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: www.pactr.org
Trial no.: PACTR201904546865585 Date of Approval: 03/04/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Practicability of unassisted versus directly assisted blood-based HIV self-testing among high-risk population for HIV infection acquisition in Democratic Republic of the Congo
Official scientific title Practicability of unassisted versus directly assisted blood-based HIV self-testing among high-risk population for HIV infection acquisition in Democratic Republic of the Congo
Brief summary describing the background and objectives of the trial Although HIV self-testing (HIVST) has been recommended by WHO since 2016 as a complementary strategy to HIV testing services to reach the UNAIDS’ goal by 2020, its implementation in sub-Saharan Africa remains a challenge [WHO, 2016; Tonen-Wolyec, 2018mst]. The directly assisted and unassisted HIVST are two delivery approaches varying in terms of the level and type of support provided. Directly assisted HIVST refers to when individuals who are performing a self-test for HIV receive an in-person demonstration from a trained provider or peer before or during HIVST with instructions on how to perform a self-test and how to interpret the self-test result. This assistance is provided in addition to the manufacturer supplied instructions for use and other materials found inside HIVST kits. Whereas unassisted HIVST refers to an individual obtaining a kit for HIV self-testing and performing the HIV test following the instructions in the insert. In the Democratic Republic of the Congo (DRC), HIVST is has been recommended by the national program against HIV and AIDS since 2016. Satisfactory success rates of practicability of directly assisted blood-based HIVST was reported in the general adult population in DRC as well as in female sex workers. This study aims to evaluate the practicability of unassisted versus directly assisted blood-based HIV self-testing in field settings using a randomized, non-blinded, non-inferiority trial among high-risk population for HIV infection acquisition in health facilities in Democratic Republic of the Congo.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) AUTOTEST
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Early detection /Screening
Anticipated trial start date 05/08/2018
Actual trial start date 26/08/2018
Anticipated date of last follow up 09/12/2018
Actual Last follow-up date 30/11/2018
Anticipated target sample size (number of participants) 422
Actual target sample size (number of participants) 530
Recruitment status Completed
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 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group unassisted HIV self testing 72 hours In the unassisted HIVST arm, clients performed the HIV self-test kit in private without 10-min demonstration and supervision. Participants were asked to perform the HIV self-test at home or in a convenient private location, and read the results guided by the instructions for use. Participant received instruction to record within 10 minutes after performing the self-test the practicability report on the standardised sheet. Then, participant was invited to return with test cassette to the facility within 12–72 h for rereading of test results, confirmatory HIV test, exit questionnaire, and post-counselling or care if necessary. Telephone assistance was offered to the participant if needed. The need for assistance from a trusted person was self-declared by the participant, and recorded by study staff. 265
Control Group directly assisted HIV self testing 3 hours In the directly assisted HIVST arm, a brief, 10-min face-to-face demonstration of how to use the self-test familiarized participants with the contents of the self-test kit. After 10-min demonstration, participant performed the HIV self-test kit in a confidential room supervised by study staff (investigator). Once the test was completed and the participant had recorded the practicability report on the standardised sheet. A confirmatory HIV test using national algorithm rapid tests was performed along with an exit questionnaire. Post-test counselling and care were provided to participant if needed. Not that, the investigator-interpreted results and appeals for oral assistance were recorded by study staff on another standardized sheet. The supervisors had received rigorous training, including how to talk to participants asking for any support concerning the HIVST. 265 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Eligibility was include all of the following criteria: (i) willingness to be tested for HIV infection; (ii) age between 18 and 49 years; (iii) possession of a 24-hour online telephone number; (iv) ignorance of own HIV status; (v) have not been tested for HIV in the last three months; (vi) reported having at least one unprotected sex in the last six months; (vii) possession of a permanent residence in the city of Kisangani (viii) ability to speak and read in French or vernacular languages (Lingala and Swahili), (viii) high risk for acquiring HIV infection,and (ix) signing of the written consent. High risk for HIV infection acquisition was defined as sexually active clients with: a history of unprotected intercourse with one or more partners of unknown HIV sero-status within the past 6 months, new sex partners in the past 6 months, symptoms of sexually transmitted infections (STIs) in the same period, commercial sex activity, or being in a known HIV discordant partnership. Following criteria was retained: (i) refuse to be tested for HIV infection; (ii) are underage (age <18 years) or older than 49 years old; (iii) do not have 24-hour online telephone number; (v) declare themselves HIV positive; (vi) were tested for HIV in the last three months; (v) are unable to speak and read in French, Lingala and Swahili, and (vi) refuse to sign the written consent. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 49 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 23/02/2016 Ethic committe of University of Kinshasa
Ethics Committee Address
Street address City Postal code Country
Mont Amba Kinshasa 11850 Democratic Republic of the Congo
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Difference in practicability of self-test kit, comparing the unassisted approach to the directly assisted approach. Practicability was defined as the ability to use the self-test autonomously or with oral assistance until obtaining valid test result (appearance of a control strip on the self-test), and to correctly interpret the HIV self-test result. 72 hours
Secondary Outcome Secondary outcomes included the proportions of participants who requested for assistance, the return rate, the linkage to post-test counselling, and the linkage to care. 72 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University Hospital of Kisangani Plateau Medical Kisangani 2012 Democratic Republic of the Congo
General Hospital of Kabondo Kabondo Kisangani Democratic Republic of the Congo
Health center of Neema Makiso Kisangani Democratic Republic of the Congo
Health center of Saint Joseph Tshopo Kisangani Democratic Republic of the Congo
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Kisangani Plateau Medical Kisangani 2012 Democratic Republic of the Congo
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Kisangani Plateau medical Kisangani 2012 Democratic Republic of the Congo University
Secondary Sponsor NACP Tombalbay Kinshasa Democratic Republic of the Congo providing rapid tests for national algorithm tests for confirmatory.
