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

University of North Carolina (UNC)

Status: Completed

Conditions: HIV Infections

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04097834

19-1784

5U24HD089880 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 103 patients

Sex: Female

Ages: 13 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Must be self-identified as born female
2. Must be able to be provide written informed consent
3. Must be able to speak and understand English as determined by staff during recruitment
4. Must be 13-45 years old at time of consent
5. Must have been seen for a patient visit in one of the three implementation clinics during the preceding 60 days and identified as a PrEP candidate based on point-of-care HIV testing and risk assessment

Exclusion criteria

1. HIV-infected at the time of screening by self-report or screening laboratory assessment
2. Currently enrolled in an HIV vaccine trial
3. Has any condition that in the opinion of study staff would make participation in the study unsafe or interfere with achieving study objectives
4. Has been on PrEP for 7 or more consecutive days in the past
5. Currently receiving PrEP services at any location outside the 3 implementation clinics
6. Currently participating in another PrEP or candidate PrEP study

Trial design

103 participants in 2 patient groups

PrEP Prescription at Enrollment

No PrEP Prescription at Enrollment