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.: PACTR202111848628644 Date of Approval: 17/11/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title AN INVESTIGATION OF INTERVENTIONS TO INCREASE UPTAKE OF HIV SELF-TESTING AND LINKAGE TO POST-TEST SERVICES AMONG HIGHER EDUCATION STUDENTS IN ZIMBABWE
Official scientific title AN INVESTIGATION OF INTERVENTIONS TO INCREASE UPTAKE OF HIV SELF-TESTING AND LINKAGE TO POST-TEST SERVICES AMONG HIGHER EDUCATION STUDENTS IN ZIMBABWE
Brief summary describing the background and objectives of the trial Southern African countries are among the worst affected by HIV and have high numbers of new HIV infections particularly among young people. Despite this, young people aged 15-24 years are less likely to know their HIV status than older adults. In Zimbabwe, only half of young people aged 15-24 years living with HIV are aware of their status, compared with over 70% of adults aged older than 24 years. Research on HIV self-testing (HIVST) - where an individual collects their own sample (oral fluid or blood) and conducts the HIV test privately without a provider – shows it is safe, accurate, and highly acceptable, including among young people who desire privacy and control while testing. HIVST may increase HIV testing uptake among young people. Although HIVST distribution is being scaled up throughout Zimbabwe, young people have not been specifically targeted. One setting in which to do so is in higher education institutions, where knowledge of HIV status is poor and sexual risk behaviours (e.g. multiple sexual partners and transactional sex) are common. The prevalence of non-communicable diseases (NCDs) has been rising over the years; it is critical that interventions are developed to promote their prevention and care. Objectives of the trial: 1. Determine the effectiveness of a peer-led, mass media supported model for providing HIV self-test services compared to use of mass media alone to increase knowledge of HIV status and linkage to appropriate prevention and care (Primary objective); 2. Develop and evaluate the use of a mobile health tool to support measurement/documentation of self-test kit distribution and follow-up self-test recipients to estimate uptake of prevention and treatment services following self-testing; 3. Determine the cost and cost-effectiveness of HIV self-testing distribution models; 4. Explore potential for adapting refined self-testing and linkage models for other conditions of public health importance.
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 Implementation science
Anticipated trial start date 01/02/2022
Actual trial start date
Anticipated date of last follow up 30/10/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 9600
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
MRCZ A 2595 Medical Research Council of Zimbabwe
20 042 Liverpool School of Tropical Medicine Research Ethics Committee
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 where factors such as age, gender, center, or previous treatment are used in the stratification 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
Experimental Group Peer led HIV self test kit distribution Four months HIV self-test (HIVST) kits will be distributed at colleges/universities by students who are recruited and trained by the research team (peer distributors). The team will work with authorities at each institution and existing student bodies to select peer distributors. Selection will ensure representation of students who are male/female, who live on/off campus and are at various levels of schooling. Peer distributors will be trained according to the Ministry of Health and Child Care (MOHCC) curriculum for HIVST kit distributors and study procedures. Distributors will distribute kits to students in their respective institutions for a period of one month. According to MOHCC guidelines, only individuals who are at least 16 years old can consent to HIV testing. Distributors will adhere to the age requirements and other eligibility criteria for distributing kits - possession of a personal mobile phone, current enrolment at a participating institution and verbal consent to test for HIV using an HIVST kit. At distribution, distributors will provide information about the study, demonstrate HIVST and highlight the importance of linking to confirmatory testing, antiretroviral therapy (ART) or preventative services (including voluntary medical male circumcision and pre-exposure prophylaxis). They will share details of local health facilities where self-testers can access these services. They will also caution that self-test kits should not be used among HIV positive individuals who are on ART. Distributors will document distribution data using a mobile health tool, an integrated application that works on computer tablets that are linked by internet to a central database. The research team will provide ongoing support during distribution through weekly phone calls and two in-person visits. Three months after distribution of HIVST kits, an online survey will be conducted among students who received kits to determine use of self-test kits and linkage to post-test services. 4800
