Plain English Summary
Background and study aims
Consistent use of Pre-Exposure Prophylaxis (PrEP) for HIV negative persons, can lower their chances of getting HIV. Black women are a group to consider PrEP use as their chances of getting HIV is much higher than all other women groups.
Who can participate?
Black women aged 18 - 24 years who attend college
What does the study involve?
Participating in either an online or in-person HIV prevention education module that promotes PrEP education and future PrEP use.
What are the possible benefits and risks of participating?:
Benefits: Increased PrEP knowledge; Risks: No risks identified
Where is the study run from?
Emory University (USA)
When is the study starting and how long is it expected to run for?
February 2017 to December 2019
Who is funding the Study?
Emory University (USA)
Who is the main contact?
Rasheeta Chandler, r.d.chandler@emory.edu
Trial website
Contact information
Type
Scientific
Primary contact
Dr Rasheeta Chandler
ORCID ID
http://orcid.org/0000-0003-2021-6346
Contact details
6876 Spreadlong Oaks Dr
Stone Mountain
30087
United States of America
+1 6788342024
r.d.chandler@emory.edu
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
IRB00091765
Study information
Scientific title
Comparing an online and in-person HIV prevention educational intervention (Pre-Exposure Prophylaxis; PrEP) for black college women
Acronym
PrEPSavvy
Study hypothesis
Post participating in the PrEP education module, regardless of delivery modality, participants will have increased PrEP knowledge and will be more likely to initiate PrEP in the future
Ethics approval
Approved 02/02/2017, Emory University Institutional Research Board (1599 Clifton Rd, Atlanta, GA 30322, USA; +1 (404) 712-0720; urcappl@emory.edu), ref: IRB00091765
Study design
Pilot single-centre randomized parallel trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Community
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Prevention of HIV
Intervention
The intervention consists of a PrEP Education Intervention that lasts one-hour and is formatted for two delivery platforms - traditional in-person small groups and an online modular session. Participants are randomized (1:1) to either the traditional in-person small group delivery platform or the online delivery platform. Once randomized, all participants complete a pre-test at baseline evaluating their PrEP knowledge prior to the intervention and after completing the pre-test they are given a follow-up post-test appointment scheduled for 2 weeks after completing the intervention.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Feasibility and acceptability of the in-person and online PrEP curriculum assessed through quantitative and qualitative methods:
1. Quantitative measurement includes survey questions administered two-weeks after the intervention using the following questions: “How helpful was the program for understanding PrEP?” “How helpful was the program for learning about PrEP?” “ Quality of the information provided” “Usefulness of the information provided”
2. Qualitative measurement obtained one-week after the intervention via two 90-minute focus groups
Secondary outcome measures
1. PrEP Knowledge measured at baseline and at two-weeks after the intervention using two questions: a) Before this study, had you ever heard of PrEP; and b) What is your knowledge of PrEP? (range: where 0 is no knowledge and 10 is expert knowledge).
2. PrEP intentions assessed at baseline and two-weeks after the intervention using the following question: How likely are you to use PrEP in the future? (Responses ranged from—Very unlikely [0] to Very likely [5])
Overall trial start date
05/10/2016
Overall trial end date
30/12/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Self-identified as black
2. Cis-gender female
3. Enrolled part-time or full-time at the designated university
4. Between the ages of 18 - 24 years
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
50
Total final enrolment
43
Participant exclusion criteria
1. Biologically born male
Recruitment start date
02/02/2017
Recruitment end date
30/12/2018
Locations
Countries of recruitment
United States of America
Trial participating centre
Emory University
1520 Clifton Rd
Atlanta
30322
United States of America
Sponsor information
Organisation
Emory University
Sponsor details
1520 Clifton Rd
Atlanta
30322
United States of America
+1 4047278164
urcappl@emory.edu
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Emory University
Alternative name(s)
Funding Body Type
unknown
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a peer-reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from (Rasheeta Chandler, PhD; r.d.chandler@emory.edu; descriptive data will be available after initial peer reviewed article [estimated to be by January 3, 2021] for at least 3 years; Access criteria: 1. Provide study proposal/protocol; and 2. IRB approval to complete secondary data analysis submitted to Rasheeta Chandler, PhD r.d.chandler@emory.edu by e-mail; 3. Any results generated and disseminated will require acknowledgement of data source and reference to any parent study publications. Agreement to adhere to any additional institutional legal requirements will be required before release of data.)
Intention to publish date
03/01/2021
Participant level data
Available on request
Basic results (scientific)
Publication list
2020 results in https://pubmed.ncbi.nlm.nih.gov/32723313/ (added 31/07/2020)