Clinical trial NCT04097834: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
First posted: 2019-09-20
Enrollment: 103
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
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).

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).

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

Primary outcomes:
measure: Proportion of participants with a PrEP prescription at baseline who initiate PrEP
timeFrame: 6 months post enrollment
measure: 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
timeFrame: 6 months post enrollment
measure: Percentage of participants with a PrEP prescription at baseline who adhere to their PrEP regimen
timeFrame: 6 months post enrollment
Secondary outcomes:
measure: Incidence rate of Neisseria gonorrhea among each participant group
timeFrame: 3- and 6-months post enrollment
measure: Incidence rate of Chlamydia trachomatis among each participant group
timeFrame: 3- and 6-months post enrollment
measure: Incidence rate of Trichomonas vaginalis among each participant group
timeFrame: 3- and 6-months post enrollment
measure: Incidence rate of unintended pregnancy among each participant group
timeFrame: 3- and 6-months post enrollment
measure: Incidence rate of HIV infection among each participant group
timeFrame: 3- and 6-months post enrollment
measure: Proportion of participants among each participant group reporting contraception use
timeFrame: Enrollment and 3- and 6-months post enrollment
measure: Proportion of participants among each participant group reporting current contraception type
timeFrame: Enrollment and 3- and 6-months post enrollment
measure: Proportion of participants adherent to current contraceptive method measured among each participant group
timeFrame: Enrollment and 3- and 6-months post enrollment
measure: Proportion of participants who are clinically-indicated to initiate PrEP
timeFrame: 3- and 6-months post enrollment
measure: Proportion of participants who indicate interest in initiating PrEP
timeFrame: Enrollment and 3- and 6-months post enrollment
measure: Proportion of all participants who initiate PrEP
timeFrame: Enrollment and 3- and 6-months post enrollment
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Jessica M Sales, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Anandi N Sheth, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Matthew A Psioda, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.