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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202004903331089 Date of Approval: 14/04/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title HIV self-testing to improve the efficiency of PrEP delivery: JiPime JiPrEP Study
Official scientific title HIV self-testing to improve the efficiency of PrEP delivery
Brief summary describing the background and objectives of the trial Maximizing access and minimizing costs of delivery are key challenges for optimizing the public health impact of pre-exposure prophylaxis (PrEP) for HIV-1 prevention, particularly for resource-constrained settings. PrEP is highly effective and safe when taken as prescribed, and demonstration studies are showing how PrEP can be delivered in clinical settings. In Africa, PrEP will be added to already-burdened health infrastructure and the ability of public health systems to afford PrEP will necessitate making it's delivery cost-effective and time-efficient. PrEP delivery programs will need to be cost-sensitive to staffing needs (e.g., frequent clinic visits); moreover, patients may not continue PrEP if their costs (e.g., travel to / waiting in clinics) are high. HIV-1 testing is central to PrEP: testing must occur prior to initiation and ongoing HIV-1 testing is essential for delivery. Like PrEP, HIV-1 self-testing is a recent innovation and its opportunities to improve HIV-1 prevention have not been fully realized. We hypothesize that HIV-1 self-testing can streamline PrEP delivery – through decreasing the frequency of PrEP clinic visits by having self-tests at home replace clinic-based testing. Both oral fluid and new finger stick blood-based HIV-1 self-tests could be used, and these two modalities might have different costs or preferences. Aim 1: In a randomized trial, we will test the use of HIV-1 self-testing to decrease the frequency and burden of clinic visits for PrEP while resulting in equivalent adherence and testing. Aim 2: We will conduct mixed-methods work to understand the user and provider experiences, preferences, barriers, and facilitators related to HIV-1 self-testing. Aim 3: We will assess the costs and cost-effectiveness of HIV-1 self-testing to optimize PrEP delivery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 01/05/2018
Actual trial start date 28/05/2018
Anticipated date of last follow up 30/06/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 495
Actual target sample size (number of participants) 495
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
ECCT 18 03 01 Pharmacy and Poisons Board
0089 3614 Kenya Medical Research Institute
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard of Care Randomization will occur in a 2:1 fashion to alternating HIV-1 testing at home and in-clinic testing, or standard of care (HIV-1 testing at in-clinic follow-up visits every 3 months). Those randomized to Standard of Care (SOC) will be the control group. 12 Months Randomization will occur in a 2:1 fashion to alternating HIV-1 testing at home and in-clinic testing, or standard of care (HIV-1 testing at in-clinic follow-up visits every 3 months). 165 Active-Treatment of Control Group
Experimental Group Blood based HIV self testing Randomization will occur in a 2:1 fashion to alternating HIV-1 testing at home and in-clinic testing. Those randomized to the self-testing arm will then be further randomized in a 1:1 fashion to either blood-based or oral fluid-based self-testing kits. 12 Months Randomization will occur in a 2:1 fashion to alternating HIV-1 testing at home and in-clinic testing. Those randomized to the self-testing arm will then be further randomized in a 1:1 fashion to either blood-based or oral fluid-based self-testing kits. 165
Experimental Group Oral fluid based HIV self testing Randomization will occur in a 2:1 fashion to alternating HIV-1 testing at home and in-clinic testing. Those randomized to the self-testing arm will then be further randomized in a 1:1 fashion to either blood-based or oral fluid-based self-testing kits. 12 Months Randomization will occur in a 2:1 fashion to alternating HIV-1 testing at home and in-clinic testing. Those randomized to the self-testing arm will then be further randomized in a 1:1 fashion to either blood-based or oral fluid-based self-testing kits. 165
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Age ≥18 years HIV-1 uninfected based on negative HIV-1 rapid testing - Not currently enrolled in an HIV-1 prevention clinical trial - Taking PrEP and planning to continue - Willing to be randomized to either clinic based HIV-1 testing or HIV-1 self testing - Note: Women who are pregnant at screening/enrollment are still eligible For the HIV-1 serodiscordant couples, HIV-1 infected members of the couple will be enrolled for a single visit at baseline, if: - Age ≥18 - Able and willing to provide written informed consent - Unable to provide written informed consent - Contraindication to use TDF/FTC/3TC Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
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 20/03/2018 Kenya Medical Research Institute
Ethics Committee Address
Street address City Postal code Country
Mbagathi way Nairobi 00100 Kenya
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 15/05/2018 Pharmacy and Poisons Board
Ethics Committee Address
Street address City Postal code Country
Lenana Road Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adherence outcome. Adherence by PrEP in dried blood spots is defined as the primary trial outcome for the purposes of sample size calculations. Cumulative and recent adherence to PrEP will be measured by concentrations of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP). Month 6 and Month 12 visits
Secondary Outcome Testing and safety outcomes. HIV-1 testing will be measured as the combination of in-clinic tests and home tests, recorded by self-report and by requesting that completed self-test cartridges be returned to the clinic for validation of self-report. Month 6 and Month 12
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Partners in Prevention House OAU Road Thika Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
United States National Institutes of Health 9000 Rockville Pike, Bethesda 20892 Bethesda United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Washington 315 15th Avenue Seattle United States of America University
COLLABORATORS
Name Street address City Postal code Country
Kenya Medical Research Institute Mbagathi way Nairobi Kenya
Universtity of Washington 315 15th Avenue Seattle United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kenneth Ngure kngure@pipsthika.org 0736464299 OAU Road
City Postal code Country Position/Affiliation
Thika Kenya Local Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Jared Baeten jbaeten@uw.edu +12066018598 315 15th Avenue
City Postal code Country Position/Affiliation
Seattle United States of America Procotocol Chair
Role Name Email Phone Street address
Public Enquiries Peter Mogere patandi@pipsthika.org 0736464299 OAU Road
City Postal code Country Position/Affiliation
Thika Kenya Study Coordinator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The principal investigator and the protocol chair commits to share this information once the study is complete, data analysed and results published. Study Protocol IPD will be shared after study completion and results published. Results of this study will be published in publicly accessible sites and journals.
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