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HIV Pre-exposure ProphylaxisNCT05545449

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

An observational study of HIV Pre-exposure Prophylaxis and Stigma, Social, run by Indiana University at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
HIV Pre-exposure Prophylaxis, Stigma, Social
What is being tested?
PrEP Peer Mentor Program
How many people
5 participants
Where
1 siteKenya
Study dates
14 Sep 2022to 30 May 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Kenya1 site
  • Moi Teaching and Referral Hospital

    Eldoret

Other trials in Kenya

About this study

Official title: 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 health records (EHR) review) to evaluate the acceptability and change in knowledge and number of adolescents.

Read the 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.

Being tested
PrEP Peer Mentor Program
Keywords
Peer mentor, Global health, Adolescent
Medical subject headings
Social Stigma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrEP Peer Mentor ProgramBehavioural

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AYA EHR visits for PrEP initiation and maintenance.

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

    Measured: 3 months before and the 1 year duration of the intervention

Secondary outcomes (3)
  1. 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.

    Measured: Monthly for 1 year

  2. 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.

    Measured: Monthly for 1 year

  3. 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.

    Measured: Monthly for 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2022
  2. Study start14 Sep 2022
  3. Primary completion14 Sep 2023
  4. Study completion30 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05545449
Sponsor's protocol ID
IUIRB-13771
Status last verified
Jan 2025
First submitted
14 Sep 2022
Last updated
8 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: A data package including focus group transcripts, EHR data, and peer mentor tracking forms will be created.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Pre-exposure Prophylaxis and Stigma, Social, run by Indiana University at 1 site in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AYA EHR visits for PrEP initiation and maintenance. (time frame: 3 months before and the 1 year duration of the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.

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