Sexual Health Access at Retail Pharmacies: Advancing Pharmacy-based Delivery of Primary STI and HIV Prevention for Cisgender Women (SHARP)

January 26, 2026 updated by: Jillian Pintye, University of Washington
This proposed 3-arm randomized study will compare different pharmacy based approaches that include HIV prevention medication (PrEP and PEP), routine STI testing, and preventive antibiotic (doxycycline) for STIs. The study will assess how well these services can be implemented, how acceptable they are to young women, and whether they are cost-effective.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Global incidence of STIs increased over the past decade, with over one million curable STIs acquired daily. In 2020, the World Health Organization (WHO) estimated 374 million new infections of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and syphilis. Young women in East Africa face high prevalence of curable STIs and HIV,4 and high STI incidence. Studies confirm higher STI prevalence among younger women compared to their male peers, and older women. STIs severely affect mortality and morbidity for cisgender women by causing tubal infertility, chronic pelvic pain, pelvic inflammatory disease, ectopic pregnancy, postpartum endometriosis, adverse neonatal outcomes, and increased susceptibility to HIV. In HIV high-burden settings, cultural, economic, and social marginalization of women contributes to the risk of HIV and STIs,10 in part by making condom use negotiation challenging. Despite high STI burden in these settings, research to address STIs lags behind HIV in young cisgender women.

WHO calls for vastly increasing STI testing and integrating STI interventions to reach priority populations.Sexually transmitted infections (STIs) disproportionately affect cisgender adolescent girls and young women (AGYW) who often experience STI complications, including infertility, chronic pelvic pain, and increased risk for HIV acquisition and peripartum morbidity. In Kenya, HIV and STIs comprise a syndemic with 40% of new HIV infections occurring among AGYW. Yet, research to address STIs lags behind HIV in this priority population and no primary STI prevention tools are currently available to cisgender women beyond condoms. In Kenya, 40% of women access contraception without interfacing with facilities, including at retail pharmacies, and are missed by facility-based HIV services like pre-exposure prophylaxis (PrEP). In the ongoing work among AGYW seeking contraception at 20 pharmacies in Kisumu, Kenya (NCT05467306); all AGYW offered STI testing accepted, 29% had CT or NG, and 70% accepted expedited partner therapy (EPT) and report no social harms. Among AGYW seeking emergency contraception, only 3% previously used HIV post-exposure prophylaxis (PEP), highlighting an opportunity to offer HIV PEP to AGYW via pharmacies. Qualitative data suggest that STI testing motivates health promoting behaviors, even when STI results are negative.

To date, no studies evaluate if serial STI testing promotes PrEP persistence. 'Event-driven' doxycycline PEP (doxy-PEP) for CT, NG, and syphilis found no protective benefit for Kenyan women accessing PrEP at facilities, likely due to low adherence. AGYW more frequently access emergency contraception at pharmacies compared to facilities; thus, 'event-driven' strategies, like HIV PEP ("PEP-in-Pocket") or doxy-PEP, may have higher use in pharmacies. The investigators propose a RCT in Kisumu, Kenya-a region with 11% HIV prevalence-to test co-offering HIV PEP/PrEP and STI testing with and without doxy-PEP in pharmacies and prospectively assess HIV PEP/PrEP use and persistence, and STI incidence among AGYW (n=720) and estimate cost and cost-effectiveness of this strategy. The investigators hypothesize that expanding HIV and STI prevention options to include HIV PEP, STI testing, EPT, and doxy-PEP in pharmacies will be cost-effective and improve HIV and STI outcomes in AGYW, a population disproportionately affected by STIs and HIV. The study is designed to inform pharmacy delivery of biomedical HIV and STI prevention services and provide evidence to inform policy for STI/HIV prevention among AGYW.

Study Type

Interventional

Enrollment (Estimated)

720

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

  • Name: Meena Lenn, MPH
  • Phone Number: 206.543.7140
  • Email: mlenn@uw.edu

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

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Cis-gender female
  • Seeking contraception (emergency contraception, oral contraceptive pills, injectables, implants, and condoms) from the retail pharmacy site
  • Age ≥ 15 and <25 years old
  • Willingness to receive PrEP screening per national guidelines including HIV testing
  • Not currently taking PrEP
  • Planning to reside in the area for the next 12 months
  • Able and willing to provide informed consent for participation

Exclusion Criteria:

  • Current participation in other ongoing studies.
  • Medical contraindications to PrEP or doxycycline use (e.g., severe allergy to doxycycline, serious hepatic or renal disease).
  • Any other condition that, in the investigator's judgment, would make participation unsafe or interfere with study procedures.

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Serial STI testing and doxy-PEP
STI testing and doxy-PEP offered with HIV PEP/PrEP services
Drug: doxy-PEP
Antiobiotic for post exposure prophylaxis
Other Names:
  • doxycycline
Diagnostic test: Serial STI testing
CT/NG and syphilis testing
Drug: HIV PEP/PrEP
HIV post and pre exposure prophylaxis
Active Comparator: Serial STI testing alone
STI testing offered with HIV PEP/PrEP
Diagnostic test: Serial STI testing
CT/NG and syphilis testing
Drug: HIV PEP/PrEP
HIV post and pre exposure prophylaxis
Active Comparator: No serial STI testing or doxy-PEP
HIV PEP/PrEP services only
Drug: HIV PEP/PrEP
HIV post and pre exposure prophylaxis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV PrEP initiation
Time Frame: From enrollment to the end of participant follow up after 12 months
HIV PrEP initiation among women seeking contraception at retail pharmacies defined as accepting either daily oral PrEP pills or the DPV-VR when offered at enrollment and evidence of self-reported use at 1-month post-acceptance
From enrollment to the end of participant follow up after 12 months
HIV PrEP persistence
Time Frame: From enrollment to the end of participant follow up at 12 months
PrEP persistence defined as continuing with HIV PrEP use at 12-months
From enrollment to the end of participant follow up at 12 months
STI incidence
Time Frame: From enrollment to the end of participant follow up at 12 months
STI incidence (CT, NG, and/or syphilis)
From enrollment to the end of participant follow up at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV PEP, PrEP method selection
Time Frame: From enrollment to the end of participant follow up at 12 months
Self-selection of DPV-VR, daily PrEP, and/or PEP when offered at enrollment compared across all randomization arms
From enrollment to the end of participant follow up at 12 months
HIV PrEP following PEP
Time Frame: From enrollment to the end of participant follow up at 12 months
Initiating HIV PrEP at anytime of the study following prior HIV PEP use
From enrollment to the end of participant follow up at 12 months
HIV PrEP adherence
Time Frame: At end of participant follow up at 12 months
Detectable TFC levels in hair at 12 month visit
At end of participant follow up at 12 months
Predictors of non-adherence
Time Frame: From enrollment through the end of participant follow up at 12 months
Factors associated with poor adherence (<90% adherence on PrEP or discontinuation)
From enrollment through the end of participant follow up at 12 months

Collaborators and Investigators

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

Sponsor

University of Washington

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Jillian Pintye, PhD, University of Washington

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 (Estimated)

May 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00022204
  • R01HD118713 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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