Control Group Mass media supported HIV self test kit distribution Four months The research team will visit the campus and determine what clinics or pharmacies are within proximity to students. They will approach managers at these sites sensitizing them to the study and requesting their involvement as sites where students can access HIVST kits from (static distribution sites). If the manager shows willingness to distribute self-test kits at their facility, the research team will be informed about which staff can be trained and when; training will be conducted using the MOHCC training curriculum for self-test kit distributors and will include study procedures. Distributors will be given kits to distribute to students in their respective institution for a period of one month. Distributors will adhere to eligibility criteria for self-test kit recipients and provide information about the study, demonstrate HIV self-testing and provide information about post-test services, similarly to peer distributors. They will document distribution data using the mobile health tool. The research team will create and share messaging to promote uptake of HIVST among students at each institution. They will work with authorities at each institution to determine where posters can be mounted and how best to share electronic flyers on WhatsApp, to reach all students. In this study arm, messaging will include availability of self-test kits from the agreed static distribution sites; in the peer-led arm, messaging will include availability of self-test kits from peer distributors. The research team will provide ongoing support during distribution through weekly phone calls and two in-person visits. Three months after distribution of HIVST kits, an online survey will be conducted among students who received kits to determine use of self-test kits and linkage to post-test services. 4800 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Aged 16 years old or over; Possesses personal mobile phone; Currently enrolled at a tertiary education institution where HIV self-test kits are being distributed as part of this study; and Willing to test for HIV using an HIV self-test kit and provide verbal consent Does not possess personal mobile phone 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 16 Year(s) 99 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 10/09/2020 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Corner Mazowe Street and Josiah Tongogara Harare 0000 Zimbabwe
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 29/09/2020 Liverpool School of Tropical Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Pembroke Place Liverpool L3 5QA United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of students taking up self-testing During distribution of HIV self-test kits
Primary Outcome Proportion of self-testers with reactive (positive) self-test results who link to confirmatory testing Three months after receipt of an HIV self-test kit
Secondary Outcome Proportion of self-testers with confirmed HIV positive results who link to HIV treatment (antiretroviral treatment) Three months after receipt of an HIV self-test kit
Secondary Outcome Proportion of self-testers who link to HIV prevention services – pre-exposure prophylaxis, PrEP, and/or voluntary medical male circumcision, VMMC Three months after receipt of an HIV self-test kit
Secondary Outcome Cost and cost effectiveness of peer-led plus mass media-supported model of self-test service provision compared to mass media alone per a) student tested for HIV, b) student started on ART, c) student started on PrEP or VMMC Three months after receipt of an HIV self-test kit
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre for Sexual Health and HIVAIDS Research Zimbabwe 4 Bath Road Belgravia Harare Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
Medical Research Council 58 Victoria Embankment London EC4Y 0DS United Kingdom
Department for International Development 22 Whitehall London SW1A 2EG United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Liverpool School of Tropical Medicine Pembroke Place Liverpool L3 5QA United Kingdom Higher education institution
COLLABORATORS
Name Street address City Postal code Country
Ministry of Health and Child Care Central Avenue between 4 th and 5 th Street Harare Zimbabwe
Ministry of Higher and Tertiary Education Innovation Science and Technology Development Corner Samora Machel Avenue and Simon Muzenda Street Harare Zimbabwe
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Euphemia Sibanda euphemia@ceshhar.co.zw +263242333393 4 Bath Road
City Postal code Country Position/Affiliation
Harare Zimbabwe Liverpool School of Tropical Medicine and CeSHHAR Zimbabwe
Role Name Email Phone Street address
Scientific Enquiries Frances Cowan Frances.Cowan@lstmed.ac.uk +263242333393 4 Bath Road
City Postal code Country Position/Affiliation
Harare Zimbabwe Liverpool School of Tropical Medicine and CeSHHAR Zimbabwe
Role Name Email Phone Street address
Public Enquiries Mary Tumushime mary@ceshhar.co.zw +263242333393 4 Bath Road
City Postal code Country Position/Affiliation
Harare Zimbabwe CeSHHAR Zimbabwe
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Informed Consent Form,Study Protocol Beginning 3 months and ending 5 years following article publication The availability of our data will be advertised on CeSHHAR and LSTM websites (www.ceshhar.org and www.lstmed.ac.uk), with details of how a potential user can apply to use the data. A data summary (dictionary/codebook) will be published on the website to help potential users decide whether the data is suitable for their purposes. External users should have pre-specified questions that they would like to answer using the data. Upon being granted permission they will be required to sign documents which specify that use of the data will be restricted to answering pre-specified questions that have ethical approval. The Principal Investigators, Professor Frances Cowan and Dr Euphemia Sibanda, will make decisions on whether to supply data to a potential user. Decisions will be made within four weeks of the request. Requests will only be denied with good reason. We will determine which online data repository we will use; the link will be accessible via www.ceshhar.org and www.lstmed.ac.uk
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