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

An observational study of HIV Infections, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 13 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: HIV Infections
How many people: 103 participants
Where: 1 siteUnited States
Study dates: 7 Oct 2019to 31 Mar 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 to 45 years
Women only
Healthy volunteers accepted
Child, Adult

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).

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Emory University
Atlanta, Georgia, 30322

Other trials in United States

About this study

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.

Read the 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).

Conditions: HIV Infections
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04097834
Study group	Role	What they receive
PrEP Prescription at Enrollment		Not described
No PrEP Prescription at Enrollment		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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)
Measured: 6 months post enrollment

Secondary outcomes (11)

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
Measured: 3- and 6-months post enrollment
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
Measured: 3- and 6-months post enrollment
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
Measured: 3- and 6-months post enrollment
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
Measured: 3- and 6-months post enrollment
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
Measured: 3- and 6-months post enrollment
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
Measured: Enrollment and 3- and 6-months post enrollment
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
Measured: Enrollment and 3- and 6-months post enrollment
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
Measured: Enrollment and 3- and 6-months post enrollment
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
Measured: 3- and 6-months post enrollment
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
Measured: Enrollment and 3- and 6-months post enrollment
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
Measured: Enrollment and 3- and 6-months post enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Oct 201931 Mar 2022

First posted20 Sep 2019
Study start7 Oct 2019
Primary completion31 Mar 2022
Study completion31 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04097834
Sponsor's protocol ID: 19-1784
Other IDs: 5U24HD089880
Status last verified: May 2022
First submitted: 13 Sep 2019
Last updated: 10 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 29020194
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.
PubMed 24421901
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.
PubMed 27098408
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.
PubMed 24853306
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.
PubMed 26103095
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.
PubMed 32975528

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Integrating PrEP Into Family Planning Services at Title X Clinics in the Southeastern US
ClinicalTrials.gov ID: NCT04097834
Acronym / sponsor ID: 19-1784
Conditions: HIV Infections
Study type: Observational
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
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)
Study start: 7 Oct 2019 (actual)
Primary completion: 31 Mar 2022 (actual)
Study completion: 31 Mar 2022 (actual)
First posted: 20 Sep 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
PrEP Prescription at Enrollment	–	–
No PrEP Prescription at Enrollment	–	–

Who may qualify

Ages: 13 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult
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).

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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)

11 secondary outcomes

Incidence rate of Neisseria gonorrhea among each participant group
Time frame: 3- and 6-months post enrollment
Incidence rate of Chlamydia trachomatis among each participant group
Time frame: 3- and 6-months post enrollment
Incidence rate of Trichomonas vaginalis among each participant group
Time frame: 3- and 6-months post enrollment
Incidence rate of unintended pregnancy among each participant group
Time frame: 3- and 6-months post enrollment
Incidence rate of HIV infection among each participant group
Time frame: 3- and 6-months post enrollment
Proportion of participants among each participant group reporting contraception use
Time frame: Enrollment and 3- and 6-months post enrollment
Proportion of participants among each participant group reporting current contraception type
Time frame: Enrollment and 3- and 6-months post enrollment
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 who are clinically-indicated to initiate PrEP
Time frame: 3- and 6-months post enrollment
Proportion of participants who indicate interest in initiating PrEP
Time frame: Enrollment and 3- and 6-months post enrollment
Proportion of all participants who initiate PrEP
Time frame: Enrollment and 3- and 6-months post enrollment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
Background: PubMed 29020194Koss 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.
Background: PubMed 24421901Liu 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.
Background: PubMed 27098408Wilson 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.
Background: PubMed 24853306Amico 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.
Background: PubMed 26103095Haberer 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.
Derived from this study: PubMed 32975528Sheth 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.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jessica M Sales, PhD principal investigator

Emory University

Anandi N Sheth, MD, MSc principal investigator

Emory University

Matthew A Psioda, PhD study director

University of North Carolina, Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with a PrEP prescription at baseline who initiate PrEP (time frame: 6 months post enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04097834, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.