Brief Summary

The long-term goal of this research is to create an effective and sustainable program to support retention in PrEP care and PrEP adherence among 18-29 year old men who have sex with men (MSM). To reach this goal, we will develop and pilot test a mobile intervention tailored to young MSM, called PrEP iT! Primary aims include: Aim 1: Develop the PrEP iT! mobile intervention through focus groups with young MSM and refine iterations through input from a community advisory board (CAB). Aim 2: Conduct a pilot randomized controlled trial to assess the feasibility, acceptability and preliminary impact of the PrEP iT! intervention for young MSM.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Mar 2021

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.1 years study duration

First Submitted

Initial submission to the registry

March 23, 2020

Completed

5 months until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed

7 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2022

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

June 15, 2023

Completed

Last Updated

July 7, 2023

Status Verified

June 1, 2023

Enrollment Period

1.1 years

First QC Date

March 23, 2020

Results QC Date

April 26, 2023

Last Update Submit

June 21, 2023

Conditions

Treatment Adherence and Compliance

Keywords

Pre-Exposure Prophylaxis (PrEPHIV Prevention

Outcome Measures

Primary Outcomes (2)

High Protective Level of PrEP Adherence From Tenofovir Diphosphate (TVF-DP) Levels
Adherence thresholds estimated through analysis of tenofovir diphosphate (TVF-DP) levels from dried blood spot (DBS) specimens were used to categorize each participant as having a high protective level (i.e., a high likelihood of protection from HIV) of PrEP (800 or greater of emtricitabine-tenofovir disoproxil fumarate \[FTC-TDF\] and 950 or greater of FTC-tenofovir alafenamide \[FTC-TAF\]) or not. Results reported here are for high protective levels of PrEP.
6-month follow up assessment
Proportion of Participants With High Self-reported PrEP Adherence in the Past 7 Days
Participants were asked at the month 6 survey to respond to the following item: "In the past 7 days, how many days did you take PrEP?" Response options ranging from 0 days to 7 days, with 1 day increments. Responses of 4, 5, 6, or 7 days were categorized as having a high protective level of PrEP (i.e., a high likelihood of protection from HIV). Results reported here are for high protective levels of PrEP.
6-month follow up assessment

Study Arms (2)

PrEP iT! (plus usual PrEP care)

EXPERIMENTAL

The PrEP iT! intervention is a mobile-optimized website with components tailored for young men who have sex with men on PrEP.

Behavioral: PrEP iT! (plus usual PrEP care)

Usual PrEP care only

PLACEBO COMPARATOR

Clinic visits every 3 months in the initial period following PrEP initiation, including HIV/STI screening and laboratory toxicity testing

Behavioral: Usual PrEP care

Interventions

PrEP iT! (plus usual PrEP care)BEHAVIORAL

The PrEP iT! intervention is a mobile-optimized website, with the following components: * PrEP Adherence, PrEP Appointment, and Sexual Activity Self-Monitoring * Tailored feedback on PrEP adherence/non-adherence * PrEP and sexual health information tailored for YMSM * Text message reminders for PrEP adherence and healthcare appointments * An "ask the expert" feature

PrEP iT! (plus usual PrEP care)

Usual PrEP careBEHAVIORAL

Clinic visits every 3 months in the initial period following PrEP initiation, including HIV/STI screening and laboratory toxicity testing

Usual PrEP care only

Eligibility Criteria

Age18 Years - 29 Years

Sexmale(Gender-based eligibility)

Gender Eligibility DetailsMale at birth; Current male gender identification

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Prescribed PrEP by a healthcare provider;
Self-reported 18-29 years of age;
Assigned male at birth;
Current male gender identification;
Gay, bisexual or other non-heterosexual identity or has had sex with a man in the past year;
Confirmed HIV-negative status (before starting PrEP);
Started PrEP in the past 6 months (either taking PrEP for the first time or restarting PrEP after prior use) and has a current PrEP prescription;
English-speaking (as the intervention will be built in English);
Able to meet with project staff at baseline and follow-up visits;
Regular access to SMS or the internet, either through a mobile device, tablet computer, and/or desktop or laptop computer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

San Diego State Universitylead
National Institute of Mental Health (NIMH)collaborator
Hennepin Healthcare Research Institutecollaborator

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (1)

Horvath KJ, Helm JL, Black A, Chase GE, Ma J, Klaphake J, Garcia-Myers K, Anderson PL, Baker JV. A Pilot Randomized Controlled Trial of an mHealth Intervention to Improve PrEP Adherence Among Young Sexual Minority Men. AIDS Behav. 2024 Aug;28(8):2804-2820. doi: 10.1007/s10461-024-04374-3. Epub 2024 May 31.
PMID: 38816592DERIVED

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Limitations and Caveats

This study was designed and conducted as a pilot trial. The goal was to initially evaluate the PrEP-iT! intervention strategy and inform the development of larger definitive clinical trial. Thus, power was limited for outcome comparisons and future larger trials are needed to formally assess efficacy of the intervention.

Results Point of Contact

Title: D. Keith Horvath, Professor of Psychology
Organization: San Diego State University

Publication Agreements

PI is Sponsor Employee: Yes

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate Professor

Study Record Dates

First Submitted

March 23, 2020

First Posted

August 11, 2020

Study Start

March 1, 2021

Primary Completion

April 15, 2022

Study Completion

April 15, 2022

Last Updated

July 7, 2023

Results First Posted

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing: Will not share

Locations

US(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

PrEP iT! (plus usual PrEP care)

Usual PrEP care only

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations