Identification of the Pre-exposure Prophylaxis (PrEP) Cascade for Women. (PrEP)

December 13, 2022 updated by: Medstar Health Research Institute

Identification of the Pre-exposure Prophylaxis (PrEP) Cascade for Women and Integration of PrEP Into Women's Family Planning Services: a Prospective Cohort

Pre-exposure prophylaxis (PrEP) is a daily pill that greatly reduces the risk of transmission of human immunodeficiency virus (HIV), however the barriers to PrEP use for women are understudied and PrEP is underutilized by women. Partnering with the DC Department of Health and the DC Center for AIDS Research (DC-CFAR), the overarching goals are (1) to identify and populate the PrEP cascade for women, (2) to provide a blueprint for family planning providers to integrate HIV prevention into their practices and target evidence-based interventions to the women at highest risk for HIV in their communities, and (3) to evaluate the cost-effectiveness of this intervention. The overarching hypotheses are that (1) the timeline and roadmap to PrEP adoption and the PrEP cascade will be different for cis-gender women than that described for men who have sex with men (MSM) and transgender women, (2) women seeking family planning services will be eligible for and interested in PrEP and family planning providers are ideally situated to provide this care, and (3) provision of PrEP in the family planning setting will be cost-effective. This research proposes to evaluate (1) PrEP cascade of events for women (eligibility for PrEP, acceptability/interest in PrEP, access/linkage to a PrEP program, initiation of PrEP, retention, and adherence to PrEP) and (2) the integration of universal screening for PrEP and PrEP provision into a women's family planning clinic. This research will allow for targeted evidence-based interventions to reach women at high-risk for HIV and will provide a blueprint for the implementation of PrEP services in the family planning setting nationally.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pre-exposure prophylaxis (PrEP) with daily tenofovir-emtricitabine (TFV/FTC) reduces transmission of human immunodeficiency virus (HIV) by up to 92%, however PrEP is underutilized, especially in women. Women account for nearly 20% of new HIV diagnoses-- most via heterosexual transmission; African-American women and women of color are disproportionately affected. PrEP is recommended for all women who "engage in sexual activity in a high prevalence area" and inconsistently use condoms. Despite this recommendation and local and national efforts to curb the HIV epidemic in the United States (US), PrEP has not been widely offered to high-risk cis-gender women and their "PrEP cascade" of events (eligibility for PrEP, acceptability/interest in PrEP, access/linkage to a PrEP program, initiation of PrEP, retention, and adherence to PrEP) for women has not been described in order to inform intervention.

PrEP is especially critical for high-risk women in Washington DC (DC), an epicenter of the HIV epidemic in the US. Recent focus groups with African-American women at risk for HIV in DC revealed inadequate knowledge about and difficulty accessing PrEP, but high levels of acceptability and interest. Qualitative research and the research team's clinical initial experience in PrEP provision demonstrate that cis-gender women require more contact with providers and have more concerns regarding logistics, interactions, and disclosure of PrEP use to partners compared to transgender women and men who have sex with men (MSM)-suggesting 1) a different timeline for initiation of PrEP and 2) a different PrEP cascade in women. Identifying and populating the PrEP cascade for women will allow the investigators to target evidence-based interventions to reach women at risk for HIV.

The same high-risk sexual activity that puts women at risk for HIV also puts women at risk for unintended pregnancy; the latter leads many of them to seek care in family planning clinics. While there may be synergies in offering PrEP along with contraception and pregnancy termination services at family planning clinics, most family planning clinics do not offer PrEP. A recent study demonstrated low levels of PrEP knowledge and of comfort prescribing PrEP among family planning providers, however 90% of providers reported interest in learning more about PrEP and the majority of family planning patients surveyed reported they would consider using PrEP. The investigators hypothesize that integrating HIV prevention into family planning services would empower women and better meet their preventative health needs.

Partnering with the DC Department of Health (DOH) and the DC Center for AIDS Research (DC-CFAR), the over-arching goals are (1) to identify and populate the PrEP cascade for women, (2) to provide a blueprint for family planning providers to integrate HIV prevention into their practices and target evidence-based interventions to the women at highest risk for HIV in their communities, and (3) to evaluate the cost-effectiveness of this intervention. The overarching hypotheses are that (1) the timeline and roadmap to PrEP adoption and the PrEP cascade will be different for cis-gender women than that described for MSM and transgender women, (2) women seeking family planning services will be eligible for and interested in PrEP and family planning providers are ideally situated to provide this care, and (3) provision of PrEP in the family planning setting will be cost-effective. MedStar Washington Hospital Center (MWHC) provides the ideal setting to elucidate the PrEP cascade in women and to design and evaluate integrated PrEP services in the family planning setting. The Family Planning and Preventative Care (FPPC) clinic at MWHC provides over 800 family planning visits annually, the majority to African-American, low socioeconomic status women at high-risk for HIV. Family planning providers at MWHC are not yet routinely assessing PrEP eligibility or prescribing PrEP, however, the investigators anticipate that the majority of patients seeking care at FPPC will be eligible for and could benefit from PrEP. The investigators propose a prospective cohort to evaluate the following specific aims:

