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.: PACTR201607001701788 Date of Approval: 29/06/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A trial of interventions to improve linkage to care after HIV self-testing
Official scientific title A cluster randomised trial of interventions to improve linkage to care following community-based distribution of HIV self-test kits in rural Zimbabwean communities
Brief summary describing the background and objectives of the trial There is sub-optimal uptake of HIV testing in many settings, including Zimbabwe. HIV self-testing (HIVST) has potential to increase uptake of testing. Preliminary research shows that it is acceptable and people are able to produce accurate self-test results. Although they have not yet issued normative guidance, WHO recognise the potential for self-testing and they have recommended that countries conduct HIVST demonstration projects. In collaboration with Zimbabwe Ministry of Health and Child Care, we are conducting research on the best models of distributing HIV self-test kits in communities. Because the benefits of testing lie in good linkage to post-test services (HIV care for those testing positive and voluntary medical circumcision, VMMC, for HIV negative males), it is important to identify and evaluate interventions for improving linkage after HIVST. In this study HIV test kits will be distributed at household level by community-based distributors (CBDs) in rural communities, and we will evaluate the effectiveness of interventions for linking self-testers to care. The primary objectives of the study are as follows: 1) To determine whether incentivising CBDs to support self-testers is effective in improving uptake of self-testing and linkage to post-test services 2) To determine whether incentivising HIV positive clients to link to government HIV treatment services through provision of funds to reimburse transport costs for their first clinic attendance is effective in increasing linkage.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) STAR Zimbabwe
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 15/07/2016
Actual trial start date
Anticipated date of last follow up 31/07/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 44
Actual target sample size (number of participants)
Recruitment status Not yet 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Stratified randomisation of clusters,stratified by district, with restriction on proximity to a health facility This is a cluster-randomised trial, randomisation of clusters will be done before the intervention begins. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Incentives for community-based distributors of HIV self-test kits Incentives for each participant who links to post-test outreach services One off CBDs will go from household to household, distributing test kits. At 1-2 weeks and 3-4 weeks after distribution, PSI Zimbabwe outreach teams will go into the community to offer services that have been branded as "well-woman" and "well-man" services in order to avoid stigma. These services include confirmatory HIV testing, blood pressure and diabetes checks, family planning and VMMC. 11
Experimental Group Incentives for HIV positive patients who are referred for HIV care Bus fare reimbursement for HIV positive patients who have been referred to an HIV Clinic for care One off When self-testers are confirmed positive at the PSI outreach site, they are referred for regular care at government clinics. Some clusters will be randomised to busfare reimbursement for each referred participant, to facilitate referral uptake. 11
Experimental Group Both incentives for CBDs and for HIV positive participants Each is given one off as described for each, above One off Both interventions given as above 11
Control Group No incentives for CBDs; no incentives for HIV positive participants who are referred N/A No incectives offered; standard services implemented 11
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Living in the study communities (clusters) 2. Aged at least 16 years old (Ministry of Health age for independent consent to test for HIV) 3. Willing to self-test for HIV None 16 Year(s) 120 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
No 03/03/2016 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Josiah Tongogara/Mazowe Street Harare 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 University College London Ethics Committe
Ethics Committee Address
Street address City Postal code Country
UCL, 1-19 Torrington Place (9th Floor) London United Kingdom
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No London School of Hygiene & Tropical Medicine
Ethics Committee Address
Street address City Postal code Country
Keppel Street London WC1E7HT United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of individuals who have self-tested in each community At end of the study
Primary Outcome Proportion of people who linked to PSI outreach services At the end of the study
Primary Outcome Proportion of men taking up VMMC in each community At the end of the study
Primary Outcome Proportion of HIV positives assessed for ART At the end of the study
Primary Outcome Proportion of HIV positives initiated on ART At the end of the study
Primary Outcome Proportion of women accessing contraception consultations in each community At the end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bulilima District Rural district Zimbabwe
Gutu District Rural district Zimbabwe
Gweru District Rural area Zimbabwe
Masvingo District Rural area Zimbabwe
Mazowe district Rural district Zimbabwe
Mberengwa district Rural area Zimbabwe
Chivi District Rural area Zimbabwe
Buhera District Rural district Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
UNITAID 1214 Vernier Geneva Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor London School of Hygiene & Tropical Medicine Keppel Street, London WC1E 7HT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Professor Elizabeth Corbett London School of Hygiene & Tropical Medicine London United Kingdom
Professor Helen Weiss London School of Hygiene & Tropical Medicine London United Kingdom
Dr Euphemia Sibanda CeSHHAR Zimbabwe Harare Zimbabwe
Dr Melissa Neuman London School of Hygiene & Tropical Medicine London United Kingdom
Professor Andrew Phillips University College London London United Kingdom
Dr Owen Mugurungi AIDS & TB Unit;Ministry of Health & Child Care Harare Zimbabwe
Ms Getrude Ncube AIDS & TB Unit;Ministry of Health & Child Care Harare Zimbabwe
Professor Frances M Cowan CeSHHAR Zimbabwe Harare Zimbabwe
Dr Valentina Cambiano University College London London United Kingdom
Dr Karin Hatzold Population Services International Harare Zimbabwe
Dr Miriam Taegtmeyer Liverpool School of Tropical Medicine Liverpool United Kingdom
Dr Fern Terris-Prestholt London School of Hygiene & Tropical Medicine London United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Frances Cowan f.cowan@ucl.ac.uk 002634333393 CeSHHAR Zimbabwe
City Postal code Country Position/Affiliation
Harare Zimbabwe Principal Investigator
Role Name Email Phone Street address
Public Enquiries Euphemia Sibanda euphemia@ceshhar.co.zw 002634333393 CeSHHAR Zimbabwe
City Postal code Country Position/Affiliation
Harare Zimbabwe Project Director
Role Name Email Phone Street address
Scientific Enquiries Frances Cowan f.cowan@ucl.ac.uk 002634333393 CeSHHAR Zimbabwe, 9 Monmouth Rd, Avondale
City Postal code Country Position/Affiliation
Harare Zimbabwe Principal Investigator
REPORTING
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