Clinical trial NCT04930198: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: HIV/AIDS
Sub-Saharan Africa
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
name: APIN Public Health Initiatives
name: Nigerian Institute of Medical Research
name: Children's Hospital of Philadelphia
First posted: 2021-06-18
Enrollment: 57
Sex: ALL
Minimum age (years): 16
Maximum age (years): 27
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Recruitment Rate
timeFrame: Baseline
measure: Retention Rate
timeFrame: 24 weeks post-randomization
measure: Feasibility of Intervention
timeFrame: 24 weeks
measure: Acceptability of Intervention
timeFrame: 24 weeks
measure: Adoption of Intervention
timeFrame: 24 weeks
measure: Preliminary Efficacy of Intervention on Viral Load
timeFrame: Baseline to 24 weeks
measure: Preliminary Efficacy of Intervention on Medication Adherence
timeFrame: Baseline to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Abuja
country: Nigeria
facility: APIN Public Health Initiatives
city: Lagos
country: Nigeria
facility: Nigerian Institute of Medical Researd
Study officials:
affiliation: Vanderbilt University Medical Center
name: Aima Ahonkhai, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Martin Were, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: