Evaluating Demand Creation Strategies for Voluntary Medical Male Circumcision (VMMC) in Kenya
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

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.
    

Detailed description: 
      STUDY AIMS Aim 1: Assess the rate of uptake of VMMC services by men aged 25-39 years exposed
      to Inter-Personal Communication (IPC) vs. Designated (older men only) Service Outlets (DSO)
      vs. IPC and DSO interventions combined vs. no intervention.

      Aim 2: Determine through testing of unlinked de-identified blood from bleeding vessels from
      the surgical wound, the proportion of men whose HIV status is unknown who are HIV infected
      (Sub-study 1).

      Aim 3: Determine the cost of providing VMMC among the three interventions relative to each
      other and to no intervention.

      MAIN STUDY DESIGN: The study proposes to conduct a cluster randomized-controlled trial, with
      Locations forming the unit of randomization. Within the selected Locations, the study shall
      randomly select approximately 16% (209) of the villages which will be sufficient to generate
      the required sample size.

      Sample size Determination:

      Sample size for detecting the impact of the interventions on VMMC uptake - in order to be
      able demonstrate at least a 33.3 % increase in the rate of VMMC among young adult men in
      intervention arms when compared to those in control arm with 80% statistical power, and
      Bonferroni adjusted two-sided α=(0.05/3)=0.017 following the implementation of study
      interventions, the study will need a sample size of 4,932 men reached with the intervention.

      Potential participants to be reached - An effect size equal to 33.3% increase in MC from 30%
      to 40% will require about 1233 participants per study arm (total 4932), while an effect size
      equal to 50% increase in VMMC from 30% to 45% will require 573 participants per study arm
      (total 2292). Adjusting for a refusal rate of 15% and a loss to follow up of 15%, suggests
      contacting 1603 per study arm resulting in a total of 6412 uncircumcised men aged 25-39
      years.

      PHASE 1: HOUSEHOLD ENUMERATION To ascertain the size of eligible population (uncircumcised
      men aged 25-39 years), the study will conduct complete household listing in all selected
      villages and enumerate male members in each household aged 25-39 years. During this exercise,
      study staff shall physically visit all homes in the study villages and assign a unique
      identification number to every household (HIN). Enumeration shall be through home visits ONLY
      and not by any other means. The unique HIN assigned during the enumeration will be entered on
      Excel database and households with men aged 25-39 years will be sorted out and put on a
      separate list. The list will be used to create a database of eligible men in each village.
      Determining the number of households with eligible men will help in knowing the denominator
      and in planning for recruitment.

      PHASE 2: CONDUCTING RAPID FORMATIVE STUDY (Sub-study 1) Justification: This phase is intended
      to provide information for use in delivering the interventions. The study have already
      drafted messages based on existing literature for use in IPC and IPC+DSO intervention
      Locations/villages. However, since almost all the available information on barriers to and
      facilitators of VMMC in literature were collected among men of all ages and were not
      disaggregated by age group, the investigators cannot assume they are automatically relevant
      to older men. As such, it will still be necessary to conduct a rapid formative study to
      explore reasons why older men aged 25-39 years go or do not go for VMMC services. Information
      obtained from this phase will be used to modify if indicated, the messages developed from
      existing literature.

      SUB-STUDY DESIGN: This phase shall comprise of Focus Group Discussions (FGDs) and In-Depth
      Interviews. Twelve FGDs, with 6-10 participants, will be held with six groups of circumcised
      men and six groups of uncircumcised men in each of the following age categories: 25-29 years,
      30-34 years and 35-39 years. A similar number of FGDs will be held with female partners of
      circumcised and female partners of uncircumcised men in same age categories.

      Besides FGDs, the investigators will conduct 48 IDIs to capture confidential information that
      some men and women would otherwise not divulge in an FGD setting.

      PHASE 3: ESTABLISHING BASELINE VMMC PREVALENCE AND PROPORTION OF ELIGIBLE MEN Based on the
      eligible participants' list, research assistants will only go back to households with men
      aged 25 to 39 years. Before administering enrollment consent, RAs will ask participants to
      identify a private location within or outside the house where they can do consenting and
      interviewing. The RA will then administer consent for participating in the study, enrol
      consenting participants and assign Participant Unique ID number.

      After assigning the participant unique ID number, the RA will conduct the baseline interview,
      verify the MC status and inform participants of their intervention arm and deliver the
      intervention if the participant is available (if not, another visit will be made at a later
      date to deliver the intervention). During the interview, study staff will document
      participants' circumcision status from the verbal report. After the interview, participants
      who consented to physical verification will be asked to choose where this can be performed.

      At enrollment, participants will be given 3 months within which to go for circumcision,
      Participants can go whenever they want for VMMC, but the study will only capture their data
      if they go within 3 months. They will also be informed that a reminder of the expiry date for
      circumcision will be sent through text message to all participants one month before the
      expiry of the circumcision window period.

      Details of participants enrolled in the study will be entered into an excel Master Log which
      will contain all participant details; 3 names, ID number, age, location, village, the
      telephone number of the participants or of close friend and date of enrollment.

