Integrating PrEP Into Family Planning Services at Title X Clinics in the Southeastern US
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

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.
    

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).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women ages 13-45 years who have been identified as PrEP eligible in one of the 3 enrolling
        FP clinics comprise the study population. PrEP eligibility will be based on
        clinic-performed HIV testing and risk assessment. All participants will be either
        PrEP-naïve (no periods of PrEP use longer than 7 consecutive days) at baseline or recipient
        of a PrEP prescription within the past 60 days (with no periods of PrEP use longer than 7
        consecutive days prior to this prescription).
      
Biospecimen description: 
      Self-collected vaginal swabs; Self-collected anal swabs; Self-collected oral swabs; Blood
      samples; Urine samples; Hair samples