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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04097834
• Other study ID #: 19-1784
• Secondary ID: 5U24HD089880
• Status: Completed
• Start date: October 7, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: May 2022
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Incidence rate of Neisseria gonorrhea among each participant group	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	3- and 6-months post enrollment
Secondary	Incidence rate of Chlamydia trachomatis among each participant group	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	3- and 6-months post enrollment
Secondary	Incidence rate of Trichomonas vaginalis among each participant group	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	3- and 6-months post enrollment
Secondary	Incidence rate of unintended pregnancy among each participant group	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	3- and 6-months post enrollment
Secondary	Incidence rate of HIV infection among each participant group	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	3- and 6-months post enrollment
Secondary	Proportion of participants among each participant group reporting contraception use	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	Enrollment and 3- and 6-months post enrollment
Secondary	Proportion of participants among each participant group reporting current contraception type	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	Enrollment and 3- and 6-months post enrollment
Secondary	Proportion of participants adherent to current contraceptive method measured among each participant group	Proportion of participants adherent to current contraceptive method measured among each participant group via self-report	Enrollment and 3- and 6-months post enrollment
Secondary	Proportion of participants who are clinically-indicated to initiate PrEP	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	3- and 6-months post enrollment
Secondary	Proportion of participants who indicate interest in initiating PrEP	Among all participants, the proportion of participants who report interest in beginning PrEP via interviewer-administered questionnaire and self-report	Enrollment and 3- and 6-months post enrollment
Secondary	Proportion of all participants who initiate PrEP	Among all participants, the proportion of participants with a PrEP-prescription, pharmacy-confirmed fill of their PrEP prescription, and who self-report initiating PrEP	Enrollment and 3- and 6-months post enrollment

External Links

•   CDC Effectiveness of Family Planning Method
•   CDC Laboratory testing for the diagnosis of HIV infection:updated recommendations
•   CDC Preexposure Prophylaxis for the Prevention of HIV Infection in the United States-2017 Update A Clinical Practice Guideline