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

NCT04097834 | Completed

• 2 other identifiers: 19-17845U24HD089880
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (3)

• Proportion of participants with a PrEP prescription at baseline who initiate PrEP

  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

  6 months post enrollment

• 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

  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

  6 months post enrollment

• Percentage of participants with a PrEP prescription at baseline who adhere to their PrEP regimen

  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)

  6 months post enrollment

Secondary Outcomes (11)

• Incidence rate of Neisseria gonorrhea among each participant group

  3- and 6-months post enrollment

• Incidence rate of Chlamydia trachomatis among each participant group

  3- and 6-months post enrollment

• Incidence rate of Trichomonas vaginalis among each participant group

  3- and 6-months post enrollment

• Incidence rate of unintended pregnancy among each participant group

  3- and 6-months post enrollment

• Incidence rate of HIV infection among each participant group

  3- and 6-months post enrollment

Study Arms (2)

PrEP Prescription at Enrollment

No PrEP Prescription at Enrollment

Eligibility Criteria

• Age: 13 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

• Must be self-identified as born female
• Must be able to be provide written informed consent
• Must be able to speak and understand English as determined by staff during recruitment
• Must be 13-45 years old at time of consent
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (6)

• Koss CA, Hosek SG, Bacchetti P, Anderson PL, Liu AY, Horng H, Benet LZ, Kuncze K, Louie A, Saberi P, Wilson CM, Gandhi M. Comparison of Measures of Adherence to Human Immunodeficiency Virus Preexposure Prophylaxis Among Adolescent and Young Men Who Have Sex With Men in the United States. Clin Infect Dis. 2018 Jan 6;66(2):213-219. doi: 10.1093/cid/cix755.

  PMID: 29020194 BACKGROUND

• Liu AY, Yang Q, Huang Y, Bacchetti P, Anderson PL, Jin C, Goggin K, Stojanovski K, Grant R, Buchbinder SP, Greenblatt RM, Gandhi M. Strong relationship between oral dose and tenofovir hair levels in a randomized trial: hair as a potential adherence measure for pre-exposure prophylaxis (PrEP). PLoS One. 2014 Jan 8;9(1):e83736. doi: 10.1371/journal.pone.0083736. eCollection 2014.

  PMID: 24421901 BACKGROUND

• Wilson IB, Lee Y, Michaud J, Fowler FJ Jr, Rogers WH. Validation of a New Three-Item Self-Report Measure for Medication Adherence. AIDS Behav. 2016 Nov;20(11):2700-2708. doi: 10.1007/s10461-016-1406-x.

  PMID: 27098408 BACKGROUND

• Amico KR, Marcus JL, McMahan V, Liu A, Koester KA, Goicochea P, Anderson PL, Glidden D, Guanira J, Grant R. Study product adherence measurement in the iPrEx placebo-controlled trial: concordance with drug detection. J Acquir Immune Defic Syndr. 2014 Aug 15;66(5):530-7. doi: 10.1097/QAI.0000000000000216.

  PMID: 24853306 BACKGROUND

• Haberer JE, Bangsberg DR, Baeten JM, Curran K, Koechlin F, Amico KR, Anderson P, Mugo N, Venter F, Goicochea P, Caceres C, O'Reilly K. Defining success with HIV pre-exposure prophylaxis: a prevention-effective adherence paradigm. AIDS. 2015 Jul 17;29(11):1277-85. doi: 10.1097/QAD.0000000000000647.

  PMID: 26103095 BACKGROUND

• Sheth AN, Hussen SA, Escoffery C, Haddad LB, Powell L, Brown N, Filipowicz TR, McCumber M, Sanchez M, Renshaw L, Psioda MA, Sales JM. 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). JMIR Res Protoc. 2020 Sep 25;9(9):e18784. doi: 10.2196/18784.

  PMID: 32975528 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Self-collected vaginal swabs; Self-collected anal swabs; Self-collected oral swabs; Blood samples; Urine samples; Hair samples

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jessica M Sales, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

• Anandi N Sheth, MD, MSc

  Emory University

  PRINCIPAL INVESTIGATOR

• Matthew A Psioda, PhD

  University of North Carolina, Chapel Hill

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 20, 2019
• Study Start: October 7, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)