | 24 weeks | Preliminary efficacy will be assessed by identifying the number of participants virally suppressed at study end (undetectable \< 1000 m/ml). |
Countries
Nigeria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 26 |
| 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. | 28 |
| Total | 54 |
Baseline characteristics
| Characteristic | Social Incentive | Social Plus Financial Incentive | Total |
|---|---|---|---|
| Age, Continuous | 18.3 years STANDARD_DEVIATION 2.8 | 19.2 years STANDARD_DEVIATION 3.9 | 18.8 years STANDARD_DEVIATION 3.4 |
| Baseline Viral Load | 14327.1 copies/mL STANDARD_DEVIATION 41822.3 | 6010.2 copies/mL STANDARD_DEVIATION 27266.1 | 9422.3 copies/mL STANDARD_DEVIATION 33734.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 28 Participants | 54 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Nigeria | 26 participants | 28 participants | 54 participants |
| Sex/Gender, Customized Female | 10 Participants | 14 Participants | 24 Participants |
| Sex/Gender, Customized Male | 14 Participants | 13 Participants | 27 Participants |
| Sex/Gender, Customized Unknown | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 28 |
| other Total, other adverse events | 0 / 26 | 0 / 28 |
| serious Total, serious adverse events | 0 / 26 | 0 / 28 |
Outcome results
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.
Time frame: 24 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social Incentive | Acceptability of Intervention | 4.2 score on a scale | Standard Deviation 0.6 |
| Social Plus Financial Incentive | Acceptability of Intervention | 4.0 score on a scale | Standard Deviation 0.7 |
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.
Time frame: 24 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social Incentive | Appropriateness of Intervention | 4.2 score on a scale | Standard Deviation 0.6 |
| Social Plus Financial Incentive | Appropriateness of Intervention | 4.0 score on a scale | Standard Deviation 0.8 |
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.
Time frame: 24 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social Incentive | Feasibility of Intervention | 4.0 score on a scale | Standard Deviation 0.7 |
| Social Plus Financial Incentive | Feasibility of Intervention | 4.0 score on a scale | Standard Deviation 0.7 |
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).
Time frame: 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Social Incentive | Preliminary Efficacy of Intervention on Viral Load | 16 Participants |
| Social Plus Financial Incentive | Preliminary Efficacy of Intervention on Viral Load | 18 Participants |
Primary
Recruitment Rate
Recruitment rate is measured by the percentage of participants randomized relative to total trial referrals.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Social Incentive | Recruitment Rate | 26 Participants |
| Social Plus Financial Incentive | Recruitment Rate | 28 Participants |
Primary
Retention Rate
Retention rate is measured by the percentage of participants who completed the 24-week follow-up.
Time frame: 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Social Incentive | Retention Rate | 19 Participants |
| Social Plus Financial Incentive | Retention Rate | 23 Participants |