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.: PACTR201908758321490 Date of Approval: 14/08/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Adaptation of health education program for improving the uptake of HIV self-testing by men in Rwanda
Official scientific title Effectiveness of a locally adapted health education program on uptake of HIV self-testing among men in Kigali, Rwanda
Brief summary describing the background and objectives of the trial Men have generally been left behind on interventions to scale-up uptake of HIV testing services. UNAIDS reports men to lag women in all “three 90s”. Consequently, men are prone to delayed HIV diagnosis and that results in preventable morbidity and mortality. HIV self- testing (HIVST) has been shown as an intervention with potential to increase uptake of HIV testing services among hard to reach populations including men. However, dedicated strategies based on research are required for this hard to reach population. Primary objective of the study is to assess the feasibility of conducting a definitive trial to determine the effectiveness of a locally adapted and optimized health education program (HEP) on up take of HIV self-testing among men in Kigali, Rwanda. The secondary objectives of this study are to determine preliminary effectiveness of the HEP on uptake of HIVST among men in Rwanda, proportion of men that seek care at health facilities post HIV self-testing, repeat tests for men who test HIV negative and HIV status disclosure to sexual partner(s) post HIV self-testing.
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 Education /Training
Anticipated trial start date 01/10/2019
Actual trial start date 10/03/2020
Anticipated date of last follow up 31/01/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status 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 Simple randomization using a randomization table created by a computer software program 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 Routine health education Once 1 hour Routine health education on sexual health and HIV 30 Uncontrolled
Experimental Group Adapted health education Once 1 hour Locally adapted health education program for imrpving uptake of HIV selfting among men 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult men 18 and older, do not know HIV status and visit the selected health facility during the enrollment period, willing to be followed up three months’ post enrollment Women Men younger than 18 years Adult men 18 years and older who self-report to know their HIV status or to not know their HIV status but unwilling to be followed up three months’ post enrollment Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 Year(s) Male
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 29/05/2019 Rwanda National Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ministry of Health Building, KN 3 Rd, Kigali Kigali 00250 Rwanda
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 17/06/2019 University Teaching Hospital of Kigali Ethics Committee
Ethics Committee Address
Street address City Postal code Country
KN 4 Ave, Kigali Kigali 00250 Rwanda
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 08/08/2019 UKZN Biomedical Ethhics Committee
Ethics Committee Address
Street address City Postal code Country
Govan Mbeki Building, Westville Campus, UKZN Durban 4000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Recruitment, uptake 3 months post enrollment
Secondary Outcome HIV diagnosis among participants, linkage to care men who tested HIV positive, repeat test from men who tested HIV negative, HIV status disclosure to sexual partner(s) post HIV self-testing 3 months post enrollment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University Teaching Hospital of Kigali KN 4 Ave, Kigali Kigali Rwanda
FUNDING SOURCES
Name of source Street address City Postal code Country
College of Health Sciences PhD Scholarship 1st Floor, George Campbell Building, Howard College, UKZN Durban 4000 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor College of Health Sciences PhD Scholarship Howard College, UKZN Durban 4000 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Tivani Phosa Mashamba Thompson Second George Campbell Building, King George V Avenue, Durban Durban 4000 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tafadzwa Dzinamarira 219095120@stu.ukzn.ac.za +250786999838 Plot 793-794, KG7 Avenue
City Postal code Country Position/Affiliation
Kigali Rwanda PhD Candidate School of Nursing and Public Health University of KwaZulu Natal
Role Name Email Phone Street address
Scientific Enquiries Tivani Phosa Mashamba Thompson Mashamba-Thompson@ukzn.ac.za +27312602530 Second George Campbell Building, King George V Avenue
City Postal code Country Position/Affiliation
Durban 4000 South Africa Academic Leader Research School of Nursing and Public Health University of KwaZulu Natal
Role Name Email Phone Street address
Scientific Enquiries Claude Mambo Muvunyi clmuvunyi@gmail.com +250252600867 KK 737 Street-Gikondo
City Postal code Country Position/Affiliation
Kigali Rwanda Professor College of Medicine and Health Sciences University of Rwanda
Role Name Email Phone Street address
Public Enquiries Tafadzwa Dzinamarira 219095@stu.ukzn.ac.za +250786999838 Plot 793-794, KG7 Avenue
City Postal code Country Position/Affiliation
Kigali Rwanda PhD Candidate School of Nursing and Public Health University of KwaZulu Natal
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Raw data file (STATA format). Study Protocol June 2020. Available for two years post end of data collection. If needed the raw data generated from this research will be available upon reasonable request in writing to the principal investigator with approval from The University Teaching Hospital of Kigali and Rwanda National Ethics Committees.
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
Trial Information Actual trial start date 10/03/2020 Inserted actual trial start date. 10 Mar 2020
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 10/03/2020 Updated recruitment status Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 08/08/2019 Correction to include minimum age of 18 years Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s) Child: 6 Year-12 Year, Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 08/08/2019 correction Child: 6 Year-12 Year, Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s) Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 10/03/2020 Updated the anticipated intervention duration. Control Group, Routine health education, Once, 30 minutes, Routine health education on sexual health and HIV, 30, Uncontrolled Control Group, Routine health education, Once, 1 hour, Routine health education on sexual health and HIV, 30, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 10/03/2020 Updated the anticipated intervention duration. Experimental Group, Adapted health education , Once, 30 minutes, Locally adapted health education program for imrpving uptake of HIV selfting among men, 30, Experimental Group, Adapted health education , Once, 1 hour, Locally adapted health education program for imrpving uptake of HIV selfting among men, 30,
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 13/08/2019 Added a collaborator. Tivani Phosa Mashamba Thompson, Second George Campbell Building, King George V Avenue, Durban, Durban, 4000, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 13/08/2019 Added Plan to Share IPD. Undecided No
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 14/08/2019 Changed IPD Statement No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 14/08/2019 Added the format in which raw data will be availed. Raw data file (STATA format).
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 14/08/2019 Raw data for this study will be available from June 2020 for a period of two years post end of data collection. June 2020. Available for two years post end of data collection.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 14/08/2019 Added statement on who may request for raw data from the study and condition thereof. If needed the raw data generated from this research will be available upon reasonable request in writing to the principal investigator with approval from The University Teaching Hospital of Kigali and Rwanda National Ethics Committees.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 14/08/2019 Study Protocol will be published in an open access peer reviewed journal. Study Protocol