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

NCT02497989 | Completed

• 1 other identifier: GH000518
• Study Type: interventional
• Target: 2,785
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Keywords

Male circumcision; Demand creation

Outcome Measures

Primary Outcomes (1)

• The rate of uptake of VMMC services among men in 4 study arms

  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.

  Three months post intervention

Secondary Outcomes (1)

• Prevalence of HIV among VMMC clients who decline HIV testing

  Three months post intervention

Other Outcomes (2)

• Cost of VMMC demand creation

  Nine months

• Role of female sexual partners in time to resumption of sex post circumcision

  Nine months

Study Arms (4)

Inter-personal Communication (IPC)

EXPERIMENTAL

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)

Dedicated Service Outlets (DSO)

EXPERIMENTAL

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)

Combined IPC & DSO

EXPERIMENTAL

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); Other: Dedicated Service Outlets (DSO)

Control

NO INTERVENTION

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.

Interventions

Inter-personal Communication (IPC) OTHER

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.

Combined IPC & DSO; Inter-personal Communication (IPC)

Dedicated Service Outlets (DSO) OTHER

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.

Combined IPC & DSO; Dedicated Service Outlets (DSO)

Eligibility Criteria

• Age: 25 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Uncircumcised men
• Aged 25 - 39 years
• 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).
• Intend to continue living in the village for the 9 months after enrollment, which is the estimated duration of data collection.
• Give written consent to participate in the study and the interventions.

You may not qualify if:

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

Sponsors & Collaborators

• Impact Research & Development Organization: lead
• Centers for Disease Control and Prevention: collaborator
• Kenya Ministry of Health: collaborator

Study Sites (1)

Impact Research and Development Organization

Kisumu, Nyanza, 40141, Kenya

Location

Related Publications (33)

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MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Kawango Agot, PhD, MPH

  Impact Research and Development Organization

  PRINCIPAL INVESTIGATOR

• Jonathan Grund, MA, MPH

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Jacob Onyango

  Impact Research and Development Organization

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 20, 2015
• First Posted: July 15, 2015
• Study Start: February 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 22, 2016
• Last Updated: March 12, 2018

Record last verified: 2018-03

Locations

KE (1)