Education for HIV prevention for black women who attend college

ISRCTN	ISRCTN14792715
DOI	https://doi.org/10.1186/ISRCTN14792715
Secondary identifying numbers	IRB00091765

Submission date: 02/07/2020
Registration date: 06/07/2020
Last edited: 31/07/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Study website

Contact information

Dr Rasheeta Chandler
Scientific

6876 Spreadlong Oaks Dr
Stone Mountain
30087
United States of America

ORCID ID	0000-0003-2021-6346
Phone	+1 6788342024
Email	r.d.chandler@emory.edu

Study information

Study design	Pilot single-centre randomized parallel trial
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Community
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Comparing an online and in-person HIV prevention educational intervention (Pre-Exposure Prophylaxis; PrEP) for black college women
Study acronym	PrEPSavvy
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
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 study start date	05/10/2016
Completion date	30/12/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	50
Total final enrolment	43
Key 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
Key exclusion criteria	1. Biologically born male
Date of first enrolment	02/02/2017
Date of final enrolment	30/12/2018

Locations

Countries of recruitment

United States of America

Study participating centre

Emory University

1520 Clifton Rd
Atlanta
30322
United States of America

Sponsor information

Emory University
University/education

1520 Clifton Rd
Atlanta
30322
United States of America

Phone	+1 4047278164
Email	urcappl@emory.edu
Website	http://www.emory.edu/home/index.html
"ROR"	https://ror.org/03czfpz43

Funders

Funder type

University/education

Emory University
Private sector organisation / Universities (academic only)

Alternative name(s): Emory, The Emory University, Emory College, EU
Location: United States of America

Results and Publications

Intention to publish date	03/01/2021
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a peer-reviewed journal.
IPD sharing plan	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.)

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	28/07/2020	31/07/2020	Yes	No

Editorial Notes

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