Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT04097834
Status:
COMPLETED
Last Update Posted:
2022-05-10
First Post:
2019-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrating PrEP Into Family Planning Services at Title X Clinics in the Southeastern US
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
Integrating PrEP Into Family Planning Services at Title X Clinics in the Southeastern US
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
Planning4PrEP is a mixed hybrid Type 1 effectiveness implementation study of three family planning clinics in Atlanta integrating PrEP into their services and evaluating the multi-level factors associated with PrEP reach, level of adoption, and implementation (e.g., PrEP screening and prescription) within and across these clinics while also evaluating the effect on PrEP uptake, continuation, and adherence over a six-month follow-up period. Variation exists among types of family planning clinics, and this variation could have an impact on how clinics decide to implement, integrate, and even sustain PrEP services. This study will evaluate three family planning clinics as they adopt and sustain PrEP into their routine services to capture details of the implementation process unique to each clinic type, as well as commonalities across the clinics, with the ultimate aim to evaluate the impact of the implementation on the primary outcome (PrEP uptake, adherence, and continuation).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5U24HD089880 | NIH | None | https://reporter.nih.gov/quic… | View |