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Evaluating Demand Creation Strategies for Voluntary Medical Male Circumcision (VMMC) in Kenya (TASCO)

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ClinicalTrials.gov Identifier: NCT02497989
Recruitment Status : Completed
First Posted : July 15, 2015
Last Update Posted : March 12, 2018
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Kenya Ministry of Health
Information provided by (Responsible Party):
Kawango Agot, Impact Research & Development Organization

Brief Summary:
The purpose of this study is to evaluate the impact of two interventions - Inter-Personal Communication [IPC] and Dedicated Service Outlets [DSOs] - in recruiting men aged 25-39 years for Voluntary Medical Male Circumcision (VMMC) services.

Condition or disease Intervention/treatment Phase
HIV/AIDS Other: Inter-personal Communication (IPC) Other: Dedicated Service Outlets (DSO) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2785 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Male Circumcision for HIV Prevention in Kenya: Seeking Effective Strategies to Recruit Older Men
Study Start Date : February 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 22, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Inter-personal Communication (IPC)
Interpersonal communication will entail delivery of intervention massages that are custom-made to address individual participants' specific barriers and facilitators of VMMC. RAs will discuss with uncircumcised men why they have not gone for VMMC using the 'VMMC Demand Creation Toolkit'. The aim will be to fully address their barriers and re-enforce their facilitators. RAS will be trained behavioral counselors, circumcised men, female partners, CHWs, or any other cadre of individuals identified during the formative phase.
Other: Inter-personal Communication (IPC)
RAs will meet older men in their households, and : i) approach the person(s), introduce self, develop rapport and request for time to discuss briefly about VMMC; ii) strike a conversation on reasons why they or their peers have not gone to be circumcised as well as reasons that would make them get circumcised, jotting down responses to guide the discussion; iii) using the 'VMMC Demand Creation Toolkit', discuss each reported barrier/facilitator carefully and completely, always ensuring the person(s) is/are engaged in the discussion (the goal is to pass correct and complete information in a relaxed and conversational manner); iv) revisiting each stated barrier/barrier and exploring what they now think about them after the discussion, and address any new or lingering concerns.

Experimental: Dedicated Service Outlets (DSO)
RAs shall visit all households with eligible men to inform them about the availability of, and give information on location of DSO sites in the Location. DSOs are sites: where services are offered exclusively to men aged ≥25 years by male service providers in the same age bracket; providing services in the evenings/weekends/designated days of the week, and through special mobile services for older men. DSO sites we will strive to shorten the waiting time to ≤ three hours. They will be informed that all other VMMC sites continue to serve all men regardless of age (i.e., including older men) while DSO sites will only serve men aged ≥25 years. RAs will respond to questions using 'All You Need to Know About VMMC' booklet, the same way current recruiters do.
Other: Dedicated Service Outlets (DSO)
RAs shall visit every household with eligible men to inform them about the availability of DSO sites in their neighborhoods. After describing the characteristics of DSO sites, the RA will share - both verbally and through a flyer, information on where to find DSO sites in the respective Location. RAs will respond to questions using 'All You Need to Know About VMMC' booklet, the same way current recruiters do. They will also inform potential participants that all other VMMC sites continue to serve all men regardless of age (i.e., including older men) while DSO sites will only serve men aged ≥25 years.

Experimental: Combined IPC & DSO
Both Inter-personal Communication (IPC) and Dedicated Service Outlets (DSO) interventions (as described above) will be implemented concurrently. This will be done to determine the effect of both interventions delivered jointly compared to each delivered singly, and compared to no intervention.
Other: Inter-personal Communication (IPC)
RAs will meet older men in their households, and : i) approach the person(s), introduce self, develop rapport and request for time to discuss briefly about VMMC; ii) strike a conversation on reasons why they or their peers have not gone to be circumcised as well as reasons that would make them get circumcised, jotting down responses to guide the discussion; iii) using the 'VMMC Demand Creation Toolkit', discuss each reported barrier/facilitator carefully and completely, always ensuring the person(s) is/are engaged in the discussion (the goal is to pass correct and complete information in a relaxed and conversational manner); iv) revisiting each stated barrier/barrier and exploring what they now think about them after the discussion, and address any new or lingering concerns.

Other: Dedicated Service Outlets (DSO)
RAs shall visit every household with eligible men to inform them about the availability of DSO sites in their neighborhoods. After describing the characteristics of DSO sites, the RA will share - both verbally and through a flyer, information on where to find DSO sites in the respective Location. RAs will respond to questions using 'All You Need to Know About VMMC' booklet, the same way current recruiters do. They will also inform potential participants that all other VMMC sites continue to serve all men regardless of age (i.e., including older men) while DSO sites will only serve men aged ≥25 years.

