Table 2.

WeExPAnd trial registration data

Data category	Information
Primary registry and trial identifying number	ClinicalTrials.gov NCT04373551
Date of registry in primary registry	4 May 2020
Secondary identifying numbers	300003885, 1R34MH118044-01A1
Source(s) of monetary or material support	National Institute of Mental Health
Primary sponsor	National Institute of Mental Health
Secondary sponsor	N/a
Contact for public queries	Mirjam-Colette Kempf, PhD (mkempf@uab.edu)
Contact for scientific queries	Mirjam-Colette Kempf, PhD University of Alabama at Birmingham
Public title	PrEP Demonstration Project Among Women at Risk for HIV Infection
Scientific title	N/a
Countries of recruitment	USA
Health condition(s) or problem(s) studied	HIV-infection/AIDS
Intervention(s)	Behavioural: cultural adaptation of a patient–provider communication tool
Key inclusion and exclusion criteria	Ages eligible for study: ≥18 years Sexes eligible for study: cisgender female Gender-based eligibility: yes Accepts health volunteers: no
	Patients Inclusion criteria: African American cisgender women aged 18 years or older without HIV; report HIV risk and/or recent PrEP use; English-speaking
	Providers Inclusion criteria: physicians, nurse practitioners, physician assistants, nurses, medical assistants, social workers/counsellors or other potential/actual PrEP service providers; English-speaking
Study type	Interventional (clinical trial)
	Allocation: N/a
	Primary purpose: health services research
	Phase: N/a
Study start date	14 April 2020
Target sample size	125 participants
Recruitment status	Enrolling by invitation
Primary outcome(s)	PrEP uptake changes (time frame: baseline, 3 months and 12 months) Intervention feasibility changes (time frame: baseline, 3 months and 12 months) Intervention acceptability (time frame: through study completion, an average of 12 months)
Secondary outcome(s)	PrEP adherence (time frame: 3 months and 12 months) Clinic visit adherence changes (time frame: 3 months and 12 months) Biological measures of HIV, STIs and pregnancy (time frame: baseline, 3 months and 12 months)

PrEP, pre-exposure prophylaxis; STI, sexually transmitted infection.