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.: PACTR201711002631294 Date of Approval: 19/09/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Intimate Partner Study
Official scientific title The Impact of Involving Intimate Female Partners in Increasing Demand for Voluntary Medical Male Circumcision in Nyanza, Kenya: A Randomized-Controlled Trial.
Brief summary describing the background and objectives of the trial Kenya is leading the way in rapidly scaling up voluntary medical male circumcision (VMMC) for HIV prevention among 14 countries in sub-Saharan Africa targeted by the United States Presidents' Emergency Plan for AIDS Relief (PEPFAR). However, at about 60% coverage of targeted population, this is still below the 80% coverage by 2015 recommended for population level impact on HIV incidence. Several meetings have been held nationally and internationally to discuss strategies to rapidly roll out safe VMMC especially among older men. The older men targeted in this study are likely to be married or in stable relationships. Because women are excluded in VMMC programs, they may not fully understand the importance of the post-operative abstinence period and therefore may not support their partners in observing it. We propose a randomized-controlled trial to compare effectiveness of three mobilization interventions in increasing demand for VMMC services, namely delivering VMMC education to: i) men alone, ii) men in the company of their female partners, iii) female partners and asking them to relay the information to their men and refer them for services. The primary objective of the study will be to assess impact of the three interventions on VMMC service uptake compared with the control arm, where men will be exposed to routine mobilization strategies. Three secondary aims will also be examined
Type of trial RCT
Acronym (If the trial has an acronym then please provide) IPS
Disease(s) or condition(s) being studied Infections and Infestations,voluntary male medical circumcision
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 26/09/2014
Actual trial start date 01/04/2015
Anticipated date of last follow up 25/09/2015
Actual Last follow-up date 12/11/2016
Anticipated target sample size (number of participants) 1800
Actual target sample size (number of participants) 1800
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Arm 1 (Male only intervention) 3 months Men randomized in arm one were educated on VMMC alone and referred for services 300
Experimental Group Arm 2 (Couples intervention) 3 months Men randomized in arm two were educated on VMMC together with their enrolled female partners then referred for the services 600
Experimental Group Arm 3 (Female only intervention) 3 Months Women were educated on VMMC then asked to discuss with their enrolled male partners and refer them for the services 600
Control Group Arm 4 (control group) 3 months No intervention administered to the Male participants enrolled in this arm, status quo is maintained. 300 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Aged 20 and 49 years; Uncircumcised; Has a live-in/regular intimate partner with whom he intends to continue having sex Able & willing to consent to join the study Resident of study sub-locations Not planning to relocate post-enrollment for at least six months Outside 20 and 49 years age bracket Circumcised No live-in/regular sexual partner Unable to or decline to provide consent Non-residents of study Sub-locations Intending to relocate within six months. For Intervention 2, men will be excluded if the female partner declines to participate in the study. 20 Year(s) 49 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 10/06/2014 KEMRI Scientific Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
P.O Box 54840 House Number 8, KEMRI Headquarter, Off Mbagathi Road Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of men who come for VMMC services in the four study arms, within three months of intervention delivery Within three months of intervention delivery
Secondary Outcome Proportion reporting resuming sex before 6 weeks post-surgery, and for those who do, the time (days) they took to resume sex from date of circumcision From time of circumcision to 6 weeks
Secondary Outcome Proportion of participants between the intervention arms who advance from one stage to the next in the transtheoretical model Within three months of intervention delivery
Secondary Outcome Proportion of men and women in the baseline interview who believe that female partners are shareholders in the man¿s decision to be circumcised; also compare participants¿ views in supporting women¿s involvement in VMMC programs Once at baseline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Masogo Sub-County Hospital P.O Box 14, Miwani Kisumu 40106 Kenya
Tuungane Youth Centres (Kibuye, Ahero) Baring Road-Milimani P.O. Box 9171 Kisumu Kisumu 40141 Kenya
Gita Health Centre P.O Box 105 Gita Kisumu 40100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Impact Research and Development Organization Baring Road-Milimani P.O. Box 9171 Kisumu Kisumu 40141 Kenya
KEMRI - FACES Near Tom Mboya Labor College - Mlimani, P. O Box 614 Kisumu 40100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Impact Research and Development Organization Baring Road-Milimani P.O. Box 9171 Kisumu Kisumu 40141 Kenya Charities/Societies/Foundation
Secondary Sponsor KEMRI - FACES Near Tom Mboya Labor College - Mlimani, P. O Box 614 Kisumu 40100 Kenya Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Impact Research and Development Organization Baring Road-Milimani P.O. Box 9171 Kisumu Kisumu 40141 Kenya
KEMRI - FACES Near Tom Mboya Labor College - Mlimani, P. O Box 614 Kisumu 40100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kawango Agot mamagifto@yahoo.com +254 727 688550 Baring Road-Milimani P.O Box 9171
City Postal code Country Position/Affiliation
Kisumu 40141 Kenya Director, Impact Research and Development Organization
Role Name Email Phone Street address
Public Enquiries Kawango Agot mamagifto@yahoo.com +254 57 2020132 Baring Road-Milimani P.O Box 9171
City Postal code Country Position/Affiliation
Kisumu 40141 Kenya Director, Impact Research and Development Organization
Role Name Email Phone Street address
Scientific Enquiries Kawango Agot mamagifto@yahoo.com +254 57 2020132 Baring Road-Milimani P.O Box 9171
City Postal code Country Position/Affiliation
Kisumu 40141 Kenya Director, Impact Research and Development Organization
REPORTING
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Result URL Hyperlinks
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