Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05545449 |
| Other study ID # |
IUIRB-13771 |
| Secondary ID |
UL1TR002529 |
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 14, 2022 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Indiana University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is to examine the implementation ( e.g. training, reach,
acceptability) of a a youth friendly pre-exposure prophylaxis (PrEP) peer mentorship program
for Adolescents and Young Adults (AYA). This program will include the use of PrEP focused
peer-mentors for education on HIV risk and on PrEP as well as for support for those who end
up starting PrEP. This will be an adaptation from the HIV peer mentor program which has been
successfully utilized at the Academic Model Providing Access to Healthcare (AMPATH) to
improve on the outcomes of Adolescents Living with HIV. Investigators use the Exploration,
Preparation, Implementation and Sustainment (EPIS) implementation science framework to guide
our research process and address our implementation aims. We will use both qualitative (key
stakeholder focus group discussions (FGDs)) and quantitative data collection methods
(electronic health records (EHR) review) to evaluate the acceptability and change in
knowledge and number of adolescents.
Description:
This study pilots the implementation of an intervention (AYA PrEP peer mentors) in increasing
knowledge, reducing stigma and increasing uptake and adherence to PrEP among AYA. In low and
middle income countries, peer mentor interventions to improve health behaviors are well
supported by evidence, and used extensively by the AMPATH programs as a best practice. We are
examining the implementation (e.g. training, reach, acceptability) rather than the
effectiveness of this intervention. The study has been approved by both the IU IRB and the
Moi University Institutional Research Ethics Committee.
The intervention will engage five PrEP focused peer-mentors, one stationed at Moi Teaching
and Referral Hospital Reproductive Health Clinic; one from the Lesbian, Gay, Bisexual,
Transgender, and Queer (LGBTQ) community, and three from specified tertiary institutions in
Eldoret, Kenya (Eldoret Medical Training College, The University of Eldoret, Eldoret
Polytechnic) to focus on college students. These peer mentors will be paid a monthly stipend,
and their roles will be to: (1) Hold one on one discussions with target AYA on PrEP; (2) To
hold group discussions on PrEP with the target AYA; (3) To champion for PrEP promotion and
provision by healthcare workers; and (4) To do outreach-work, adherence support and clinic
reminders for those on PrEP. Peer mentors received PrEP and peer mentor training adapted from
an existing USAID curriculum, as well as training in research procedures. Peer mentors will
complete a pre-and post-training survey to measure their efficacy and knowledge on HIV and
PrEP.
The EHR aspect of the study will involve extraction of data before and during the peer mentor
intervention. The data extraction will include de-identified information from visits for PrEP
initiation and PrEP maintenance among AYA in Uasin Gishu County. We will collect the
socio-demographic and clinical data of PrEP initiation and maintenance visits among AYA aged
15-24 years. The qualitative data aspects will involve FGDs with 1) the PrEP focused peer
mentors, 2) PrEP AYA initiators, and 3) Healthcare workers. This FGDs will explore the
acceptability, feasibility and adaption of the AYA PrEP peer mentor program. The quantitative
data will also include PrEP peer mentors completing a tracking form that describes
characteristics of the outreach interaction, including the total # people, topics discussed,
and whether the group was a high risk group (e.g. LGBTQ, pregnant/parenting, discordant
relationship). No personal identifiers or identifiable characteristics of individuals will be
collected, and a waiver of informed consent has been granted.
For data analysis to look at effectiveness, the number of visits for PrEP initiation and
maintenance in the system for a 3 month period before the intervention starts will be
compared to the number of visits for PrEP initiation during the intervention. De-identified
EHR data will be used. To qualitatively examine the effect of the intervention on stigma and
barriers, FGDs will be conducted with AYA, healthcare workers, and peer mentors at the end of
the intervention. To examine the implementation of the intervention, (1) the number of of
participants overall, (2) the total number of interactions/outreach, (3) the total number of
interactions/outreach that include someone from higher HIV risk groups, and (4) the topics of
the outreach interaction will be tracked using run charts.
