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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04097834
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : October 10, 2019
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date September 13, 2019
First Posted Date September 20, 2019
Last Update Posted Date October 10, 2019
Actual Study Start Date October 7, 2019
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 18, 2019)
  • Proportion of participants with a PrEP prescription at baseline who initiate PrEP [ Time Frame: 6 months post enrollment ]
    Among participants with a PrEP prescription at baseline, the proportion who initiate PrEP measured via pharmacy prescription fill data, medical chart abstraction, and participant self-report
  • Proportion of participants with a PrEP prescription at baseline who attend at least one follow-up visit and have at least one documented PrEP prescription refill during each 3-month interval [ Time Frame: 6 months post enrollment ]
    Among participants with a PrEP prescription at baseline, the proportion who continue their PrEP regimen evidenced by pharmacy prescription fill data, medical chart abstraction, and participant self-report
  • Percentage of participants with a PrEP prescription at baseline who adhere to their PrEP regimen [ Time Frame: 6 months post enrollment ]
    Among participants with a PrEP prescription at baseline, percentage who adhere to PrEP, defined by 3 data sources at each follow-up visit—pharmacologic, self-report, and pharmacy. Pharmacological data will include: average ng/mg tenofovir (TFV) concentration measured via hair sample; percentage of participants with adherence level consistent with 7 doses/week (TFV ng/mL≥ 0.0370 ng/mL); percentage of participants with dried blood spot TFV concentration≥1250 fmol/punch; percentage of participants with urine TFV immunoassay detected. Self-report data will include: percentage of participants reporting no missed doses in the past 7 days; percentage of participants reporting very good or excellent adherence (5 or 6 on a 6-level scale) in the past 30 days; percentage of participants who self-report adherence of ≥90%. Pharmacy fill data will include: percentage of participants with 80% adherence measured by medication possession ratio (the # of dispensed pills/# of days since starting PrEP)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 18, 2019)
  • Incidence rate of Neisseria gonorrhea among each participant group [ Time Frame: 3- and 6-months post enrollment ]
    For each participant group (those with and those without a PrEP prescription at baseline) the incidence rate of STIs per total follow-up period will be calculated as the ratio of new STI infections (confirmed via multiplex PCR testing or chart review) to the total amount of person-time in each group
  • Incidence rate of Chlamydia trachomatis among each participant group [ Time Frame: 3- and 6-months post enrollment ]
    For each participant group (those with and those without a PrEP prescription at baseline) the incidence rate of STIs per total follow-up period will be calculated as the ratio of new STI infections (confirmed via multiplex PCR testing or chart review) to the total amount of person-time in each group
  • Incidence rate of Trichomonas vaginalis among each participant group [ Time Frame: 3- and 6-months post enrollment ]
    For each participant group (those with and those without a PrEP prescription at baseline) the incidence rate of STIs per total follow-up period will be calculated as the ratio of new STI infections (confirmed via multiplex PCR testing or chart review) to the total amount of person-time in each group
  • Incidence rate of unintended pregnancy among each participant group [ Time Frame: 3- and 6-months post enrollment ]
    For each participant group (those with and those without a PrEP prescription at baseline) the incidence rate of unintended pregnancies (pregnancies that do not match a participant's self-reported pregnancy intentions) per total follow-up period will be calculated as the ratio of new pregnancies (confirmed via positive urine pregnancy test) to the total amount of person-time in each group
  • Incidence rate of HIV infection among each participant group [ Time Frame: 3- and 6-months post enrollment ]
    For each participant group (those with and those without a PrEP prescription at baseline) the incidence rate of HIV infection per total follow-up period will be calculated as the ratio of new HIV infections (defined as a positive HIV test based on an FDA-approved HIV test with confirmatory negative testing of samples collected at baseline) to the total amount of person-time in each group
  • Proportion of participants among each participant group reporting contraception use [ Time Frame: Enrollment and 3- and 6-months post enrollment ]
    For each participant group (those with and those without a PrEP prescription at baseline), contraception use will be calculated as the percentage of participants who self-report use of a CDC-defined Tier 1 or Tier 2 contraception method
  • Proportion of participants among each participant group reporting current contraception type [ Time Frame: Enrollment and 3- and 6-months post enrollment ]
    For each participant group (those with and those without a PrEP prescription at baseline), contraception type will be determined as the self-reported current contraception type used
  • Proportion of participants adherent to current contraceptive method measured among each participant group [ Time Frame: Enrollment and 3- and 6-months post enrollment ]
    Proportion of participants adherent to current contraceptive method measured among each participant group via self-report
  • Proportion of participants who are clinically-indicated to initiate PrEP [ Time Frame: 3- and 6-months post enrollment ]
    Among all participants, the proportion of participants whose current clinical and behavioral profile indicate, per CDC clinical practice guidelines, they could begin PrEP, measured via STI testing, medical chart review, and self-report
  • Proportion of participants who indicate interest in initiating PrEP [ Time Frame: Enrollment and 3- and 6-months post enrollment ]
    Among all participants, the proportion of participants who report interest in beginning PrEP via interviewer-administered questionnaire and self-report
  • Proportion of all participants who initiate PrEP [ Time Frame: Enrollment and 3- and 6-months post enrollment ]
    Among all participants, the proportion of participants with a PrEP-prescription, pharmacy-confirmed fill of their PrEP prescription, and who self-report initiating PrEP
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Integrating PrEP Into Family Planning Services at Title X Clinics in the Southeastern US
Official Title Integrating PrEP Into Family Planning Services at Title X Clinics in the Southeastern US
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Self-collected vaginal swabs; Self-collected anal swabs; Self-collected oral swabs; Blood samples; Urine samples; Hair samples
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).
Condition HIV Infections
Intervention Not Provided
Study Groups/Cohorts
  • PrEP Prescription at Enrollment
  • No PrEP Prescription at Enrollment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 18, 2019)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 13 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Tess R Filipowicz, MPH 919-445-1032 tfilipow@email.unc.edu
Contact: Maria C Sanchez, BS 919-962-8571 marias@email.unc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04097834
Other Study ID Numbers 19-1784
5U24HD089880 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: De-identified study dataset will be submitted and made publicly available to the NICHD's Data and Specimen Hub (DASH) after completion of the study in accordance with the NICHD DASH Data Archive Policy.
Time Frame: De-identified data will become available on the DASH hub no later than the acceptance for publication of the main findings from the final dataset
Access Criteria: De-identified dataset will be publicly available on the DASH hub.
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor University of North Carolina, Chapel Hill
Collaborators
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Jessica M Sales, PhD Emory University
Principal Investigator: Anandi N Sheth, MD, MSc Emory University
Study Director: Matthew A Psioda, PhD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date October 2019