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

NCT05545449 | Completed

• 1 other identifier: IUIRB-13771
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Pre-exposure Prophylaxis; Stigma, Social

Keywords

Peer mentor; Global health; Adolescent

Outcome Measures

Primary Outcomes (1)

• AYA EHR visits for PrEP initiation and maintenance.

  The number of visits for PrEP initiation and maintenance in the AMPATH EHR system.

  3 months before and the 1 year duration of the intervention

Secondary Outcomes (3)

• Number of AYA reached by PrEP peer mentors

  Monthly for 1 year

• Number and proportion of peer mentor interactions involving individuals from higher risk group

  Monthly for 1 year

• Number of peer mentor interactions resulting in referrals for PrEP

  Monthly for 1 year

Other Outcomes (1)

• PrEP stigma

  Focus groups will be conducted 9-12 months after the start of the intervention

Interventions

PrEP Peer Mentor Program BEHAVIORAL

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.

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead
• Academic Model Providing Access to Healthcare (AMPATH): collaborator
• Indiana CTSI: collaborator

Study Sites (1)

Moi Teaching and Referral Hospital

Eldoret, Kenya

Location

MeSH Terms

Conditions

Social Stigma

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Mary A Ott, MD MA

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Juddy Wachira, PhD

  Moi University

  PRINCIPAL INVESTIGATOR

• Edith Apondi, MBChB MMed

  Academic Model Providing Access to Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 19, 2022
• Study Start: September 14, 2022
• Primary Completion: September 14, 2023
• Study Completion: May 30, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

KE (1)