An interventional study of doxy-PEP and Serial STI testing in Sexually Transmitted Infections (Not HIV or Hepatitis) and HIV Infections, sponsored by University of Washington. Not yet recruiting. Open to female participants aged 15 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by University of Washington · Not applicable, Interventional, and Prevention
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.
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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's planned enrollment of 720 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →University of Washington is the lead sponsor of 1,433 studies on the registry; 225 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
Compared within HIV Infections, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sexually Transmitted Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
STI testing and doxy-PEP offered with HIV PEP/PrEP services
Drug: doxy-PEP · Diagnostic Test: Serial STI testing · Drug: HIV PEP/PrEP
STI testing offered with HIV PEP/PrEP
Diagnostic Test: Serial STI testing · Drug: HIV PEP/PrEP
HIV PEP/PrEP services only
Drug: HIV PEP/PrEP
Antiobiotic for post exposure prophylaxis
Also known as: doxycycline
CT/NG and syphilis testing
HIV post and pre exposure prophylaxis
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
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
STI incidence
STI incidence (CT, NG, and/or syphilis)
Time frame: From enrollment to the end of participant follow up at 12 months
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
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
HIV PrEP adherence
Detectable TFC levels in hair at 12 month visit
Time frame: At end of participant follow up at 12 months
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
No study locations are listed for this record.
Start is estimated for May 2026; primary completion for Jun 2029, 37 months later.
Of 393 non-industry interventional studies with no phase under HIV Infections, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's planned 37 months is above that.
Counting every sponsor, half of 402 studies reached it within 28 months; a quarter within 16 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Doxycycline