NCT04097834

Integrating PrEP Into Family Planning Services at Title X Clinics in the Southeastern US

Completed Last updated 10 May 2022

What this trial tests

trial in HIV Infections in 103 participants. Completed in 31 March 2022.

Timeline

7 October 2019

Primary endpoint
31 March 2022

31 March 2022

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Status	Completed
Study type	OBSERVATIONAL
Enrollment	103
Start date	7 October 2019
Primary completion	31 March 2022
Estimated completion	31 March 2022
Sites	1 location across United States

Conditions studied

• HIV Infections — all drugs for HIV Infections →

Sponsor

University of North Carolina, Chapel Hill

Who can join

Adults 13 to 45, female only, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pre-exposure Prophylaxis (PrEP) is a daily pill to prevent HIV that, when taken as prescribed, reduces the risk of getting HIV from sexual intercourse or drug use. In the United States, most studies which examine prescribing PrEP have not included young women. PrEP provides a way for women to take control of their HIV prevention and may be a good option for some women.

Family planning clinics are a trusted source of preventative, routine, and symptom-driven gynecological care for adolescent and young adult women (AYAW). Thus, these clinics are a natural setting to provide PrEP services for AYAW. This study will examine how effectively three clinics in Atlanta are able to implement a PrEP program for their eligible female patients as well as follow a cohort of 300 women for six months (150 starting PrEP immediately and 150 electing to not take PrEP, at least initially) to characterize individual, provider, and clinic-level variables and constructs that are associated with PrEP uptake, continuation, and adherence.

Both participant and biological data will be collected to answer the primary research question. Women will provide blood, urine, oral, vaginal, anal, and hair samples at three different time points. These samples will be tested to measure incident sexually transmitted infections and unplanned pregnancies as well as PrEP adherence (for women who initiated PrEP). Ultimately, this data will describe each clinic's effectiveness at providing PrEP services to AYAW.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pre-Exposure Prophylaxis Integration Into Family Planning Services at Title X Clinics in the Southeastern United States: Protocol for a Mixed Methods Hybrid Type I Effectiveness Implementation Study (Phase 2 ATN 155).
   Sheth AN, Hussen SA, Escoffery C, Haddad LB, et al · · 2020 · cited 10× · PMID 32975528 · DOI 10.2196/18784