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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- HIV Pre-exposure Prophylaxis, Stigma, Social
- 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.
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)
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
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
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.
- First posted19 Sep 2022
- Study start14 Sep 2022
- Primary completion14 Sep 2023
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Pre-exposure ProphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Model Providing Access to Healthcare (AMPATH), Indiana CTSI
- Responsible party
- Principal investigator, Mary A. Ott, Indiana University
- Investigators
- Mary A Ott, MD MA, Principal investigator, Icahn School of Medicine at Mount SinaiJuddy Wachira, PhD, Principal investigator, Moi UniversityEdith Apondi, MBChB MMed, Principal investigator, Academic Model Providing Access to Healthcare
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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers to Adolescent PrEP in Western Kenya: An Implementation Sciences Approach
- ClinicalTrials.gov ID
- NCT05545449
- Acronym / sponsor ID
- IUIRB-13771
- Conditions
- HIV Pre-exposure Prophylaxis, Stigma, Social
- Keywords
- Peer mentor, Global health, Adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Academic Model Providing Access to Healthcare (AMPATH), Indiana CTSI
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- for FGD: unable to speak English or Swahili, intoxicated or high
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrEP Peer Mentor ProgramFive 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. | Behavioural | – |
Primary outcome
AYA EHR visits for PrEP initiation and maintenance.
Time frame: 3 months before and the 1 year duration of the intervention
The number of visits for PrEP initiation and maintenance in the AMPATH EHR system.
3 secondary outcomes
Number of AYA reached by PrEP peer mentors
Time frame: Monthly for 1 year
Number and proportion of peer mentor interactions involving individuals from higher risk group
Time frame: Monthly for 1 year
Number of peer mentor interactions resulting in referrals for PrEP
Time frame: Monthly for 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: Undecided. A data package including focus group transcripts, EHR data, and peer mentor tracking forms will be created.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary A Ott, MD MA principal investigator
Icahn School of Medicine at Mount Sinai
Juddy Wachira, PhD principal investigator
Moi University
Edith Apondi, MBChB MMed principal investigator
Academic Model Providing Access to Healthcare
1 site in 1 country: see every site and its status.
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.