Clinical trial NCT03705663: Identification of the Pre-exposure Prophylaxis (PrEP) Cascade for Women.
Official title: Identification of the Pre-exposure Prophylaxis (PrEP) Cascade for Women and Integration of PrEP Into Women's Family Planning Services: a Prospective Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-Exposure Prophylaxis
Keywords: HIV prevention, PrEP cascade, women
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women at high risk for HIV interested in and/or initiating pre-exposure prophylaxis (PrEP)

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: PrEP cascade in cis-gender women
timeFrame: 2 years
Secondary outcomes:
measure: Implementation analysis of universal PrEP screening
timeFrame: 2 years
measure: Cost effectiveness analysis of universal PrEP screening
timeFrame: 2 years
Other outcomes:
Locations:
city: Washington
country: United States
facility: DC Health and Wellness Center
state: District of Columbia
city: Washington
country: United States
facility: Rachel Scott
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Rachel K Scott, MD
role: PRINCIPAL_INVESTIGATOR
References: