Health TrialsbyHealthPanel

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

ConditionsSexually Transmitted Infections (Not HIV or Hepatitis)HIV Infections
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age15-24
SponsorUniversity of Washington

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • doxy-PEP

    Drug

    Antiobiotic for post exposure prophylaxis

  • Serial STI testing

    Diagnostic test

    CT/NG and syphilis testing

  • HIV PEP/PrEP

    Drug

    HIV post and pre exposure prophylaxis

Treatment groups

720 Participants
are divided into 3 treatment groups
Group A: Serial STI testing and doxy-PEPActive comparator 3 interventions
Group B: Serial STI testing aloneActive comparator 2 interventions
Group C: No serial STI testing or doxy-PEPActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From enrollment to the end of participant follow up after 12 months
2

HIV PrEP persistence

PrEP persistence defined as continuing with HIV PrEP use at 12-months

Time frame
From enrollment to the end of participant follow up at 12 months
3

STI incidence

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

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

Secondary outcomes

1

HIV PEP, PrEP method selection

Self-selection of DPV-VR, daily PrEP, and/or PEP when offered at enrollment compared across all randomization arms

Time frame
From enrollment to the end of participant follow up at 12 months
2

HIV PrEP following PEP

Initiating HIV PrEP at anytime of the study following prior HIV PEP use

Time frame
From enrollment to the end of participant follow up at 12 months
3

HIV PrEP adherence

Detectable TFC levels in hair at 12 month visit

Time frame
At end of participant follow up at 12 months
4

Predictors of non-adherence

Factors associated with poor adherence (\<90% adherence on PrEP or discontinuation)

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

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

Collaborator

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: