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PeerNaija: A Mobile Health Platform Incentivizing Medication Adherence Among Youth Living With HIV in Nigeria

Primary Purpose

HIV/AIDS

Status
Recruiting
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
PeerNaija
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV/AIDS focused on measuring HIV/AIDS, Sub-Saharan Africa

Eligibility Criteria

16 Years - 27 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • APIN Public Health Initiatives
  • Nigerian Institute of Medical ReseardRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Social Incentive

Social Plus Financial Incentive

Arm Description

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.

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."

Outcomes

Primary Outcome Measures

Recruitment Rate
Recruitment rate is measured by the proportion of participants randomized relative to total trial referrals
Retention Rate
Retention rate is measured by the proportion of participants who have recorded medication adherence in the PEERNaija app
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.
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.
Adoption of Intervention
Adoption 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
Preliminary efficacy will be assessed by comparing change in HIV viral load (undetectable < 250 m/ml).
Preliminary Efficacy of Intervention on Medication Adherence
Preliminary efficacy will be assessed by comparing change in medication adherence. Thresholds for medication adherence thresholds for ART adherence will be defined as optimal (>94%), suboptimal (80-94%), and poor (<80%) over a 1-month period.

Secondary Outcome Measures

Full Information

First Posted
May 25, 2021
Last Updated
October 3, 2022
Sponsor
Vanderbilt University Medical Center
Collaborators
Fogarty International Center of the National Institute of Health, APIN Public Health Initiatives, Nigerian Institute of Medical Research, Children's Hospital of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT04930198
Brief Title
PeerNaija: A Mobile Health Platform Incentivizing Medication Adherence Among Youth Living With HIV in Nigeria
Official Title
PeerNaija: A Mobile Health Platform Incentivizing Medication Adherence Among Youth Living With HIV in Nigeria
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
Fogarty International Center of the National Institute of Health, APIN Public Health Initiatives, Nigerian Institute of Medical Research, Children's Hospital of Philadelphia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
HIV/AIDS, Sub-Saharan Africa

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Social Incentive
Arm Type
Other
Arm Description
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.
Arm Title
Social Plus Financial Incentive
Arm Type
Other
Arm Description
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."
Intervention Type
Behavioral
Intervention Name(s)
PeerNaija
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment Rate
Description
Recruitment rate is measured by the proportion of participants randomized relative to total trial referrals
Time Frame
Baseline
Title
Retention Rate
Description
Retention rate is measured by the proportion of participants who have recorded medication adherence in the PEERNaija app
Time Frame
24 weeks post-randomization
Title
Feasibility of Intervention
Description
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.
Time Frame
24 weeks
Title
Acceptability of Intervention
Description
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.
Time Frame
24 weeks
Title
Adoption of Intervention
Description
Adoption 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
Title
Preliminary Efficacy of Intervention on Viral Load
Description
Preliminary efficacy will be assessed by comparing change in HIV viral load (undetectable < 250 m/ml).
Time Frame
Baseline to 24 weeks
Title
Preliminary Efficacy of Intervention on Medication Adherence
Description
Preliminary efficacy will be assessed by comparing change in medication adherence. Thresholds for medication adherence thresholds for ART adherence will be defined as optimal (>94%), suboptimal (80-94%), and poor (<80%) over a 1-month period.
Time Frame
Baseline to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
27 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aima Ahonkhai, MD, MPH
Phone
+1 (615)875-5111
Email
aimalohi.a.ahonkhai@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Leslie Pierce, MPH
Phone
+1 (615)875-4209
Email
leslie.pierce@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aima Ahonkhai, MD, MPH
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Were, MD, MS
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
APIN Public Health Initiatives
City
Abuja
Country
Nigeria
Individual Site Status
Active, not recruiting
Facility Name
Nigerian Institute of Medical Researd
City
Lagos
Country
Nigeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Ezechi, FWACS, PhD
Phone
+2348033065683
Email
oezechi@nimr.gov.ng

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

PeerNaija: A Mobile Health Platform Incentivizing Medication Adherence Among Youth Living With HIV in Nigeria

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