      PHASE 4: IMPLEMENTING THE INTERVENTIONS The study has four intervention arms: Inter-Personal
      Communications (IPC), Dedicated Service Outlets (DSOs), a combination of IPC and DSO
      (IPC+DSO), and Control. The interventions and how each of them will be implemented are
      described under 'Protocol arms and interventions' section below.

      HIV TESTING OF PARTICIPANTS WITH UNKNOWN HIV STATUS (Sub-study 2) In VMMC program undertaken
      by Impact Research and Development Organization (IRDO) and in other Kenyan programs as well,
      between 10% and 30% of men decline HIV testing. Given that VMMC is offered principally as an
      HIV prevention strategy, it is important to determine the HIV status of those who decline
      testing, and if the prevalence is significantly higher than those who accept testing, there
      will be need to design approaches to improve uptake of testing. This is particularly
      important following results from a recently concluded study that indicated that 44% of
      HIV-infected men resumed sex before the recommended 6 weeks of sexual abstinence.

      Sample size for HIV prevalence among uncircumcised men whose HIV status is unknown (Sub-study
      2):

      Investigators estimated that they will need to test randomly selected unlinked blood samples
      from 163 men per arm whose HIV status is unknown in order to estimate a HIV prevalence that
      falls within 10% points of the true population prevalence with 95% confidence. The study
      staff will collect samples from all of men who refuse testing but consent to Unlinked HIV
      testing.

      With a refusal rate of 23.6% voluntary HIV testing, and a consenting rate of 60%, then the
      rate of getting a man who refuses testing but consents to the testing of unlinked blood
      sample from his bleeding vessels is 14.2%. In other words, of the 4932 participants in the
      main study, investigators expect 1164 (4932*0.236) to refuse HIV testing. With assumed
      unlinked HIV testing acceptance rate of 60%, the study can obtain 700 such men from a sample
      size of 4932 in the main study. For a design effect of 2.5, using a sample size of 700 for
      the sub-study will enable us to estimate the HIV prevalence of 21.6% with a precision of
      4.8%=sqrt[(2.5*1.96^2*.216*.784)/700].

      Methods/Procedure:

      RAs will perform unlinked testing of blood from bleeding vessels or finger prick of those
      whose HIV status is unknown. While the call for proposals recommended testing blood from the
      excised foreskin, investigators are concerned that they may not be able to harvest sufficient
      blood from most foreskins to perform the test. This is because the forceps-guided method
      being used in Kenya crushes the foreskin and compresses the blood vessels that supply the
      distal section. This results in little or no bleeding on the excised foreskin. The study,
      therefore, propose to only collect blood samples from the bleeding vessels or finger prick
      from participants (n=700).

      COSTING VMMC IN THE CONTEXT OF THE INTERVENTIONS (SUB-STUDY 3) Study Design: Data on costing
      will be collected across all the study arms. Whereas economic evaluation of service delivery
      has been conducted in several contexts there is limited information on the cost-effectiveness
      of various approaches used for recruitment to increase service uptake. The study plan to
      assess the cost-effectiveness of demand creation for VMMC services based on the three
      interventions. The results will demonstrate the accrued costs and net savings associated with
      each intervention strategy.

      Methods: The primary outcome of the main study is the incremental change in circumcisions
      performed attributable to the respective demand creation interventions. Costs will be
      estimated for primary outcome with reference to the control group, in which the study will
      continue to provide routine recruitment approaches. This will demonstrate how the costs vary
      depending on the mode of demand creation.

      The study shall adopt a societal perspective because of the ability to integrate diverse
      factors into the model and the role the public sector plays in HIV prevention and management.
      This approach incorporates all costs borne by the implementers in recruiting participants for
      services.

      Sources of costing data:

      The study will collect data from all study sites using a tool adapted from the Male
      Circumcision Decision-Makers' Program Planning Tool (DMPPT) for each of the demand creation
      strategies. The DMPPT was developed by the USAID/Health Policy Initiative in collaboration
      with UNAIDS to enable decision-makers to understand the potential cost and impact of various
      options for scaling up male circumcision services. The DMPPT has previously been used to
      undertake costing of male circumcision services in East and Central Africa. The study shall
      use this instrument as a data collection tool to estimate the cost of demand creation and the
      unit cost of providing VMMC (i.e. cost per adult circumcised) in each of the four study arms.

      PHASE 5: ESTABLISHING ENDLINE MC PREVALENCE/ESTIMATING IMPACT OF INTERVENTIONS At Endline,
      the study will review Participant Master Log to identify those who did not go for VMMC at the
      45 VMMC clinics participating in the study. The study will use the telephone numbers obtained
      during enrollment to contact the participants. Those who say that they got circumcised but
      are not in the Participant Master Log, study staff will make an appointment and visit them at
      home, or another convenient location, to administer consent, conduct Endline interview and
      verify their circumcision status. Those who report not having gone for VMMC will be asked why
      they did not go, and their response recorded.
    

Intervention name(s): Inter-personal Communication (IPC); Dedicated Service Outlets (DSO)
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Male circumcision; Demand creation