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.: PACTR201711002697316 Date of Approval: 16/10/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their Partners
Official scientific title Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their Partners
Brief summary describing the background and objectives of the trial This is an unblinded cluster-randomized study to evaluate the feasibility and cost-effectiveness of HIV self-testing strategies compared to standard of care in outpatient departments (OPD) and sexually transmitted infection (STI) clinics. The first aim of the study will be conducted in Malawi at 15 clusters among 15,000 individuals (15 years or older) to test the feasibility and cost-effectiveness of group HIV self-testing for patients in OPD and STI clinic waiting areas. The second aim of the study will be conducted in Malawi at 15 clusters among 7,500 individuals (15 years or older) to test the feasibility and cost-effectiveness of HIV self-testing for partners of newly identified HIV-positive clients.
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 Diagnosis / Prognosis
Anticipated trial start date 25/09/2017
Actual trial start date 25/09/2017
Anticipated date of last follow up 30/06/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 22500
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
NCT03271307 ClinicalTrials.gov
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 Stratified allocation by facility Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation by facility 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 Standard of care (SOC) n/a n/a SOC facilities will not receive an intervention and will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling for index client testing (informing OPD/STI patients about HIV testing and referral to testing services) and for index partner referral mechanisms (offering referral slips to newly identified HIV+ clients). 5000 Active-Treatment of Control Group
Experimental Group Optimized standard of care (OSOC) n/a n/a OSOC facilities will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling for index client testing and for index partner referral mechanisms (same as SOC), though these facilities will receive additional guidance and support from the study team to adopt and maintain the guidelines. 5000
Experimental Group HIV self-testing (HIVST) n/a n/a HIVST facilities will implement HIV self-testing procedures in lieu of provider-initiated counseling and testing. Index clients will be offered HIV self-test kits in OPD or STI waiting areas. Newly identified HIV+ clients will be offered HIV self-test kits to distribute to their partners. 5000
Control Group Standard of care (SOC) n/a n/a SOC facilities will not receive an intervention and will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling for index client testing (informing OPD/STI patients about HIV testing and referral to testing services) and for index partner referral mechanisms (offering referral slips to newly identified HIV+ clients). 7500 Active-Treatment of Control Group
Experimental Group HIV self-testing (HIVST) n/a n/a HIVST facilities will implement HIV self-testing procedures in lieu of provider-initiated counseling and testing. Index clients will be offered HIV self-test kits in OPD or STI waiting areas. Newly identified HIV+ clients will be offered HIV self-test kits to distribute to their partners. 7500
Experimental Group Optimized standard of care (OSOC) n/a n/a OSOC facilities will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling for index client testing and for index partner referral mechanisms (same as SOC), though these facilities will receive additional guidance and support from the study team to adopt and maintain the guidelines. 7500
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
15 years or older Willing and able to provide informed consent Being seen for OPD or STI services at the time of the study (Aim 1) HIV-positive (Aim 2) Have at least one sex partner in the catchment area with an unknown HIV status at the time of study enrollment (Aim 2) Currently enrolled in the INTERVAL study Guardians attending clinics with OPD or STI clients (Aim 1) History of intimate partner violence in the past 12 months (Aim 2) Fear of intimate partner violence as a consequence of participating in the study (Aim 2) 15 Year(s) 100 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 17/05/2017 UCLA Office of the Human Research Protection Program
Ethics Committee Address
Street address City Postal code Country
11000 Kinross Avenue, Suite 211 Los Angeles, CA 90095 United States of America
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 31/01/2017 Malawi National Health Sciences Research Committee
Ethics Committee Address
Street address City Postal code Country
P.O. Box 30377 Lilongwe 3 Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Number of patients and partners tested for HIV in OPD and STI clinics 2 months
Primary Outcome Cost-effectiveness of HIV self-testing in OPD and STI clinics and distributing HIV self-test kits for index partner testing 2 months
Secondary Outcome Acceptability of HIV self-testing in waiting areas of OPD and STI clinics and for index partner testing 2 months
Secondary Outcome Testing yield of HIV-positive individuals from OPD and STI clinics and index partners 2 months
Secondary Outcome Rate of linkage to care (ART services) for HIV positive index clients and index partners 2 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Partners in Hope Area 36, Plot 8, M1 Road South Lilongwe Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
U.S. Agency for International Development (USAID) Washington, DC United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor EQUIP, Right to Care 3rd Floor Outspan Building, 1006 Lenchen North Ave. Centurion South Africa Commercial Sector/Industry
Secondary Sponsor Partners in Hope Area 36, Plot 8, M1 Road South Lilongwe 3 Malawi Hospital
COLLABORATORS
Name Street address City Postal code Country
UCLA 10833 Le Conte Ave., CHS 37-121 Los Angeles, CA 90095 United States of America
Malawi Ministry of Health P.O. Box 30377 Lilongwe 3 Malawi
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kathryn Dovel kdovel@mednet.ucla.edu 265-99-764-5317 Area 36, Plot 8, M1 Road South
City Postal code Country Position/Affiliation
Lilongwe 3 Malawi Adjunct Assistant Professor
Role Name Email Phone Street address
Public Enquiries Frackson Shaba fraxonnuka@gmail.com 265-88-853-1006 Area 36, Plot 8, M1 Road South
City Postal code Country Position/Affiliation
Lilongwe 3 Malawi Study Coordinator
Role Name Email Phone Street address
Scientific Enquiries Kathryn Dovel kdovel@mednet.ucla.edu 265-99-764-5317 Area 36, Plot 8, M1 Road South
City Postal code Country Position/Affiliation
Lilongwe 3 Malawi Adjunct Assistant Professor
REPORTING
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