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.: PACTR201804003064160 Date of Approval: 08/02/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Cluster randomized trial of VMMC demand creation strategies
Official scientific title A cluster randomized controlled trial of innovative demand creation strategies to increase voluntary medical male circumcision uptake in Zimbabwe
Brief summary describing the background and objectives of the trial There is currently little evidence on what works best for voluntary medical male circumcision (VMMC) demand creation within the international VMMC community. The proposed initiative seeks to evaluate the demand creation and service delivery models developed and deployed for the current VMMC "catch-up" phase (targeting adolescent, younger and older males, 15-29 years) to the "maintenance" phase (targeting only younger adolescent males, 10-14 years). The proposed initiative will provide evidence to key stakeholders on approaches that can be replicated and taken to national scale in Zimbabwe and in other 14 VMMC priority countries. A four armed study of community-based VMMC mobilization will be conducted comparing i) standard community mobilization; ii) standard community mobilization with the offer of an HIV self-test kit; iii) a new interpersonal demand creation (IPC) approach and; iv) new IPC demand creation with the offer of a self test kit in order to generate evidence of the approaches' effectiveness. On-going evaluation will be conducted across VMMC delivery sites in 18 Gates-funded districts. Costing studies will be conducted to determine the cost and cost-effectiveness of the various approaches. Additional surveys to assess effectiveness of the approaches will be conducted at selected sites at two time points, at beginning of study implementation and after 6 months to assess the VMMC site utilization, staff capacity utilization by VMMC service delivery model, age and population segment based on data collected routinely. Research findings will be used by Ministry of Health and VMMC implementing partners to prepare for transition from the current VMMC phase (targeting adolescent, younger and older males, 15-29 years) to the sustainability phase (targeting only younger adolescent males, 10-14 years). Findings will also inform and shape on-going VMMC implementation at national and international level.
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 15/02/2018
Actual trial start date
Anticipated date of last follow up 30/09/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 140
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 Randomization was restricted by age and sex of IPC agent, and mobilization experience. 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 Standard community mobilization 6 months VMMC IPC agents randomized to the standard community mobilization arm will receive basic training on VMMC as an additional HIV prevention intervention. Thereafter, they will mobilize men for VMMC within a community setting. Each IPC agent will record the number of men they talk to about VMMC, refer for VMMC, and those that eventually take up VMMC. 35
Experimental Group Standard community mobilization plus offer of HIVST 6 months In addition to standard community mobilization, VMMC IPC agents will offer the men they mobilize an HIV self-test (HIVST) kit. These IPC agents will be trained on how to demonstrate use of the kits and will be able to assist men with this if required. IPC agents will record whether VMMC referees opted to take a self test kit or not. Men referred for VMMC will be asked to bring their referral card. 35
Experimental Group New IPC demand creation approach 6 months IPC agents randomized to this arm will receive basic training as already described. They will additionally be trained to prioritize the three groups of potential VMMC clients (enthusiasts, neophytes and embarrassed rejecters). They will also be trained around how to deliver targeted messages as well as how to use relevant tools. 35
Experimental Group New IPC demand creation approach plus offer of HIVST 6 months In addition to the new IPC demand creation approach, IPC agents will offer the men they mobilize an HIVST kit. These IPC agents will be trained on how to demonstrate use of the kits and will be able to assist men with this if required. IPC agents will record whether VMMC referees opted to take a self test kit or not. All men referred for VMMC will be asked to bring their referral card. 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Willing and able to provide written informed consent for participation. Mobilizes men for VMMC Mobilized for VMMC using one of 4 approaches Unwillingness to provide written informed consent Too physically or psychologically unwell Does not mobilize men for VMMC Was not mobilized for VMMC using one of 4 approaches 13 Year(s) 60 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 29/11/2017 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Josiah Tongogara/Mazowe 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 15/12/2017 LSTM Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Pembroke Place Liverpool L3 5QA 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
Yes 01/12/2017 LSHTM Observational / Interventions Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Keppel Street London WC1E 7HT United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome comparison of the absolute number of men circumcised over period of trial by trial arm 1 month after end of trial
Secondary Outcome ¿ The mean conversion rate by trial arm (conversion rate defined as number of men who are circumcised divided by the number of men reached by IPC agent per month) 1 month after end of trial
Secondary Outcome ¿ The number of men spoken to by IPC agents 1 month after end of trial
Secondary Outcome ¿ The number of men actually reached (and number of times subsequently contacted) 1 month after end of trial
Secondary Outcome ¿ The number of men booked for VMMC 1 month after end of trial
Secondary Outcome ¿ The number of men who present for VMMC (by trial arm) 1 month after end of trial
Secondary Outcome ¿ Proportion of men who were offered HIV self test kits and accepted/declined (and reasons) 1 month after end of trial
Secondary Outcome ¿ Proportion of men who obtain HIV self test kits and go on to self-test 1 month after end of trial
Secondary Outcome ¿ Proportion of men with a reactive HIV self test result who link to post test services 1 month after end of trial
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Buhera District Zimbabwe
Zvimba District Zimbabwe
Mutasa District Zimbabwe
Gokwe North Zimbabwe
Mangwe District Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
BMGF through PSI Zimbabwe Block E, Emerald Office Park, 30 The Chase West, Emerald Hill Harare Zimbabwe
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor London School of Hygiene & Tropical Medicine Keppel St London WC1E 7HT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Elizabeth Corbett Keppel Street London WC1E 7HT United Kingdom
Frances Cowan Pembroke Street Liverpool L3 5QA United Kingdom
Karin Hatzold 30 The Chase Harare Zimbabwe
Ngonidzashe Madidi 30 The Chase Harare Zimbabwe
Webster Mavhu 9 Monmouth Avondale Harare Zimbabwe
Noah Taruberekera 8 Hillside Road Parktown Johannesburg South Africa
Helen Weiss Keppel Street London WC1E 7HT United Kingdom
Euphemia Sibanda 9 Monmouth Avondale Harare Zimbabwe
Melissa Neuman Keppel Street London WC1E 7HT United Kingdom
Katherine Fielding Keppel Street Harare WC1E 7HT United Kingdom
Andrew Phillips Gower Street London WC1E 6BT United Kingdom
Getrude Ncube Livingstone Avenue Harare Zimbabwe
Sinokuthemba Xaba Livingstone Avenue Harare Zimbabwe
Owen Mugurungi Livingstone Avenue Harare Zimbabwe
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Elizabeth Corbett lizcorbett04@gmail.com +44 20 7927 2116 Keppel Street
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Department of Clinical Research
Role Name Email Phone Street address
Public Enquiries Stephen Buzuzi sbuzuzi@gmail.com +263 4 333393 9 Monmouth Road Avondale
City Postal code Country Position/Affiliation
Harare Zimbabwe Study Coordinator
Role Name Email Phone Street address
Scientific Enquiries Webster Mavhu webster@ceshhar.co.zw +263 4 333393 9 Monmouth Road, Avondale
City Postal code Country Position/Affiliation
Harare Zimbabwe co-investigator
REPORTING
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