Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607850859928 Date of Registration: 06/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title SHARP- Sexual Health at Retail Pharmacies
Official scientific title Advancing pharmacy-based delivery of primary STI and HIV prevention for cisgender women
Brief summary describing the background and objectives of the trial Sexually transmitted infections (STIs) and HIV disproportionately affect adolescent girls and young women (AGYW) in Kenya, where they account for approximately 40% of new HIV infections. Many AGYW obtain contraception from community pharmacies rather than health facilities, limiting their access to integrated HIV and STI prevention services. Although oral HIV pre-exposure prophylaxis (PrEP) is available, persistence remains suboptimal, and there are currently limited primary STI prevention options for cisgender women. Preliminary studies conducted by the investigators demonstrated high acceptability of pharmacy-based PrEP delivery and STI testing among AGYW, supporting pharmacies as an effective platform for expanding prevention services. This trial aims to evaluate the effectiveness, feasibility, acceptability, and cost-effectiveness of delivering integrated HIV and STI prevention services through retail pharmacies in Kisumu, Kenya. In a three-arm, individually randomized controlled trial, participants will receive: (1) HIV PEP/PrEP, serial STI testing, and doxycycline prophylaxis; (2) HIV PEP/PrEP and serial STI testing; or (3) HIV PEP/PrEP alone. The study will compare HIV prevention uptake and persistence, STI incidence, expedited partner therapy uptake, implementation outcomes, and cost-effectiveness. Findings will inform policy and implementation strategies for expanding pharmacy-based HIV and STI prevention services for AGYW in Kenya and similar high-burden settings.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SHARP
Disease(s) or condition(s) being studied Infections and Infestations,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 05/10/2026
Actual trial start date
Anticipated date of last follow up 28/09/2029
Actual Last follow-up date
Anticipated target sample size (number of participants) 720
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group HIV PEP PrEP only no serial STI testing and no doxycycline prophylaxis HIV pre-exposure prophylaxis (PrEP): Tenofovir disoproxil fumarate 300 mg plus lamivudine 300 mg orally once daily, or dapivirine vaginal ring replaced every 28 days. HIV post-exposure prophylaxis (PEP): Tenofovir disoproxil fumarate 300 mg, lamivudine 300 mg, and dolutegravir 50 mg orally once daily for 28 days, according to Kenya Ministry of Health (NASCOP) guidelines. No serial STI testing or doxycycline prophylaxis will be provided in this arm. STI testing will only be done at enrolment and month 12. 12 months Participants will receive standard pharmacy-based HIV prevention services according to Kenya Ministry of Health (NASCOP) guidelines. Eligible participants will be offered HIV post-exposure prophylaxis (PEP), PEP-in-Pocket, or HIV pre-exposure prophylaxis (PrEP), including daily oral PrEP or the dapivirine vaginal ring (DPV-VR), based on clinical eligibility and participant preference. Services include HIV risk assessment, HIV testing, adherence counseling, remote clinician oversight for prescribing, and follow-up for 12 months. Participants in this arm will not receive serial STI testing or doxycycline prophylaxis. STI testing will only be done at enrolment and month 12. 240 Active-Treatment of Control Group
Experimental Group HIV PEP PrEP serial STI testing and doxycycline prophylaxis HIV pre-exposure prophylaxis (PrEP): Tenofovir disoproxil fumarate 300 mg plus lamivudine 300 mg orally once daily, or dapivirine vaginal ring replaced every 28 days. HIV post-exposure prophylaxis (PEP): Tenofovir disoproxil fumarate 300 mg, lamivudine 300 mg, and dolutegravir 50 mg orally once daily for 28 days. Doxycycline prophylaxis: Doxycycline 100 mg orally once daily (doxycycline pre-exposure prophylaxis) or doxycycline hyclate 200 mg orally within 72 hours after condomless sexual intercourse, not exceeding 200 mg in 24 hours, according to participant preference. STI testing will be done at enrolment, month 1, month 3, month 6, month 9, and month 12. 12 months Participants will receive standard pharmacy-based HIV prevention services according to Kenya Ministry of Health (NASCOP) guidelines, including HIV PEP, PEP-in-Pocket, or HIV PrEP (daily oral PrEP or the dapivirine vaginal ring [DPV-VR]) based on clinical eligibility and participant preference. In addition, participants will undergo serial STI testing and be offered expedited partner therapy (EPT) for eligible bacterial STIs. Participants will also receive doxycycline prophylaxis and may choose either doxycycline pre-exposure prophylaxis (doxy-PrEP; 100 mg orally once daily) or doxycycline post-exposure prophylaxis (doxy-PEP; 200 mg doxycycline hyclate within 72 hours after condomless sexual intercourse, with a maximum dose of 200 mg per day). Enhanced adherence counseling and optional SMS reminders and follow-up support will be provided. STI testing will be done at enrolment, month 1, month 3, month 6, month 9, and month 12. 240
