An Effectiveness Trial of the PrEP for WINGS Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorColumbia University
About this trial
(Effectiveness Aim 1) To test the comparative effectiveness of PreP for WINGS versus PrEP alone on primary outcomes of increasing PrEP initiation measured by self-report/medical records, recent adherence and longer-term adherence by self-report/medical records over the 6-month follow-up; and secondary outcomes of decreasing IPV, hazardous drinking, recidivism, and HIV risks.
(Moderation Aim 2) To test if the effectiveness of WINGS+PrEP on study outcomes is moderated by key participant subgroups based on race/ethnicity, sexual orientation, age, education, incarceration history, IPV severity, substance use disorders (SUDs), digital access and literacy, housing stability, and medical mistrust.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
PrEP for WINGS
BehavioralThe PrEP for WINGS intervention involves three sessions of a self-paced and self-directed intervention delivered via a mobile health platform. Session 1 will focus on HIV risk reduction and provide the PrEP Decision Aid, where participants will learn information about PrEP to help them decide if it is appropriate for them. Sessions 2-3 will involve integrated Screening, Brief Intervention, Referral to Treatment (SBIRT) modules focused on IPV and alcohol reduction. The PrEP for WINGS intervention will also involve peer navigation sessions with Community Health Advocates to help intervention participants trouble shoot any barriers to achieving goals they set during the self-paced sessions. The PrEP for WINGS intervention will take place over a 30 day period and Sessions 2-3, and the peer navigation sessions may be delivered using smart phones or using tablets available at study data collection sites.
PrEP Decision Aid
BehavioralThe PrEP Decision Aid will be delivered to participants in the control condition, and focus on helping study participants decide if they should initiate PrEP. This single session will focus on HIV risk reduction, and then launch the patient-centered PrEP Decision Aid. This individual session will be identical to the first session of the PrEP for WINGS three session intervention, and will also be delivered through an online survey platform. In addition, study participants in the control condition will also have one peer navigation session with a Community Health Advocate at the end of the self-paced session to help facilitate linkage to care.
Treatment groups
307 Participants
are divided into 2 treatment groupsGroup A: PrEP for WINGS (intervention arm)Experimental treatment 1 intervention
Group B: PrEP alone (control arm)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of completed PrEP provider meetings (PrEP Initiation)
Meeting with a PrEP provider to start PrEP once will meet the threshold for PrEP initiation.
Time frame
From enrollment (baseline) to the end of 12-month follow upSecondary outcomes
1
Revised Conflict Tactic Scale Score
This is designed to assess intimate partner violence (IPV) based on self-reporting on quantitative behavioral survey assessments using the Revised Conflict Tactic Scale 2. Questions are asked for 21 behaviors occurring in the three time frames prior to assessment: ever, past year, and past six months. Positive endorsement of any item will be scored with 1; negative endorsements will be scored 0. Scores range from 0 to 21 for each timeframe, with low score indicated fewer episodes of IPV in the given timeframe, where higher scores indicate higher number of episodes of IPV.
Time frame
From enrollment (baseline) to the end of 12-month follow up2
AUDIT Score
The self-report version of the AUDIT will be used to assess hazardous alcohol use. The AUDIT has 10 questions and the possible responses to each question are scored 0, 1, 2, 3 or 4, with the exception of questions 9 and 10 which have possible responses of 0, 2 and 4. The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder).
Time frame
From enrollment (baseline) to the end of 12-month follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov