NCT03699722: Just4Us

A Women-Focused PrEP Intervention

Completed Phase 1 Last updated 13 November 2020

What this trial tests

Phase 1 trial testing Education + Activities in Behavior and Behavior Mechanisms in 83 participants. Completed in 10 November 2019.

Timeline

3 November 2018

Primary endpoint
10 October 2019

10 November 2019

Quick facts

Lead sponsor	University of Pennsylvania
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	83
Start date	3 November 2018
Primary completion	10 October 2019
Estimated completion	10 November 2019
Sites	1 location across United States

Drugs / interventions tested

• Education + Activities
• Information

Conditions studied

• Behavior and Behavior Mechanisms — all drugs for Behavior and Behavior Mechanisms →
• Information Literacy — all drugs for Information Literacy →

Sponsor

University of Pennsylvania

Who can join

Adults 18 to 55, female only, with Behavior and Behavior Mechanisms or Information Literacy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Many women at high risk for acquiring HIV infection are not aware of preexposure prophylaxis (PrEP), an efficacious, self-administered, woman-controlled, HIV prevention product. The objective of this study is to evaluate the feasibility and acceptability of a theory-based intervention to promote PrEP uptake and adherence in a pilot trial among 80 women. The study will also measure intention to use PrEP and actual initiation of PrEP use. The investigators hypothesize that the intervention will be acceptable and feasible and that the intervention group will report higher levels of PrEP uptake, intention to use and adhere to PrEP, and other variables regarding PrEP uptake, comparing baseline, post-intervention and 3 month follow-up assessments.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Just4Us: Development of a Counselor-Navigator and Text Message Intervention to Promote PrEP Uptake Among Cisgender Women at Elevated Risk for HIV.
   Teitelman AM, Koblin BA, Brawner BM, Davis A, et al · · 2021 · cited 14× · PMID 33427767 · DOI 10.1097/jnc.0000000000000233
2. A Randomized Controlled Pilot Study of Just4Us, a Counseling and Navigation Intervention to Promote Oral HIV Prophylaxis Uptake Among PrEP-Eligible Cisgender Women.
   Teitelman AM, Tieu HV, Chittamuru D, Shaw PA, et al · · 2023 · cited 6× · PMID 36869921 · DOI 10.1007/s10461-023-04017-z
3. A Randomized Controlled Pilot Study of Just4Us, a Counseling and Navigation Intervention to Promote Oral HIV Prophylaxis Uptake Among PrEP-Eligible Cisgender Women
   Teitelman A, Tieu H, Chittamuru D, Shaw PA, et al · · 2022 · DOI 10.21203/rs.3.rs-2322407/v1