Specific Aim 1 To test the hypothesis that the PrEP cascade for women will be different than that described for men, the investigators will identify and populate the PrEP cascade by assessing women's risk factors for and perceived vulnerability to HIV, PrEP acceptability, initiation, continuation, and adherence. The investigators will describe the timeline and roadmap to PrEP uptake and will explore determinants of the stages of the PrEP cascade.

Specific Aim 2 To test the hypotheses that (a) family planning clinics provide a high-yield and feasible venue in which to reach women at high-risk for HIV acquisition and to offer PrEP initiation and follow-up, and (b) provision of PrEP in the family planning setting will be cost-effective, the investigators will assess the reach, effectiveness, adoption, implementation, maintenance (RE-AIM)[8], and cost-effectiveness of the integration and provision PrEP in a family planning clinic.

These results will overcome the primary obstacle to more effective provision of PrEP to high-risk cis-gender women by describing the PrEP cascade, which is needed to inform HIV prevention for women. Additionally, this study will provide critical insight into the provision of PrEP in a novel and practical setting. These results will lead directly to evidence based PrEP programs that can be integrated into family planning care nationally in high-risk areas, thereby addressing persisting disparities in gender and race in HIV prevention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20002
        • DC Health and Wellness Center
      • Washington, District of Columbia, United States, 20010
        • Rachel Scott

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women at high risk for HIV interested in and/or initiating pre-exposure prophylaxis (PrEP)

Description

Inclusion Criteria:

  1. Cis-gender women
  2. Interested in PrEP and/or initiating PrEP

Exclusion Criteria:

  1. HIV positive
  2. Severe liver disease
  3. Severe renal (kidney) disease
  4. Signs/symptoms of acute HIV infection (such as fever, swollen lymph nodes, sore throat, skin rash, body aches)
  5. Do not speak English or Spanish
  6. No access to a telephone for follow-up
  7. Planning to leave the Washington, DC area in the next 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Women interested in HIV PrEP
Cis-gender women at high risk for HIV interested in or initiating HIV PrEP
Behavioral: PrEP initiation
Women who are interested in or who initiate PrEP will be followed in a prospective cohort to identify and populate the PrEP cascade for cis-gender, high risk women

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PrEP cascade in cis-gender women
Time Frame: 2 years
We will be using a variety of measures to describe the "PrEP cascade" for women, specifically the proportion of women who initiate, continue, and adhere to PrEP and the timeline associated with the steps of the PrEP cascade.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Implementation analysis of universal PrEP screening
Time Frame: 2 years

Descriptive implementation analysis using the RE-AIM framework:

Reach - The absolute number/proportion/representativeness of women who initiate PrEP, continue PrEP etc.

Efficacy - The impact of universal PrEP screening on PrEP initiation and HIV prevention.

Adoption - The absolute number/proportion/representativeness of clinics/providers who are willing to initiate universal PrEP Implementation - At the setting level, the providers' fidelity to the intervention's protocol. At the individual level, implementation refers to women's PrEP uptake.

Maintenance - The extent to which the PrEP program becomes institutionalized or part of the routine organizational practices and policies. Within the RE-AIM framework, maintenance also applies at the individual level, defined as the long-term effects of a program on outcomes after 6 or more months after the most recent intervention contact-in this case continuation of PrEP
2 years
Cost effectiveness analysis of universal PrEP screening
Time Frame: 2 years
Cost-effectiveness analysis of the integration and provision PrEP in a family planning clinic using quality adjusted life years (QALY) and cost.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medstar Health Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rachel K Scott, MD, Medstar Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 27, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-0870

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Sharing of our data on 1) the PrEP cascade for women and 2) the integration of PrEP provision into the family planning setting that will result from this proposed study is an integral part of both our proposed research activities and planned next steps. We plan to make our results available both to the community of clinicians and researchers interested in HIV prevention in women and/or the integration of PrEP in the family planning setting to avoid duplication of research, to allow the clinical and research community to benefit from the novel conclusions and insights that may arise from this research, and to foster research collaboration with other sites to build upon our findings.

IPD Sharing Time Frame

Upon request.

IPD Sharing Access Criteria

Pending review of concept sheet.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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