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

NCT07361926 | Not Yet Recruiting DMC

• 2 other identifiers: STUDY00022204R01HD118713
• Study Type: interventional
• Target: 720
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sexually Transmitted Infections (Not HIV or Hepatitis); HIV Infections

Keywords

STI prevention; HIV prevention; Pharmacy delivery

Outcome Measures

Primary Outcomes (3)

• HIV PrEP initiation

  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

  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

  STI incidence (CT, NG, and/or syphilis)

  From enrollment to the end of participant follow up at 12 months

Secondary Outcomes (4)

• HIV PEP, PrEP method selection

  From enrollment to the end of participant follow up at 12 months

• HIV PrEP following PEP

  From enrollment to the end of participant follow up at 12 months

• HIV PrEP adherence

  At end of participant follow up at 12 months

• Predictors of non-adherence

  From enrollment through the end of participant follow up at 12 months

Study Arms (3)

Serial STI testing and doxy-PEP

ACTIVE COMPARATOR

STI testing and doxy-PEP offered with HIV PEP/PrEP services

Drug: doxy-PEP; Diagnostic Test: Serial STI testing; Drug: HIV PEP/PrEP

Serial STI testing alone

ACTIVE COMPARATOR

STI testing offered with HIV PEP/PrEP

Diagnostic Test: Serial STI testing; Drug: HIV PEP/PrEP

No serial STI testing or doxy-PEP

ACTIVE COMPARATOR

HIV PEP/PrEP services only

Drug: HIV PEP/PrEP

Interventions

doxy-PEP DRUG

Antiobiotic for post exposure prophylaxis

Also known as: doxycycline

Serial STI testing and doxy-PEP

Serial STI testing DIAGNOSTIC_TEST

CT/NG and syphilis testing

Serial STI testing alone; Serial STI testing and doxy-PEP

HIV PEP/PrEP DRUG

HIV post and pre exposure prophylaxis

No serial STI testing or doxy-PEP; Serial STI testing alone; Serial STI testing and doxy-PEP

Eligibility Criteria

• Age: 15 Years - 24 Years
• Gender Eligibility Details: Cis-gender female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institutes of Health (NIH): collaborator

MeSH Terms

Conditions

Sexually Transmitted Diseases; Hepatitis; HIV Infections

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Jillian Pintye, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meena Lenn, MPH

CONTACT

206.543.7140; mlenn@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 3 arm, non blinded, individually randomized controlled trial to compare 1) HIV PEP/PrEP plus serial STI testing and non doxy-PEP, 2) HIV PEP/PrEP plus serial STI testing alone, and 3) HIV PEP/PrEP only, with embedded mixed-methods implementation and economic evaluation components.

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 23, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: January 28, 2026

Record last verified: 2026-01