Experimental Group HIV PEP PrEP and Serial STI Testing HIV pre-exposure prophylaxis (PrEP): Tenofovir disoproxil fumarate 300 mg plus lamivudine 300 mg orally once daily, or dapivirine vaginal ring replaced every 28 days. HIV post-exposure prophylaxis (PEP): Tenofovir disoproxil fumarate 300 mg, lamivudine 300 mg, and dolutegravir 50 mg orally once daily for 28 days, according to Kenya Ministry of Health guidelines. No doxycycline prophylaxis will be provided. STI testing done at enrolment, month 1, month 3, month 6, month 9, and month 12. 12 months. Participants will receive standard pharmacy-based HIV prevention services according to Kenya Ministry of Health (NASCOP) guidelines, including HIV post-exposure prophylaxis (PEP), PEP-in-Pocket, or HIV pre-exposure prophylaxis (PrEP) (daily oral PrEP or the dapivirine vaginal ring [DPV-VR]) based on clinical eligibility and participant preference. In addition, participants will undergo serial sexually transmitted infection (STI) testing at scheduled follow-up visits and will be offered expedited partner therapy (EPT) for eligible bacterial STIs in accordance with Kenya national guidelines. Participants in this arm will not receive doxycycline prophylaxis. 240
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• 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 • Willing and eligible to take doxycycline • Planning to reside in the area for the next 12 months • Able and willing to provide informed consent for participation • 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 Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s) 15 Year(s) 24 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/06/2026 Kenya Medical Research Institute Scientific Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
Raila Odinga Highway Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome HIV PrEP Initiation 1 month after enrolment
Primary Outcome HIV PrEP persistence 12 months after enrolment
Primary Outcome STI Incidence Month 1, Month 3, Month 6, Month 9, and Month 12 after enrolment.
Secondary Outcome HIV PEP, PrEP Method Selection At Enrolment
Secondary Outcome HIV PrEP following PEP Initiating HIV PrEP at anytime of the study following prior HIV PEP use
Secondary Outcome HIV PrEP adherence 12 months after enrolment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KEMRI RCTP KEMRI CIS Building, Lumumba Sub-County Hospital, Along Ondiek Highway Kisumu 614-40100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institutes of Health 9000 Rockville Pike Bethesda 20892 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Washington International Clinical Research Center 908 Jefferson Street Seattle 98104 United States of America University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Elizabeth Bukusi ebukusi@kemri.go.ke +254733617503 KEMRI CIS Building, Lumumba Sub-County Hospital, Along Ondiek Highway
City Postal code Country Position/Affiliation
Kisumu 614-40100 Kenya Principal Investigator
Role Name Email Phone Street address
Public Enquiries Elizabeth Bukusi ebukusi@kemri.go.ke +254733617503 KEMRI CIS Building, Lumumba Sub-County Hospital, Along Ondiek Highway
City Postal code Country Position/Affiliation
Kisumu 614-40100 Kenya Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Elizabeth Bukusi ebukusi@kemri.go.ke +254733617503 KEMRI CIS Building, Lumumba Sub-County Hospital, Along Ondiek Highway
City Postal code Country Position/Affiliation
Kisumu 614-40100 Kenya Principal Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified participant data may be stored and shared for future research with other researchers and, where applicable, large data repositories. Access to repository-held data will be limited to qualified researchers with prior approval Clinical Study Report,Informed Consent Form,Study Protocol Within 24 months of the study completion De-identified data only; access by qualified researchers with prior approval/oversight.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information