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

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04930198
• Other study ID #: 200116
• Secondary ID: R21TW011327
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: January 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 57
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 27 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Nigeria	APIN Public Health Initiatives	Abuja
Nigeria	Nigerian Institute of Medical Researd	Lagos

Sponsors (5)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	APIN Public Health Initiatives, Children's Hospital of Philadelphia, Fogarty International Center of the National Institute of Health, Nigerian Institute of Medical Research

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate	Recruitment rate is measured by the proportion of participants randomized relative to total trial referrals	Baseline
Primary	Retention Rate	Retention rate is measured by the proportion of participants who have recorded medication adherence in the PEERNaija app	24 weeks post-randomization
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.	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.	24 weeks
Primary	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.	24 weeks
Primary	Preliminary Efficacy of Intervention on Viral Load	Preliminary efficacy will be assessed by comparing change in HIV viral load (undetectable < 250 m/ml).	Baseline to 24 weeks
Primary	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.	Baseline to 24 weeks