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

Barriers to Adolescent PrEP in Western Kenya: An Implementation Sciences Approach

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 medical records (EMR) review) to evaluate the acceptability and change in knowledge and number of adolescents.

Study Overview

• Status: Enrolling by invitation
• Conditions: Stigma, Social; HIV Pre-exposure Prophylaxis
• Intervention / Treatment: Behavioral: PrEP Peer Mentor Program

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 EMR aspect of the study will involve extraction of data before and after 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 and maintenance during the final 3 months of the intervention. De-identified EMR 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.

• Study Type: Observational
• Enrollment (Estimated): 36

Contacts and Locations

Study Locations

• Kenya
  • Eldoret, Kenya
    • Moi Teaching and Referral Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

• For Focus Group Discussions: (1) 18-24 year olds AYA selected from PrEP users identified from the EMR (n=12); (2) peer mentors (all 5); (3) health care staff/providers (n=12).
• For EMR review: 15-24 year olds attending AMPATH clinics in Uasin Gishu county for PrEP initiation or maintenance.
• For peer mentor tracking: 15-24 year olds interacting with peer mentors.

Description

Inclusion Criteria:

• for FGD: 18-24 year old AYAs, peer mentors, and health care providers.
• for EMR: 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of visits for PrEP initiating and maintenance	AMPATH has an electronic medical records system that includes all clinics in the AMPATH network. There are designated EMR PrEP forms that are completed by clinicians. These include demographic and behavioral information, and whether PrEP was started. Visits for PrEP initiation and maintenance among 15-24 year olds will be selected and counts by age, clinic, and PrEP prescriptions will be abstracted.	3 month period before and 3 month period after the peer mentor intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of AYA reached by PrEP peer mentors	For each peer mentor interaction (both informal discussions and formal group outreach), peer mentors will complete a tracking that captures number of individuals in the outreach/interaction.	Monthly for 1 year
Number and proportion of peer mentor interactions involving individuals from higher risk group	For each interaction (both informal discussions and formal group outreach), peer mentors will complete a tracking that captures number of individuals in the outreach/interaction, the age range, and whether the interaction/outreach included anyone from a high risk group (e.g. LGBTQ, pregnant, serodiscordant). We will examine the total number of interactions (both formal and information) and the number and proportion involving a higher risk group.	Monthly for 1 year
Number of peer mentor interactions resulting in referrals for PrEP	The Peer Mentor tracking forms collect whether anyone in the outreach/interaction is referred for PrEP. We will identify the number of interactions resulting referrals resulting from PrEP peer mentor outreach interactions.	Monthly for 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP stigma	From focus group discussions we will describe participants' perceptions of PrEP stigma expressed by peer mentors, AYA, and health care providers, including the type of stigma and the effects of stigma.	Focus groups will be conducted 9-12 months after the start of the intervention

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Institutes of Health (NIH); National Center for Advancing Translational Sciences (NCATS); Indiana Clinical and Translational Sciences Institute; Academic Model Providing Access to Healthcare (AMPATH)
• Investigators: Principal Investigator: Mary A Ott, MD MA, IU School of Medicine; Principal Investigator: Juddy Wachira, PhD, Moi University; Principal Investigator: Edith Apondi, MBChB MMed, Academic Model Providing Access to Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): February 28, 2024

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 19, 2022

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Adolescent; Global health; Peer mentor
• Other Study ID Numbers: IUIRB-13771; UL1TR002529 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: A data package including focus group transcripts, EMR data set, and peer mentor tracking forms will be created.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No