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.: PACTR201711002632911 Date of Approval: 19/09/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Key Population Implementation Science Study
Official scientific title Oral Self Testing and optimum Peer Educator to Female Sex Worker ratio for increased uptake of HIV testing and follow up among female sex workers in Kenya
Brief summary describing the background and objectives of the trial The HIV epidemic in Kenya is mixed, with a higher prevalence among key populations ¿ KPs (female and male sex workers, men who have sex with men and people who inject drugs). Sex workers of both genders are at a higher risk of HIV infection due to their high risk sexual behavior and contribute to about 14% of new infections in Kenya. This is because they have many sexual partners, engage in numerous sexual acts with the partners, have concurrent relationships with regular partners, engage in unprotected vaginal and anal sex, and may engage in drug and alcohol use prior to sex. Existing HIV prevention interventions employed for KPs in Kenya need to be evaluated to determine if innovations in service delivery improve the programs¿ feasibility, acceptability, and scalability of the programs. Study objectives: i) To determine the optimum peer educator-to-female sex worker ratio (PE: FSW) that improves quarterly HIV testing uptake among HIV-negative (female sex workers) FSWs. ii) To determine the optimum PE: FSW ratio that improves routine clinic visits among HIV-positive FSWs. iii) To assess user acceptability, competence and feasibility of oral HIV self-testing (OST) and its impact on enrollment of FSWs into drop-in centers (DiCEs).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) IPS
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 25/09/2015
Actual trial start date 15/02/2016
Anticipated date of last follow up 01/02/2018
Actual Last follow-up date 01/02/2018
Anticipated target sample size (number of participants) 3880
Actual target sample size (number of participants) 4405
Recruitment status Closed to recruitment,follow-up continuing
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group HIV oral self-testing (OST) kit 6 months Issuing of OST kits, followed with 3 months of washout period when no OST was issued to any group 880
Control Group Standard treatment 6 months No intervention implemented, followed with 3 months of washout period when no OST was issued to any group 495
Experimental Group Peer Educator to FSW ratio N/A 18 months Peer educators randomly assigned half the number of sex workers they were serving 926
Experimental Group Peer Educator to FSW ratio 18 months PEs maintain the full number of sex workers they have been serving 2084
Experimental Group HIV oral self-testing (OST) kit 6 months Issuing of OST kits, followed with 3 months of washout period when no OST was issued to any group 900
Control Group Standard treatment 6 months No intervention implemented, followed with 3 months of washout period when no OST was issued to any group 495
Experimental Group Peer Educator to FSW ratio 18 months Peer educators randomly assigned half the number of sex workers they were serving 926
Experimental Group Peer Educator to FSW ratio 18 months PEs maintain the full number of sex workers they have been serving 2084
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Female sex worker who is 18 years of age or older Any female sexually exploited child who are less than 18 years of age, FSWs who do not give informed consent or do not have cognitive ability to consent (e.g. intoxicated) 18 Year(s) 80 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 11/05/2016 KEMRI Scientific Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
P.O Box 54840 House Number 8, KEMRI Headquarter, Off Mbagathi Road Nairobi 00200 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 25/05/2015 KEMRI Scientific Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
P.O Box 54840 House Number 8, KEMRI Headquarter, Off Mbagathi Road Nairobi 00200 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 06/06/2017 KEMRI Scientific Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
P.O Box 54840 House Number 8, KEMRI Headquarter, Off Mbagathi Road Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of HIV negative FSWs who test for HIV quarterly Quarterly for 18 months
Primary Outcome Proportion of HIV positive FSWs retained in HIV care and treatment (visit the DICE quarterly) Quarterly for 18 months
Primary Outcome Proportion of new FSWs enrolled in the DICEs who received OST 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mombasa Region (ICRHK DICEs in Mvita, Mtwapa, Likoni and Kisauni) Technical University of Mombasa Kwa Kiziwi Campus (Hotel School) Obote Avenue - Tudor Estate PO Box 91109 Mombasa Mombasa 80103 Kenya
Kisumu Region (Tumaini DICEs in Kisumu, Sondu, Awasi and Asembo Bay) Baring Road-Milimani P.O. Box 9171 Kisumu Kisumu 40141 Kenya
Migori Region (Tekeleza DICEs in Kisii, Migori, Mbita and Sindo) Baring Road-Milimani P.O. Box 9171 Kisumu Kisumu 40141 Kenya
Nairobi Region (SWOP DICEs in City, Langata, Donholm, and Majengo) Kenya AIDS Control Project, Department of Medical Microbiology, University of Nairobi, PO Box 69555 Nairobi Nairobi 00400 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
President¿s Emergency Plan for AIDS Relief (PEPFAR) Office of the U.S. Global AIDS Coordinator and Health Diplomacy 1800 G Street, N.W., Suite 10300 Washington, DC 20006 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Centers for Disease Control and Prevention KEMRI Complex, Mbagathi Road off Mbagathi Way PO Box 606 Nairobi 00621 Kenya Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Kenya Ministry of Health (MoH) Kenyatta National Hospital Grounds P.O Box 19361 Nairobi 00201 Kenya
Impact Research and Development Organization Baring Road-Milimani P.O. Box 9171 Kisumu Kisumu 40141 Kenya
International Center for Reproductive Health Technical University of Mombasa Kwa Kiziwi Campus (Hotel School) Obote Avenue - Tudor Estate PO Box 91109 Mombasa Mombasa 80103 Kenya
University of Nairobi/University of Manitoba Kenya AIDS Control Project, Department of Medical Microbiology, University of Nairobi, PO Box 69555 Nairobi Nairobi 00400 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kawango Agot mamagifto@yahoo.com +254 727 688550 Baring Road-Milimani P.O Box 9171
City Postal code Country Position/Affiliation
Kisumu 40141 Kenya Director, Impact Research and Development Organization
Role Name Email Phone Street address
Principal Investigator Joshua Kimani jkimani@csrkenya.org +254 20 2713179 Kenya AIDS Control Project, Department of Medical Microbiology, University of Nairobi, PO Box 69555
City Postal code Country Position/Affiliation
Nairobi 00400 Kenya Clinical Director, Kenya AIDS Control Project
Role Name Email Phone Street address
Principal Investigator Peter Gichangi peter@icrhk.org +254 722 208 652 Technical University of Mombasa Kwa Kiziwi Campus (Hotel School) Obote Avenue - Tudor Estate PO Box 91109
City Postal code Country Position/Affiliation
Mombasa 80103 Kenya Director, International Center for Reproductive Health, Kenya
Role Name Email Phone Street address
Public Enquiries Kawango Agot mamagifto@yahoo.com +254 57 2020132 Baring Road-Milimani P.O Box 9171
City Postal code Country Position/Affiliation
Kisumu 40141 Kenya Director, Impact Research and Development Organization
Role Name Email Phone Street address
Scientific Enquiries Kawango Agot mamagifto@yahoo.com +254 57 2020132 Baring Road-Milimani P.O Box 9171
City Postal code Country Position/Affiliation
Kisumu 40141 Kenya Director, Impact Research and Development Organization
REPORTING
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