COLLABORATORS
Name Street address City Postal code Country
Laurent Belec 20 Rue Leblanc, 75015 Paris Paris France
Ralph Sydney Mboumba Bouassa 20 Rue Leblanc, 75015 Paris Paris France
Jeremie Muwonga Tombalbay Kinshasa Democratic Republic of the Congo
Salomon Batina Agasa Plateau medical Kisangani Democratic Republic of the Congo
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Serge Tonen Wolyec wolyec@gmail.com +243815791076 Plateau medical
City Postal code Country Position/Affiliation
Kisangani Democratic Republic of the Congo Assistant Professor at the faculty of Medicine and Pharmacy of Kisangani University
Role Name Email Phone Street address
Public Enquiries Salomon Batina agasasalomon@yahoo.fr +243970007241 Plateau medical
City Postal code Country Position/Affiliation
Kisangani Democratic Republic of the Congo professor at University of Kisangani
Role Name Email Phone Street address
Scientific Enquiries Laurent Belec laurent.belec@aphp.fr +33156093958 20 Rue Leblanc, 75015 Paris
City Postal code Country Position/Affiliation
Paris France professor at Paris Descartes University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We declare that the results of this essay will be shared via an original scientific publication. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 1 year Open
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
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 29/03/2019 because it was a mistake during the first submission Experimental Group, unassisted HIV self testing , , 72 hours , In the unassisted HIVST arm, clients performed the HIV self-test kit in private without 10-min demonstration and supervision. Participants were asked to perform the HIV self-test at home or in a convenient private location, and read the results guided by the instructions for use. Participant received instruction to record within 10 minutes after performing the self-test the practicability report on the standardised sheet. Then, participant was invited to return with test cassette to the facility within 12–72 h for rereading of test results, confirmatory HIV test, exit questionnaire, and post-counselling or care if necessary. Telephone assistance was offered to the participant if needed. The need for assistance from a trusted person was self-declared by the participant, and recorded by study staff., 265,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 29/03/2019 because it was a mistake during the first submission Control Group, directly assisted HIV self testing, , 3 hours, In the directly assisted HIVST arm, a brief, 10-min face-to-face demonstration of how to use the self-test familiarized participants with the contents of the self-test kit. After 10-min demonstration, participant performed the HIV self-test kit in a confidential room supervised by study staff (investigator). Once the test was completed and the participant had recorded the practicability report on the standardised sheet. A confirmatory HIV test using national algorithm rapid tests was performed along with an exit questionnaire. Post-test counselling and care were provided to participant if needed. Not that, the investigator-interpreted results and appeals for oral assistance were recorded by study staff on another standardized sheet. The supervisors had received rigorous training, including how to talk to participants asking for any support concerning the HIVST. , 1, Uncontrolled Control Group, directly assisted HIV self testing, , 3 hours, In the directly assisted HIVST arm, a brief, 10-min face-to-face demonstration of how to use the self-test familiarized participants with the contents of the self-test kit. After 10-min demonstration, participant performed the HIV self-test kit in a confidential room supervised by study staff (investigator). Once the test was completed and the participant had recorded the practicability report on the standardised sheet. A confirmatory HIV test using national algorithm rapid tests was performed along with an exit questionnaire. Post-test counselling and care were provided to participant if needed. Not that, the investigator-interpreted results and appeals for oral assistance were recorded by study staff on another standardized sheet. The supervisors had received rigorous training, including how to talk to participants asking for any support concerning the HIVST. , 265, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 29/03/2019 because it was a mistake during the first submission University of Kisangani, Plateau Medical, Kisangani, 2012, Democratic Republic of the Congo, University,
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 29/03/2019 I did not understand this topic during the first submission. Laurent Belec, 20 Rue Leblanc, 75015 Paris, Paris, , France
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 29/03/2019 I did not understand this topic during the first submission. Ralph Sydney Mboumba Bouassa, 20 Rue Leblanc, 75015 Paris, Paris, , France
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 29/03/2019 I did not understand this topic during the first submission. Jeremie Muwonga, Tombalbay, Kinshasa, , Democratic Republic of the Congo
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 29/03/2019 I did not understand this topic during the first submission. Salomon Batina Agasa, Plateau medical, Kisangani, , Democratic Republic of the Congo
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 29/03/2019 to indicate our willingness to share the research report. Undecided Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 29/03/2019 to indicate our willingness to share the research report. We declare that the results of this essay will be shared via an original scientific publication.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 29/03/2019 to indicate our willingness to share the research report. 1 year
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 29/03/2019 to indicate our willingness to share the research report. Open
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 29/03/2019 to indicate our willingness to share the research report. Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 01/04/2019 pactr update Adult: 19 Year-44 Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 01/04/2019 We had mistakenly introduced the personal email of the Dean of the Faculty of Medicine and Pharmacy of Kisangani University. We have corrected this mistake. TRUE, Ethic committe of University of Kinshasa, Mont Amba, Kinshasa, 11850, Democratic Republic of the Congo, , 23 Feb 2016, +243853846680, agasasalomon@yahoo.fr, 6032_5315_4737.pdf TRUE, Ethic committe of University of Kinshasa, Mont Amba, Kinshasa, 11850, Democratic Republic of the Congo, , 23 Feb 2016, +243851463831, contact@espkinshasa.net, 6032_5315_4737.pdf