Condition category
Infections and Infestations
Date applied
02/07/2020
Date assigned
06/07/2020
Last edited
31/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

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

https://prepsavvy.emory.edu/

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

http://www.emory.edu/home/index.html

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)

Publication citations

Additional files

Editorial Notes

31/07/2020: Publication reference added. 06/07/2020: Trial’s existence confirmed by Emory University.