Adapting an Adolescent Friendly PrEP Program for Uasin Gishu County-Kenya

NCT ID: NCT05545449

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-14
• Study Completion Date: 2024-05-30

Brief 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.

Detailed 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.

Conditions

HIV Pre-exposure Prophylaxis; Stigma, Social

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

PrEP Peer Mentor Program

Five PrEP peer mentors will provide outreach, education, and referral for HIV pre-exposure prophylaxis. Peer mentors have received training on HIV, PrEP, family planning, adolescent development, peer support, and action planning. Interactions will include 1:1 informal interactions as well as planned group outreach interactions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• for FGD: 18-24 year old AYAs, peer mentors, and health care providers.
• for EHR: 15-24 year olds initiating and maintaining PrEP
• from peer mentor tracking: 15-24 year old interacting with peer mentors

Exclusion Criteria

• for FGD: unable to speak English or Swahili, intoxicated or high

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academic Model Providing Access to Healthcare (AMPATH)

OTHER

Sponsor Role: collaborator

Indiana CTSI

UNKNOWN

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Mary A. Ott

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary A Ott, MD MA

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Juddy Wachira, PhD

Role: PRINCIPAL_INVESTIGATOR

Moi University

Edith Apondi, MBChB MMed

Role: PRINCIPAL_INVESTIGATOR

Academic Model Providing Access to Healthcare

Locations

Moi Teaching and Referral Hospital

Eldoret, , Kenya

Countries

Kenya

Other Identifiers

IUIRB-13771

Identifier Type: -

Identifier Source: org_study_id