No Intervention: Control
In these Locations, participants will only be given the 'All You Need to Know About VMMC' booklet at the time of enrollment, which is the standard of care.



Primary Outcome Measures :
  1. The rate of uptake of VMMC services among men in 4 study arms [ Time Frame: Three months post intervention ]
    We will assess the rate of uptake of VMMC services by men aged 25-39 years exposed to (i) Inter-personal communication (IPC) intervention vs. (ii) Designated (older men only) Service Outlets (DSO) intervention vs. (iii) IPC and DSO interventions combined vs. (iv) No intervention.


Secondary Outcome Measures :
  1. Prevalence of HIV among VMMC clients who decline HIV testing [ Time Frame: Three months post intervention ]
    Determine HIV prevalence among men in the study target group who refuse routine HIV testing but consent to the testing of unlinked blood sample from bleeding vessels or finger prick.


Other Outcome Measures:
  1. Cost of VMMC demand creation [ Time Frame: Nine months ]
    Determine the overall cost of VMMC demand creation, as well as the unit cost of providing VMMC services under each of the proposed 3 demand creation strategies.

  2. Role of female sexual partners in time to resumption of sex post circumcision [ Time Frame: Nine months ]
    The level of involvement of female sexual partners in their partners' decisions and activities before, during and after circumcision and the association between the level of partner involvement in circumcision decision-making and the length of post-surgical sexual abstinence, condom use, and sexual partnerships.



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Ages Eligible for Study:   25 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Uncircumcised men
  2. Aged 25 - 39 years
  3. Residents of the study village (has been living in the physical structure such as a compound or homestead identified during the enumeration and who has been consuming or making some contribution to food and other shared household resources).
  4. Intend to continue living in the village for the 9 months after enrollment, which is the estimated duration of data collection.
  5. Give written consent to participate in the study and the interventions.

Exclusion Criteria:

  1. Circumcised men
  2. Aged <25- or >39 years
  3. Non-resident of target villages
  4. Plans to move away from the village within 9 months after enrollment
  5. Does not give consent to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497989


Locations
Kenya
Impact Research and Development Organization
Kisumu, Nyanza, Kenya, 40141
Sponsors and Collaborators
Impact Research & Development Organization
Centers for Disease Control and Prevention
Kenya Ministry of Health
Investigators
Principal Investigator: Kawango Agot, PhD, MPH Impact Research and Development Organization
Principal Investigator: Jonathan Grund, MA, MPH Centers for Disease Control and Prevention
Study Director: Jacob Onyango Impact Research and Development Organization

Publications:
Marya Plotkin, Hawa Mziray, Jan Küver Judith Prince, et al (2011). Embe Halijamenywa: The unpeeled mango: A Qualitative Assessment of Views and Preferences concerning Voluntary Voluntary Medical Male Circumcision in Iringa Region, Tanzania.
KNBS (2010) 2009 Kenya Population and Housing Census, Volume I A; Population by Administrative Units, Kenya National Bureau of Statistics, Nairobi, Kenya
E.Odoyo-June , J H Rogers, W Jaoko, et al. Sex before wound healing and condom use among newly circumcised HIV-positive and HIV-negative men in Kisumu, Kenya. 19th International AIDS Conference. Abstract no MOPE170
National AIDS and STI Control Programme NASCOP (2008). Adapted by the Male Circumcision Task Force, Ministry of Health, Kenya, from the WHO/UNAIDS/JHPIEGO Manual for Male Circumcision under Local Anaesthesia. Version 2.5C, February 2008.
Bollinger L W, Plosky D, Stover J. (2009). Male circumcision: Decision Maker's Program Planning Tool, calculating the costs and Impacts of a Male Circumcision Program. Washington, DC: Futures Group, Health Policy Initiative , Task Order 1
National AIDS Control Council 2. (NACC), N.A.C.C., The Kenya National HIV/AIDS Strategic Plan 2010-2013 (KNASP III). 2009: Nairobi, Kenya.. (2009). The Kenya National HIV/AIDS Strategic Plan 2010 - 2013 (KNASP III). Ministry of Public Health and Sanitation, Nairobi, Kenya.
Male Circumcision Consortium 1. (MCC), M.C.C. 2011. News. December 2011; issue 33

Responsible Party: Kawango Agot, Director, Impact Research & Development Organization
ClinicalTrials.gov Identifier: NCT02497989     History of Changes
Other Study ID Numbers: GH000518
First Posted: July 15, 2015    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018

Keywords provided by Kawango Agot, Impact Research & Development Organization:
Male circumcision
Demand creation